Extracorporeal life support (ECLS) systems have been increasingly applied to groups of patients with cardiorespiratory failure, including pediatric and adult patients with respiratory failure. Current pulsatile ECLS systems use a single pulsatile blood pump that generates a high inlet pressure in the membrane oxygenator. To minimize this high inlet pressure, we have developed a new and improved ECLS system, twin pulse life support (T-PLS). To analyze the advantages of T-PLS, we have compared T-PLS with a single pulsatile ECLS system. An acute heart failure model was constructed by using a pulmonary artery banding technique. Fourteen pigs (22-31 kg) were used, with cardiac outputs of 2.0 l/min and a V/Q ratio set at 1. Cannulae of 28 Fr and 18 Fr were used in the right atrium and aorta, respectively. A polypropylene hollow-fiber membrane oxygenator and four polymer valves 30 mm in diameter were used in the T-PLS system. In the single pulsatile ECLS system, Medtronic Hall monostrut valves were used. To evaluate blood cell trauma in both pulsatile ECLS systems, plasma free hemoglobin (fHb) was measured while the systems were in use. The results show that fHb levels in T-PLS are lower than fHb levels in the single pulsatile ECLS system. There is a possibility that T-PLS could be used as an ECLS system for emergency situations.

Introduction T-PLS (Twin-Pulse Life Support) is the first commercial pulsatile ECLS (Extra Corporeal Life Support) device (1). The dual sac structure of T-PLS can effectively reduce high membrane oxygenator inlet pressure and hemolysis. To verify both the use of T-PLS for ECLS and the advantages of T-PLS, we tested various models. Method and Results In the partial CPB (cardio pulmonary bypass) model (swine), T-PLS (N=6), and Biopump (N=2), a single pulsatile pump (N=2), were compared. In the case of single pulsatile flow, during pump systole, pressure increased to 700 - 800 mmHg at the inlet port of the membrane oxygenator. fHb, a hemolysis measurement value, was about 80 mg / dL at 3 hours. On the contrary, because of T-PLS's dual sac system, the pressure of T-PLS had a maximum value of about 250 mmHg and fHb was similar to that of the commercial centrifugal pumps. In the total CPB model (bovine, N=6), the heart was stopped via cardioplegia (Kcl). T-PLS flow was maintained at 3.0 - 4.5 L/min. T-PLS functioned like a natural heart, having a pulse pressure of 26 - 43 mmHg and a pulse rate of 40 - 60 bpm (beats per minute). In the emergency case model (canine, N=6), T-PLS was started 10 minutes after cardiac arrest from electronic shock. In spite of cardiac arrest for a period of 40 minutes, the heart was recovered after defibrillation. In the ARDS (Acute Respiratory Distress Syndrome) model (canine, N=6), minimal ventilator parameters were set: tidal volume 130 ml, respiration rate = bpm, FiO2 = 10%. Three hours after starting T-PLS, PO2 of the carotid artery blood (after 2 hours: 195 ±89.4; after 3 hours: 258 ±99.3 mmHg) was above half the value of the femoral artery but was within normal range. Conclusion It is suggested that a portable pulsatile ECLS like T-PLS may be used as a CPB device and as an alternative CPR (cardiopulmonary resuscitation) device in the case of cardiac arrest. Due to the pulsatile flow, oxygenated blood is delivered to the patient without overloading the ARDS patient's heart.

A Korean artificial heart (AnyHeart) has been implanted in 29 various animals (52-470 kg) to evaluate hemodynamic performance and electromechanical stability. Most were implantable biventricular assist devices in use. A right thoracotomy approach has been a standard technique of implantation. A preclinical fitting test was also performed to observe anatomical feasibility and to compare surgical techniques in 10 human cadavers. The first case of human application was made as a lifesaving procedure on June 12, 2001.

The mechanical circulatory support system using moving-actuator mechanisms were developed by Seoul National University and Korea University. AnyHeart is a fully implanted pulsatile bi-ventricular assist device, and T-PLS is a pulsatile flow versatile extracorporeal life support system. Through lots of in-vitro and in-vivo experiments, the developed mechanical systems are faced to produce on commercial scale. This paper describes the recent progress of two mechanical circulatory support systems, AnyHeart and T-PLS.

A multifunctional, Korean-made artificial heart (AnyHeart™) was developed, and prior to its clinical application, a cadaver-fitting study was performed. The study proposed to determine the optimal cannulation approach, implantation technique and route of the cannula to minimize the organ compression of AnyHeart™. The anatomical feasibility and a variety of surgical techniques were evaluated using ten preserved, human cadavers. Implanting AnyHeart™ with ease is possible using various approaches, including a median sternotomy, and a right or left lateral thoracotomy. The lateral thoracotomy approach is shown to be safe and reproducible, especially in patients who have already undergone an operation that used a median sternotomy. The results of this study will guide improvements in the designs of cannulae and AnyHeart™ for future clinical applications.