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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