Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- Number of participants with Electrode Dislocation
研究概览
简要总结
During Transcatheter aortic valve implantation (TAVI) procedure, a new valve is implanted. The valve can be CoreValve (Medtronic Company) or Edward SAPIENS (Edwards Company).
All TAVI patients require a temporary pacemaker(PMK), which is usually performed by insertion of a standard temporary electrode through the femoral vein. The temporary PMK is associated with a small but significant rate of complications.
The PMK is usually removed immediately at the end of the TAVI procedure, only when using the Edward SAPIENS valve. The CoreValve valve is more associated with conduction complications, and thus the PMK is later removed in these cases.
PMK Complications seen include:
- Right Ventricle perforation by temporary electrode, leading to Pericardial bleeding, in some cases with Tamponade
- Infection
- Electrode dislocation causing In-effective pacing (and/or sensing)
- Prolonged bed rest
- Prolonged hospitalization
- Access related problems (hematoma, pneumothorax) In a review of a large cohort (1) of patients from Milan (JACC 2012) the rate of tamponade was 4.3% most of which was associated with the temporary PMK.
详细描述
The investigators had experienced not infrequent occurrences of temporary electrode associated tamponade, either acutely after Transcatheter aortic valve implantation (TAVI) completion, or delayed, in association with the electrode removal.
The tamponade rate in patients with a temporary pacemaker(PMK) was 14/150 (9.3%). Not all tamponade cases were related to the temporary PMK, 2 occurred in the setting of catastrophic annular rupture and one of the first cases was related to the Left Ventricle stiff wire.
The investigators also noted a significant prolongation of bed rest and hospital stay in patients with temporary PMK.
Using a flexible permanent pacing electrode which is actively fixed to the Right Ventricle and is placed through the jugular vein will reduce pacing-related complication rates (due to the flexibility of the electrode), time to ambulation (due to the fixation of the electrode), hospital stay and also unnecessary PMK. Cost will also be reduced due to prevention of complications and reduction in Intensive Cardiac Care Unit time.
Procedure time might be slightly prolonged since the placement of the standard electrode is more timely, however this prolongation is negligible, and the benefits of the flexible permanent pacing electrode are worth this prolongation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All TAVI patients
排除标准
- •Existing contraindication for either femoral or jugular venous access
- •Refused informed consent
- •Permanent PMK
- •Platelets count less than 50 K.
结局指标
主要结局
Number of participants with Electrode Dislocation
时间窗: 1 week
Electrode Dislocation (sensing / pacing problems, requiring lead re-positioning). The dislocation will be diagnosed by chest X ray or by sensing / pacing parameters.
Number of participants with access site complications
时间窗: 1 week
Access site complications describe as perforation of near organs (jugular artery)
Number of participants with pacemaker failure
时间窗: 1 week
Rates of Pacing or sensing failure during the procedure, or the days after,
Number of participants with Bleeding complications
时间窗: 1 week
Bleeding complications, described as local hematoma within the area of the electrode insertion, during the procedure or the hospitalization.
Number of participants with Infections complications
时间窗: 1 week
Infections complications, described as fever above 38.0 celsius degree or positive blood culture during the hospitalization after the procedure.
Number of participants with pericardial effusion with or without tamponade
时间窗: 1 week
Pericardial effusion estimated by echocardiography, will be done during the hospitalization. It will be described as minimal/mild/moderate/large
Number of participants with Pneumothorax
时间窗: 1 week
Pneumothorax diagnosed by clinical examination and CXR within 3 days after the procedure.
次要结局
- The time (in days) the patients has stayed in Intensive Cardiac Care Unit(2 weeks)
- The Cost of Pacing equipment(1 week)
- The TAVI fluoroscopic time(1 day)
- An implantation of permanent pacemaker(one year)
- The time (in days) the patient was able to get down from his bed to a chair, after the procedure(week)
- The permanent pacemaker activation (if implanted)(1 year)
- The TAVI procedure time(1 day)
研究者
Orlev Amir
Dr
Hadassah Medical Organization