This is What I do to Improve CRT Response for CRT Non-Responders
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1 This is What I do to Improve CRT Response for CRT Non-Responders Michael R Gold, MD, PhD Medical University of South Carolina Charleston, SC Disclosures: Steering Committees (unpaid) and Clinical Trials, Medtronic, Boston Scientific, St Jude
2 Nonresponders Most clinical studies report CRT nonresponder rates of about 30% This percentage remained stable over two decades of trials involving both severe and mild heart failure However, the non-response rate is very dependent on endpoint measured and time
3 Nonresponder Rates
4 Nonresponders Non-responders exist & magnitude of response is variable Birnie. Curr Opin Cardiol. 2006;21:20-26.
5 What defines a responder vs. "non-responder"? Status CRT Implantation Super- Responder Responder "Non progressor" Negative responders Non-responder Time Steffel & Ruschitzka, Circulation 2015
6 Determinants of Response: 1 THE APPROPRIATE PATIENT 2 VENTRICULAR LEAD PLACEMENT 3 OPTIMAL PROGRAMMING & FOLLOW UP 16
7 First Principles: Prevent non-responders by patient selection. Clinical predictors of response rate Women Non-ischemic Cardiomyopathy QRS duration LBBB Clinical predictor of poor response Inotropic dependent Scar
8 BBB Morphology and Width after CRT-D Outcomes Among 24,169 Medicare Beneficiaries All-Cause Mortality by QRS Morphology and Width All-Cause Readmission by QRS Morphology and Width Peterson et al. JAMA 2013.
9 Ruschitzka et al. NEJM 2013 CRT in Narrow QRS
10 Resynchronization Therapy Electrical Fix For a Complex Problem Truong QA, et al; Critical Pathways in Cardiology 2008
11 LV Lead Position Traditionally, LV leads are placed by anatomic criteria on the lateral wall of the left ventricle More recent studies have not supported solely using anatomic guidance, other than avoiding the apex However, recent studies have shown the importance of physiologic guidance of lead placement
12 LV Lead Position & Clinical Outcome Death &/or Heart Failure Anterior, posterior and lateral position Apical versus Non-apical position No difference amongst Anterior, Posterior and Lateral lead positions Apical lead positions associated with a significantly worse clinical outcome Differences maintained even after non-apical leads sub-stratified into midventricular and basal
13 REVERSE LV Lead Analysis: Apical vs Non-Apical C Thébault et Al Eur Heart J 2012
14 REVERSE: LV lateral vs LV Non-lateral CThébault et Al Eur Heart J 2012
15 Imaging Guided LV Lead Positioning TARGET & STARTER TARGET: Khan JACC 59:1509, 2012 RCT of 220 CRT pts Control: post-lat / lat CS branch Targeted: 2D echo speckle-tracking: latest activated segment LV pacing concordance Control: 47% Targeted: 63% STARTER: Saba Circ HF 6:427, 2013 RCT of 187 CRT pts Also used speckle-tracking ECHO LV pacing concordance Control: 66% Targeted: 85%
16 Physiologic Guided Lead Positioning: QLV Interval Measurement
17 %LV+ dp/dtmax Q-LV Interval to Predict Acute Response R = Q-LV (ms) R NR Gold et al, J Cardiovasc Electrophysiol 2014
18 Impact of QLV on Reverse and QOL with CRT Gold et al, Eur Heart J. 2011
19 % OF PATIETNS QLV and Reduction in MR at 6 Months 70 3 Months Post-Implant 6 Months Post-Implant P, across P, across MR grade MR grade = 0.03 = 0.93 P, across P, across MR MR grade grade = 0.03 = 0.03 P, across MR grade Baseline 3 Months Post-Implant 6 Months Post-I Longer 48 QLV associated with MR at months 0 None/Mild Moderate Severe Severe None/Mild Moderate Severe Severe None/Mild Moderat QLV 95 msec QLV <95 QLV >95 QLV < 95 msec QLV <95 QLV >95 Chatterjee, Gold, et al, Heart Rhythm 2016
20 Relationship between Electrical Intervals and Anatomical Locations Most leads were placed in the anterolateral or posterolateral veins, as reported by the implanting physicians Mid-anterolateral (n=89): QLV range = ms Mid-posterolateral (n=230): QLV range = ms
21 Interventricular Conduction Delay The electrical time between RV and LV leads is a surrogate for QLV (LV delay) It measures the electrical resynchronization that will occur with biventricular stimulation It is a simple measure that can be manually or automatically measured by devices
22 Interventricular Electrical Delay
23 Association of RV-LV Time with LV Remodeling and QOL
24 RV-LV Time: SMART AV
25 RV-LV Time and Clinical Outcome: PEGASUS
26 Pacing site Importance of CRT Outcome Patient selection Right Wrong R i g h t W r o n g + - / + - Same considerations for devices optimization
27 LVESV Response by Subgroup Univariate Logistic Regression Results
28 FREEDOM Trial Results: Primary Endpoint HF Clinical Composite Score (Intent-to-Treat Analysis) Treatment Control HF CCS n % n % p-value Improved Unchanged Worsened Total No treatment differences in pre-specified ischemic and non-ischemic sub groups
29 SMART AV
30 ADAPTIVE CRT Martin et al Heart Rhythm 2012
31 Response rate (%) CLEAR: Primary Endpoint Clinical response rate to CRT (composite criterion) 100% 80% 60% 78% 62% 40% 20% p= % SonR group (n=87) Control group (n=99) *Composite criterion including NYHA functional class, death from any cause, deaths and hospitalizations for management of HF, and QOL Free from deaths / HF hospitalizations 84% 75% 0.13 NYHA class decrease 81% 64% QOL score increase 74% 65% 0.19
32 Are We Thinking About AV Optimization Wrong? We can not always turn lemons into lemonade! A nonresponder may be a nonresponder (narrow QRS, scar, lead position) However, optimal pacing may maximize a positive response
33 Changes in LVESV as a function of QLV and AV optimization
34 Adaptive LV Pacing Subgroup Analysis Patients with Higher Percentage Synchronized LV Pacing in the acrt Arm had a lower rate of death and HF hospitalizations Logrank P = Birnie D. et al., Heart Rhythm 2013.
35 PEGASUS: HF Hospitalizaton or Death
36 Impact of BiV pacing % on Survival with CRT Hayes et al, Heart Rhythm 2011
37 Consider Reversible Causes Non-responder Atrial Fibrillation Volume Status Cardiac Ischemia Other Co-morbidities Maintain NSR Rate control (AVN vs. MED) Adjust upper pacing rate Program VVIR/VS Response Individualize strategy (LV) Rule out ischemia Treat ischemia Depression COPD Arthritis Anemia etc.
38 Evaluation of Non-responder Is it an inappropriate candidate Consider a trial of no CRT Assess for reversible and treatable causes Lead dislodgement Loss of capture Atrial fibrillation Metabolic or medical issues exacerbating HF Low LV pacing percentage Consider interventions to improve CRT response Optimize medical regimen Programming AV delays or rate to improve LV pacing Invasive lead reposition or additions
39 The Initial Evaluation NON-RESPONDER CXR Lateral Wall (Mid-Ventricular) LV and RV capture AF Device Interrogation Dislodged into CS ECG Lead Position
40 CRT Follow-Up Clinic Altman R / Singh JP et al, AHA 2011 Altman R / Singh JP et al, AHA 2011
41 Summary There are many definitions of CRT response with no consensus on the best choice In practice, non-responders are classified by subjective assessment. However, given the placebo effect of device implantation this should be supplemented with some objective criteria such as exercise or echo response A systematic approach to the evaluation and treatment of nonrepsonders is vital, including device evaluation, HF status and noncardiac contributing causes Multidisciplianry clinics can reduce nonresponder rates
42 Electrical Targeting in non-lbbb Clinical & Echocardiographic outcome Intra-procedural left ventricular lead electrical delay LVLED in non-lbbb a determinant of outcome Graded remodeling response IVCD (32) RBBB (18) LBBB (71) Kandala J et al. European Heart Journal 2013
43 FREEDOM Trial Results: Primary Endpoint HF Clinical Composite Score (Intent-to-Treat Analysis) Treatment Control HF CCS n % n % p-value Improved Unchanged Worsened Total No treatment differences in pre-specified ischemic and non-ischemic sub groups
44 CRT Response Evaluation
45 Clinical Case 68 y/o woman, DCM, NYHA III Medications: Carvedilol, lisinopril, spironolactone, furosemide ECG: LBBB (QRS 162 msec, PR 208 msec) LVEF: 25%, LVEDD: 66 mm The perfect CRT-D candidate!
46 In which vein to Implant?
47 Which targeted position? 2 1
48 Pragmatic consideration: lead stability
49 170 ms RV LV 94 ms LV
50 BiV pacing
51 BiV pacing
52 BiV pacing
53 Percentage Hospitalized for HF or Died REVERSE 30% 25% 20% 15% 10% HR (95%CI): 0.38 ( ) P=0.003 CRT OFF 24.0% 11.7% 5% 0% Months Since Randomization CRT ON Number at Risk CRT OFF CRT ON Daubert C. J Am Coll Cardiol. 2009;54(20):
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