DECLARATION OF CONFLICT OF INTEREST None to declare
Influence of left and right ventricular leadtip position on clinical outcome after CRT: results from REVERSE C Thébault 1, C Meunier 1, R Gervais 1, B Gerritse 2, M Gold 3, WT Abraham 4, C Linde 5, JC Daubert 1 1 University Hospital of Rennes, Department of Cardiology, France 2 Medtronic Bakken Research Center, Maastricht, Netherlands 3 Medical University of South Carolina, Charleston, USA 4 Davis Heart and Lung Research Institute, Columbus, USA 5 Karolinska University Hospital, Department of Cardiology, Stockholm, Sweden ESC Paris 2011
Introduction Influence of left (LV) and right ventricular (RV) lead-tip position on clinical outcome and the response to CRT : still unclear (1) LV lateral wall: usually targeted LV lead position No controlled trial supports the superiority of LV lateral wall position (2-4) No controlled studies about the influence of RV lead positions 1. Butter et al. Circ 2001;104:3026-9 2. Mortensen et al. Europace 2010;12:1750-56 3. Singh et al. Circ 2010;123:1159-66 4. Saxon et al. JCE 2009;20:764-8
Study objective Influence of the LV and RV lead-tip position on outcome after CRT in a pre-specified analysis of a randomised controlled trial in mildly symptomatic heart failure (HF) patients
REVERSE study REVERSE study (1) : 610 patients, NYHA II or I-stage C (previously symptomatic), LV ejection fraction (LVEF) 40%, QRS 120ms, on optimal medical therapy Randomization 2:1 to CRT ON or CRT OFF after CRT device implantation in all subjects Primary endpoint: clinical composite response (CCS) at 1 year (2) Clinical Pre-specified Composite clinical Response: secondary endpoints: time to 1st hospitalisation for HF death or all-cause death hospitalisation for HF Statistical cross over analysis or permanently conducted for discontinued the clinical secondary double-blind endpoints: treatment 1-year follow-up in the US cohort and 2-year in the EU cohort because of worsening HF LV lead NYHA placement: class change lateral or postero lateral position recommended RV patient lead placement: global assessment no recommendation 1 year 1.Linde et al. JACC 2008;52:1834-43 2.Packer et al. JCardFail 2001;7:176-82
REVERSE study REVERSE study (1) : 610 patients, NYHA II or I-stage C (previously symptomatic), LV ejection fraction (LVEF) 40%, QRS 120ms, on optimal medical therapy Randomization 2:1 to CRT ON or CRT OFF after CRT device implantation in all subjects Primary endpoint: clinical composite response (CCS) at 1 year (2) Pre-specified clinical secondary endpoint: time to 1st hospitalisation for HF or all-cause death Statistical analysis conducted for the clinical secondary endpoints: 1-year follow-up in the US cohort and 2-year in the EU cohort Lead placement recommendation: LV lead : lateral or postero lateral position RV lead : no recommendation 1.Linde et al. JACC 2008;52:1834-43 2.Packer et al. JCardFail 2001;7:176-82
POSTEROLATERAL ANTEROLATERAL Methods Pre specified protocol: post operative chest X ray in antero-posterior and lateral view Each film was centrally analyzed by an expert radiologist and an expert cardiologist not otherwise involved in the REVERSE study Additional study: QRS at baseline, discharge, 12-months centrally measured by an expert unaware of the patient s outcome
Methods Chest X ray s of acceptable quality were available in 346 of the 419 patients randomized to the CRT ON group. Exact lead-tip position could be determined in 345 patients for the RV lead and in 285 patients for the LV lead (68%) Missing data for LV lead position: No lateral view (>95% of cases) Two LV leads No datation Non Lateral Lateral Non apical Apical
Methods Right ventricular lead position: AP view Non apical Apical
Results: LV lead position CRT ON group 35 (12.3%) 23 (8.1%) 27 (9.5%) 8 (2.8%) 88 (30.9%) 25 (8.8%) 9 (3.2%) 1 (0.4%) 48 (16.8%) 10 (3.5%) 9 (3.2%) 2 (0.7%)
Results: LV lead position CRT ON group Lateral N=229 80.3% Non lateral N=56 19.7%
Results: LV lead position CRT ON group Non apical N=246 86.3% Apical N=39 13.7%
Clinical outcome and LV lead-tip position Non lateral vs lateral p= 0.041
Clinical outcome and LV lead-tip position Non apical vs apical p= 0.0011
Clinical outcome and RV lead-tip position p= 0.5
QRS variation and LV lead-tip position LV lateral vs non lateral LV apical vs non apical All patients Lateral n=229 Non lateral n=56 p-value LV apical n=39 LV nonapical n=246 p-value QRS at baseline 151 ± 22 152 ± 22 149 ± 23 0.32 149 ± 24 152 ± 22 0.57 QRS change (12-months - baseline) -3.4 ± 27.2-8.4 ± 26 14.3 ± 24 <0.0001 11.3 ± 28.3-5.9 ± 26.3 <0.001
QRS variation and RV lead-tip position RV apical vs non-apical All patients RV apical n=237 RV non-apical n=108 p-value QRS at baseline 151 ± 22 152 ± 22 151 ± 23 0.7 QRS change (12-months - baseline) -3.4 ± 27.2-4.6 ± 28.1-0.7 ± 25 0.33
Conclusion Lateral and non apical LV lead-tip positions are associated with a more favorable outcome in the REVERSE study Favourable effect of a non apical LV lead-tip position: in line with MADIT CRT data in class I-II HF patients (1) Significant QRS reduction in the lateral and non apical LV lead position No influence of the RV lead-tip position on clinical outcome 1. Singh et al. Circ 2010123:1159-66