Clinical evaluation of the Spiral Pump® after improvements to the original project in patients submitted to cardiac surgeries with cardiopulmonary bypass

• Published in: Revista brasileira de cirurgia cardiovascular Vol. 29; no. 3; pp. 330 - 337
• Main Authors: Dinkhuysen, Jarbas Jakson, Andrade, Aron Jose Pazin de, Leme, Juliana, Silva, Cibele, Medina, Claudia Sanches, Pereira, Cristiane Célia, Biscegli, José Francisco
• Format: Journal Article
• Language: English
• Published: Brazil Sociedade Brasileira de Cirurgia Cardiovascular 01-07-2014
• Subjects: Adult; Aged; Aged, 80 and over; Bombas Centrífugas; Bombas de Fluxo Axial; CARDIAC & CARDIOVASCULAR SYSTEMS; Cardiac Surgical Procedures - instrumentation; Cardiac Surgical Procedures - methods; Cardiology; Cardiopulmonary Bypass - instrumentation; Cardiopulmonary Bypass - methods; Circulação Extracorpórea; Equipment Design - standards; Equipment Safety; Female; Fibrinogen - analysis; Heart surgery; Heart-Assist Devices - standards; Hemólise; Humans; L-Lactate Dehydrogenase - blood; Male; Medical Illustration; Middle Aged; Models, Cardiovascular; Platelet Count; Ponte Cardiopulmonar; Reproducibility of Results; Statistics, Nonparametric; SURGERY; Time Factors; Treatment Outcome; Young Adult; Hemolysis; Axial Flow Pumps; Ponte Cardiopulmonar; Extracorporeal Circulation; Circulação Extracorpórea; Bombas Centrífugas; Cardiopulmonary Bypass; Centrifugal Pumps; Bombas de Fluxo Axial; Hemólise
• ISSN: 0102-7638; 1678-9741; 1678-9741
• DOI: 10.5935/1678-9741.20140095

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.
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).
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.
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.