Rashtian Mayer Y, Ip James E, Exner Derek V, Reddy Vivek Y, Doshi Rahul N, Defaye Pascal, Canby Robert C, Bongiorni Maria Grazia, Shoda Morio, Hindricks Gerhard, Nevo Jordan R, Ligon David, Bulusu Anu, Knops Reinoud E
Huntington Memorial Hospital, Pasadena, California.
Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York.
Heart Rhythm. 2025 Jun;22(6):1533-1540. doi: 10.1016/j.hrthm.2024.11.032. Epub 2024 Nov 22.
A new dual-chamber leadless pacemaker (DR-LP) system, composed of 2 implantable devices in the right ventricle and right atrium, uses a less common temperature-based rate-response sensor. There is a need to understand the effectiveness of the rate response during exercise in both the ventricular (VR-LP) and atrial (AR-LP) devices.
We sought to determine whether temperature-based rate-responsive pacing is proportional to metabolic workload during an exercise test in a leadless pacemaker system.
After 6 weeks of implantation, we administered a treadmill exercise protocol to eligible participants concurrently enrolled in the LEADLESS II-Phase 2 and Aveir DR i2i studies. Programmed settings were optimized after a prior 6-minute walk test. We evaluated the ventricular and atrial rate-response sensors in participants implanted with the VR-LP and DR-LP system, respectively. For each device, the normalized slopes of sensor-indicated rate vs metabolic workload were aggregated across all analyzable patients. If the mean slope's 95% confidence interval (CI) fell within the prespecified 0.65 and 1.35 acceptance range, the rate response was considered proportional to metabolic demand.
Seventeen participants had a mean ventricular rate-response slope of 0.93 ± 0.29 (CI, 0.78-1.08), which fell within the acceptance criteria (P = .001). Twenty participants had a mean atrial rate-response slope of 0.91 ± 0.28 (CI, 0.78-1.05), also falling within the prespecified criteria (P < .001).
The temperature-based sensor in a dual-chamber leadless pacemaker system was shown to be effective at modulating pacing rate in response to increased metabolic demand for right ventricular and atrial devices.
NCT04559945 (LEADLESS II-Phase 2 study) and NCT05252702 (Aveir DR i2i study).
一种新型双腔无导线起搏器（DR-LP）系统，由右心室和右心房中的两个可植入装置组成，使用了一种不太常见的基于温度的速率响应传感器。有必要了解心室（VR-LP）和心房（AR-LP）装置在运动期间速率响应的有效性。
我们试图确定在无导线起搏器系统的运动测试中，基于温度的速率响应起搏是否与代谢负荷成比例。
植入6周后，我们对同时参与LEADLESS II-2期和Aveir DR i2i研究的符合条件的参与者实施了跑步机运动方案。在先前的6分钟步行测试后，对程控设置进行了优化。我们分别评估了植入VR-LP和DR-LP系统的参与者的心室和心房速率响应传感器。对于每个装置，在所有可分析的患者中汇总传感器指示的速率与代谢负荷的标准化斜率。如果平均斜率的95%置信区间（CI）落在预先指定的0.65至1.35接受范围内，则认为速率响应与代谢需求成比例。
17名参与者的心室平均速率响应斜率为0.93±0.29（CI，0.78-1.08），落在接受标准范围内（P = 0.001）。20名参与者的心房平均速率响应斜率为0.91±0.28（CI，0.78-1.05），也落在预先指定的标准范围内（P < 0.001）。
双腔无导线起搏器系统中基于温度的传感器在调节起搏速率以响应右心室和心房装置增加的代谢需求方面显示出有效性。
NCT04559945（LEADLESS II-2期研究）和NCT05252702（Aveir DR i2i研究）。
