Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure

Kansas City Heart Rhythm Research Foundation

Status

Enrolling

Conditions

Heart Failure With Reduced Ejection Fraction

Treatments

Other: Coronary Sinus Lead Revision

Study type

Observational

Funder types

Other

Identifiers

NCT06342492

KCHRRF_CS Lead Failure_0025

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.