A growing population experiencing heart failure (100,000 patients/year), combined with a shortage of donor organs (less than 2200 hearts/year), has led to increased and expanded use of mechanical circulatory support (MCS) devices. MCS devices have successfully improved clinical outcomes, which are comparable with heart transplantation and result in better 1-year survival than optimal medical management therapies. The quality of perfusion provided during MCS therapy may play an important role in patient outcomes. Despite demonstrated physiologic benefits of pulsatile perfusion, continued use or development of pulsatile MCS devices has been widely abandoned in favor of continuous flow pumps owing to the large size and adverse risks events in the former class, which pose issues of thrombogenic surfaces, percutaneous lead infection, and durability. Next-generation MCS device development should ideally implement designs that offer the benefits of rotary pump technology while providing the physiologic benefits of pulsatile end-organ perfusion.
This investigation compared pressure drops and surplus hemodynamic energy (SHE) levels in eight commercially available pediatric aortic cannulae (10 Fr) with different geometries during pulsatile and nonpulsatile perfusion conditions in an in vitro infant model of cardiopulmonary bypass. For each trial, the cannula was placed at the distal end of the arterial line, and the insertion tip was fixed to the inlet of the simulated patient. The pseudo patient was subjected to seven pump flow rates ranging from 400 to 1000 ml/min (at 100 ml/min increments), and the mean arterial pressure was set at a constant 40 mm Hg via Hoffman clamp. Of the eight cannulae, the Surgimedics and THI models had significantly larger pressure drops (48.8 +/- 0.3 mm Hg and 48.3 +/- 1.4 mm Hg, respectively; 600 ml/min pulsatile) compared with the RMI cannula (27.6 +/- 1.2 mm Hg; 600 ml/min pulsatile), which created, on average, half of the pressure drop seen in the poorest performing cannulae. When perfusion mode was switched from nonpulsatile to pulsatile, there was a 7-9 fold increase in delivery of SHE recorded at both the pre- and postcannulae sites, regardless of which cannula was being tested. Despite being classified under the same size (10 Fr), these eight cannulae were found to vary considerably in length, inner diameter, and geometrical design. The results suggest that these differences can have a significant impact on pressure drops, as well as generation and delivery of SHE. Furthermore, it was found that pulsatile perfusion produced more "extra" hemodynamic energy when compared with nonpulsatile perfusion, regardless of cannula model.
The objective of this study was to detect and classify the number and size of gaseous microemboli in a simulated pediatric model of cardiopulmonary bypass. Tests were conducted at five different flow rates (400-1,200 ml/min in 200 ml/min increments), pulsatile versus nonpulsatile perfusion modes, and under normothermic, hypothermic, and deep hypothermic (35 degrees C, 25 degrees C, and 15 degrees C) conditions, yielding 180 total experiments. The circuit was primed with lactated Ringer's solution and filled with heparinized bovine blood. At the beginning of each experiment, 5 ml of air were injected into the venous line via the luer port of the oxygenator. Microemboli were quantified and classified by size for 5 minute segments at three transducer sites: postpump, postoxygenator, and postarterial filter. The purge line of the arterial filter was closed during all experiments. In all but one experiment, 90% of emboli at the postpump site were found to be smaller than 40 microm. At the postarterial filter site, nearly 99% of the emboli were smaller than 40 microm. Additionally, increasing microemboli counts were observed when the flow rate was increased and when the temperature was decreased. Lower temperatures, higher flow rates, and pulsatile perfusion were all associated with higher emboli counts. The majority of gaseous microemboli found in the simulated circuit was significantly below 40 microm; the smallest level detectable by traditional Doppler devices.
Perfusion quality is an important issue in extracorporeal life support (ECLS); without adequate perfusion of the brain and other vital organs, multiorgan dysfunction and other deficits can result. The authors tested three different pediatric oxygenators (Medos Hilite 800 LT, Medtronic Minimax Plus, and Capiox Baby RX) to determine which gives the highest quality of perfusion at flow rates of 400, 600, and 800 mL/min using human blood (36 degrees C, 40% hematocrit) under both nonpulsatile and pulsatile flow conditions. Clinically identical equipment and a pseudo-patient were used to mimic operating conditions during neonatal ECLS. Traditionally, the postoxygenator surplus hemodynamic energy value (SHE(post), extra energy obtained through pulsatile flow) is the one relied upon to give a qualitative determination of the amount of perfusion in the patient; the authors also examined SHE retention through the membrane, as well as the contribution of SHE(post) to the postoxygenator total hemodynamic energy (THE(post)). At each experimental condition, pulsatile flow outperformed nonpulsatile flow for all factors contributing to perfusion quality: the SHE(post) values for pulsatile flow were 4.6-7.6 times greater than for nonpulsatile flow, while the THE(post) remained nearly constant for pulsatile versus nonpulsatile flow. For both pulsatile and nonpulsatile flow, the Capiox Baby RX oxygenator was found to deliver the highest quality of perfusion, while the Minimax Plus oxygenator delivered the least perfusion. It is the authors' recommendation that the Baby RX oxygenator running under pulsatile flow conditions be used for pediatric ECLS, but further studies need to be done in order to establish its effectiveness beyond the FDA-approved time span.
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