Mahender Macha

Controller for an Axial Flow Blood Pump

A rotary blood pump inherently provides only one noninvasive observable parameter (motor current) and allows for only one controllable parameter (pump speed). To maintain the systemic circulation properly, the pump speed must be controlled to sustain appropriate outlet Hows and perfusion pressure while preventing pulmonary damage caused by extremes in preload. Steady-state data were collected at repeated intervals during chronic trials of the Nimbus AxiPump (Nimbus, Inc., Rancho Cordova, California, U.S.A.) in sheep (n = 7) and calves (n = 12). For each data set, the pump speed was increased at increments of 500 rpm until left ventricular and left atrial emptying was observed by left atrial pressure diminishing to zero. The effect of decreasing preload was evaluated perioperatively by inferior vena cava occlusion at a constant pump speed. Fourier analysis established a relationship between changes in the pump preload and the power spectra of the pump current waveform. Based on these results, a control method was devised to avoid ventricular collapse and maintain the preload within a physiologic range. The objective of this controller is the minimization of the second and third harmonic of the periodic current waveform. This method is intended to provide a noninvasive regulation of the pump by eliminating the need for extraneous transducers.

ECMO support for adult patients with acute respiratory failure.

The authors analyzed factors that may influence the outcome of adult patients with respiratory failure who were treated with ECMO. Between December 1990 and July 1995, the authors used ECMO to support 33 patients (age range, 17-56 years) with respiratory failure from adult respiratory distress syndrome (ARDS; n = 9), primary graft failure after lung transplantation (n = 16), late graft failure after lung transplantation (n = 5), and miscellaneous reasons (n = 3). Twenty (61%) patients were successfully weaned from ECMO, and 13 (39%) survived to hospital discharge. Venoarterial ECMO was used in 46% of survivors, compared with 60% of nonsurvivors (p = 0.43). The time on mechanical support before ECMO and the duration on ECMO for survivors and nonsurvivors was 2.9 +/- 1.8 days vs 5.0 +/- 1.3 days (p = 0.35), and 6.5 +/- 1.8 days vs 5.7 +/- 1.1 days (p = 0.68), respectively. Compared with the nonsurvivors, survivors had higher PF ratios (PaO2/FIO2; 104 +/- 33 vs 81 +/- 8, p = 0.43) before ECMO was initiated, although the differences were not significant. Among the patients who received ECMO for primary graft failure, 75% were weaned from ECMO, and 56% survived to discharge. ECMO is beneficial for adult patients with respiratory failure, especially those with primary graft failure after lung transplantation.

An intraventricular axial flow blood pump integrated with a bearing purge system

The future development of implantable axial flow blood pumps must address two major issues: mechanically induced hemolysis and shaft seal reliability. The recent revisions to our miniature intraventricular axial flow left ventricular assist device (LVAD) were aimed particularly at addressing these concerns. To improve hemocompatibility, a new impeller has been designed according to the following criteria: 1) gradual pressure rise along the blade chord; 2) minimized local fluid acceleration to prevent cavitation; 3) minimum surface roughness; and 4) radius edges. Subsequent in vitro hemolysis tests conducted with bovine and ovine blood have demonstrated very low hemolysis (normalized index of hemolysis = 0.0051 +/- 0.0047 g/100 L) with this new impeller design. To address the need for a reliable seal, we have developed a purged seal system consisting of a miniature lip seal and ceramic pressure groove journal bearing that also acts as a purge pump. Several spiral grooves formed on the bearing surface provide viscous pumping of the purge fluid, generating more than 3,000 mmHg at 10,000 rpm. This purge flow flushes the lip seal and prevents blood backflow into the bearing. We have found this purge pump to offer several advantages because it is simple, compact, durable, does not require separate actuation, and offers a wide range of flow, depending upon the groove design. In vivo animal tests demonstrated the potential of the purged seal system.

Acute in vivo studies of the Pittsburgh intravenous membrane oxygenator.

The efficacy of an innovative intravenous membrane oxygenator (IMO) was tested acutely (6-8 hrs) in seven calves. The IMO prototypes consisted of a central polyurethane balloon within a bundle of hollow fibers with a membrane surface area of 0.14 m2. The IMO devices were inserted through the external jugular vein into the inferior vena cava of anesthetized calves (68.9 +/- 2.3 kg). Rhythmic balloon pulsation (60-120 bpm) was controlled with an intra-aortic balloon pump console. Oxygen sweep gas was delivered through the device at 3.0 L/min. Gas concentrations were monitored continuously by mass spectroscopy. The principal results were as follows: 1) oxygen and carbon dioxide exchange ranged from 125 to 150 ml/min/m2 and 150 to 200 ml/min/m2, respectively; 2) there was at least a 30-50% augmentation of gas exchange with balloon pulsation; 3) maximum exchange occurred with 60-90 bpm balloon pulsations; and 4) hemodynamic parameters remained unchanged. There were no device related complications, and the feasibility of insertion of the device by a cervical cut-down was established. These acute in vivo experiments show that the Pittsburgh IMO device can exchange oxygen and carbon dioxide gases in vivo at levels consistent with this current prototype design, and that intravenous balloon pulsation significantly enhances gas exchange without causing any end-organ damage.

The vasoregulatory role of endothelium derived nitric oxide during pulsatile cardiopulmonary bypass.

The role of pulsatile flow as a physiologic stimulus for endothelium mediated vasoregulation is poorly understood. Furthermore, non pulsatile flow, which is associated with increased vascular resistance and end-organ failure, has been demonstrated to lead to a decrease in nitric oxide (NO) production in vitro. Anesthetized pigs (23.4 +/- 0.3 kg) were placed on cardiopulmonary bypass using either non pulsatile or pulsatile perfusion for 60 min. In both groups, animals were maintained with a constant mean aortic flow (1.0-1.3 L/min). Serum samples obtained during bypass were assayed for the stable end-products of NO (nitrate [NO3-] and nitrite [NO2-]) by a method based on the Greiss reaction. Systemic vascular resistance was higher after 60 min in the non pulsatile (3712.5 +/- 481.2 dyne sec cm(-5)) vs the pulsatile group (2672.6 +/- 427.0 dyne sec cm(-5)), but not statistically significant (p > .05). However, NO production was decreased in the non pulsatile flow group (27 +/- 6%) vs the pulsatile flow group (14 +/- 5%) at a statistically significant level (p < .005). The results suggest that non pulsatile flow is associated with diminished endothelial shear stress and a reduction in endothelial nitric oxide production. This may contribute to the detrimental physiologic effects observed in prolonged non pulsatile flow states.

In vivo evaluation of an extracorporeal pediatric centrifugal blood pump

This paper summarizes the authors in vivo experience in evaluating a miniature centrifugal blood pump designed for pediatric/neonatal ventricular support. Left ventricular bypass was accomplished in two adult sheep and five juvenile lambs (5.5-80.0 kg) via either central (left ventricle to carotid artery) or peripheral (jugular vein to carotid artery) cannulation. Animals were weaned from mechanical ventilation and continuously monitored. Hemodynamic parameters remained within a normal range over the duration of the bypass. Two of five lambs were electively killed at 8, and 76 hours; the remaining three lambs died from respiratory complications at 33, 44, and 156 hours. There were no mechanical complications, and blood seal integrity was confirmed beyond 6 days. The pump speed was maintained at 3,000-4,500 rpm with pump flow rates between 0.4-1.5 L/min. Average plasma free hemoglobin was below 20 mg/dl in the five lamb experiments. Renal, hepatic, and hematologic indices also remained within physiologic ranges. Histopathologic analyses of major organs revealed renal cortical infarctions in two of five lambs. Examination of the pump surfaces after explant indicated small areas of thrombus in the housing adjacent to the outflow ports in two experiments. These encouraging results support further testing and refinement of this miniature centrifugal pump.

Low Hemolytic Intraventricular Axial Flow Blood Pump Integrated with Totally Implantable Bearing Purge System

Future development of implantable axial flow blood pumps must address two major issues: mechanically induced hemolysis and shaft seal reliability. Recent revisions of the design of our miniature intraventricular axial flow left ventricular assist device (LVAD) were aimed particularly toward addressing these concerns. To improve hemocompatibility, a new impeller (13.5-mm diameter) has been designed according to the following criteria: (1) gradual pressure rise along the blade chord, (2) minimized local fluid acceleration to prevent cavitation, (3) minimum surface roughness, and (4) radiused edges. Subsequent in-vitro hemolysis tests conducted with bovine and ovine blood have demonstrated very low hemolysis (normalized index of hemolysis, 0.005 ± 0.002 g/1001) with this new impeller design. These studies were conducted for 4h at 37°C, with an impeller speed maintained between 10000 and 11 000 rpm, providing a flow rate of 4–51/min against a 90–100 mmHg afterload. To address the need for a reliable seal system, we have recently developed an implantable purge system consisting of a miniature lip seal and a ceramic pressure-groove journal bearing (7 × 10mm). Several spiral grooves formed on the bearing surface provide viscous pumping of the purge fluid, generating over 3000 mmHg at 10000 rpm. This purge flow flushes the lip seal and prevents blood back-flow into the bearing. We have found this purge pump to offer several advantages, since it is simple, compact, durable, and does not require separate actuation. These recent developments with our device provide additional promise towards realizing a totally implantable purged axial flow LVAD.