Everything you need to know about His bundle pacing October 20, 2017

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1 Everything you need to know about His bundle pacing October 20, 2017 Gopi Dandamudi, MD FHRS System Medical Director, IUH Cardiac Electrophysiology Program Director, IUH Atrial Fibrillation Center Assistant Professor of Clinical Medicine Indiana University School of Medicine Disclosures Medtronic, Inc.- Consultant, Advisory Board, Steering Committee 10/26/

2 Case 1 75 year old female with complete infra-nodal heart block 15 yrs. ago and VF Underwent dual chamber ICD 2015: RV lead fracture (non-functioning lead) & wide complex ventricular escape rhythm EF declining over the past 3 years (from 54% to 25%); NYHA class II; received chemorx for breast CA Consented to CRT-D upgrade with RV lead revision RV Pacing 2

3 Escape Rhythm with no AVN conduction 10/26/ Case 1 No suitable anatomy for LV lead placement Surgical placement? His bundle pacing? 3

4 EGMs via Pace-Sense Analyzer Post Implant ECG 4

5 Echo at 2 months, EF 50%, NYHA Class I symptoms, His pacing threshold after 2 years 1ms CXR His Lead 5

6 Case 2 19 year old with hx of congenital CHB dx at age 6 Age 17, underwent DDD-PPM 2 years later develops progressive shortness of breath, fatigue & loss of appetite Presented in severe HF, shock liver, multisystem organ failure & evaluation for LVAD & transplant EF 14%, biventricular failure, severe dilatation of both RV and LV 10/26/ Case 2 HF team suspected possible pacing induced cardiomyopathy (PIC) EP consulted for HBP Pt treated with milrinone and dobutamine for 1 week & underwent procedure thereafter 10/26/

7 RV paced ECG (QRS 200 ms) 10/26/ HBP (QRS 128 ms) 10/26/

8 HBP (4 days later); electrical remodeling (QRS 108 ms) 10/26/ Metabolic Profile [VALUE] [VALUE] [VALUE] [VALUE] [VALUE] [VALUE] [VALUE] [VALUE] [VALUE] platelets INR Cr Bili D Bili T BNP ph 10/26/

9 Current Common Ventricular Pacing Techniques RV apical pacing Time tested and still the most common form of pacing RV septal pacing Due to concern related to RV apical pacing May be better? Biventricular Pacing Derived from HF trials and LBBB pts Cardiovascular Outcomes With Atrial-Based Pacing Compared With Ventricular Pacing: Meta-Analysis of Randomized Trials, Using Individual Patient Data Healey et al., Circulation 2006; 114:11-17 Pacing Mode & AF Pacing Mode & Stroke 9

10 MOST (Mode Selection Trial) Sweeney et al., Circulation 2003; 107: Event rates by % Vp during the first 30 days Freedom From Heart Failure DDDR Atrial Fibrillation Incidence DDDR VVIR VVIR DAVID (Dual Chamber and VVI Implantable Defibrillator) Trial Wilkoff et al., AMA 2002; 288(24): pts with ICD indication and no pacing indication, DDDR 70 BPM vs. VVI 40 BPM >40% pacing had worse outcomes 10

11 Effect of right ventricular pacing lead site on left ventricular function in patients with high-grade atrioventricular block: results of the Protect-Pace study Kaye et al., European Heart Journal 2015: 36, RVA vs RV high septal (RVHS), > 90% paced, EF > 50 No difference between the 2 groups EF, HF hospitalization, mortality, AF, BNP, 6 minute walk greater time to place the lead in the RVHS position ( vs min, P, ) longer fluoroscopy times ( vs min, P=0.0001) 1/3 rd of the RVHS patients did not have the lead in the prespecified position BiV pacing to the rescue in patients who need chronic pacing? Two large trials BLOCK-HF & BIOPACE Rationale Clearly BiV pacing is superior in all HF patients with EF <35% and wide QRS (LBBB > 150 ms) It has to be better in patients with CHB who need pacing 11

12 BLOCK-HF (primary endpoint driven by LVSVI change) AB Curtis et al., N Engl J Med 2013; 368: BLOCK-HF (HF urgent visit) AB Curtis et al., N Engl J Med 2013; 368:

13 BIOPACE (Biventricular Pacing for Atrio-ventricular Block to Prevent Cardiac Desynchronization), BioPace Trial Investigators, Preliminary Results Indications for V pacing, any EF (PR >220 ms) Facts about CRT To date, only patients with advanced HF and wide LBBB (>150 ms) clearly benefit from CRT 2013 ACC/AHA/HRS guidelines (sinus, EF <35%, GDMT) Strong recommendation & strong evidence NYHA class III/IV, LBBB>150 ms (weaker evidence for class II) NYHA class III/IV, non-lbbb>150 ms (weak recommendation) NYHA class II/III/IV, LBBB ms (weak recommendation with weak evidence) 10/26/

14 Why should we consider His bundle pacing? Replicates true human physiology (evolution has selected HPS as the most efficient way to activate the ventricles) Lead tip & body potentially within the right atrium Could prevent lead related issues such as tricuspid regurgitation Ideal form of AV and VV (intraventricular and interventricular) Data not convincing for other forms of pacing RV pacing and its detrimental effects BiV pacing equivocal in EF > 35% (BLOCK-HF/BIOPACE) Should eliminate pacing induced cardiomyopathy 27 pts. with LBBB (24 pts. with prolonged HV conduction) 25 pts. with proximal HB stimulation demonstrated identical QRS complexes as baseline QRS (S-QRS=intrinsic HV interval) Pacing slightly distal resulted in narrowing of QRS (S-QRS onset < intrinsic HV interval) 14

15 Seminal Publication P Deshmukh et al., Circulation. 2000;101: Deshmukh et al. published the first clinical experience on human implants 18 pts. (mean age 69± 10 yrs) with chronic AF, dilated cardiomyopathy (EF <40%), QRS <120 ms, NYHA class III-IV HF symptoms AVJ ablation and HBP Showed feasibility in clinical practice 15

16 Permanent His-bundle pacing is feasible, safe, and superior to right ventricular pacing in routine clinical practice (Heart Rhythm, Feb 2015) Permanent His Bundle Pacing for Cardiac Resychronization Therapy Ajijola et al., Heart Rhythm April 2017 HBP successful in 16/21 pts with BBB who qualified for CRT 16

17 J Am Heart Association 2017 Apr 1;6(4) Benefits of Permanent His Bundle Pacing Combined With Atrioventricular Node Ablation in Atrial Fibrillation Patients With Heart Failure With Both Preserved and Reduced Left Ventricular Ejection Fraction Weijian Huang, Lan Su, Shengjie Wu, Lei Xu, Fangyi Xiao, Xiaohong Zhou, Kenneth A. Ellenbogen 10/26/ Acute and long term improvement in LVEDd (left) and LVEF(right) after His bundle pacing in patients with HFrEF Weijian Huang et al. J Am Heart Assoc 2017;6:e Weijian Huang et al. 17

18 Sharma et al. Heart Rhythm October 2017 Group 1: Failed BiV, Non-responders Group 2: Pts with current indications for CRT 10/26/ Sharma et al. Heart Rhythm October /26/

19 HBP Definitions Selective HBP (S-HBP): Easy to recognize: paced QRS morphology identical to intrinsic QRS with an isoelectric segment between pacing stimulus and QRS onset Non-selective HBP (NS-HBP) Fusion between local myocardium and His bundle conduction Can be harder to decipher at times due to wider QRS complex Should see varying QRS morphologies with varying pacing outputs followed by fixed morphology once His bundle capture is lost (septal pacing) Selective HBP 19

20 Non-Selective HBP Non-selective Selective Anatomy of the His bundle A macroscopic anatomical investigation of atrioventricular bundle locational variation relative to the membranous part of the ventricular septum in elderly human hearts Tomokazu Kawashima & Hiroshi Sasaki, Surg Radiol Anat (2005) 27:

21 Anatomy Types Kawashima & Sasaki, Surg Radiol Anat (2005) 27: Type 1 Type 2 Type 3 Type I 21

22 Type I His bundle and minimal RV capture with fusion at higher outputs Pure His capture at lower output His capture thresholds are usually at <1-2 V Type I VVI Pacing ms ms AAI pacing 22

23 Type II Type II Para-Hisian Capture with fusion Almost impossible to obtain Pure His capture without RV fusion. RV capture threshold is lower than His bundle capture Often can get RV myocardial injury current 23

24 Type II EGM 0.05 mv/mm EGM 0.2 mv/mm Type II ms ms 24

25 Type III Type III Direct His bundle capture at all outputs May capture adjacent myocardium at high outputs (3-5V or higher) More likely to get His bundle injury current 25

26 Type III AH V AH V AH V Imaging evaluation of implantation site of permanent direct His bundle pacing lead (Vijayaraman et al., Heart Rhythm (3): ) 26

27 His bundle pacing Correa et al, Circ Arrhythm Electrophysiol Feb;5(1): /26/ Histology Correa et al, Circ Arrhythm Electrophysiol Feb;5(1):244-6 Correa de Sa et al.circ AE

28 64 yo with SCA, heart block, dual chamber ICD, 1.5 yrs later SOB and EF 40% 10/26/ Underlying Rhythm 10/26/

29 HBP- T wave memory changes 10/26/ T waves changes resolved; EF 55% 10/26/

30 52 yo TOF, AT, AVJ abl, CRT, LV lead failure, EF 35% after 3 yrs, referred for CRT-D via His lead 10/26/ Dual chamber PPM with DVIR pacing mode (HBP 1 ms) EF 2 months later 54% 10/26/

31 Fluoroscopy 10/26/ LBBB cardiomyopathy 52 year old female with progressive non-ischemic CM for past 4 years LBBB for past 4 years documented on multiple ECGs On GDMT for > 2 years Appropriately referred for CRT-D Discussed about HBP and patient consented to it 10/26/

32 /26/ /26/

33 2017 pre-procedure 10/26/ Selective HBP 10/26/

34 EF measurements EF 15-20% EF 20% months after HBP- EF 54% Highlights that LBBB induced cardiomyopathy is a real entity GDMT is not enough 10/26/ Current Limitations Tools! Single sheath and lead for all anatomy types and all ages (yet we are achieving relatively high success rates- imagine doing CRT with one lead and one sheath) Devices designed for RV and CRT (sensing, pacing and battery consumption not optimized for HBP) Large scale randomized trials Competes with all other technologies (leadless, biventricular pacing); inertia from companies as it goes against existing pacing platforms such as CRT and leadless pacemakers 10/26/

35 Current Limitations Perception! Still hard to convince some electrophysiologists that HBP is feasible and has the potential to permanently change the pacing landscape We don t really understand the His Purkinje system (both anatomically and functionally) 10/26/ Conclusion HBP is an emerging technique that allows for true physiological pacing It results in true synchronous contraction with atrioventricular, intraventricular and interventricular synchrony Early stages have shown not only feasibility but safety and efficacy Larger randomized trials are needed (vs. RV and BiV pacing) New investments need to be made to improve tools/devices Its current limitations have to be appreciated and respected 35

36 Maurice Maeterlinck ( ) Belgian Playwright, Poet, Nobel Prize in Literature 1911 At every cross road on the road that leads to the future, each progressive spirit is opposed by a thousand men appointed to guard the past Thousand men - current pacing techniques Progressive spirit - HBP #dontdisthehis 10/26/

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