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Targeted Left Ventricular Lead Placement to Guide Cardiac Resynchronisation Therapy: A Randomised Controlled Trial (TARGET study) Khan FZ 1,2, Virdee MS.

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Presentation on theme: "Targeted Left Ventricular Lead Placement to Guide Cardiac Resynchronisation Therapy: A Randomised Controlled Trial (TARGET study) Khan FZ 1,2, Virdee MS."— Presentation transcript:

1 Targeted Left Ventricular Lead Placement to Guide Cardiac Resynchronisation Therapy: A Randomised Controlled Trial (TARGET study) Khan FZ 1,2, Virdee MS 2, Palmer CR 3, Pugh PJ 1, O’Halloran D 1, Elsik M 2, Read PA 2, Begley D 2, Fynn SP 2, Dutka DP 1 1 Addenbrooke’s Hospital, Cambridge, UK 2 Papworth Hospital, Cambridge, UK 3 Centre for Applied Medical Statistics, Cambridge, UK

2 Disclosures Disclosures:None Sponsorship:Papworth Hospital, Cambridge, UK Funding:NIHR UK Papworth Hospital, Addenbrooke’s Charitable Trust Trial Registration:ISRCTN19717943

3 Introduction Cardiac Resynchronisation Therapy (CRT) has evolved as established treatment for advanced heart failure symptoms, impaired LV systolic function and intraventricular conduction delay 30-40% of patients fail to gain significant clinical benefit Left ventricular (LV) lead position has emerged as an important determinant of response

4 LV Lead Position in CRT Higher response when pacing the latest site of contraction 1 Lower response when pacing areas of scar 2 1 Ypenburg et al J Am Coll Cardiol.2009;53(6):483-490 2 Bleeker et al Circulation 2006;113(7):969-976.

5 Hypothesis There have been no randomised controlled trials to investigate the impact of LV lead position The TARGET study designed to prospectively assess the feasibility of a targeted approach to LV lead placement and the impact of LV lead targeting on CRT outcomes We tested the hypothesis that targeted LV lead placement to the latest site of contraction and away from areas of scar would enhance CRT response when compared to usual (unguided) treatment

6 Single blinded, randomised controlled trial, 2 UK centres Inclusion: Sinus rhythm, NYHA Class III/IV, LVEF 120ms Baseline (all patients): LV volumes, EF, NYHA, 6MWT, MLHFLQ Randomisation CONTROL GroupTARGET Group Targeted LV Lead Speckle Tracking Echocardiography used to identify optimal site and LV lead targeted to this site Standard CRT LV Lead Placement without echocardiographic guidance All CRT devices optimised using echo following implant Study Design

7 Speckle Tracking Echocardiography to Identify Optimal Site – Latest Site

8 Speckle tracking radial strain imaging correlates with delayed enhanced CMR imaging for determination of scar 1,2 In CRT patients, a <10% amplitude of radial strain at the LV pacing site has a high negative predictive value (91%) for response (LV reverse remodelling) 3 1 Becker et al J Am Coll Cardiol 2008 51(15):1473-1481 2 Delagado et al Circulation 2011 123 (1):70-8 3 Khan et al J Am Soc Echocardiogr. 2010 23(11):1168-1176 Speckle Tracking Echocardiography to Identify Optimal Site – Scar Determination

9 Step 1: Identify optimal site as the latest site with an amplitude >10% to signify freedom from scar Step 2: Coronary sinus venography in steep left anterior oblique (LAO) view (50-90º) and coronary vein closest to optimal site identified Step 3: LV lead placed to optimal site (anterior, lateral, posterior or inferior in LAO view and basal or mid LV in the RAO view) Step 4: LV lead position correlated with echocardiographic data and described as: Concordant (pacing the optimal site) Adjacent (1 segment away) Remote (≥2 segments away from the optimal site) LV Lead Targeting – TARGET Group

10 Study Endpoints Primary endpoint Comparison of response rates between groups (≥15% reduction of LVESV at 6 months) Secondary endpoints Clinical response rates (≥1 improvement in NYHA class) All cause mortality Combined mortality & heart failure hospitalisation Statistics: 80% power to identify a 20% difference in response rates between groups (one-sided α value of 0.05)

11 Assessed for eligibility (n=247) Excluded (n= 27) Inadequate images to perform speckle tracking echocardiography Randomized (n= 220) TARGET Group (n=110) Died prior to receiving CRT (n=1)* Failure to implant an LV Lead (n= 4) Lost to follow-up (n=6) * Died prior to 6 month follow up (n=3) *Excluded from analysis (n=7) All patients included for long term endpoints Total data analysed n=103 for primary and secondary endpoints CONTROL Group (n=110) Died prior to receiving CRT (n=1) * Failure to implant an LV Lead (n= 3) ALLOCATION Lost to follow-up (n=5) * Died prior to 6 month follow up (n=4) FOLLOW UP *Excluded from analysis (n=6) All patients included for long term endpoints Total data analysed n=104 for primary and secondary endpoints ANALYSIS

12 Target Group (n=110) Control Group (n=110) Age (mean ± SD) yrs70 ± 971 ± 10 Male n (%)85 (77)88 (80) NYHA III/IV95/1593/17 Ischemic Cardiomyopathy n (%)62 (56)61 (56) Diabetes Mellitus n (%)30 (27)29 (26) QRS duration (mean ± SD) ms161 ± 21161 ± 23 LVEDV (mean ± SD) ml202 ± 66200 ± 58 LVESV(mean ± SD) ml157 ± 56154 ± 52 LVEF (mean ± SD) %23 ± 624 ± 7 ACEI or ARB n (%)104 (95)103 (94) B-blockers n (%)78 (71)77 (70) Spironolactone n (%)63 (57)59 (54) IVMD (mean ± SD) ms45 ± 2744 ± 24 AS-P Delay (mean ± SD) ms190 ± 136177 ± 148 Baseline Characteristics

13 Target Group (n=103) Control Group (n=104) P Value Latest Site of Activation %0.961 Inferior1314 Posterior3841 Lateral3231 Anterior97 Anteroseptal44 Inferoseptal43 LV Lead Position %0.443 Inferior126 Posterior3538 Lateral4647 Anterior36 Failed Implant43 Latest Site and LV Lead Position

14 Target Group (n=103) Control Group (n=104) P Value Relationship of LV Lead to Late Site % (n)0.011 Concordant61 (63)45 (47) Adjacent25 (26)28 (29) Remote10 (10)24 (25) Scar at LV Lead Site % (n)8 (8)16 (15)0.133 LV Lead Targeting

15 Target Group (n=103) Control Group (n=104) P Value Implant Related Complications0.991 Total % (n)13 (13)14 (13) Failure to implant LV lead4 (4)3 (3) LV Lead Displacement (repositioning)5 (5)6 (6) Phrenic nerve stimulation (reposition)1 (1)2 (2) Device infection (extraction/re-implant)1 (1) Pneumothorax1 (1) Myocardial perforation1 (1) Procedural Characteristics Procedural Length (mins)139 ± 36138 ± 420.823 Screening time (mins)25 ± 1419 ± 130.031 Screening dose (mGy/cm2)133 ± 10791 ± 690.024 Procedural Characteristics

16 Primary Endpoint Response Rates: TARGET vs. Control (70% vs. 55%, p=0.031) Absolute difference in the primary endpoint of 15% [95% CI (2%, 28%)]

17 Secondary Endpoint Clinical Response Rates: TARGET vs. Control (83% vs. 65%, p=0.003)

18 Target vs. Control

19 All Patients: Effect of LV Lead Position

20 All Patients: Effect of Scar

21 OR95% CIP value Univariate Regression Analysis Age1.051.01-1.080.007 Male Gender2.090.99-4.430.054 Ischaemic Aetiology1.740.97-3.120.063 QRS duration1.000.98-1.010.47 Scar at LV pacing site2.401.02-5.700.046 Dyssynchrony5.512.9-10.4<0.01 Concordant Lead5.302.8 – 9.96<0.01 Multivariate Regression Analysis Age1.061.01-1.110.018 Male Gender2.851.02-7.960.045 Ischaemic Aetiology1.540.69-3.430.29 QRS duration0.990.97-1.010.22 Scar at LV pacing site3.061.01-9.260.048 Dyssynchrony5.952.78-12.7<0.01 Concordant Lead4.432.09-9.40<0.01

22 Conclusions The TARGET study is the first randomised controlled trial of LV lead targeting Targeted LV lead placement is feasible and associated with enhanced CRT response Concordant LV lead placement, baseline dyssynchrony and pacing away from areas of scar are strongly related to improved CRT outcomes


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