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Clinical Articles, Lead Article

Mini ventricular support system for patients with chronic heart failure

Haemodynamics, exercise capacity and quality of life in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) 4, 5 and 6 patients1 with chronic heart failure were significantly improved through a miniature ventricular support system (Synergy® CircuLite® Inc.), according to results2 from the ongoing CE Mark trial.

The results were presented recently at the International Society for Heart and Lung Transplantation’s (ISHLT) 32nd Annual Meeting and Scientific Sessions in Prague.

A second presentation described the induction of positive physical changes to the left ventricle with the system, including size reductions toward normalcy. These data came from a study conducted in a preclinical model of heart failure and from a comparative analysis of explanted hearts conducted at the time of heart transplantation.

“Approximately 90% of the patients in the ongoing CE Mark trial were classified as INTERMACS 4, 5 and 6.  The risk of currently marketed cardiac support device implantation could be considered too high for many in this group, yet these patients are very sick and their quality of life is severely impacted,” said Professor Bart Meyns, Chief of Cardiac Surgery at Gasthuisberg University Hospital.

Synergy surgical system

Synergy® surgical system

“The Synergy System is implanted in an off-bypass procedure and results from early clinical experience for this first-of-its-kind technology are encouraging and support the potential for Synergy to treat a larger proportion of heart failure patients who are not responding to standard medical care and are not candidates or eligible for heart transplantation.”

The system includes a micro-blood pump the size of a AA battery that can be implanted superficially in a “pacemaker-like” pocket. It is the first and smallest surgically implanted device designed for partial circulatory support (up to 4.25L/min) in patients with heart failure.

References

1. INTERMACS defines subsets within the New York Heart Association functional class III and IV categories.  Patient profiles include: profile 1, Critical Cardiogenic Shock; profile 2, Progressive Decline on Inotropic Support; profile 3, Stable but Inotrope Dependent; profile 4, Resting Symptoms Home on Oral Therapy; and profiles 5, 6, and 7, Continuum of Class IV Patients with Restricted Activity and with Little Fluid Overload.

2. Meyns B, Rega F, Strueber M, Barbone A, Vitali E, Burkhoff D. A New Treatment Option for INTERMACS Profile 4, 5 and 6 Patients with the Circulite® Synergy® System.  Oral presentation at ISHLT 32nd Annual Meeting and Scientific Sessions

Published on: May 24, 2012

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  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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