Permanent HBP vs Septal vs RVP: What evidence do we have

jipmer.jpg

18-01-2020

Raja Selvaraj, JIPMER

Introduction

Formulating the question - Hypothetical patient

  • 60 year old male with syncope
  • Complete heart block
  • Normal Echo
  • DDD pacemaker implant

Question we want to answer

  • Best way to pace this patient ?
  • RV apical pacing
  • RV septal pacing
  • His bundle pacing
  • Others

Disclosure

  • My direct experience with HB pacing is small
  • Govt funded, academic institute
  • New drugs and therapies trickle in slowly
  • Which is often not a bad thing
    • Seven year rule
    • Some distance to look at it objectively

RV apical pacing

RV apical pacing

rv_apex.png

RV apical pacing - Harmful ?

most_results.jpg

Mode Selection Trial - Analysis

most_cumvpace_hfh.jpeg

Pacing induced cardiomyopathy

picm.png

Khurshid, … Marchlinski, Francis … Incidence and Predictors of Right Ventricular Pacing-Induced Cardiomyopathy. Heart Rhythm 2014;11:1619-1625

Predictors of PICM

  • Male sex
  • Baseline QRS duration
  • Baseline LV function
  • Percent pacing
  • Site of pacing ?

RV septal pacing

Theoretical benefits

  • Better synchrony
  • Narrower QRS
  • Conduction system capture in some ?

Summary of evidence

  • Metaanalysis (1) - Better LV function with septal pacing
  • PROTECT-PACE (2) - Randomized, prospective, multi-center - No clear benefit after two years
  1. Shimony A, Eisenberg MJ, Filion KB, Amit G. Beneficial effects of right ventricular non-apical vs. apical pacing: a systematic review and meta-analysis of randomized-controlled trials. Europace. 2012;14(1):81–91.
  2. Kaye GC, Linker NJ, Marwick TH, et al. Effect of right ventricular pacing lead site on left ventricular function in patients with high-grade atrioventricular block: results of the Protect-Pace study. Eur Heart J. 2015;36(14):856–862.

PROTECT-PACE

  • RCT, 240 patients
  • RV apex or RV high septum
  • 2 years FU
  • Decrease in LVEF in both, no difference
  • No difference in mortality, HFH or AF

Biventricular pacing

Biventricular pacing ?

  • Block HF - Patients with AV block and EF < 50%, BiV pacing better
  • BIOPACE - BiV pacing not better then RV pacing in patients with AV block

HB pacing

Permanent His bundle pacing

  • First described in 2000 (1)
  • Picked up momentum within last 10 years

Deshmukh P, Casavant DA, Romanyshyn M, Anderson K. Permanent, direct His-bundle pacing: a novel approach to cardiac pacing in patients with normal His-Purkinje activation. Circulation. 2000;101(8):869–877

Theoretical benefit

  • Best way to provide synchrony

Issues

  • Success rate around 75%
  • Longer procedural and fluoroscopy times
  • High threshold (> 2.5 V at 1 ms) in 10%
  • Increase in threshold by > 1V in 10%
  • Battery longevity
  • Sensing issues
  • Late development of infra-hisian block ?

Issues - Success rate

  • Around 80-90% in experienced centers
  • 75% more realistic (1)
  • Success rate varies with substrate

Bhatt, A. G. et al. The efficacy of His bundle pacing: lessons learned from implementation for the first time at an experienced electrophysiology center. JACC Clin.Electrophysiol. 4, 1397–1406 (2018).

Issues - Capture thresholds

  • On average, higher than RV pacing
  • At 2 years, threshold > 2.5 in 14%
  • Lead revision required in 4.2 % (1)

Abdelrahman, M. et al. Clinical outcomes of his bundle pacing compared to right ventricular pacing. J. Am. Coll. Cardiol. 71, 2319–2330 (2018).

Real world single center experience

  • 101 implants at a single center (Valley Hospital, NJ)
  • 75% acute success
  • 56% in patients with CHB
  • Early or late threshold rise in 32%
  • Lead revision in 8%

Bhatt, A. G. et al. The efficacy of His bundle pacing: lessons learned from implementation for the first time at an experienced electrophysiology center. JACC Clin.Electrophysiol. 4, 1397–1406 (2018).

High pacing threshold - Cascading effects

  • Need for lead revision
  • More pulse generator replacements
    • Cost (added to higher initial cost)
    • Risk of complications during each replacement procedure

Evidence - Prospective crossover trials

  • Ochetta 2006 - 6 mths 18 pts Improved NYHA, 6MWT, QOL, hemodynamics (1)
  • Kronberg 2014 - 24 mths, 38 pts, Improvement in EF, no improvement in functional class (2)
  • Pastore 2014 - 37 pts, better LV synchrony, better LA function (3)
  • Catanzanti 2014 - 26 pts, 36 mths. improved indices of ventricular function (4)
  1. E. Occhetta et al. Prevention of ventricular desynchronization by permanent para-Hisian pacing after atrioventricular node ablation in chronic atrial fibrillation: a crossover, blinded, randomized study versus apical right ventricular pacing. J Am Coll Cardiol, 47 (2006), pp. 1938-1945
  2. M.B. Kronborg et al. His or para-His pacing preserves left ventricular function in AV block: a double-blind, randomized, crossover study. Europace, 16 (2014), pp. 1189-1196
  3. G. Pastore et al. Hisian area and right ventricular apical pacing differently affect left atrial function: an intra-patients evaluation. Europace, 16 (2014), pp. 1033-1039
  4. Catanzariti D et al. Permanent His‐bundle pacing maintains long‐term ventricular synchrony and left ventricular performance, unlike conventional right ventricular apical pacing. Europace. 2012; 15:546–553

Evidence - Retrospective comparison

  • Pastore 2016. 12 mths FU, 148 HBP. Lower risk of AF progression
  • Vijayaraman 2018. Observational, case control. 5 yrs, endpoint - hfh + mortality reduced, less pacing induced cmp, no ef reduction
  • Abdelrahman 2018. Observational cohort, 332 hbp, 432 rvp, reduced primary endpoint - mortality + HFH
  1. Pastore, G. et al. The risk of atrial fibrillation during right ventricular pacing. Europace 18, 353–358 (2016).
  2. P. Vijayaraman, A. Naperkowski, F.A. Subzposh, et al. Permanent His bundle pacing: Long-term lead performance and clinical outcomes. Heart Rhythm, 15 (2018), pp. 696-702
  3. M. Abdelrahman, F.A. Subzposh, D. Beer, et al. Clinical outcomes of His bundle pacing compared to right ventricular pacing: Results from the HBP registry. J Am Coll Cardiol, 71 (2018), pp. 2319-2330

Pastore 2016

pastore_af.jpg

Pastore, G. et al. The risk of atrial fibrillation during right ventricular pacing. Europace 18, 353–358 (2016).

Vijayaraman 2018

  • 94 pts with HBP (80% success) vs 98 pts with RVP (RVA 60, RVS 38)
  • Decline in LVEF in RVP group
  • Less pacing induced CMP (2% vs 22%) vijayaraman_itt.png

P. Vijayaraman, A. Naperkowski, F.A. Subzposh, et al. Permanent His bundle pacing: Long-term lead performance and clinical outcomes. Heart Rhythm, 15 (2018), pp. 696-702

Abdelrahman 2018

  • Implants from 2013-2016
  • newer experience, larger data, less follow up
  • Successful HBP in 92%
  • Endpoint - composite of death, HFH, BiV upgrade - 25% vs 32%
  • Trend towards lower mortality (17.2 vs 21.4)

M. Abdelrahman, F.A. Subzposh, D. Beer, et al. Clinical outcomes of His bundle pacing compared to right ventricular pacing: Results from the HBP registry. J Am Coll Cardiol, 71 (2018), pp. 2319-2330

Summary

Summary

  • Is RVS pacing better than RVA pacing - Maybe (small)
  • Does RVS pacing have downsides - No
  • Is HB pacing feasible ? - Yes (not in all)
  • Does HB pacing result in better outcomes ? - Maybe
  • Does HB pacing have downsides ? - Yes
  • Do the benefits outweigh the downsides ? - Dont know
  • Is LB area pacing a better option ? - Dont know
  • Is this the final word ? - No

What do the guidelines say?

guidelines.png

2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society