Heart Failure With Reduced Ejection Fraction
Conditions
Brief summary
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.
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.
Interventions
OTHERCoronary Sinus Lead Revision
Coronary Sinus Lead Revision
Sponsors
Kansas City Heart Rhythm Research Foundation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for lead revision | Procedure Day | Compare the need for lead revision between conduction system pacing (CSP) and transthoracic left ventricular (LV) epicardial pacing approach |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrocardiography characteristics - QRS Interval | Procedure Day | Compare electrocardiography characteristics - QRS Interval measured in seconds between conduction system pacing (CSP) and transthoracic left ventricular (LV) epicardial pacing approach |
Countries
United States
Contacts
Primary ContactDonita Atkins
Outcome results
None listed