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


CONCLUSIONS
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.
Instituto Dante Pazzanese de Cardiologia (IDPC), Faculdade de Medicina, Universidade de São Paulo (FMUSP), São Paulo, SP, Brazil.
Jarbas Jakson
JJ
Dinkhuysen
Instituto Dante Pazzanese de Cardiologia (IDPC), São Paulo, SP, Brazil.
Aron Jose Pazin de
AJ
Andrade
Instituto Dante Pazzanese de Cardiologia (IDPC), São Paulo, SP, Brazil.
Juliana
J
Leme
Instituto Dante Pazzanese de Cardiologia (IDPC), São Paulo, SP, Brazil.
Cibele
C
Silva
Instituto Dante Pazzanese de Cardiologia (IDPC), São Paulo, SP, Brazil.
Claudia Sanches
CS
Medina
Instituto Dante Pazzanese de Cardiologia (IDPC), São Paulo, SP, Brazil.
Cristiane Célia
CC
Pereira
Instituto Dante Pazzanese de Cardiologia (IDPC), São Paulo, SP, Brazil.
José Francisco
JF
Biscegli
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006348:Cardiac Surgical Procedures / Q000295:instrumentation* / Q000379:methods; D002315:Cardiopulmonary Bypass / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design / Q000592:standards; D004869:Equipment Safety; D005260:Female; D005340:Fibrinogen / Q000032:analysis; D006353:Heart-Assist Devices / Q000592:standards*; D006801:Humans; D007770:L-Lactate Dehydrogenase / Q000097:blood; D008297:Male; D008488:Medical Illustration; D008875:Middle Aged; D008955:Models, Cardiovascular; D010976:Platelet Count; D015203:Reproducibility of Results; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D005340:Fibrinogen; D007770:L-Lactate Dehydrogenase