STIMulation Cardiaque et TAVI : évolution Des Troubles Conductifs Atrio-ventriculaires après TAVI
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 275
- 主要终点
- To look for one or several high level A-V block episodes beyond seven days after a TAVI procedure, by the analysis of the EKG and of the pacemaker memories during the follow-up visits
研究概览
简要总结
The investigators propose to carry out an observational study of patients implanted with a pacemaker using AAI SafeR® mode after a TAVI procedure. This study aims to define the persistence or not of high-grade AVB beyond seven days after the procedure, based on the analysis of PM memories, and define definitive cardiac pacing indications after TAVI procedure.
详细描述
Atrioventricular (A-V) conduction disorders are common after Transcatheter Aortic Valve Implantation (TAVI) and the average of a pacemaker implantation after TAVI is 15% to 17%.
The European Society of Cardiology recommends to implant a permanent pacemaker (PM) in case of persistant high-grade A-V block (AVB) within 7 days of a TAVI procedure (class I recommendation, level of evidence C).
Some conduction disturbances are transient and might not need a definitive indication for pacemaker implantation. A recent study, based on dependency of patients to pacing, estimate that in half the patients, conduction disturbances that led to the implantation of a pacemaker after TAVI procedure would have disappear 30 days after the procedure.
Many studies tried to better define the indications of these devices. However, their evaluation criteria do not allow to prove these pacemakers were useful, because these studies are mainly based on the rate of implantation of pacemakers, or on the percentage of ventricular pacing. These studies may overestimate the usefulness of the pacemaker because of unnecessary ventricular pacing, or underestimate it in patients with high grade paroxysmal AVB, that could have been responsible for syncope or death.
Today some pacemakers allow a better occurrence of spontaneous A-V conduction and monitor precisely the atrioventricular conduction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients over 18 years who underwent implantation of a TAVI and that were implanted during the hospitalization with a dual chamber pacemaker Sorin®, set in AAI SafeR ® or AAI SafeR-R® mode.
排除标准
- •Patients with life expectancy at hospital discharge estimated as less than 1 year
- •TAVI procedure failure
- •Patients refusing to be involved in the study
- •Patients implanted with a PM of a brand different than Sorin® during the hospital phase or implanted Sorin® PM but not set in a AAI or AAI SafeR SafeR-R mode
- •Patients with PM implant before TAVI
- •Permanent AF at the implantation time
- •Patients with Single or Triple chamber PM
结局指标
主要结局
To look for one or several high level A-V block episodes beyond seven days after a TAVI procedure, by the analysis of the EKG and of the pacemaker memories during the follow-up visits
时间窗: Until the completion of the study (first follow-up visit 1 to 3 months after TAVI, last follow-up visit 1 year after TAVI)
High level A-V Block in patients after TAVI procedure is defined: * Either by the analysis of the pacemaker memories during the follow-up visits showing the switches from AAI Safe-R to DDD mode after one or more of these three reasons: * a succession of at least 2 consecutive blocked P waves * more than 3 blocked P waves among 12 consecutive cycles * ventricular pause for over 2 seconds with at least one blocked P wave * Either by the presence of a high level AVB on the EKG during the follow-up visit (pacemaker temporally set to DDI 30 bpm mode) We classify as transitional AVB (D7 persistent, non-persistent beyond 1 month), and permanent AVB (persistent beyond 1 month).
次要结局
- To study the influence of certain predefined factors on the risk of high-level A-V block after a TAVI procedure.(An average of 8 days (from the day before the TAVI procedure to 7 days after TAVI))