The challenges of generating evidence to guide mechanical circulatory support-based management of advanced heart failure

Abstract

This editorial refers to ‘Advanced heart failure: feasibility study of long-term continuous axial flow pump support’† by M.P. Siegenthaler et al. , on page 1031 The heart failure epidemic is increasing globally. The epidemiological transition will, because of (i) a reduction of mortality from infectious diseases and (ii) increased life expectancy, go with an increased mortality risk secondary to cardiovascular diseases including heart failure. Within this background scenario, in the USA and Europe alone, with more than 600 million inhabitants and more than 6 million patients with heart failure, the prevalence of advanced heart failure, constituting 1–10% of the heart failure population, is estimated to total between 60 000 and 600 000 patients. Correspondingly, the evolution of treatment options for advanced heart failure patients over the last decades has been impressive. It includes medical treatment (angiotensin-converting enzyme inhibitors, beta-blockade), defibrillator therapy, heart transplantation, and most recently mechanical circulatory support devices (MCSDs). The comparison of outcomes between different therapies for advanced heart failure has been challenging. For example, heart transplantation has never been tested in a randomized clinical trial because of the obvious survival advantage in the 1970s when compared with medical therapy1 which has been questioned during the last decade.2 Therefore, the clinical decision making algorithm is subject to continuing debate3 and consensus processes, as exemplified by the recent guideline development initiative of the International Society for Heart and Lung Transplantation. In 2001, in the first randomized clinical trial testing the survival benefit of MCSDs in a patient population ineligible for heart transplantation secondary to noncardiac reasons including age and comorbidities, the HeartMate I pulsatile MCSD has been shown to improve survival as well as quality of life.4 Within the evolving family … *Corresponding author. Tel: +1 212 305 0200; fax: +1 212 305 7439. E-mail address : md785{at}columbia.edu