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1 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,

2 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

3 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: Mortensen et al. Europace 2010;12: Singh et al. Circ 2010;123: Saxon et al. JCE 2009;20:764-8

4 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

5 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: Packer et al. JCardFail 2001;7:176-82

$REVERSE study REVERSE study (1) : 610 patients, NYHA II or I-stage C (previously symptomatic), LV ejection fraction (LVEF) 40%, QRS 120ms, on optimal medical therapy Randomization 2:1 to CRT ON or$

6 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: Packer et al. JCardFail 2001;7:176-82

7 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

8 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

9 Methods Right ventricular lead position: AP view Non apical Apical

10 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%)

11 Results: LV lead position CRT ON group Lateral N= % Non lateral N= %

12 Results: LV lead position CRT ON group Non apical N= % Apical N= %

13 Clinical outcome and LV lead-tip position Non lateral vs lateral p= 0.041

14 Clinical outcome and LV lead-tip position Non apical vs apical p=

15 Clinical outcome and RV lead-tip position p= 0.5

16 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 ± ± ± ± ± QRS change (12-months - baseline) -3.4 ± ± ± 24 < ± ± 26.3 <0.001

17 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 ± ± ± QRS change (12-months - baseline) -3.4 ± ± ±

18 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 :

Is QRS width predictive of the clinical and echocardiographic response to chronic CRT in mildly symptomatic HF patients?

Is QRS width predictive of the clinical and echocardiographic response to chronic CRT in mildly symptomatic HF patients? Data from REVERSE C Thébault 1, M Gold 2, C Linde 3, WT Abraham 4, C Leclercq 1,