Qu attendre de la technologie pour un meilleur suivi? (traitement) D Gras, MD, Nantes, France

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1 Qu attendre de la technologie pour un meilleur suivi? (traitement) D Gras, MD, Nantes, France

2 New Technologies in CRT How do they impact daily clinical practice? Septal CRT Dual-Site LV CRT Quadripolar CRT System LV Endocardial CRT

3 Apical Septal CRT Mid-septal AP view LAO view 3

4 Septal CRT: Baseline Characteristics Men (%) Age, (y) NYHA class II (%) NYHA class III (%) NYHA IV ambulatory (%) Ischemic CM (%) LVEF (%) Baseline medication : Diuretics (%) ACE inhibitor or ARB (%) Aldosterone antagonist (%) Beta-blocker (%) Primary prevention (%) QRS duration, ms RVA (132) ± ± ± 21.4 RVMS (131) ± ± ± 22.9 Total (263) ± ± ± 22.1 No significant difference between RA and RVMS populations for all parameters Christophe Leclercq, ESC 14

5 SEPTAL CRT RVA (n=92) RVMS (n=90) LVESV baseline (ml) ± ± 83 LVESV 6 months (ml) ± ± 86 Difference (ml) ± ± 39 PP analysis : mean difference in LVESV reduction: -4.7 ml with lower limit of the unilateral 97.5% confidence interval at ml (p= 0.006) Per-protocol analysis p = Intent to treat analysis Non-inferiority margin Christophe Leclercq, ESC p =

6 SEPTAL CRT No in the percentage of echo-responders, i.e. reduction in LVESV > 15% at 6 months, 50% in both groups, p = 0.99 No in RV lead pre-specified electrical criteria 90.0% in the Septum randomized group 86.8% in the Apex randomized group Mostly due to the lack of defibrillation testing (n = 27) 2 patients crossed over due to failure of fulfilling the RV implantation criteria in each group Christophe Leclercq, ESC 14

7 Septal CRT: 1-year Mortality

8 New Technologies in CRT How do they impact daily clinical practice? Septal CRT Dual-Site LV CRT Quadripolar CRT System LV Endocardial CRT

9 Goal: To Improve Ventricular activation & CRT Impact Potential Difficulties - Subclavian Vein Occlusion - Y Adaptor & Electrical csqces - Higher Risks of PNS - Anatomical Limitations

10 Right Subclavian vein Occlusion DDD-PM Upgrade

11 Main endpoint: HF Composite Clinical Score 100% 90% 80% 70% 60% 50% 40% 30% Improved Unchanged Worsened 20% 10% 0% V3 BiV p = 0.59 No statistical difference between the distribution of both groups P Bordachar, HRS 14

12 Secondary endpoint Time to first HF hospitalization or death No difference between groups whatever the time period (p=0.8, p=0.9) P Bordachar, HRS 14

13 Other secondary endpoints (12 M FU) BiV V 3 p Patients with 1 hospitalization for heart failure 19 (46%) 21 (49%) 0.82 Number of hospitalizations for heart failure Mean time between enrolment - first hospitalization for HF 86 ± ± Δ Six minute hall walk distance (m) 47 ± 117 (n=20) 29 ± 77 (n=13) 0.60 NYHA class (I/II/II/IV) 0 / 53 / 43 / 3 10 / 53 / 37 / Δ MLHF Quality of Life Score -7 ± 27-5 ± Δ LVESV (ml) -19 ± ± Δ LVEDV (ml) -18 ± ± LVEF (%) 34 ± ± Δ LVEF (%) 6 ± 11 3 ± P Bordachar, HRS 14

14 Dual Site RV Pacing to Optimize Hemodynamics in CRT Patients F Anselme, TriV Study, HRS 14

15 New Technologies in CRT How do they impact daily clinical practice? Septal CRT Dual-Site LV CRT Quadripolar CRT System LV Endocardial CRT

16 Subselection of Lateral Cardiac Vein during Quadripolar LV Lead Implant

17 Quadripolar LV Lead in case of LSVC

18 Benefits of 4Polar vs Bipolar LV Lead Linde C, Ellenbogen K, McAlister FA Cardiac resynchronization therapy (CRT): Clinical trials, guidelines, and target populations. Heart Rhythm Aug;9(8 Suppl):S3-S13. Offering Multiple Pacing Vectors to individually adjust LV Pacing in Long-Term. Less Phrenic Nerve Stimulation. Optimal PT (multiple vectors). Pacing Vectors to Optimize Hemodynamics. Better Lead Stability, Less Lead revision. Similar LV Lead Implantation

19 MORE-CRT Study Design Objective Number of patients enrolled Randomization prospective, randomized parallel open trial Determine if using a quadripolar CRT system results in better LV lead-related complication-free survival compared to bipolar CRT systems :2 (Bipolar*:Quadripolar) Primary Endpoint Survival free from composite endpoint of intra- and postoperative LV lead-related complications at 6 months *Control (bipolar LV leads) pts were further randomized to a 1:2 ratio of SJM to non-sjm manufacturer Intra-operative complications definition: Overall lead implant failure, PNS, lead instability, or high capture threshold that lead to >1 lead location attempt, >1 LV lead used, or use of device for lead fixation Post-operative complications definition: LV lead-related SAE or abandoned CRT for any reason

20 MORE-CRT Trial, N=1079 Intra & post-operative LV lead-related events between bipolar vs. SJM 4P CRT systems Quartet TM lead: increased freedom from events by 11.85% compared to bipolar LV leads A significant reduction in relative risk of 40.8% in the quadripolar CRT group 85.97% 76.86% p= months Boriani et al., Cardiac resynchronization therapy with a novel quadripolar lead decreases complications at six months: preliminary results of the MORE-CRT trial, ESC 2014, FP# 887

21 Quadripolar CRT system associated with increased survival compared to bipolar CRT system Patients with a quadripolar system may receive more effective CRT than those with bipolar LV pacing Methods N=23,178 (78% quadripolar vs. 22% bipolar) from SJM device registration records Survival analysis performed based on data obtained from Social Security Death Index. Results Quadripolar and bipolar groups had 5.88 and 7.23 deaths per patient-year, respectively (p = 0.003). After multivariate adjustment, the quadripolar lead was associated with a lower risk of death (HR 0.794, 95% CI [0.696, 0.906], p < 0.001). Turakhia M et al. Reduced mortality with quadripolar versus bipolar left ventricular leads in cardiac resynchronization therapy. HRS PO01-51.

22 Goals of 4polar vs Bipolar LV Pacing Additional Hemodynamic Impact of MPP

23 Endocardial vs Epicardial CRT provides: Better LV Filling and Systolic Performance More Homogenous Resynchronization Pooled data from 8 LV sites *=p<0.05 with BL; =p<0.05 with EPI-BiV Prinzen et al Van Deursen, Circ Arrhythmia Electrophysiol. 2009;2:

24 LV Endocardial or Triventricular Pacing to Optimize CRT in a Chronic Canine Model of Ischemic HF Pierre Bordachar, MD, PhD 2*, Nathan Grenz, BSEE 1*, Pierre Jais, MD 2, Philippe Ritter, MD 2, Christophe Leclercq, MD, PhD 3, John M. Morgan, MD 4, Daniel Gras, MD 5, Ping Yang, PhD 1 Am J Physiol Heart Circ Physiol 2012.

25 TEE Evaluation before Transseptal Puncture Location of Fossa Ovalis

26 LV endocardial Pacing during CRT AP View LAO View

27 LV Endo Pacing in Non CRT Responder AP View LAO View

28 JM Morgan HRS 14

29 Morgan HRS 14

30 Permanent LV Endocardial Pacing in Clinical Practice Expected Benefits of LVEP: Local Recruitment, V propagation 20% improvement in hemodynamics Optimized LV Pacing Location Lower risk of PNS, Better PT Potential Side Effects: TE events Impact on MR Lead Extraction Indications: Non Responders Failure to Classical Approach First Line option? Next Steps - Clinical Studies - Improved Implant Tools - New LVEP Lead Design

31 New Technologies in CRT How do they impact daily clinical practice? Septal CRT: RV lead at the apex or septum Dual-Site LV CRT: Feasible, not conclusive Quadripolar CRT System: first line option LV Endo CRT: promising, risk benefit ratio?