A minimally invasive axial blood flow pump : an experimental and clinical study

Abstract: The first aim of this thesis was to evaluate a new minimally invasive axial blood flow pump for treatment of patients needing circulatory support after open heart surgery. This system, the Hemopump temporary cardiac assist device, is a very small catheter mounted intracorporeal pump, which is introduced transvalvularly into the left ventricle. The pump can be inserted either through the femoral artery or directly through a graft sutured to the ascending aorta. In an experimental model, the flow capacity of three different designs of the system was investigated. Flow capacity varied between 2.0 and 4.5 liters per minute, depending on the working conditions for the different pump models. Twenty,four patients were treated for post,cardiotomy heart failure. Fourteen patients (58 %) were weaned from the device and later discharged from the hospital. In a subgroup of these patients (54%) where early intervention was instituted, the survival rate was 85%. The pump proved to be an effective tool for unloading a failing left ventricle with preservation of multi-organ perfusion. A clinical protocol was established for postoperative management. The Hemopump was easy to adapt to the clinical setting, and device~ related complications were few.The second aim was to develop a new less invasive procedure for CABG, avoiding the need for cardio~pulmonary bypass during these procedures. First an animal trial was performed as a feasibility study. In combination with the administration of a short~acting ~~blocker, esmolol, this method enabled precise coronary bypass surgery. When results became consistent a small pilot study was done on five patients showing that this was a reproducible technique. Finally a prospective randomized trial comparing this technique with conventional bypass surgery was carried out. The Hemopump supported bypass surgery did not prolong the procedure, did not require a longer time on circulatory support and bleeding was less. Postoperative enzyme levels indicated that ischemic insult to the myocardium was less than with conventional surgery.In summary, this minimally invasive axial blood flow pump proved to be a powerful left ventricular assist system enabling a less invasive approach during conditions where circulatory support is needed.