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

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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

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CON: HIS-Bundle Pacing Should be First Line Therapy for AV block with Preserved LV Function California HRS 2019

Byron K. Lee MD Professor of Medicine Director of the EP Laboratory and Clinics Division of Cardiology University of California, San Francisco

Disclosures

Research

Medtronic Zoll Boston Scientific

Consulting

Biotelemetry Cook Medical

Dr. Vijayaraman

Arne Larsson: First Pacemaker Patient

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Traditional Pacemakers What Are We Really Comparing?

 HIS-Bundle Pacing has been studied intensively only the last several years  41 patients randomized in His-Sync Trial  RV Pacing has been saving lives since 1958  BiV Pacing has been studied over 20 years in RCTs with over 10,000 patients randomized

Reasons HIS-Bundle Pacing Should be First Line Therapy Reason#1: Longer Procedure Time

Abdelrahman et al. JACC 2018

27% longer procedure

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Reason#2: More Fluoroscopy Exposure

Abdelrahman et al. JACC 2018

39% more fluoroscopy

Reason #3: Higher Cost

5076 3830 C304 C315 $437 $232 $495 $768 Standard Pacemaker System: $5582 HIS-Pacing System: $5872 → 5% increase HIS-Pacing System with C304: $6640 → 19% increase Failed His-Pacing System Implant with C304: $7077 → 27% increase

Reason # 4: More Redo Procedures

 HIS-Bundle Pacing

 14/304 (4.2%) patients needed 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

 RV Pacing

 2/433 (0.5%) patients needed RV lead revision Abdelrahman et al. JACC 2018

Reason #5: Shorter Battery Life

Abdelrahman et al. JACC 2018 Huang et al. Heart 2018

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Reason #6: Unknown Long Term Risks

Vijayaraman et al. JACC 2018

Possible Permanent Damage to HIS-Bundle Reason #7: Observational Comparison Skewed Reason #7: Observational Comparison Skewed

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Reason #8: No Randomized Controlled Trials CAST Trial CAST Trial WHI Trial

WHI Investigators et al. JAMA 2002

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WHI Trial