A preclinical cadaver fitting study of implantable biventricular assist device-- AnyHeart.

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.

Recent progress of moving-actuator type mechanical circulatory support systems: AnyHeart and T-PLS.

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.

Applications of the pulsatile flow versatile ECLS: in vivo studies.

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 patients heart.

Application of the moving-actuator type pump as a ventricular assist device: in vitro and in vivo studies.

A moving actuator type pump has been developed as a multifunctional Korean artificial heart (AnyHeart). The pump consists of a moving actuator as an energy converter, right and left sacs, polymer (or mechanical) valves, and a rigid polyurethane housing. The actuator containing a brushless DC motor moves back and forth on an epicyclical gear train to produce a pendular motion, which compresses both sacs alternately. Of its versatile functions of ventricular assist device and total artificial heart use, we have evaluated the system performance as a single or biventricular assist device through in vitro and in vivo experiments. Pump performance and anatomical feasibility were tested using various animals of different sizes. In the case of single ventricular assist device (VAD) use, one of the sacs remained empty and a mini-compliance chamber was attached to either an outflow or inflow port of the unused sac. The in vitro and in vivo studies show acceptable performance and pump behavior. Further extensive study is required to proceed to human application.