Evaluation of an Anti-Thrombotic Continuous Lactate and Blood Pressure Monitoring Catheter in an In Vivo Piglet Model undergoing Open-Heart Surgery with Cardiopulmonary Bypass

Abstract

Blood lactate and blood pressure measurements are important predictors of life-threatening complications after infant open-heart surgeries requiring cardiopulmonary bypass (CPB). We have developed an intravascular nitric oxide (NO)-releasing 5-Fr catheter that contains a lactate sensor for continuous in-blood lactate monitoring and a dedicated lumen for third-party pressure sensor attachment. This device has antimicrobial and antithrombotic properties and can be implanted intravascularly. The importance of this design is its ability to inhibit thrombosis, due to the slow release of NO through the surface of the catheter and around the electrochemical lactate sensors, to allow continuous data acquisition for more than 48 h. An in vivo study was performed using six piglets undergoing open-heart surgery with CPB and cardioplegic arrest, in order to mimic intra-operative conditions for infants undergoing cardiac surgery with CPB. In each study of 3 h, two 5-Fr NO-releasing lactate and blood-pressure monitoring catheters were implanted in the femoral vessels (arteries and veins) and the CPB circuitry to monitor changing lactate levels and blood pressures during and immediately after aortic cross-clamp removal and separation from CBP. Electrical signals continuously acquired through the sensors were processed and displayed on the device’s display and via Bluetooth to a computer in real-time with the use of a two-point in vivo calibration against blood gas results. The study results show that lactate levels measured from those sensors implanted in the CPB circuit during CPB were comparable to those acquired by arterial blood gas measurements, whereas lactate levels measured from sensors implanted in the femoral artery were closely correlated with those acquired intermittently by blood gas prior to CPB initiation, but not during CPB. Blood pressure sensors attached to one lumen of the device displayed accurate blood pressure readings compared to those measured using an FDA approved pressure sensor already on the market. We recommend that the sensor be implanted in the CPB’s circuit to continuously monitor lactate during CPB, and implanted in the femoral arteries or jugular veins to monitor lactate before and after CPB. Blood pressures dramatically drop during CPB due to lower blood flow into the lower body, and we suspect that the femoral arteries are likely collapsing or constricting on the implanted catheter and disrupting the sensor-to-blood contact. This study shows that the device is able to accurately and continuously monitor lactate levels during CPB and potentially prevent post-surgery complications in infants.