Mechanical circulatory support devices: is it time to focus on the complications, instead of building another new pump?

COMPLICATIONS—THE CATCH-22. .. complications remain primarily patient related, not device related. 1994 Report—Combined Registry for the Clinical Use of Mechanical Ventricular Assist Pumps and the Total Artificial Heart Millions of patients suffer from heart failure worldwide , with many dying each and every year. For over 60 years, scientists and clinicians from all over the world have been working on mechanical circulatory support (MCS) devices (total artificial hearts and ventricular assist devices using both pulsatile and nonpulsatile flow approaches). The results of this work impact only a small number of patients and are not really helping the millions of patients suffering from heart failure. Despite the significant advances, MCS remains largely the technology of last resort. Those actively involved in the field have witnessed the impressive potential of the technology; however, it remains a difficult sell as an earlier-stage intervention in the so-called less " sick " patients. It is that old " catch-22 " ; the rate of complications is simply too high to expose less sick patients to, and the rate of complications cannot be reduced in the moribund patients the technology is currently being utilized in, or can it be? In 1994, the sixth and final official report of the Combined Registry for the Clinical Use of Mechanical Ventricular Assist Pumps in Conjunction with Heart Transplantation was published (1). In that report, some of the most frequent complications were bleeding, infection, renal failure, respiratory failure, and neurological complications. Interestingly, the incidence of device malfunction (e.g., mechanical/ electrical/technical problems) was relatively low, occurring in just 6.7% of all patients. Since that time, many new devices have been developed, with many entering the clinical arena. However, 13 years and thousands of MCS patients later, the latest data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) (2) has confirmed that the same complications continue to plague the use of MCS technology today. As aptly titled by Dr. Hunt in her recent editorial " New data, old problems " (3), the key issues facing the field remain largely the same. These same problems were identified many years ago; is it now time to implement a different strategy for helping the millions of suffering heart failure patients and those who die each year? HISTORICAL COMPLICATION RATES Figure 1 provides historical data on complications from the three major MCS registries: These data span an extensive time frame from 1985 to the …