Sperzel Johannes, Nowak Bernd, Himmrich Ewald, Zhang Geng, König Andreas, Willems Roger, Reister Craig, Sathaye Alok, Fröhlig Gerd
Kerckhoff-Klinik GmbH, Department of Cardiology and Electrophysiology Benekestrasse 2-8, D-61231 Bad Nauheim, Germany.
Europace. 2006 Jan;8(1):65-9. doi: 10.1093/europace/euj008.
This study evaluated the acute clinical performance of a new ventricular automatic capture algorithm developed to work with all lead types and pacing vectors.
During regular pacemaker implant or replacement, AutoThreshold and manual threshold tests were performed in ventricular unipolar (UP) and bipolar (BP, if applicable) pacing using a customized external prototype INSIGNIA pacemaker. The success rate and accuracy of two different modes (commanded and ambulatory) of the automatic capture algorithm were used to evaluate the performance. Loss-of-capture events (two consecutive non-captured beats without backup pacing) were used to assess safety. Data of 53 patients (33 DDD/20 VVI) from four medical centres were analysed. Tested leads included 43 BP and 10 UP from nine manufacturers, and seven had electrodes with low polarization. The rate of successful commanded and ambulatory AutoThreshold tests was 96 and 94%, respectively, with an average absolute threshold difference compared with manual threshold of < 0.1 V at 0.4 ms (commanded 0.07 +/- 0.07 V and ambulatory 0.08 +/- 0.07 V). There was no significant difference in performance between UP/BP pacing, polarization, and lead type. No loss-of-capture event was observed.
When successful, the ventricular automatic capture algorithm accurately determined pacing thresholds in either a UP or BP pacing configuration among all leads tested.
本研究评估了一种新开发的心室自动夺获算法的急性临床性能，该算法适用于所有类型的导线和起搏向量。
在常规起搏器植入或更换过程中，使用定制的外部原型INSIGNIA起搏器在心室单极（UP）和双极（如适用则为BP）起搏中进行自动阈值和手动阈值测试。使用自动夺获算法的两种不同模式（指令模式和动态模式）的成功率和准确性来评估性能。夺获失败事件（连续两个未夺获的搏动且无备用起搏）用于评估安全性。分析了来自四个医疗中心的53例患者（33例DDD/20例VVI）的数据。测试的导线包括来自九个制造商的43根BP和10根UP，其中七根具有低极化电极。指令模式和动态自动阈值测试的成功率分别为96%和94%，与手动阈值相比，在0.4毫秒时平均绝对阈值差异<0.1伏（指令模式为0.07±0.07伏，动态模式为0.08±0.07伏）。UP/BP起搏、极化和导线类型之间的性能无显著差异。未观察到夺获失败事件。
成功时，心室自动夺获算法能在所有测试导线的UP或BP起搏配置中准确测定起搏阈值。
