Clinical Evaluation of the Spiral Pump® After Improvings to the Original Project in Patients Submitted to Cardiac Surgeries With Cardio Pulmonary by Pass

Abstract

Objective The objective of this paper is to present the results from Spiral Pump clinical trial after design modifications performed at its previous project. This pump applies axial end centrifugal hydraulic effects for blood pumping during cardiopulmonary bypass for patients under cardiac surgery. Methods This study was performed in 52 patients (51% males), between 20 to 80 (67±14.4) years old weighing 53 to 102 (71.7±12.6) kg, mostly under myocardial revascularization surgery (34.6%) and valvular surgery (32.8%). Besides the routine evaluation of the data observed in these cases, we monitored pump rotational speed, blood flow, cardiopulmonary bypass duration, urine free hemoglobin for blood cell trauma analysis (+ to 4+), lactate desidrogenase (UI/L), fibrinogen level (mg/dL) and platelet count (nº/mm3). Results Besides maintaining appropriate blood pressure and metabolic parameters it was also observed that the Free Hemoglobin levels remained normal, with a slight increase after 90 minutes of cardiopulmonary bypass. The Lactate Dehydrogenase showed an increase, with medians varying between 550-770 IU/L, whereas the decrease in Fibrinogen showed medians of 130-100 mg/dl. The number of platelets showed a slight decrease with the medians ranging from 240,000 to 200,000/mm3. No difficulty was observed during perfusion terminations, nor were there any immediate deaths, and all patients except one, were discharged in good condition. CONCLUSION The Spiral Pump, as blood propeller during cardiopulmonary bypass, demonstrated to be reliable and safe, comprising in a good option as original and national product for this kind of application.

Safety Control Architecture for Ventricular Assist Devices

“…Once approved in animals, the last stage of in vivo tests is to carry out the evaluation in human beings. In this context, there is a subproject focused solely on the clinical evaluation study of VAD, which involves the Instituto Dante Pazzanese de Cardiologia [31]. The initial step was to submit a Clinical Assessment Protocol to the National Research Ethics Council and the National Health Surveillance Agency, receiving authorization from both bodies to implant devices in 10 patients.…”