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

Overview

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

• Other Coronary Sinus Lead Revision
  Coronary Sinus Lead Revision

Primary outcome measures

• Need for lead revision [Time frame: Procedure Day]

Secondary outcome measures (1)

• Electrocardiography characteristics - QRS Interval [Time frame: Procedure Day]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Kansas City Heart Rhythm Institute — Overland Park

Publications

• Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53. doi: 10.1056/NEJMoa013168. PMID 12063368
• Butter C, Georgi C, Stockburger M. Optimal CRT Implantation-Where and How To Place the Left-Ventricular Lead? Curr Heart Fail Rep. 2021 Oct;18(5):329-344. doi: 10.1007/s11897-021-00528-9. Epub 2021 Sep 8. PMID 34495452
• Daubert C, Behar N, Martins RP, Mabo P, Leclercq C. Avoiding non-responders to cardiac resynchronization therapy: a practical guide. Eur Heart J. 2017 May 14;38(19):1463-1472. doi: 10.1093/eurheartj/ehw270. PMID 27371720
• Pothineni NVK, Gondi S, Cherian T, Kovelamudi S, Schaller RD, Lakkireddy D, Gopinathannair R, Deshmukh A. Complications of Cardiac Resynchronization Therapy: Comparison of Safety Outcomes from Real-world Studies and Clinical Trials. J Innov Card Rhythm Manag. 2022 Aug 15;13(8):5121-5125. doi: 10.19102/icrm.2022.130805. eCollection 2022 Aug. PMID 36072440
• Alonso C, Leclercq C, d'Allonnes FR, Pavin D, Victor F, Mabo P, Daubert JC. Six year experience of transvenous left ventricular lead implantation for permanent biventricular pacing in patients with advanced heart failure: technical aspects. Heart. 2001 Oct;86(4):405-10. doi: 10.1136/heart.86.4.405. PMID 11559679
• Ahsan SY, Saberwal B, Lambiase PD, Chaubey S, Segal OR, Gopalamurugan AB, McCready J, Rogers DP, Lowe MD, Chow AW. An 8-year single-centre experience of cardiac resynchronisation therapy: procedural success, early and late complications, and left ventricular lead performance. Europace. 2013 May;15(5):711-7. doi: 10.1093/europace/eus401. Epub 2013 Jan 12. PMID 23315159
• Navia JL, Atik FA, Grimm RA, Garcia M, Vega PR, Myhre U, Starling RC, Wilkoff BL, Martin D, Houghtaling PL, Blackstone EH, Cosgrove DM. Minimally invasive left ventricular epicardial lead placement: surgical techniques for heart failure resynchronization therapy. Ann Thorac Surg. 2005 May;79(5):1536-44; discussion 1536-44. doi: 10.1016/j.athoracsur.2004.10.041. PMID 15854930
• Sharma PS, Vijayaraman P. Conduction System Pacing for Cardiac Resynchronisation. Arrhythm Electrophysiol Rev. 2021 Apr;10(1):51-58. doi: 10.15420/aer.2020.45. PMID 33936744

Identifiers

NCT: NCT06342492 · KCHRRF_CS Lead Failure_0025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗