Emerging Technologies in the Cath & EP Labs. EP Labs
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1 Ohio-ACC 27 th Annual Meeting Emerging Technologies in the Cath & EP Labs 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
2 Disclosures Consultant / Speaker / Advisor Biosense Webster Abbott Stereotaxis No Investigational Technologies
3 Electrophysiology Center Electrophysiology EPS Ablation Cardioversion EP Clinics Genetics Clinic Telemetry Outpatient Research / Clinical Trials Pacing Device Implants Device Clinics Lead Management Extraction Program Clinical Trials New Programs LAA Occlusion VT / VF ICU
4 Subcutaneous Event Monitor
5 Brady Therapies Leadless Cardiac Pacemaker
6 1.5T and 3T Full Body MRI Scanning No restrictions on Scan duration Number of scans R-wave amplitude Pacemaker dependency 6
7 LV Lead Location Matters For Better CRT Outcomes
8 Subcutaneous ICD
9 Lead Extraction
10 Technologies CARTO SMARTTOUCH Technology Arrhythmia Mapping and Ablation Left Common PV SVC SVC CS
11 Robotic Magnetic Navigation Arrhythmia Mapping and Ablation
12 Atrial Fibrillation Non-Pharmacologic Management Catheter Ablation for Rhythm Control
13 Society Guidelines for AF Ablation Class RECOMMENDATION 1 Level LEVEL OF EVIDENCE A THE STRONGEST RECOMENDATION THE HIGHEST LEVEL OF EVIDENCE 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. 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 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary. J Am Coll Cardiol. 2014;64(21):
14 Timeline Rate vs. Rhythm Control AFFIRM Study No survival advantage of Rate vs. Rhythm control DIAMOND Study NSR leads to significant reduction in mortality Corley (AFFIRM sub-analysis) NSR associated with 47% reduction on risk of death Wilber RFCA is superior in efficacy and safety to AAD Ionescu Mortality among patients on rhythm control gradually decreased relative to rate control Ghanbari NSR after RFCA is associated with 60% reduction in CV mortality Class III Level C Class II Level B Society Guidelines for Afib Ablation Class I Level A* *Class I Level A for PAF with no or minimal heart disease
15 Antiarrhythmic Drugs vs. Ablation (PVI) for Paroxysmal AF ThermoCool AF Paroxysmal AF 167pts Catheter Ablation: 106 AADs: 61 PVI by Ablation AAD PVI 100.0%, CTI 35.9%, Linear Ablation 22.3%, SVC 16.5%, Non-PV trigger 16.5%. Freedom from recurrence at 9 months. Ablation: 66% AAD: 16% Log-rank P<0.01 Wilber et al. JAMA 2010;303:
16 EGM-Guided PVI A LSPV Antrum B LSPV A B C LSPV D RSPV LIPV LSPV RSPV RSPV Pre Isolation E RSPV F RIPV C G H SCV CS RSPV Post Isolation
17 CFAEs and Linear Ablation for Persistent AF STAR AF II Freedom from recurrence at 18 months (Log-rank P=0.15). PVI : 59% PVI + CFAE : 49% PVI + Roof + Mitral Line : 46% Persistent AF 589 pts (PVI: 67, PVI + CFAE: 263, PVI + Roof + Mitral Line: 259) No difference in long-term outcome between the 3 strategies. Verma et al. N Engl J Med 2015;372:
18 Left Atrial Fibrotic Substrate Ablation as an Adjunct to PVI
19 Persistent AF Mild LVd SVC-RA LSPV SVC-RA LIPV RSPV MA CS CS RIPV AP CT Patients with localized LVd in the posterior wall. Note mid and lower posterior lines enclosing LVd. PA CT
20
21 Case Presentation 78yo, male Pt with persistent AF Miral valvuloplasty (2004) Broad low voltage area in the LA on Voltage map AP PA
22 Ⅰ Ⅱ avf V1 RA CS ABL 3-4 ABL 1-2 LSPV
23 AF Termination during Ablation at the LA Roof Ⅰ Ⅱ avf V1 RA CS ABL 3-4 ABL 1-2 PA LSPV
24 Ventricular Fibrotic Substrate Ablation VT / VF
25 VT 7 Arruda et. Al.
26 LV and RV Endocardial Electroanatomic Voltage Mapping Arruda et. Al.
27 Endocardial and Epicardial Electroanatomic Voltage Mapping Arruda et. Al.
28 Ablation LV Endocardial Arruda et. Al.
29 VF Storm Cardiogenic Shock Status post CABG and mitral valve repair Frequent VT/VF episodes preceded by a single PVC Refractory amiodarone EF 25%, global LV hypokinesis Circulatory support - Impella ECMO Catheter Ablation
30 Monomorphic VT (RBBB Morphology and superior Axis) changed to Fast Polymorphic VT I II III 500ms avr avl avf V1 V2 V3 V4 V5 V6
31 Monomorphic VT(RBBB Morphology and superior Axis) changed to VF DC Shock I II III 500ms avr avl avf V1 V2 V3 V4 V5 V6
32 VT Elimination of VT/VF After Fibrotic Substrate Homogenization PM at LV septum LV Voltage map Scar Homogenization I II III II III avr avr avl avl avf avf RAO RAO V1 V1 V2 V2 V3 V3 V4 V4 V5 V5 V6 V6 LAO LAO
33 Intracardiac Echo (ICE) In The EP Lab
34 ICE-Guided Pulmonary Vein Electrical Isolation
35 ViewFlex Xtra ICE Catheter Anterior / Posterior Left / Right
36 Trans-Septal Puncture
37
38 ICE Assessment of Catheter Contact
39 Case Presentation 76yo, Female, PVC from Anterior Papillary Muscle
40 Clinical PVC RBBB / Inferior Axis Morphology I II III avr avl avf 500ms V1 V2 V3 V4 V5 V6
41 I II avf V1 SR Activation Mapping at the APM PVC RA p ABL d CS p -24 d
42 ICE Imaging to guide Ablation at Pappilary Muscle
43 I II III avr avl avf V1 V2 V3 V4 V5 V6 PVC Pace Mapping at the APM I II III avr avl avf V1 V2 V3 V4 V5 V6 PM 500ms
44 VT during RF Ablation at APM I II III 100ms avr avl avf V1 V2 V3 V4 V5 V6
45 Pericardial Effusion Before Transeptal Catheterization
46 Pericardial Effusion After Pericardiocentesis
47 ICE Imaging Miscellaneous
48 Saline Irrigation - tip of Ablation Catheter
49 RF Lesion Formation in the LA During RFA After RFA
50 Atrial Fibrillation Non-Pharmacologic Management Left Atrial Appendage Occlusion Stroke Prevention
51 LAA Closure for Stroke Prevention in NVAF LAA STROKE
52 Atrial Fibrillation Clinical Pathway Atrial Fibrillation Confirmed by ECG Stable Patient? CP, SOB, HF Yes No Emergency Department Heart Rate Control Beta Blockers Diltiazem, Verapamil Digoxin Contraindications Target Heart Rate: Resting bpm Stroke Risk Assessme nt Oral Anticoagulation CHADS 2-VA 2S C 1? Yes Yes Valv ular Disease By Echocardiogram? No Underlying Conditions DM, HTN, HLP, Obesity Thyroid Disease, OSA, CAD, Valv ular Disease, HF Echocardiogram TSH Basic Metabolic Panel Lipid Panel Liv er Function Tests Sleep Study Restore Sinus Rhythm Cardiov ersion Antiarrhythmic Drugs Flecainide, Propafenone Dronedarone, Sotalol Dofetilide, Amiodarone Contra-indications Warfarin Warfarin NOACs LAAO Electrophysiology / Cardiology Catheter ablation Atrial Fibrillation AV junction + Pacemaker LA Appendage Occlusion Stress Test Exercise, Pharmacologic Nuclear Left Heart Catheterization
53 LAA Anatomy - LAA were were distributed into 4 morphologies 932 AF patients Cactus (30%) Chicken Wing (48%) Windsock (19%) Cauliflower (3%) LAA Closure Devices Di Biase et al. JACC 2012, 60: Endocardial PLAATO Watchman ACP Amulet Coherex Prolipsis Occlutech PFM Medical Lifetech Cardia Gore CE, FDA CE CE - US trial - starting CE Epicardial SentreHeart AEGIS Surgical AtriCure Medtronic Maquet CE, FDA 510K 53
54 WATCHMAN LAAC Device Overview 160 Micron Membrane 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 Designed specifically for the left atrial appendage
55 Assessment of LAA size for proper device choice a 22mm 20mm a LCX mm 21mm Tug test 20% Compression Color Flow around device 55
56 WATCHMAN Device Endothelialization Canine Model 30 Day Canine Model 45 Day Human Pathology - 9 Months Post-implant (Non-device related death) Imag es on file at Boston Scientif ic Corporatio n. Results in animal models may not necessarily be indicative of clinical outcomes.
57 Procedural Success ~50% new operators ~70% new operators 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
58 AMPLATZER Amulet Device Lobe Inside the LAA neck Designed to conform to LAA anatomy Disc Completely seal at the orifice Stabilizing Wires Engage with LAA wall Help hold the device in place Waist Maintains tension between lobe and disc Allows device to self-orient Amulet is an investigational device in the US and not approved by FDA for commercial distribution.
59 Amplatzer Amulet Device Implant Procedure 1 2 Measure LAAorifice, landing zone, depth Deploy LOBE in landing zone 3 4 Deploy the DISC, to cover the ostium Release Amulet is an investigational device in the US and not approved by FDA for commercial distribution.
60 Coherex WAVECREST LAA Closure Device
61 LARIAT Suture Delivery Device Permanent Ligation Approximation Closure and Exclusion
62 LARIAT Suture Delivery Device Bartus K et al. J Am Coll Cardiol 2013;62:
63 Ohio-ACC 27 th Annual Meeting Emerging Technologies in the Cath & EP Labs Thank You
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