Update on Cardiac Resynchronization Therapy

Transcription

1 Update on Cardiac Resynchronization Therapy Nitish Badhwar, MD, FACC, FHRS Associate Chief, Cardiac Electrophysiology Director, Cardiac Electrophysiology Training Program Stone-Chamberlain Endowed Chair in Cardiology University of California, San Francisco Innovative Procedures, Devices, and State of the Art Care for Arrhythmias, Heart Failure and Structural Heart Disease October 8, 2015 Disclosures Honoraria - St. Jude, Biosense, Senterheart Fellowship Support Medtronic, St. Jude, Boston Scientific, Biotronik, Update on indications CRT optimization Role of imaging 1

2 Burden of Heart Failure Annual incidence 550,000 Incidence 10/1000 population > 65 years Prevalence Acute HF hospitalization 4.7 million 3 million Annual mortality 250,000 LBBB and Heart Failure Narrow QRS EF 47% LBBB EF 30% Deleterious Effects of Ventricular Dyssynchrony Reduced diastolic filling time 1 + Weakened contractility 2 + Protracted mitral regurgitation 2 + Post systolic regional contraction 3 = Diminished stroke volume 1. Grines CL, et al Circulation 1989;79: Xiao HB, et al Br Heart J 1991;66: Søgaard P, et al. J Am Coll Cardiol 2002;40:

3 9/28/15 Cardiac Resynchronization Therapy (CRT) Baseline qrs 160 ms Biv pacing qrs 120 ms Effects on Remodeling Pre CRT Post CRT 3

4 Effects on Remodeling Pre CRT Post CRT Benefits of CRT in Advanced Heart Failure Clinical outcomes Exercise capacity Quality of life Heart failure hospitalization CRT leads to reverse remodeling Mortality benefit (COMPANION, CARE-HF) Sinus rhythm Indications for CRT Advanced heart failure (NYHA Class III or IV) QRS complex duration > 120 ms (Electrical dyssynchrony assumed to be a correlate of mechanical dyssynchrony) Left Ventricle Ejection Fraction (LVEF) < 35% Ischemic or non-ischemic cardiomyopathy Optimal drug therapy for heart failure Strickberger SA et al. Circulation. 2005;111:

5 QRS Duration and Morphology QRS morphology LBBB RBBB Non LBBB QRS duration > 150 ms ms < 120 ms RV Pacing PAVE: BiV vs RV pacing in pts with AF and AVN ablation Doshi et al. JCE 2005;Vol 16:

6 Block HF: CRT in pts with AV block and mild LV dysfunction (EF 50%) Event-free Rate (%) Right ventricular pacing Biventricular pacing Months No. at Risk Biventricular pacing Right ventricular pacing Curtis AB et al. NEJM 2013;368(17): Indications for CRT Sinus rhythm class I indication RV pacing induced class IIa indication Atrial fibrillation class IIa indication Can CRT benefit patients with early heart failure REVERSE REMODELING WITH CRT (BIV) in NYHA Class III-IV DYSFUNCTIONAL REMODELING Early Late LV MI CRT LV MI LV MI Remodeling Can CRT prevent this? LV MI EF=0.20 EF=0.36 EF=0.30 EF=0.20 NYHA III-IV NYHA II-III NYHA I-II NYHA III-IV ECG ECG QRS = 0.15s QRS = 0.14s QRS = 0.12s QRS = 0.16s 6

7 CRT and mild HF (NYHA II) MADIT CRT, RAFT, MIRACLE-ICD II, REVERSE Improved mortality and hospitalization Lead to LV reverse remodeling Santangeli P et al. JICE. 2011;32(2): QRS Morphology and CRT MADIT-CRT: Outcome by LBBB & Non-LBBB HR=0.45 P=0.001 HR=1.25 P=0.25 QRS duration and CRT CRT-D:ICD Hazard Ratios for Prespecified Subgroups Significant Sex-Rx Interaction Significant QRS-Rx Interaction CRT-D Better ICD-only Better 7

8 Tracy et al Device-Based Therapy Guideline Focused Update JACC Vol. 60, No. 14, 2012 October 2, 2012: /28/15 Appendix 3. Indications for CRT Therapy Algorithm JACC Vol. 60, No. 14, 2012 October 2, 2012: CRT Guideline Update Tracy et al Device-Based Therapy Guideline Focused Update Table 2. Recommendations for CRT in Patients With Systolic Heart Failure 2012 DBT Focused Update Recommendations Comments Class I 1. CRT is indicated for patients who have LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration greater than or equal to 150 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT. (Level of Evidence: A for NYHA class III/IV (16 19); Level of Evidence: B for NYHA class II (20,21)) Class IIa 1. CRT can be useful for patients who have LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration 120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT (16 18,20 22). (Level of Evidence: B) 2. CRT can be useful for patients who have LVEF less than or equal to 35%, sinus rhythm, a non-lbbb pattern with a QRS duration greater than or equal to 150 ms, and NYHA class III/ambulatory class IV symptoms on GDMT (16 18,21). (Level of Evidence: A) Modified recommendation (specifying CRT in patients with LBBB of!150 ms; expanded to include those with NYHA class II symptoms). New recommendation New recommendation 3. CRT can be useful in patients with atrial fibrillation and LVEF less than or equal to Modified recommendation (wording changed to indicate benefit 35% on GDMT if a) the patient requires ventricular pacing or otherwise meets CRT based on ejection fraction rather than NYHA class; level of criteria and b) AV nodal ablation or pharmacologic rate control will allow near 100% evidence Update. changed from C to B).2012;60 (14): ACCF/AHA/HRS Focused JACC. ventricular pacing with CRT (23 26,26a,48). (Level of Evidence: B) 4. CRT can be useful for patients on GDMT who have LVEF less than or equal to Modified recommendation (wording changed to indicate benefit CRT indicates cardiac resynchronization therapy; CRT-D, cardiac resynchronization therapy defibrillator; GDMT, guideline-directed medical therapy; ICD, implantable 35% and are undergoing new or replacement device placement with based on ejection fraction and need for pacing rather than cardioverter-defibrillator; LV, left ventricular; LVEF, left ventricular ejection fraction; LBBB, left bundle-branch block; MI, myocardial infarction; and NYHA, New York anticipated requirement for significant (#40%) ventricular pacing (25,27 29). NYHA class); class changed from IIb to IIa). Heart Association. (Level of Evidence: C) Class IIb 1. CRT may be considered for patients who have LVEF less than or equal to 30%, New recommendation ischemic etiology of heart failure, sinus rhythm, LBBB with a QRS duration of greater than or equal to 150 ms, and NYHA class I symptoms on GDMT (20,21). (Level of Evidence: C) 2. CRT may be considered for patients who have LVEF less than or equal to 35%, sinus New recommendation rhythm, a non-lbbb pattern with QRS duration 120 to 149 ms, and NYHA class III/ambulatory class IV on GDMT (21,30). (Level of Evidence: B) 3. CRT may be considered for patients who have LVEF less than or equal to 35%, sinus New recommendation rhythm, a non-lbbb pattern with a QRS duration greater than or equal to 150 ms, and NYHA class II symptoms on GDMT (20,21). (Level of Evidence: B) Class III: No Benefit 1. CRT is not recommended for patients with NYHA class I or II symptoms and nonnew recommendation LBBB pattern with QRS duration less than 150 ms (20,21,30). (Level of Evidence: B) 2. CRT is not indicated for patients whose comorbidities and/or frailty limit survival with Modified recommendation (wording changed to include cardiac good functional capacity to less than 1 year (19). (Level of Evidence: C) as well as noncardiac comorbidities) CRT Guideline Update See Appendix 3, Indications for CRT Therapy Algorithm. CRT indicates cardiac resynchronization therapy; DBT, device-based therapy; GDMT, guideline-directed medical therapy; LBBB, left bundle-branch block; LVEF, left ventricular ejection fraction; and NYHA, New York Heart Association. is less compelling than in the presence of LBBB (45 47). The mary endpoint of death or hospitalization for HF in patients with impact of the specific QRS morphology on clinical event QRS duration!150 ms (HR: 0.58; 95% CI: 0.50 to 0.68; reduction with CRT was evaluated in a meta-analysis of 4 p! ) but not in patients with QRS duration!150 ms clinical trials including 5,356 patients (43). In those with (HR: 0.95; 95% CI: 0.83 to 1.10; p"0.51) (42). In addition, LBBB, CRT significantly reduced composite adverse clinical subgroup analyses from several studies have suggested that a Update. JACC. (14): events (RR:Focused 0.64; 95% CI: 0.52 to 2012; ; p" ). No QRS duration!150 ms is a risk factor for failure to respond toaccf/aha/hrs benefit was observed for patients with non-lbbb conduction CRT therapy (43,44). The observed differential benefit of CRT abnormalities (RR: 0.97; 95% CI: 0.82 to 1.15; p"0.75). was seen across patients in NYHA classes I through IV. It has Specifically, there was no benefit in patients with right not been possible to reliably identify those with shorter QRS bundle-branch block (RR: 0.91; 95% CI: 0.69 to 1.20; durations who may benefit. Patients with shorter QRS durations p"0.49) or nonspecific intraventricular conduction delay who otherwise qualify for CRT are afforded Class II recommen(rr: 1.19; 95% CI: 0.87 to 1.63; p"0.28). Overall, the dations in these guidelines. difference in effect of CRT between LBBB versus non-lbbb An additional difference in the present document compared patients was highly statistically significant (p"0.0001) (43). with the 2008 DBT guideline (4) is the limitation of the Nevertheless, other studies have shown that CRT is more likely recommendation for Class I indication to patients with LBBB to be effective in patients with advanced HF and non-lbbb pattern as compared to those with non-lbbb. For patients morphologies if they have a markedly prolonged QRS duration with QRS duration!120 ms who do not have a complete (21,30) (see RAFT [Resynchronization-Defibrillation for AmLBBB (non-lbbb patterns), evidence for benefit with CRT CRT in narrow QRS patients: Negative study To Test the Hypothesis that CRT Can Help Heart Failure Patients With Narrow QRS if they have a positive Dyssynchrony Echo Dyssynchrony Echo NARROW QRS + 8

9 Update on indications CRT optimization Role of imaging Cardiac Resynchronization Therapy 30% patients with HF NYHA III-IV qualify for CRT based on EKG criteria 30-40% patients with HF NYHA III-IV and narrow QRS who do not qualify for EKG criteria for CRT have evidence of mechanical dyssynchrony by imaging 30% patients do not respond to CRT 10-29% patients show super or hyper response with EF > 50% and NYHA I Poor Responders to CRT RBBB Ischemic cardiomyopathy NYHA IV Advanced age Discordant LV lead and myocardial scar 9

10 Non responders : Medical causes Suboptimal HF therapy Mitral regurgitation +/- ischemia Comorbidities (COPD, anemia, arthritis, amiodarone) End stage heart disease Restricitve pattern on echo RV dysfunction Non responders : Device causes Lower % BiV pacing due to AT/AFib/Aflutter with rapid ventricular rates Higher threshold with loss of LV capture Lead dislodgement Phrenic stimulation Anodal stimulation Inadequate rate response Suboptimal PV or AV delay Suboptimal V-V timing LV lead position LV dyssynchrony ECG to Assess BiV Pacing BIV capture produces a rightward axis (negative or initial negative in leads I, AVL and positive in avr) and R>S in lead V 1. R S ratio 1 in lead V 1, q in lead I, R-S ratio of 1 in lead I suggest BIV pacing. 12 lead ecg in basal post lat vein does not give complete negative complex in 1, avl..it looks like LBBB with narrower QRS. 10

11 Maximizing Biventricular Pacing Options for patients at risk of rapid intrinsic conduction? Maximizing beta-blocker therapy Negative AV/PV hysteresis ensures constant ventricular pacing by shortening the AV/PV delay if intrinsically conducted R waves are sensed. Biv trigger pacing; adaptive CRT AV Junction ablation in patients with Atrial fibrillation and rapid ventricular conduction (< 85% biv pacing) AV and VV optimization Echo based (Mitral inflow and Aortic VTI) EKG based EGM based (through the device) AV and V-V Optimization Statistically speaking: the average optimal AV delays were between ms, and the average optimal V-V delays were between ms. In almost all studies, approximately 60% of all patients were paced LV first. 11

12 Update on indications CRT optimization Role of imaging Mechanical Dyssynchrony Electrical dyssynchrony (wide QRS) = Mechanical dyssynchrony Some patients with wide QRS may not have mechanical dyssynchrony Narrow QRS patients with heart failure may have mechanical dyssynchrony A B 12

13 Equilibrium Radionuclide Angiogram (ERNA) Dyssynchrony - A Dyssynchrony + B B The Solution Need imaging modality that reliably measures mechanical dyssynchrony Echo MRI / CT ERNA (Equilibrium radionuclide angiogram) Role of ERNA to select patients for CRT A combined preoperative value of S 0.88 and E > 0.69 predicted clinical improvement in 86% of the patients after CRT. The remainder showed clinical improvement only in 56% of the patients. Badhwar N et al. J Nucl Med. 2008;49(1):274P. 13

14 Levophase for Coronary Sinus Anatomy Coronary Sinus Anatomy Anterior Anterolateral Lateral Posterolateral Posterior LV lead position and Clinical Outcomes Anterior, posterior and lateral position Apical versus Non-apical position No difference among Anterior, Posterior and Lateral lead positions Apical lead positions associated with a significantly worse clinical outcome Singh J P et al. Circulation 2011;123:

15 LV Lead Concordance with Latest Activated Segment by ERNA Predicts Improvement after CRT CRT Non-Response:Postlateral Aneurysm by Echo I avr V1 V4 II avl V2 V5 III avf V3 V6 LV pacing in scar region Long delay from stimulus to LV capture No benefit derived from BiV pacing, can even lead to worsening of symptoms due to RV pacing Rarely can lead to ventricular tachycardia in patients with ischemic heart disease (inferoposterior MI) Role of viability assessment (PET scan, MRI) 15

16 Role of Imaging in CRT Dyssynchrony evaluation Predict response in patients with QRS >150 ms Select patients with QRS ms and < 120 ms (pending results of ECHO CRT) Select patient with non LBBB and RBBB Guiding LV lead placement Assessment of coronary sinus anatomy Assessment of scar and viability Optimization of CRT with echo Baseline ECG Virtual CRT Imaging to assess mechanical dyssynchrony, scar and area of latest LV contraction Body surface map to assess latest electrical activation CT / MRI to assess coronary sinus anatomy Heart model to predict response to CRT Plan coronary sinus vs endocardial LV vs surgical epicardial LV lead placement based on imaging Thank you 16