Abstract：
Leadless pacemakers (PMs) were recently introduced to overcome lead-related complications. They showed high safety and efficacy profiles. Prospective studies assessing long-term safety on cardiac structures are still missing.
The purpose of this study was to compare the mechanical impact of Micra with conventional PM on heart function.
We conducted a non-inferiority trial in patients with an indication for single chamber ventricular pacing. Patients were 1:1 randomized to undergo implantation of either Micra or conventional monochamber ventricular pacemaker (PM). Patients underwent echocardiography at baseline, 6 and 12 months after implantation. Analysis included left ventricular ejection fraction (LVEF), global longitudinal strain (GLS) and valve function. N-terminal-pro hormone B-type natriuretic peptide (NT-pro-BNP) levels were measured at baseline and 12 months.
Fifty-one patients (27 in Micra group and 24 in conventional group) were included. Baseline characteristics were similar for both groups. At 12 months, (1) the left ventricular function as assessed by LVEF and GLS worsened similarly in both groups (∆LVEF -10 ± 7.3% and ∆GLS +5.7 ± 6.4 in Micra group vs. -13.4 ± 9.9% and +5.2 ± 3.2 in conventional group) (p = 0.218 and 0.778, respectively), (2) the severity of tricuspid valve regurgitation was significantly lower with Micra than conventional pacing (p = 0.009) and (3) median NT-pro-BNP was lower in Micra group (970 pg/dL in Micra group versus 1394 pg/dL in conventional group, p = 0.041).
Micra is non inferior to conventional PMs concerning the evolution of left ventricular function at 12-month follow-up. Our data suggest that Micra has a comparable mechanical impact on the ventricular systolic function but resulted in less valvular dysfunction.
The purpose of this study was to compare the mechanical impact of Micra with conventional PM on heart function.
We conducted a non-inferiority trial in patients with an indication for single chamber ventricular pacing. Patients were 1:1 randomized to undergo implantation of either Micra or conventional monochamber ventricular pacemaker (PM). Patients underwent echocardiography at baseline, 6 and 12 months after implantation. Analysis included left ventricular ejection fraction (LVEF), global longitudinal strain (GLS) and valve function. N-terminal-pro hormone B-type natriuretic peptide (NT-pro-BNP) levels were measured at baseline and 12 months.
Fifty-one patients (27 in Micra group and 24 in conventional group) were included. Baseline characteristics were similar for both groups. At 12 months, (1) the left ventricular function as assessed by LVEF and GLS worsened similarly in both groups (∆LVEF -10 ± 7.3% and ∆GLS +5.7 ± 6.4 in Micra group vs. -13.4 ± 9.9% and +5.2 ± 3.2 in conventional group) (p = 0.218 and 0.778, respectively), (2) the severity of tricuspid valve regurgitation was significantly lower with Micra than conventional pacing (p = 0.009) and (3) median NT-pro-BNP was lower in Micra group (970 pg/dL in Micra group versus 1394 pg/dL in conventional group, p = 0.041).
Micra is non inferior to conventional PMs concerning the evolution of left ventricular function at 12-month follow-up. Our data suggest that Micra has a comparable mechanical impact on the ventricular systolic function but resulted in less valvular dysfunction.
摘要：
背景：最近引入了无导线起搏器（PM）以克服与导线相关的并发症。他们表现出很高的安全性和有效性。评估心脏结构长期安全性的前瞻性研究仍然缺失。
目的：本研究的目的是比较Micra与常规PM对心脏功能的机械影响。
方法：我们在有单腔心室起搏指征的患者中进行了一项非劣效性试验。患者以1：1的比例随机接受Micra或常规单腔心室起搏器（PM）的植入。患者在基线时接受超声心动图检查，植入后6个月和12个月。分析包括左心室射血分数（LVEF），全球纵向应变（GLS）和阀门功能。在基线和12个月时测量N末端激素水平B型利钠肽（NT-pro-BNP）水平。
结果：纳入51例患者（Micra组27例，常规组24例）。两组的基线特征相似。12个月时,（1）通过LVEF和GLS评估的左心室功能在两组中均相似地恶化（Micra组的LVEF-10±7.3％和ΔGLS5.7±6.4与常规组的-13.4±9.9％和5.2±3.2）（分别为p=0.218和0.778），（2）Micra组三尖瓣返流的严重程度明显低于常规起搏（p=0.009），（3）Micra组的NT-pro-BNP中位数较低（Micra组970pg/dL与常规组1394pg/dL相比，p=0.041)。
结论：在12个月的随访中，Micra在左心室功能的演变方面不劣于常规PM。我们的数据表明，Micra对心室收缩功能具有相当的机械影响，但导致瓣膜功能障碍减少。
目的：本研究的目的是比较Micra与常规PM对心脏功能的机械影响。
方法：我们在有单腔心室起搏指征的患者中进行了一项非劣效性试验。患者以1：1的比例随机接受Micra或常规单腔心室起搏器（PM）的植入。患者在基线时接受超声心动图检查，植入后6个月和12个月。分析包括左心室射血分数（LVEF），全球纵向应变（GLS）和阀门功能。在基线和12个月时测量N末端激素水平B型利钠肽（NT-pro-BNP）水平。
结果：纳入51例患者（Micra组27例，常规组24例）。两组的基线特征相似。12个月时,（1）通过LVEF和GLS评估的左心室功能在两组中均相似地恶化（Micra组的LVEF-10±7.3％和ΔGLS5.7±6.4与常规组的-13.4±9.9％和5.2±3.2）（分别为p=0.218和0.778），（2）Micra组三尖瓣返流的严重程度明显低于常规起搏（p=0.009），（3）Micra组的NT-pro-BNP中位数较低（Micra组970pg/dL与常规组1394pg/dL相比，p=0.041)。
结论：在12个月的随访中，Micra在左心室功能的演变方面不劣于常规PM。我们的数据表明，Micra对心室收缩功能具有相当的机械影响，但导致瓣膜功能障碍减少。
