2007 William W. L. Glenn Lecture—Fulfilling the Promise of Long-Term Mechanical Circulatory Support
Despite considerable progress in the pharmacological and electrophysiological management of heart failure, morbidity and mortality due to inadequate cardiac output represent a large and growing public health challenge. More than 3 decades of progress in the development of mechanical circulatory support devices has generated a multitude of both implantable and extracorporeal devices capable of sustaining normal cardiac output, yet their clinical use has been accompanied by an unacceptably high incidence of serious adverse events. These include bleeding, thrombo-embolism, device infection, and mechanical failure of the devices themselves. Despite these problems, the RE-MATCH trial documented the survival and quality-of-life benefit of permanent implantation of an earlier-generation left ventricular assist device (LVAD) in non-transplantable end-stage heart failure patients refractory to optimal medical management. The associated morbidity and high frequency of device failure after 1 year of support have limited the application of “destination therapy” LVAD implantation, despite approval from the US Food and Drug Administration and Centers for Medicare and Medicaid Services.
A new generation of smaller and more efficient implantable devices has now been introduced clinically, with dramatic reduction in the incidence of late device failure and infection and a manageable thromboembolic profile. Although a high early mortality rate persists when these devices are used in medically refractory end-stage heart failure patients, the hypothesis that these devices could benefit medically stabilized but disabled patients with advanced heart failure now deserves evaluation.