Mechanical circulatory support for end-stage heart failure has become routine and is now increasingly used as definitive treatment. Several small devices qualify for this purpose, but only a few have gained US Food and Drug Administration (FDA) approval as yet. Several studies, including the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) study, the Investigation of Non-transplant-Eligible Patients Who Are Inotrope Dependent (INTrEPID) and the HeartMate (HM) II trial have confirmed a significantly improved quality of life and functional capacity after device placement. However, cerebrovascular events, infection and device malfunction still pose a considerable risk to patients and hinder widespread use.
Heart failure, ventricular assist device, mechanical circulatory support
Disclosure: The authors have no conflicts of interest to declare.
Received: 5 October 2010 Accepted: 20 October 2010 Citation: European Cardiology, 2010;6(4):22├óÔé¼ÔÇ£5
Correspondence: Christof Schmid, Department of Cardiothoracic Surgery, University Medical Center, Franz-Josef-Strauss-Allee 11, 93053 Regensburg, Germany. E: firstname.lastname@example.org
Support: The publication of this article was funded by Berlin Heart GmbH. The views and opinions expressed are those of the authors and not necessarily those of Berlin Heart GmbH.
End-stage heart failure is a leading cause of death of modern society. In the US almost five million people suffer from heart failure, with an annual incidence of 500,000 new cases. About 10% of the population beyond 70 years of age are affected (www.nhlbi.nih.gov). Estimations for Europe amount to 10 million and heart failure has overtaken cancer as the leading cause of death (www.destatis.de). Medical therapy is standardised in the treatment guidelines of the respective national and international societies, and is highly effective in the early stages of the disease. For late stages, including New York Heart Association (NYHA) class IV and Stage D (American Heart Association, AHA), heart transplantation is the treatment of choice as it provides excellent long-term survival and a good quality of life.1 However, not all patients can undergo heart transplantation. The supply of donor organs can never meet the demand such that only four to eight patients per million inhabitants in Europe and the US can have a heart transplantation.2 In other continents and countries the situation is much worse, and heart transplantation is restricted to very few patients or even not performed at all. Furthermore, many traditional Muslims refuse organ donation as body desecration and also refuse to receive life-saving transplants.
The realisation of these facts led to the progressive use of mechanical ventricular assist devices, especially during the last decade. The main intention still remains to provide a bridge to transplantation, as the overall results for transplantation, i.e. survival and quality of life, are superior to any kind of long-tem mechanical support.3 Accordingly, every third to fourth heart transplant procedure is currently performed on a patient with prior implanted ventricular assist device. Despite focusing on transplantation, a lot of experience with longer-term mechanical support has been gained during the past two decades.4,5 Due to the scarcity of donor organs patients had to be supported for periods from many months to more than a year. During that time, many problems and complications become apparent and lead the patient as well as the cardiovascular team to realise what destination therapy means.6 Nevertheless, as many of the therapeutic challenges could be successfully met, finally, the way was carefully paved for chronic mechanical support with ventricular assist devices.7