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The purpose of this experiment was to study the effects of the St. Jude Lifestream centrifugal pump on hemodynamic and hematologic parameters and the incidence of postmortem findings in a subchronic ex vivo left ventricular assist animal model. Five calves were implanted with the pump as a left ventricular assist device (left atrial to thoracic aorta bypass) and studied for 96 h of continuous pumping under identical conditions. Heparin (100 IU/kg) was administered only in the initial saline pump prime. Throughout the protocol, mean arterial and central venous pressures averaged 102.1 +/- 4.6 and 3.4 +/- 2.2 mm Hg, respectively. Pump flow was 47.8 +/- 8.4 ml/kg/min at a mean pump speed of 1,676.3 +/- 106.1 rpm. No clinical abnormalities or mechanical malfunctions attributable to the pump were detected during the 96 h of continuous pumping for each calf. Mean plasma-free hemoglobin after 96 h was 3.9 +/- 3.7 mumol/L (p = 0.337 compared to baseline). At post mortem, renal infarctions were detected in 1 calf. No other pump-associated lesions were detected in any of the other calves. We have concluded that the St. Jude Lifestream centrifugal pump functions reliably during 96 h of continuous left heart bypass in a calf model.

The purpose of this study was to determine whether the major centrifugal pumps currently in use in the United States (Medtronic, BioMedicus BioPump and Carmeda-coated BioPump, Sarns 3M centrifugal pump, and St. Jude Medical Lifestream) could function as left mechanical assist devices in the subchronic (72 h) unheparinized calf model. Calves were instrumented for left atrial to aorta ex vivo assist, and the pump flow was set at 3.5 +/- 0.4 L/min. Two calves (Sarns 3M and St. Jude) survived 72 h of pumping without clinical complications. The other 2 calves died at 62 and 66 h (Medtronic BioPump and Carmeda-coated BioPump, respectively); both had pelvic limb paralysis. The seal of the Sarns 3M pump head ruptured after approximately 36 h of pumping and required replacement. On postmortem examination, pump-associated thromboembolic lesions were detected in 3 of the 4 calves in one or more of the following organs: kidneys, pancreas, abomasum, duodenum, ileum, spleen, and lumbar spinal cord. The calf with the Sarns 3M pump had no discernable lesions. Because of the clinical abnormalities and postmortem lesions in the unheparinized calf model, it was suggested that anticoagulation is necessary for conducting centrifugal mechanical assist studies in calves using presently available technology.

The increased use of centrifugal mechanical assist (CMA) for treatment of refractory postcardiotomy cardiogenic shock highlights the need for experimental testing to improve clinical results. This report describes the preoperative conditioning, anesthetic and surgical technique, and postoperative management of a reliable calf model refined in this laboratory for in vivo subchronic (96 h) testing of CMA. Holstein bull calves (2 to 3 months old; mean body weight, 78 kg; n = 35) were instrumented for left ventricular CMA; 4 of these calves were sham-operated controls. Anesthetic recovery and postoperative restraint were accomplished in a specially designed crate to which each calf was preconditioned extensively. Younger calves were more readily conditioned and more tolerant of postoperative restraint than older calves. One calf died of ventricular fibrillation intraoperatively. One calf that had been heparinized developed uncontrollable hemothorax and died 12 h postoperatively. One calf prematurely dislodged his aortic cannula 15 h postoperatively and exsanguinated. Six calves developed pelvic limb paresis or paralysis because of lumbar spinal cord thromboembolism by 36 h postoperatively, and 3 of these calves were sacrificed by 42 h postoperatively. Fifteen calves required sedation in the first 12 h after the operation. Tachycardia associated with bottle feeding occurred in 15 calves. Second-degree atrioventricular block was noted frequently during deep relaxation. Postmortem examination demonstrated the absence of surgical wound and distant infection, security of cannulae in all but the calf that prematurely dislodged the aortic cannula, absence of thrombus formation at cannulation sites, and presence of thromboembolism in 51% of the calves. The incidence of thromboembolic lesions was not influenced by the need for chemical restraint, by the occurrence of feeding-associated tachycardia, or by the presence of atrioventricular block. There were no thromboembolic lesions in any of the sham-operated controls.

The purpose of this experiment was to study the effects of the St. Jude Lifestream centrifugal pump on hemodynamic and hematologic parameters and the incidence of postmortem findings in a subchronic ex vivo left ventricular assist animal model. Five calves were implanted with the pump as a left ventricular assist device (left atrial to thoracic aorta bypass) and studied for 96 h of continuous pumping under identical conditions. Heparin (100 IU/kg) was administered only in the initial saline pump prime. Throughout the protocol, mean arterial and central venous pressures averaged 102.1 ± 4.6 and 3.4 ± 2.2 mm Hg, respectively. Pump flow was 47.8 ± 8.4 ml/kg/min at a mean pump speed of 1,676.3 ± 106.1 rpm. No clinical abnormalities or mechanical malfunctions attributable to the pump were detected during the 96 h of continuous pumping for each calf. Mean plasma-free hemoglobin after 96 h was 3.9 ± 3.7 u, mol/L (p = 0.337 compared to baseline). At post mortem, renal infarctions were detected in 1 calf. No other pump-associated lesions were detected in any of the other calves. We have concluded that the St. Jude Lifestream centrifugal pump functions reliably during 96 h of continuous left heart bypass in a calf model., (© 1996 International Society for Artificial Organs.)

The purpose of this study was to determine whether the major centrifugal pumps currently in use in the United States (Medtronic, BioMedicus BioPump and Carmeda-coated BioPump, Sams 3M centrifugal pump, and St. Jude Medical Lifestream) could function as left mechanical assist devices in the subchronic (72 h) unheparinized calf model. Calves were instrumented for left atrial to aorta ex vivo assist, and the pump flow was set at 3.5 ± 0.4 L/min. Two calves (Sarns 3M and St. Jude) survived 72 h of pumping without clinical complications. The other 2 calves died at 62 and 66 h (Medtronic Bio-Pump and Carmeda-coated BioPump, respectively); both had pelvic limb paralysis. The seal of the Sarns 3M pump head ruptured after approximately 36 h of pumping and required replacement. On postmortem examination, pump-associated thromboembolic lesions were detected in 3 of the 4 calves in one or more of the following organs: kidney, pancreas, abomasum, duodenum, ileum, spleen, and lumbar spinal cord. The calf with the Sarns 3M pump had no discernable lesions. Because of the clinical abnormalities and postmortem lesions in the unheparinized calf model, it was suggested that anticoagulation is necessary for conducting centrifugal mechanical assist studies in calves using presently available technology., (© 1996 International Society for Artificial Organs.)

Between October 1986 and May 1994, 65 patients undergoing cardiac surgery required centrifugal mechanical assist devices to separate from cardiopulmonary bypass. This experience was arbitrarily divided into early (n = 33) and recent (n = 32) groups for the purpose of comparing trends in morbidity and mortality. The incidence of mechanical assist application decreased from 2.19% in the early group to 0.96% in the recent group (p < 0.0001). Ability to wean patients from centrifugal assist increased from 33% in the early group to 53% in the more recent group, and hospital survival increased from 15 to 28%. The median chest tube drainage during the first 24 h decreased from 3,245 ml to 1,535 ml, and the incidence of renal failure decreased from 39.4% and 18.8% in the more recent group. Clinically relevant improvement in patient outcome following application of centrifugal mechanical assist for postcardiotomy ventricular failure is being observed.

We have used the Sarns centrifugal pump for uni- or biventricular assist in 58 patients with postcardiotomy cardiogenic shock. This device utilizes a spinning impeller pump that is magnetically coupled to a motor imparting rotary motion to incoming perfusate. Nine patients (16%) experienced 22 device failures, which consisted of a nonvisible disruption of the seal within the pumphead. This allowed fluid to accumulate between the pumphead and the motor necessitating change of the pumphead. The time to seal disruption was 10-149 h (median 48). Of the 22 seal disruptions, 18 occurred in 73 left ventricular pumps (25%), and 4 occurred in 38 right ventricular pumps (11%) p = 0.015. Left ventricular pumps failed at 10-144 h (median 48), and right ventricular pumps failed at 48-149 h (median 83) p = 0.02. The Sarns centrifugal pump is dependable for its intended use of cardiopulmonary perfusion. However, when used for postcardiotomy assist, seal disruption should be expected. It occurs sooner and is more common during left ventricular assist. We recommend inspection of the magnet chamber for evidence of seal disruption every 12 h with left ventricular assist and every 24 h with right ventricular assist.

Since October 1986, we have had experience with 96 Sarns centrifugal pumps in 72 patients (pts). Heparinless left atrial to femoral artery or aorta bypass was used in 14 pts undergoing surgery on the thoracic aorta with 13 survivors (93%). No paraplegia or device-related complications were observed. In 57 patients, the Sarns centrifugal pump was used as a univentricular (27 pts) or biventricular (30 pts) cardiac assist device for postcardiotomy cardiogenic shock. In these patients, cardiac assist duration ranged from 2 to 434 h with a hospital survival rate of 29% in those requiring left ventricular assist and 13% in those requiring biventricular assist. Although complications were ubiquitous in this mortally ill patient population, in 5,235 pump-hours, no pump thrombosis was observed. Hospital survivors followed for 4 months to 6 years have enjoyed an improved functional class. We conclude that the Sarns centrifugal pump is an effective cardiac assist device when used to salvage patients otherwise unweanable from cardiopulmonary bypass. Partial left ventricular bypass using a centrifugal pump has become our procedure of choice for unloading the left ventricle and for maintenance of distal aortic perfusion pressure when performing surgery on the thoracic aorta. This clinical experience with the Sarns centrifugal pump appears to be similar to that reported with other centrifugal assist devices.