Boston Scientific Corporation · NYSE:BSX
Boston Scientific — Heart Rhythm Society (HRS) 2020
14 slides from Boston Scientific's conference presentation, 2020
Slide 1: Local Impedance Drop during PVI Predicts Late Reconnection: LOCALIZE Clinical Trial
Local Impedance Drop during Pulmonary Vein Isolation Predicts Late Reconnection in Patients with Paroxysmal Atrial Fibrillation: Results of the LOCALIZE Clinical Trial Ignacio García-Bolao1, Armin Luik2, Ewen Shepherd3, Matthew Sulkin4, Jacob Laughner4, Tobias Oesterlein4, Elizabeth Duffy4, Christia
Slide 2: Disclosures
Disclosures IGB has received speaker and proctorship fees from Boston Scientific; MD has received Research funding and Speaker fees from Boston Scientific; MS, JL, TO, ED are salaried Boston Scientific employees
Slide 3: Background
Background • Creation of an RF lesion results in an impedance drop that reflects a temperature increase within the tissue. • Pre-clinical and clinical evaluation of an advanced local impedance (LI) metric found that greater LI drops were indicative of more effective lesion formation. Representative
Slide 4: Methods
Methods • LOCALIZE is a single arm, nonrandomized, prospective, multicenter clinical trial (NCT03232645) • The study consists of an index PVI procedure and a mandated 3-month follow-up mapping procedure • PVs were divided into 16 anatomical segments • PVI was performed using point-by-point ablation
Slide 5: Median Local Impedance Drop
Median Local Impedance Drop Representative activation map at 3-month follow-up. Median local impedance drops per segment are displayed. Tag Colors Cyan Tags: Segment Borders Pink Tags: Segment Centers Gray Tag: Reconnected segment with LI drop of 8W
Slide 6: Results: Patient Demographics
Results: Patient Demographics To-date, a total of 44 paroxysmal AF patients underwent PVI and had their 3-month mapping procedures analyzed Subjects (n=44) Subjects (n=44) Age (years) 62±11 Anti-Arrhythmic Drugs 41 (93.2%) Male (n) 27 (61.4%) Class I: Sodium 17 (39.5%) Channel Blockers LA Diameter <
Slide 7: Results: Safety
Results: Safety Acute Safety (Up to 7 days post index procedure or hospital discharge, n=44 patients): • There were no reported device related serious adverse events • One instance of supraventricular tachycardia that was adjudicated as not related to the procedure or device. • Death (n=0), tamponad
Slide 8: Results: Local Impedance and Durable Block
Results: Local Impedance and Durable Block Starting Impedance Impedance Drop Segment Durable Block (%) (Ω) (Ω) Superior 109.8 ± 17.1 21.0 ± 11.4 94.7 Anterior Superior 105.9 ± 15.0 19.6 ± 9.9 86.8 Anterior 102.8 ± 12.9 18.1 ± 8.8 65.7 Anterior Inferior 104.6 ± 15.9 18.7 ± 10.4 92.7 Left Inferior 106
Slide 9: Results: Durable Block vs PV Reconnection
Results: Durable Block vs PV Reconnection • Segments with durable block had significantly larger LI drop compared to segments with late PV reconnections • When interlesion spacing was accounted for, the largest segmental LI drop that was associated with a late PV reconnection was 22.6Ω Threshol Spec
Slide 10: Results: Regional Analysis
Results: Regional Analysis • Regionally, segments with durable block had significantly larger LI drop compared to late PV reconnections segments • Achieving a LI drop of ≥16.9Ω in anterior/superior segments was highly predictive of durable segment block • Achieving a LI drop of ≥14.2Ω in posterior/i
Slide 11: Conclusions
Conclusions • In 44 paroxysmal AF patients: • There were no reported device related serious adverse events at the index PVI (first pass ablations: blinded; touch-up ablations: unblinded) or follow-up procedures (LI unblinded) • The magnitude of LI drop was predictive of durable PVI segment conductio
Slide 12: Thank You
Thank You @HRS 2020 SCIENCE ONLINE
Slide 13: RHYTHMIA HDx Mapping System Intended Use
RHYTHMIA HDx™ Mapping System INTENDED USE: The RHYTHMIA HDx™ Mapping System (the system) is a 3D mapping and navigation system used in EP procedures. The SiS and related accessories provide data connection pathways for external input/output devices (e.g. catheters and recording systems) and serve as
Slide 14: IntellaNav MiFi Open-Irrigated Ablation Catheter Indications
INTELLANAV MIFI™ OPEN-IRRIGATED Ablation Catheter INTENDED USE/INDICATIONS FOR USE: The IntellaNav MiFi™ OI Catheter, when used with a compatible Radiofrequency Controller and Irrigation Pump, is indicated for: cardiac electrophysiological mapping. delivering diagnostic pacing stimuli. RF ablation o