MULTICENTER CLINICAL-EVALUATION OF A NEW SSIR PACEMAKER
MULTICENTER CLINICAL-EVALUATION OF A NEW SSIR PACEMAKER
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DOI：
10.1111/j.1540-8159.1992.tb02971.x
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发表时间：
1992-11-01
影响因子：
1.8
通讯作者：
BIAGINI, A
中科院分区：
文献类型：
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作者：
BONGIORNI, MG;SOLDATI, E;BIAGINI, A
Sorin Swing 100是一种新型SSIR起搏器，具有重力传感器，在7个不同的中心进行了多中心临床评价，共招募了89例患者，其中男性56例，女性33例，平均年龄73.1岁，起搏器拆除（73例）或起搏器更换（16例）。73例患者的起搏模式为VVIR，16例患者为AAIR。植入后3个月，通过进行24小时霍尔特监测、运动负荷试验和机械外部干扰（MEI）评估试验，评价起搏频率的行为。在霍尔特监测期间，始终观察到起搏频率的生理行为。在52例完全起搏的患者中，平均日间、夜间和最大心率分别为74.9 +/- 5.7 ppm、58.1 +/- 5.8 ppm和113.4 +/- 12.7 ppm;平均5.6次/霍尔特监测仪显示起搏频率超过100 ppm。除两名患者外，所有患者在夜间或长时间休息期间均达到睡眠率（55 ppm）。在运动负荷试验中，起搏频率的增加与工作负荷的增加直接相关;在49名完全起搏的患者中达到的平均最大心率分别为：17名完成阶段1的患者为102.8 +/-9ppm，28名完成阶段2的患者为116.2 +/-13.6ppm，完成布鲁斯方案第3阶段的10名患者中为133 +/- 6.7 ppm。MEI测试从未将起搏频率增加到超过噪声频率（超过基本频率10 ppm）。仅7例患者的结果表明需要改变起搏器的标称设置。我们的经验清楚地表明Swing 100是一种有效、可靠和易于使用的SSIR起搏器。睡眠频率的可用性允许起搏频率的更生理模式，并且可以导致显著的能量节省。
A multicenter clinical evaluation of Sorin Swing 100, a new SSIR pacemaker with a gravimetric sensor, was performed by seven different centers enrolling a total of 89 patients, 56 men and 33 women, mean age 73.1 years, for pacemaker implantion (73 patients) or pacemaker replacement (1 6 patients). Pacing mode was VVIR in 73 patients and AAIR in 16. The behavior of pacing rate was evaluated 3 months after the implant by performing a 24-hour Holter monitor, an exercise stress test, and tests for the assessment of mechanical external interference (MEI). A physiological behavior of the paced rate was always observed during Holter monitoring. In 52 completely paced patients mean diurnal, nocturnal, and maximal heart rate were, respectively, 74.9 +/- 5.7 ppm, 58.1 +/- 5.8 ppm, and 113.4 +/- 12.7 ppm; a paced rate exceeding 100 ppm was reached on the average 5.6 times/Holter monitor. In all but two patients the sleep rate (55 ppm) was reached during the night or long resting time. During exercise stress test a direct correlation between the increase in pacing rate and the increase in workload was observed; the mean maximal heart rate reached in 49 completely paced patients was, respectively, 102.8 +/- 9 ppm in 17 patients who accomplished stage 1, 116.2 +/- 13.6 ppm in 28 patients who accomplished stage 2, and 133 +/- 6.7 ppm in 10 patients who accomplished stage 3 of the Bruce protocol. MEI testing never increased the pacing rate over the noise rate (10 ppm over the basic rate). In only seven patients the results obtained suggested to change the nominal set up of the pacemaker. Our experience clearly indicates that Swing 1 00 is an effective, reliable, and easy to use SSIR pacemaker. The availability of the sleep rate allows a more physiological pattern of pacing rate and can lead to significant energy saving.