EP Labs Emerging Technologies in the Cath & EP Labs Mauricio Arruda, MD John R. Antonucci Master Clinician of Cardiovascular Innovation Director of Electrophysiology Center UH Harrington Heart & Vascular Institute Associate Professor of Medicine Case Western Reserve University School of Medicine Ohio-ACC 27 th Annual Meeting
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Emerging Technologies in the Cath & EP Labs EP Labs · Case Presentation 76yo, Female, PVC from Anterior Papillary Muscle. Clinical PVC RBBB / Inferior Axis Morphology V1 V2 V3 V4
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EP Labs
Emerging Technologies in the Cath & EP Labs
Mauricio Arruda, MDJohn R. Antonucci Master Clinician of Cardiovascular Innovation
Director of Electrophysiology Center
UH Harrington Heart & Vascular Institute
Associate Professor of Medicine
Case Western Reserve University
School of Medicine
Ohio-ACC 27th Annual Meeting
Disclosures
Consultant / Speaker / Advisor
• Biosense Webster
• Abbott
• Stereotaxis
No Investigational Technologies
Electrophysiology Center
Electrophysiology Pacing
• EPS
• Ablation
• Cardioversion
• EP Clinics
• Genetics Clinic
• Telemetry – Outpatient
• Research / Clinical Trials
• New Programs
LAA Occlusion
VT / VF – ICU
• Device Implants
• Device Clinics
• Lead Management
Extraction Program
• Clinical Trials
Subcutaneous Event Monitor
Brady TherapiesLeadless Cardiac Pacemaker
1.5T and 3T Full Body MRI Scanning
No restrictions on
– Scan duration
– Number of scans
– R-wave amplitude
– Pacemaker dependency
6
LV Lead Location Matters For Better CRT Outcomes
Subcutaneous ICD
Lead Extraction
CARTO® SMARTTOUCH® Technology
CS
Left Common PV
SVC
SVC
Technologies Arrhythmia Mapping and Ablation
Robotic Magnetic Navigation Arrhythmia Mapping and Ablation
Catheter Ablation for Rhythm Control
Atrial FibrillationNon-Pharmacologic Management
1. Craig T. January, MD, PhD, FACC; L. Samuel Wann, MD, MACC, FAHA; Joseph S. Alpert, MD, FACC, FAHA; Hugh Calkins, MD, FACC,ET AL. 2014 AHA/ACC/HRS Guideline
for the Management of Patients With Atrial Fibrillation: Executive Summary. J Am Coll Cardiol. 2014;64(21):2246-2280
The 2014 AHA/ACC/HRS Guidelines for Afib Management provide the highest level
of recommendation (Class: 1; Level of Evidence: A) for catheter ablation as
treatment for drug-refractory, symptomatic paroxysmal Afib.
ClassRECOMMENDATION
THE STRONGEST RECOMENDATION
1 LevelLEVEL OF EVIDENCE
THE HIGHEST LEVEL OF EVIDENCE
A
Society Guidelines for AF Ablation
Rate vs. Rhythm ControlTimeline
AFFIRM StudyNo survival
advantage of
Rate vs. Rhythm control
2002 2006 20142012
Class
III
Level C
2001
Class II
Level B
Ionescu Mortality among
patients on rhythm
control gradually decreased relative
to rate control
Class I
Level
A*
Ghanbari NSR after RFCA is
associated with
60% reduction in CV mortality
Society Guidelines for Afib Ablation
*Class I Level A for PAF with no or minimal heart disease
2010
Wilber RFCA is superior in
efficacy and safety
to AAD
2004
Corley (AFFIRM sub-analysis)
NSR associated
with 47% reduction on risk of death
2003
DIAMOND Study
NSR leads to
significant reduction in
mortality
2002
✓ Paroxysmal AF 167pts ➢Catheter Ablation: 106➢AADs: 61
LAA Anatomy - LAA were were distributed into 4 morphologies 932 AF patients
• Nitinol frame radially expands to maintain position in LAA
• 10 fixation anchors engage LAA tissue for stability and retention
• Polyethylene terephthalate (PET) membrane designed to block emboli from exiting the LAA
Anchors
160 Micron Membrane
Designed specifically for the left atrial appendage
WATCHMAN LAAC Device Overview
55
Assessment of LAA size for proper device choice
00 900
1350
22mm
20mm
20mm
21mm
LCX
450
a a
Tug test Color Flow around device20% Compression
WATCHMAN™ Device Endothelialization
Canine Model – 30 Day
Canine Model – 45 DayHuman Pathology - 9 Months Post-implant
(Non-device related death)
Images on file at Boston Scientif ic Corporation.
Results in animal models may not necessarily be indicat ive of clinical outcomes.
Procedural Success
Implant success defined as deployment and release of the device into the LAA; no leak ≥ 5 mm* The EWOLUTION Registry is a European prospectiv e registry which reflects CE Mark indications for use which differ from the FDA indications for use.
1 Boersma, L.et al. EHJ; published online Jan 2016 in press; 2 Reddy VY, Holmes DR, et al. JACC 2016; Article in press
~50% new operators ~70% new operators
AMPLATZER™
Amulet™
Device
Lobe▪ Inside the LAA neck
▪ Designed to conformto LAA anatomy
Stabilizing
Wires▪ Engage with LAA wall▪ Help hold the device in place
Waist▪ Maintains tension between lobe and disc
▪ Allows device to self-orient
Disc• Completely seal
at the orifice
“Amulet is an investigational device in the US and not approved by FDA for commercial distribution.”
Amplatzer™ Amulet™
Device Implant Procedure
Measure LAA orifice, landing zone, depth Deploy LOBE in landing zone
Deploy the DISC, to cover the ostium Release
1 2
3 4
“Amulet is an investigational device in the US and not approved by FDA for commercial distribution.”
Coherex WAVECREST LAA Closure Device
Permanent Ligation Approximation Closure and Exclusion