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4 color_02021_5/8/02 A 11.5.2002 R R O W I 15:12 Stránka 1 N T E R N A T I O N A L IABP system analysis Comparison of Volume Displacement During Heart Rate Changes Intra-aortic balloon counterpulsation (IABP) is the most frequently employed method of assistance for patients with left ventricular (LV) failure. Over 125,000 intra-aortic balloons (IAB) are placed worldwide annually. Although the IABP is an adjunctive rather than primary therapy, many studies have shown that counterpulsation has a positive impact on patient outcome. The effectiveness of IABP is determined by several factors such as IAB size relative to the aorta (occlusivity), ability to track arrhythmias, speed of inflation and deflation and proper timing of IAB inflation and deflation within the cardiac cycle. While speed is important, the ability to displace volume is the actual event which determines the effectiveness of augmentation and unloading. The purpose of this test is to quantify the impact of heart rate (HR) changes (increases) on volume displacement by the IAB. Methods: Experiments were performed using the TMS (Test Measurement System, Arrow International, Everett, MA.) This system is a heated water bath with the ability to measure IAB/IABP performance parameters. These measurements include inflation/deflation speed and total volume displaced by the IAB. This system is used to provide data for FDA 510(k) regulatory review. Data was collected on a standard PC via a data acquisition card at 250Hz. Data was imported into Excel for storage and graphing. Data collection was commenced and the HR on the simulator was increased from 80 bpm to 120 bpm and from 80 to 130 bpm. No changes were made to any of the IABP console settings. The results were recorded and compared. Test protocol: An Arrow IAB-05840U was used for all tests. The same IAB was compared on 3 different IABP systems, the Arrow ACAT® 1 PLUS, Arrow AutoCAT™, and the Datascope® System 98. All IABP systems were operating in their latest configuration. The test was performed under standard FDA 510(k) measurement conditions. These include bath heat 98.6 degrees (37ºC) and a system pressure at midpoint of the IAB 75 mmHg. Trace 3: AP waveform The IAB was connected to each IABP console as recommended by Arrow International instructions for use, using the standard driveline tubing included in the IAB packaging. Each IABP console was connected to the IAT-00201 Interactive Simulator as specified in each operator’s manual. The HR was set to 80 bpm and timing was set per manufacturer’s instructions. Purge or fill cycles were instituted on all pumps to ensure optimal performance of each IABP system, as per manufacturer’s instructions. Summary of Results: Data from each IABP console was recorded. The following 4 traces are shown on the graphs: Trace 1: Inflate/Deflate commands (Assist Marker) Trace 2: ECG waveform Trace 4: Volume displacement curve The ACAT® 1 PLUS and the AutoCAT™ volume displacement dropped slightly after the initial increase in HR to an average of 40.2cc and 36cc at a HR of 120 and 39.1cc and 36.3cc at a HR of 130, respectively. Volume displacement was within the acceptable range of +/- 10% of actual IAB size. The Datascope® System 98 displaced an average volume of 38.3cc at 80 bpm. When the HR was increased to 120 bpm, the displaced volume dropped to an average of 26cc, a 35% reduction. When the HR was increased from 80 to 130 bpm, the displaced volume decreased to an average of 19cc, a 52% reduction. 4 color_02021_5/8/02 11.5.2002 15:12 Stránka 2 Conclusion: Which would you rather have 15m sec (11%) faster deflation or 14 to 20cc (35-50%) more volume? The Arrow IABP systems (ACAT ® 1 PLUS and AutoCAT™) provided more volume displacement with heart rate increases from 80 to 120 bpm and 80 to 130 bpm. This would improve hemodynamic support under this type of clinical condition. For information regarding distribution in your area, contact: www.arrowintl.com ©2002 Arrow International, Inc. All rights reserved. Datascope® is a registered trademark of Datascope, Inc. ISA1-M 5/02 6M