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

Gopi Dandamudi, MD FHRS

System Medical Director, IUH Cardiac ElectrophysiologyProgram Director, IUH Atrial Fibrillation CenterAssistant Professor of Clinical MedicineIndiana University School of Medicine

Disclosures

• Medtronic, Inc.- Consultant, Advisory Board, Steering Committee

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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

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Escape Rhythm with no AVN conduction

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Case 1

• No suitable anatomy for LV lead placement

• Surgical placement?

• His bundle pacing?

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EGMs via Pace-Sense Analyzer

Post Implant ECG

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Echo at 2 months, EF 50%, NYHA Class I symptoms, His pacing threshold after 2 years 1.75V @ 1ms

CXR

His Lead

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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

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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

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RV paced ECG (QRS 200 ms)

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HBP (QRS 128 ms)

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HBP (4 days later); electrical remodeling (QRS 108 ms)

Metabolic Profile

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124 [VALUE] 104 111[VALUE] 174 193 198 212 234 256

2.8 2.712.03 1.8 1.92 1.84 1.7 [VALUE] 1.51 1.45 1.32 1.23 1.17 1.12 1.14 1.08

1.53 1.41 1.41 1.51 1.46 1.37 [VALUE] 1.331.07 1.04

0.87 0.9 0.871.07 0.95 1

0.81 0.870.71

5.66.7

8.2 8.4 9.5

13.8

[VALUE] 7.8 6.8 6.75.5

4.73.8

13.6 14.116.5 17.3 19.6 20.8

[VALUE]13.9 12.4 12.1

10.38.8

7.1

[VALUE][VALUE] 795

635

379

7.51 7.53 7.59 7.6 [VALUE] 7.44 7.45 7.44 7.42 7.42 7.44

0.5

5

50

500

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

platelets INR Cr Bili D Bili T BNP pH

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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

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MOST (Mode Selection Trial)Sweeney et al., Circulation 2003; 107:2932-2937

Freedom From Heart Failure Atrial Fibrillation Incidence

DDDR

VVIR

DDDR

VVIR

Event rates by % Vp during the first 30 days

DAVID (Dual Chamber and VVI Implantable Defibrillator) Trial Wilkoff et al., AMA 2002; 288(24):3115-3123

• >40% pacing had worse outcomes

506 pts with ICD indication and no pacing indication, DDDR 70 BPM vs. VVI 40 BPM

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Effect of right ventricular pacing lead site on left ventricular function in patients with high-grade atrioventricular block: results of the Protect-Pace studyKaye et al., European Heart Journal 2015: 36, 856–862

• 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 (70

+ 25 vs. 56 + 24 min, P , 0.0001) – longer fluoroscopy times (11 + 7 vs. 5 + 4 min,

P=0.0001)

• 1/3rd of the RVHS patients did not have the lead in the prespecified position

RVA vs RV high septal (RVHS), > 90% paced, EF > 50

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

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BLOCK-HF (primary endpoint driven by LVSVI change) AB Curtis et al., N Engl J Med 2013; 368:1585-1593

BLOCK-HF (HF urgent visit)AB Curtis et al., N Engl J Med 2013; 368:1585-1593

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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 120-149 ms (weak recommendation with weak

evidence)

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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)

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Seminal Publication P Deshmukh et al., Circulation. 2000;101:869-877

• 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

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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 TherapyAjijola et al., Heart Rhythm April 2017

• HBP successful in 16/21 pts with BBB who qualified for CRT

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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 FractionWeijian Huang, Lan Su, Shengjie Wu, Lei Xu, Fangyi Xiao, Xiaohong Zhou, Kenneth A. Ellenbogen

J Am Heart Association 2017 Apr 1;6(4)

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:e005309© 2017 Weijian Huang et al.

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

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Sharma et al. Heart Rhythm October 2017

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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

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Non-selective Selective

Non-Selective HBP

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: 206–213

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Anatomy Types Kawashima & Sasaki, Surg Radiol Anat (2005) 27: 206–213

Type 1 Type 2

Type 3

Type I

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• 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

Type I

VVI Pacing 2 V @ 0.5 ms 1 V @ 0.5 ms AAI pacing

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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

Type II

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Type II

EGM 0.05 mV/mm

EGM 0.2 mV/mm

Type II

2 V @ 0.5 ms 1 V @ 0.5 ms

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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

Type III

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Type III

AHV

AHV

AHV

Imaging evaluation of implantation site of permanent direct His bundle pacing lead (Vijayaraman et al., Heart Rhythm 2014 11(3): 529-30)

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His bundle pacing Correa et al, Circ Arrhythm Electrophysiol. 2012 Feb;5(1):244-6

Histology Correa et al, Circ Arrhythm Electrophysiol. 2012 Feb;5(1):244-6

Correa de Sa et al.Circ AE 2012

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64 yo with SCA, heart block, dual chamber ICD, 1.5 yrs later SOB and EF 40%

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Underlying Rhythm

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HBP- T wave memory changes

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T waves changes resolved; EF 55%

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52 yo TOF, AT, AVJ abl, CRT, LV lead failure, EF 35% after 3 yrs, referred for CRT-D via His lead

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Dual chamber PPM with DVIR pacing mode (HBP 1.5V @ 1 ms) EF 2 months later 54%

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Fluoroscopy

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• 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

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LBBB cardiomyopathy

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2014

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2016

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2017 pre-procedure

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Selective HBP

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EF measurements

• 2014- EF 15-20%

• 2016- EF 20%

• 2017- 2 months after HBP- EF 54%– Highlights that LBBB induced cardiomyopathy is a real entity– GDMT is not enough

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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

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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)

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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

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Maurice Maeterlinck (1862-1949)Belgian Playwright, Poet, Nobel Prize in Literature 1911

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“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