1 9/14/2019 Traditional Pacemakers What Are We Really Comparing? - PDF document

9/14/2019 Disclosures CON: HIS-Bundle Pacing Should be First Line Therapy for AV block with Preserved  Research LV Function  Medtronic  Zoll California HRS 2019  Boston Scientific  Consulting  Biotelemetry Byron K. Lee MD Professor of Medicine  Cook Medical Director of the EP Laboratory and Clinics Division of Cardiology University of California, San Francisco 2 Arne Larsson: First Pacemaker Patient Dr. Vijayaraman 4 1

9/14/2019 Traditional Pacemakers What Are We Really Comparing?  HIS-Bundle Pacing has been studied  RV Pacing has been saving lives since intensively only the last several years 1958  BiV Pacing has been studied over 20  41 patients randomized in His-Sync Trial years in RCTs with over 10,000 patients randomized Reasons HIS-Bundle Pacing Should be First Line Therapy Reason#1: Longer Procedure Time 27% longer procedure Abdelrahman et al. JACC 2018 2

9/14/2019 Reason#2: More Fluoroscopy Exposure Reason #3: Higher Cost C304 3830 C315 5076 $437 39% more fluoroscopy $495 $232 $768 Standard Pacemaker System: $5582 HIS- Pacing System: $5872 → 5% increase Abdelrahman et al. JACC 2018 HIS-Pacing System with C304: $6640 → 19% increase Failed His-Pacing System Implant with C304: $7077 → 27% increase Reason # 4: More Redo Procedures Reason #5: Shorter Battery Life  RV Pacing  HIS-Bundle Pacing  2/433 (0.5%) patients needed RV  14/304 (4.2%) patients needed lead revision lead revision  6 patients had unacceptably high capture threshold within 30 days  8 patients had unacceptably high capture threshold within 30 days  2/14 patients had no HIS capture at lead revision Abdelrahman et al. JACC 2018 Abdelrahman et al. JACC 2018 Huang et al. Heart 2018 3

9/14/2019 Reason #6: Unknown Long Term Risks Possible Permanent Damage to HIS-Bundle Vijayaraman et al. JACC 2018 Reason #7: Observational Comparison Skewed Reason #7: Observational Comparison Skewed 4

9/14/2019 Reason #8: No Randomized Controlled Trials CAST Trial CAST Trial WHI Trial WHI Investigators et al. JAMA 2002 5

9/14/2019 WHI Trial Reason #8: No Randomized Controlled Trials WHI Investigators et al. JAMA 2002 https://sites.google.com/site/evidencebasedd/types-of-pyramid 8 Reasons HIS-Bundle Pacing Should NOT be First Line Therapy for AV Block with Preserved LV Function  Longer procedure time  Shorter battery life  More fluoroscopy exposure  Unknown long term risks My True Feelings?  Higher Cost  Observational data is skewed  More redo procedures  No randomized controlled trials 6

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