Artificial lung: progress and prototypes.

Lung disease is the fourth leading cause of death (one in seven deaths) in the USA. Acute respiratory distress syndrome (ARDS) affects approximately 150,000 patients a year in the USA, and an estimated 16 million Americans are afflicted with chronic lung disease, accounting for 100,000 deaths per year. Medical management is the standard of care for initial therapy, but is limited by the progression of disease. Chronic mechanical ventilation is readily available, but is cumbersome, expensive and often requires tracheotomy with loss of upper airway defense mechanisms and normal speech. Lung transplantation is an option for less than 1100 patients per year since demand has steadily outgrown supply. For the last 15 years, the authors' group has studied ARDS in order to develop viable alternative treatments. Both extracorporeal gas exchange techniques, including extracorporeal membrane oxygenation, extracorporeal and arteriovenous CO(2) removal, and intravenous oxygenation, aim to allow for a less injurious ventilatory strategy during lung recovery while maintaining near-normal arterial blood gases, but precludes ambulation. The paracorporeal artificial lung (PAL), however, redefines the treatment of both acute and chronic respiratory failure with the goal of ambulatory total respiratory support. PAL prototypes tested on both normal sheep and the absolute lethal dose smoke/burn-induced ARDS sheep model have demonstrated initial success in achieving total gas exchange. Still, clinical trials cannot begin until bio- and hemodynamic compatibility challenges are reconciled. The PAL initial design goals are for a short-term (weeks) bridge to recovery or transplant, but eventually, for long-term support (months).