Abstract：
BACKGROUND: Cardiac resynchronization therapy (CRT) is associated with challenges such as elevated capture thresholds, diaphragmatic stimulation, and lead instability.
OBJECTIVE: This study aimed to assess the long-term safety and efficacy of the quadripolar CRT-defibrillator (CRT-D) device system with the Quartet 1458Q left ventricular (LV) lead in a CRT-indicated population observed for 5 years and to evaluate all-cause mortality and impact of baseline characteristics on survival through 5 years.
METHODS: Patients indicated for a CRT-D system were observed every 6 months after implantation for 5 years, and device performance and adverse events were assessed at each visit. The 3 primary end points were freedom from quadripolar CRT-D system-related complications through 5 years, freedom from Quartet 1458Q LV lead-related complications through 5 years, and mean programmed pacing capture threshold at 5 years.
RESULTS: The study enrolled 1970 participants at 71 sites. The quadripolar CRT-D system was successfully implanted in 97.2% of participants. Freedom from quadripolar CRT-D device system-related complications through 5 years was 89.7%. Freedom from Quartet 1458Q LV lead-related complications through 5 years was 95.7%; 3.49% of participants had LV lead-related complications, and an overall LV lead complication rate was 0.0122 event per patient-year. The mean LV pacing capture threshold was 1.52 ± 1.01 V at 5 years. The 5-year survival rate was 67.4%.
CONCLUSIONS: The quadripolar CRT-D system with the Quartet 1458Q LV lead exhibited low rates of complications and stable electrical performance through 5 years of follow-up and suggested a higher 5-year survival rate compared with traditional CRT systems.
OBJECTIVE: This study aimed to assess the long-term safety and efficacy of the quadripolar CRT-defibrillator (CRT-D) device system with the Quartet 1458Q left ventricular (LV) lead in a CRT-indicated population observed for 5 years and to evaluate all-cause mortality and impact of baseline characteristics on survival through 5 years.
METHODS: Patients indicated for a CRT-D system were observed every 6 months after implantation for 5 years, and device performance and adverse events were assessed at each visit. The 3 primary end points were freedom from quadripolar CRT-D system-related complications through 5 years, freedom from Quartet 1458Q LV lead-related complications through 5 years, and mean programmed pacing capture threshold at 5 years.
RESULTS: The study enrolled 1970 participants at 71 sites. The quadripolar CRT-D system was successfully implanted in 97.2% of participants. Freedom from quadripolar CRT-D device system-related complications through 5 years was 89.7%. Freedom from Quartet 1458Q LV lead-related complications through 5 years was 95.7%; 3.49% of participants had LV lead-related complications, and an overall LV lead complication rate was 0.0122 event per patient-year. The mean LV pacing capture threshold was 1.52 ± 1.01 V at 5 years. The 5-year survival rate was 67.4%.
CONCLUSIONS: The quadripolar CRT-D system with the Quartet 1458Q LV lead exhibited low rates of complications and stable electrical performance through 5 years of follow-up and suggested a higher 5-year survival rate compared with traditional CRT systems.
摘要：
背景：心脏再同步治疗（CRT）与诸如捕获阈值升高等挑战有关，膈肌刺激,和铅不稳定。
目的：在接受CRT治疗的人群随访5年后，评估带有四极1458Q左心室（LV）导线的四极CRT-D装置系统的长期安全性和有效性，并评估全因死亡率和基线特征对5年生存率的影响。
方法：植入后每6个月对需要使用CRT-D系统的患者进行随访，随访5年，并在每次访视时评估器械性能和不良事件。三个主要终点是5年无四极CRT-D系统相关并发症,在5年内摆脱四方1458Q左心室导线相关并发症，和5年时的平均编程起搏捕获阈值。
结果：该研究纳入了71个地点的1,970名受试者。在97.2％的受试者中成功植入了四极CRT-D系统。5年内无四极CRT-D装置系统相关并发症为89.7%,5年内无四极CRT-D装置系统相关并发症为95.7%。3.49%的受试者有LV导线相关并发症，总LV导线并发症发生率为0.0122事件/受试者年。5年时的平均LV起搏捕获阈值为1.52±1.01V。5年生存率为67.4%。
结论：采用四极1458QLV导线的四极CRT-D系统在5年的随访中表现出较低的并发症发生率和稳定的电气性能，与传统的CRT系统相比，5年生存率更高。
目的：在接受CRT治疗的人群随访5年后，评估带有四极1458Q左心室（LV）导线的四极CRT-D装置系统的长期安全性和有效性，并评估全因死亡率和基线特征对5年生存率的影响。
方法：植入后每6个月对需要使用CRT-D系统的患者进行随访，随访5年，并在每次访视时评估器械性能和不良事件。三个主要终点是5年无四极CRT-D系统相关并发症,在5年内摆脱四方1458Q左心室导线相关并发症，和5年时的平均编程起搏捕获阈值。
结果：该研究纳入了71个地点的1,970名受试者。在97.2％的受试者中成功植入了四极CRT-D系统。5年内无四极CRT-D装置系统相关并发症为89.7%,5年内无四极CRT-D装置系统相关并发症为95.7%。3.49%的受试者有LV导线相关并发症，总LV导线并发症发生率为0.0122事件/受试者年。5年时的平均LV起搏捕获阈值为1.52±1.01V。5年生存率为67.4%。
结论：采用四极1458QLV导线的四极CRT-D系统在5年的随访中表现出较低的并发症发生率和稳定的电气性能，与传统的CRT系统相比，5年生存率更高。
