Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure
Purpose
This a single-center, retrospective, observational study of patients that undergo coronary sinus(CS) lead revision, comparing epicardial lead placement to coronary sinus pacing(CSP) in those that had lead failure.
Condition
- Heart Failure With Reduced Ejection Fraction
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- All patients older than 18 years of age - Patients with HFrEF that underwent BVP-CRT - Experienced CS lead failure, whether initial or recurrent, subsequently replaced with transthoracic epicardial lead placement or CSP - Underwent Medtronic, Boston Scientific, or Abbott lead placement
Exclusion Criteria
- Patients younger than 18 years of age - Transthoracic epicardial lead placement or CSP performed as the initial approach or for other reasons than lead replacement - Those for which CRT no longer provides symptom relief or mortality benefit.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Conduction System Pacing | Subjects who had lead placement via conduction system pacing approach |
|
| Epicardial Lead Placement | Subjects who had lead placement via transthoracic, epicardial approach |
|
Recruiting Locations
Overland Park, Kansas 66211
More Details
- Status
- Recruiting
- Sponsor
- Kansas City Heart Rhythm Research Foundation
Detailed Description
Cardiac resynchronization therapy with defibrillator(CRT-D) improves quality of life, functionality, and even mortality for select patients with severe heart failure with reduced ejection fraction (HFrEF). It traditionally consists of three leads placed endovascularly into the right atrium, right ventricle, and left ventricle (LV) [typically placed into the CS], known as biventricular pacing resynchronization (BVP-CRT), respectively, from which electrical stimulation enables improved cardiac synchrony. Nonetheless, the placement of a CRT-D is not without risks. Lead-related complication is high and CRT-D implantation fails in up to 30% of patients due to lead placement alone. Epicardial lead placement and CSP have been deemed viable alternatives to CRT-D. It has even been shown to be options in patients that fail conventional BVP-CRT. This is primarily due to increased accuracy, decreased complications, and even durability. However, guidelines for decision between a transthoracic approach and CSP is unclear, even more so after lead failure. Instead, this decision is currently individualized to the patient. There is a lack of prospective and head-to-head data between the two, and this study is aimed to compare transthoracic LV epicardial lead placement and CSP in patients with lead failure after BVP-CRT.