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Whats new in CRT? Research support VA, AHA, Janssen, Medtronic, - PDF document

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12/3/17 Disclosures Whats new in CRT? Research support VA, AHA, Janssen, Medtronic, Cardiva, AstraZeneca, Boehringer Ingelheim, Apple, Bristol-Myers Squibb MINTU TURAKHIA, MD MAS Associate Professor of Medicine

  1. 12/3/17 Disclosures What’s new in CRT? § Research support § VA, AHA, Janssen, Medtronic, Cardiva, AstraZeneca, Boehringer Ingelheim, Apple, Bristol-Myers Squibb MINTU TURAKHIA, MD MAS Associate Professor of Medicine § Advisor/Consultant/Equity Executive Director, Center for Digital Health § Abbott, Medtronic, Boehringer Ingelheim, Zipline Medical, Stanford University Precision Health Economics, AliveCor, Armetheon, Akebia, Director, Cardiac Electrophysiology VA Palo Alto Health Care System iBeat, Forward mintu@stanford.edu § Lecture honoraria @leftbundle § Medtronic, Abbott Native BiV Pacing QRS 160 msec QRS 120 msec 1

  2. 12/3/17 Indications for CRT-D CRT trials NYHA QRS* Sinus ICD? § In EF < 35% + optimal medical therapy MIRACLE III, IV ≥ 130 Normal No MUSTIC SR III >150 Normal No § Most likely to benefit (Class I) MUSTIC AF III >200 † AF No § NYHA class III/IV, LBBB>150 ms PATH CHF III, IV ≥ 120 Normal No CONTAK CD II-IV ≥ 120 Normal Yes § Less likely (Class IIa) MIRACLE ICD II-IV ≥ 130 Normal Yes § NYHA class II/III/IV, LBBB 120-149 ms PATH CHF II III, IV ≥ 120 Normal No COMPANION III, IV ≥ 120 Normal No § NYHA class III/IV, non-LBBB>150 ms CARE HF III, IV ≥ 120 Normal No RETHINQ III < 130 Normal Yes § Nonischemics respond better MADIT-CRT I, II ≥ 130 NSR, AF Yes RAFT II, III ≥ 120 NSR, AF/L Yes CRT Improves QOL and NYHA class CRT Improves Exercise Capacity 6-Min Walk Peak VO 2 Exercise Time QOL Score NYHA Class MIRACLE 1 (N=453) ↑ ↑ ↑ MIRACLE 1 (N=453) Randomized ↓ ↓ MIRACLE ICD 2 (N=247) ↔ ↑ ↑ Randomized MIRACLE ICD 2 (N=247) ↓ ↓ MUSTIC 3 (N=67) ↑ ↑ na MUSTIC 3 (N=67) ↓ na PATH CHF 4 (N=41) ↑ ↑ na PATH-CHF 4 (N=41) ↓ ↓ CONTAK CD 5 (N=203) na ↑ ↑ CONTAK CD 5 (N=203) ↓ ↓ French Pilot 6 (N=50) Observational na na Observational ↑ French Pilot 6 (N=50) na ↓ InSync–Europe 7 (N=103) na na ↑ InSync–Europe 7 (N=103) ↓ ↓ InSync ICD–Europe 8 (N=84) na na ↑ InSync ICD–Europe 8 (N=84) ↓ ↓ 1. Abraham WT, et al. N Engl J Med. 2002;346:1845-1853. 1. Abraham WT, et al. N Engl J Med. 2002;346:1845-1853. 2. Young JB, et al. JAMA. 2003;289:2685-2894. 2. Young JB, et al. JAMA. 2003;289:2685-2894. 3. Cazeau S. N Engl J Med. 2001;344:873-880. 3. Cazeau S. N Engl J Med. 2001;344:873-880. 4. Auricchio A, J Am Coll Cardiol. 2002;39:1895-1898. 4. Auricchio A. J Am Coll Cardiol 2002;39:1895-1898. 5. Thackery S, et al. Eur J Heart Fail. 2001;3:491-494. 5. Thackery S, et al. Eur J Heart Fail. 2001;3:491-494. 6. LeclercqaC. Am Heart J. 2000;140(6):862-870. 6. Leclercq C. Am Heart J. 2000;140(6):862-870. 7. Gras D. Eur J Heart Fail. 2002; 4 311–320. 7. Gras D. Eur J Heart Fail. 2002;4311-4320. 8. Kühlkamp V. J Am Coll Cardiol 2002;39:790-797 8. Kühlkamp V. J Am Coll Cardiol 2002;39:790-797. 2

  3. 12/3/17 CRT Improves Cardiac Structure and Meta-analysis for mortality Function LVEDV/ LV Filling LVEF MR LVESV Time Queen Mary Hospital 1 ↑ ↓ ↓ ↑ MIRACLE 2 ↑ ↓ ↓ ↑ PATH CHF 3,4 ↑ na ↓ ↑ MUSTIC 5 na ↓ na ↑ MIRACLE ICD 6 ↔ * ↔ ↓ ↑ *Favorable trend, P =0.06 1.Yu C-M. Circulation. 2002;105:438-445. Absolute risk reduction (unweighted): 4.6% 2.St. John Sutton MG. Circulation. 2001;104(suppl 2):II-618 (abstract). 3.Breithardt OA. Am Heart J. 2002;143:34-44. 4.Stellbrink C. J Am Coll Cardiol. 2001;38:1957–1965. § Conclusion: CRT improves survival 5.Linde C. J Am Coll Cardiol. 2002;40:111-118. 6.Young JB, et al. JAMA. 2003;289:2685-2894. (Wells G, CMAJ 2011) QRS duration and response Guidelines QRS > 150 § Class I (“is indicated”) § LVEF ≤ 35%; sinus; LBBB QRS ≥ 150, NYHA II-IV § Class IIa (“can be useful”) § LBBB QRS 120-149 § non-LBBB QRS ≥ 150; NYHA III-IV § AF, EF ≤ 35% with near 100% BiV pacing § LVEF ≤ 35% with > 40% RV pacing expected QRS < 150 § Class IIb (“may be considered”) § LVEF ≤ 30%, ischemic NYHA I § non-LBBB QRS 120-149; NYHA III-IV § non-LBBB QRS ≥ 150; NYHA II Epstein AE, et al. 2012 ACCF/AHA/HRS focused update (Sipahi I, Arch Int Med, 2011) 3

  4. 12/3/17 BLOCK-HF § AV block with LVEF < 50% § NYHA I-III on optimal medical therapy What about in mild to § CRT-P or CRT-D implanted § Randomized to RV or BiV pacing moderate LV dysfunction? § 40-50% with AF § Time to composite § Death § HF exacerbation § LVESV increase of 15% (Curtis AB, NEJM 2013) § Time to death or HF exacerbation § HR 0.73 (0.57- What if my patients has 0.92) § Also atrial fibrillation? improvements in reverse remodeling (LVESV Curtis AB, NEJM 2013 4

  5. 12/3/17 CRT trials did not evaluate AF patients Improvement in EF § Virtually all CRT trials evaluated resychronization of § Change in EF: greater benefit in AF sinus rhythm § AF was a key exclusion § AF is very common HF (~20-30%) § Prevalence of AF increases with increase NYHA severity Upadhyay G / Singh J, JACC 2008 Reverse remodeling (LVESV) Benefit of AVN ablation in CRT with AF Gasparini M, JACC HF , 2013 Wilton SB / Exner D, Heart Rhythm 2011 5

  6. 12/3/17 Marrouche N, ESC 2017 (unpublished) Marrouche N, ESC 2017 (unpublished) AF and CRT: summary § In patients with AF, decreased EF, and heart failure, CRT is effective, if… § Virtually 100% BiV pacing (usually permanent AF) New Developments § Low threshold for AV Node ablation § Strongly consider restoration of sinus rhythm first (ablation) , especially if AF rhythm, not just rate, is HF trigger 6

  7. 12/3/17 Nonresponder rate: ~ 30-40% Insights from a CRT clinic LV lead issues § Phrenic nerve stimulation § LV pacing vector § LV pacing thresholds § Lead stability 4.7F lead body 5.3F lead body 5.2F lead body 4.0F tip 5.1F “swell” on 2.6F tip S-Curve electrodes Asymmetric Optim insulation 3 curves spacing on spiral 7

  8. 12/3/17 LV lead deactivation-free survival Customizable pacing vectors Prox 4 Mid 3 RV Coil Mid 2 Distal 1 Turakhia M, et al . JACC EP, 2016. LV lead replacement-free Cumulative Shock Burden survival Bipolar at Risk Bipolar Events Quadripolar at Risk Turakhia M, et al . JACC EP, 2016. Quadripolar Events 8

  9. 12/3/17 Summary: benefits of quadripolar CRT Multipoint pacing Implant success rate 1,2 95 – 97% Response rate 1 71.3% Dislodgement 1,2 2.7 – 3.5% Resolution of PNS 100% Reduced fluoroscopic exposure 48% Risk of inactivation 0.62 (0.46-0.84) Risk of replacement HR 0.67 (0.55-0.83) Risk of death HR 0.77 (0.68-0.86) Risk of shocks HR 0.74 (0.57-0.96) Decreased health care utilization Forleo GB, Heart Rhythm ; 2012; Tomassoni G, JCE 2013; Hussain M, PACE 2013; Della Rocca, Int J Card 2012. Multipoint pacing challenging § RCT of 44 patients § What is the optimal programming? § LV structural § Too many vectors outcome § Symptom-pacing correlation § No RCT § Still… data with § Benefits likely to emerge clinical § Most quadrapolar generators support or will support outcomes MPP § “Future-proofing” strategy Pappone C, Heart Rhythm, 2015 9

  10. 12/3/17 His bundle pacing: a new paradigm? § Replicates true physiology § Most efficient way to stimulate the Can we simplify a little? ventricles § Only form of pacing that where activation is physiologic 9/13/17 2 weeks later: NYHA class I 56 yo WF with NICM, EF 20%, NYHA III for 2 yrs, prior chemotherapy Courtesy of Gopi Dandamudi MD Courtesy of Gopi Dandamudi MD 9/13/17 10

  11. 12/3/17 Permanent His Bundle Pacing for CRT ECG 2 months later (EF 12 months later 50%) § HBP successful in 16/21 CRT- eligible patients Ajijola et al., Heart Rhythm April 2017 Courtesy of Gopi Dandamudi MD Reverse remodeling is sustained His bundle pacing § May avoid lead related tricuspid regurgitation Correa et al., Circ AE 2012 Courtesy of Gopi Dandamudi MD Huang, W et al. J Am Heart Assoc , 2017 11

  12. 12/3/17 Summary § CRT-D is stable and mature with clear benefit in carefully-selected populations § CRT-P has a role in moderate LV dysfunction with high expected pacing burden § Quadrapolar leads are the standard; multipoint pacing seems promising but how to optimize is unclear § His bundle pacing will continue to gain traction and may replace conventional RV (and BiV) pacing Potential effects of MRI on CIEDs § Leads § Excessive heating from induced currents Thank you ! § Generator § Modification of pacemaker function § Pacing, shocks § Inappropriate sensing or triggering of the device mintu@stanford.edu @leftbundle 12

  13. 12/3/17 MRI Conditional Devices § Generator § Less ferromagnetic material § Improved circuitry protection § No “reed” switch § Leads § Inner coil with two filars rather then four § “Smaller antenna” § Retroactive conditional approval Are MRIs safe in non-conditional CIEDs? § Yes, most of the time § Caveats § No uniformly safe MRI protocol § “Absolute contra-indication” is the rule § Not covered by Medicate § Legal precedent not established § Find a center willing to do this (Russo RJ, AHA 2014) 13

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