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

TUCSON, Ariz., Nov. 5, 2013 — SynCardia Systems, Inc.  — 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:

Francisco Arabia, MD, Surgical Director of Mechanical Circulatory Support. (PRNewsFoto/SynCardia Systems, Inc.)

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 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 the SynCardia temporary Total Artificial Heart 

SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure). There have been more than 1,200 implants of the Total Artificial Heart, accounting for more than 335 patient years of life on the device.

Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end­-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at 89 SynCardia Certified Centers worldwide with 36 others in the process of certification.

The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

Forbes Ranks SynCardia #69 Among “America’s Most Promising Companies”  In its February 2013 issue, Forbes selected SynCardia as one of “America’s Most Promising Companies” for the second consecutive year. On the list of 100 privately held, high-growth companies with bright futures, SynCardia was selected #69, moving up eight spots from its #77 ranking last year.

See the full list of SynCardia Awards & Recognition.

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SOURCE  SynCardia Systems, Inc.

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