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Press Release:

Bridge to Transplant Patients Should Not Suffer from End-stage Biventricular Failure

Renowned Surgeon Francisco Arabia Discusses His Experience with Implantation of Over 100 SynCardia Total Artificial Hearts as it Relates to INTERMACS Statistics

 

Francisco Arabia, MD, Surgical Director of Mechanical Circulatory Support

TUCSON, Ariz. – Nov. 5, 2013 –  Veteran heart surgeon Dr. Francisco Arabia tells colleagues there is no reason for bridge to transplant patients to suffer from end-stage biventricular failure if they are bridged with the SynCardia temporary Total Artificial Heart because it is the only device that eliminates the source and symptoms of this severe form of heart disease. 

›› Watch the Presentation

INTERMACS classifies heart failure patients into seven levels of severity with Profile 1 as the sickest. “Crash and Burn” is used to describe these patients with the need for medical intervention defined by INTERMACS as “definitive intervention needed within hours.”

“We looked at all the devices that we put in patients: LVADs, BiVADs and the SynCardia Total Artificial Heart, and related them to the INTERMACS profiles,” Arabia says in a five-minute video presentation recorded earlier this year.

“What we have learned from the INTERMACS papers is that an LVAD is primarily for INTERMACS 2 and 3,” says Arabia. “With LVADs, we experienced about an 80-percent survival rate.”

He goes on to say that for INTERMACS 1 patients, “which by definition you can think of those patients as having biventricular failure…we put in SynCardia Total Artificial Hearts and BiVADs and what we found was (many) more patients made it to transplant with a SynCardia Heart than made it with a BiVAD.”

It is also important to note that “patients that were INTERMACS 1, 2 and 3 who got a SynCardia Heart had the same survival (rate) as a patient who got an LVAD who was less sick,” says Arabia. “What we are finding more and more is there (are) groups of patients that the SynCardia Heart is the solution.”

“Don’t be mistaken, if they are INTERMACS 1, that we can wait here and see what happens, try to get them to INTERMACS 2 or 3 and then put in another device,” cautions Arabia. “In most cases anything short of (the SynCardia Total Artificial Heart) is just compromising the patient.

“Once you make the determination that they are INTERMACS 1—they are in biventricular failure—and if they are on ECMO, you only have 24-48 hours to make a decision to go to the next step. Basically, the patient who is a bridge to transplant should have an incidence of biventricular failure of zero percent.”

Similar to a heart transplant, the SynCardia Heart replaces the two ventricles and four heart valves. If a patient needs a bridge to heart transplant, the SynCardia Total Artificial Heart is the only device that eliminates the source and symptoms of biventricular heart failure.

 

INTERMACS 1 Patients & Biventricular Failure

Francisco Arabia, MD
Surgical Director of Mechanical Circulatory Support

Dr. Francisco Arabia explains why implanting the SynCardia Total Artificial Heart as a bridge to donor heart transplant is the most viable avenue for INTERMACS 1 patients (patients at risk of imminent death) who are suffering end-stage biventricular (both sides) heart failure. The Total Artificial Heart is the only device that eliminates the source and symptoms of this severe form of heart disease.

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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.

About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the temporary Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

 

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