Atrioventricular Block, Left Bundle Branch Area Pacing
Conditions
Keywords
Atrioventricular Block, left bundle branch area pacing
Brief summary
Right ventricular pacing (RVP) causes left ventricular mechanical dyssynchrony by inducing electrical interventricular and intraventricular dyssynchrony. His bundle pacing may restore the the atrioventricular, interventricular and intraventricular electrical synchronization, however, Increased pacing threshold might result in the early depletion of the pacemaker, and finally brought on pacemaker replacement, which was one of the major causes of device infection. Pacing the left bundle branch beyond the conduction block site might achieve a low and stable output and narrow QRSd. The investigators were prepared to consecutively include patients with atrioventricular block, divided into the left bundle branch area pacing(LBBAP) group and the conventional right ventricular pacing group. The electrophysiological characteristics of LBBAP and right ventricular pacing were compared with ECG characteristics. The left and right ventricular synchrony and left and right cardiac function were evaluated by 3D ultrasound, and the short-term and long-term safety and efficacy of LBBAP were evaluated.
Detailed description
This study is intended to be included in Fuwai hospital for admission to the atrioventricular block, with permanent pacemaker implant indications recommended by current guidelines. Patients were assessed for preoperative electrocardiogram, quality of life scores, cardiac function, and left and right ventricular synchrony. Patients were followed up by regular outpatients. The electrocardiogram, quality of life score, echocardiographic function, left and right ventricular synchrony, pacing parameters and pacing ratio were evaluated immediately after surgery, 3 months, 6 months, and 12 months after surgery. At the same time, the left bundle branch area pacing success rate, complications during intraoperative and postoperative follow-up were recorded.
Interventions
DEVICEpermanent left bundle branch area pacing
Implant the pacing lead in the left bundle branch area instead of traditional RV pacing site(septal or apical). Successful LBBAP was defined as the paced QRS morphology of right bundle branch block pattern in lead V1 and QRS duration (QRSd) less than 130ms.
Sponsors
Fu Wai Hospital, Beijing, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age over 18 years old; 2. Atrioventricular block patients with indication for permanent ventricular pacing; 3. LVEF\> 40%; 4. With informed consent signed
Exclusion criteria
1. Persistent atrial fibrillation; 2. Moderate or more severe valvular disease; 3. Hypertrophic cardiomyopathy； 4. Myocardial amyloidosis； 5. With indication for CRT or ICD implantation according to the current guideline; 6. Poor condition of the acoustic window because of emphysema or other reasons; 7. Patients refused postoperative follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The synchronization status change at 3 months and 1 year as compared with baseline status. | 3 months and 1 year | Left ventricualr strain change from baseline to 3 month, from baselin to 1 year post operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LBBAP related adverse events at 3 months and 1 year as compared with baseline status. | 3 months and 1 year | The adverse events includes perforation, acute myocardial infarction, loss of capture, increase of pacing threshold, et al. These events were evaluated at baseline, 3 months and 1 year after the procedure, respectively. |
| left ventricular ejection fraction change at 3 months and 1 year | 3 months and 1 year | Left ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation. |
| Pacing threshold change at 3 months and 1 year as compared with baseline status. | 3 months and 1 year | The pacing threshold changes between 3-month and baseline status, changes between 1 year and the baseline status. |
| Left ventricular end systolic diameter change at 3 months and 1 year | 3 months and 1 year | Left ventricular end systolic diameter change from baseline to 3 month, from baselin to 1 year post operation. |
| Left ventricular end diastolic diameter change at 3 months and 1 year | 3 months and 1 year | Left ventricular end diastolic diameter change from baseline to 3 month, from baselin to 1 year post operation. |
| Right ventricular ejection fraction change at 3 months and 1 year | 3 months and 1 year | Right ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation. |
Countries
China
Outcome results
None listed