论文部分内容阅读
目的:观察起搏器新型心房自动阈值管理功能ACapTMconfirm的开启情况,通过比较该功能打开后的心房手动及自动测试阈值,评价该功能的准确性、安全性和临床等效性.方法:选取33例置入Zephyr5826型双腔起搏器且资料完整的患者,至观察期植入时间平均20.5个月.记录打开ACapTMconfirm功能的患者数,并收集ACapTMconfirm功能打开后的自动及手动阈值.通过比较自动、手动测量心房起搏阈值,评估心房自动阈值管理功能ACapTMconfirm的临床等效性.结果:33例患者中有14例打开了ACapTMconfirm功能,1 9例未打开.未打开ACapTMconfirm的原因包括基础心率过快(1例,5.3％)及心房刺激除极波感知不足(18例,94.7％).随访过程中总共获得22组自动、手动心房阈值,其中自动阈值平均0.375～1.375 V,平均(0.528±0.270) V;手动阈值平均0.500～1.250 V,平均(0.580±0.223)V;自动、手动阈值之间差异有统计学意义(P＜0.05);打开ACapTMconfirm后1、2、4个月测得的自动、手动阈值均比较差异均无统计学意义(P＞0.05).随访的33例患者中,ACapTMconfirm的总打开率为42.4％.结论:心房自动阈值管理功能ACapTMconfirm通过准确判断心房起搏阈值,调整心房输出,可起到减少起搏器耗电,延长起搏器使用时间的作用,具有临床使用的安全性和有效性.“,”Objective:By observing the atrial capture management in the new atrial threshold monitoring algorithm,ACapTMconfirm,we evaluate its safety,reliability and applicability in clinical practice.Method:A total of 33 patients implanted with ACapTMconfirm were enrolled from December 2008 to September 2012.Data were collected at implant,opening of ACapTMconfirm,visits scheduled 1 month,2 month and 4 month thereafter,and upon notification of adverse events.Data were collected in order to calculate the open rate of ACapTMconfirm in different circumstances and compare atrial thresholds measured automatically and manually.Result:ACapTMconfirm function was turned on in 14 patients,while in 19 not.Causes of the unsuccessful attempts to perform automatic atrial threshold includetachycardia(1,5.3％)、and atrial safety margin not met(18,94.7oo).A total of 22 pairs of atrial thresholds measured automatically and manually were gained.The auto threshold was 0.528±0.270 V,and the manual threshold was 0.580±0.223 V.There is a strict correlation between the automatic measurements and those conducted manually by the physician with P＜0.05.No significant differences were observed during the 1 month,2 month and 4 month follow-up.Conclusion:ACapTMconfirm is safe,reliable and applicable over time.ACapTMconfirm tested atrial threshold was demonstrated to be clinically equivalent to the manual atrial threshold test.The addition of ACapTMconfirm will benefit the patients by reducing energy cost and enhancing pacemaker safety.