Advances in management of Atrial Fibrillation Dr Gurudutt
Advances in management of Atrial Fibrillation Dr. Gurudutt Kulkarni, MD and Dr. Mayank Mittal, M. D Beacon Watchman Program
Learning Objectives 1. Understand the basic electrophysiology of atrial fibrillation 2. Novel techniques in the ablation treatment of atrial fibrillation 3. Role of left atrial appendage occlusion devices as non-pharmacologic strategy to prevent thromboembolic complication of AF 11/18/2020
Contemporary AF Management Triggers, mechanisms, and AF ablation strategies 11/18/2020
Etiology: Key Concepts Triggers: Rapidly firing focus that initiates arrhythmia Substrate: Electrophysiological, mechanical and anatomical characteristics of atria that sustain AF. APD and RP are shorter in Atria particularly in LA. 11/18/2020
Diagram of the Sites of 69 Foci Triggering Atrial Fibrillation in 45 Patients. 5 Beacon Watchman Prgram 11/18/2020
Angiogram of a Left Inferior Pulmonary Vein Depicting the Source and Exit of Ectopic Activity. 6 Beacon Watchman Prgram 11/18/2020
Two Examples of the Onset of Atrial Fibrillation from Foci in a Right Inferior Pulmonary Vein and a Left Superior Pulmonary Vein. 7 Beacon Watchman Prgram 11/18/2020
Non PV triggers 1. SVC, Ligament of Marshall, CS, LAA, Crista, LAPW, Ganglionic plexii. 2. More common in advanced types of AF. 3. - 8 Triggers can be initiated or maintained by upstream processes: Atrial stretch(MR) Ischemia Autonomic imbalance(vagal stimulation) Beacon Watchman Prgram 11/18/2020
Mechanism contd. 1. PVs themselves can sustain AF. 2. Concept of “ROTORS” as functional reentry. Rotors are curve /spiral shaped functional reentry. 3. Although animal data exists, reliable techniques to identify Rotors have been some what disappointing. 9 Beacon Watchman Prgram 11/18/2020
Key concepts underlying the induction and maintenance of atrial fibrillation (AF). Rohan S Wijesurendra, and Barbara Casadei Heart 2019; 105: 1860 -1867 10 Beacon Watchman Prgram Copyright © BMJ Publishing Group Ltd & British Cardiovascular Society. All rights reserved. 11/18/2020
Progression in atrial fibrillation (AF) mechanisms over time. Rohan S Wijesurendra, and Barbara Casadei Heart 2019; 105: 1860 -1867 11 Beacon Watchman Prgram Copyright © BMJ Publishing Group Ltd & British Cardiovascular Society. All rights reserved. 11/18/2020
Current hypotheses for atrial fibrillation (AF) maintenance. Rohan S Wijesurendra, and Barbara Casadei Heart 2019; 105: 1860 -1867 12 Beacon Watchman Prgram Copyright © BMJ Publishing Group Ltd & British Cardiovascular Society. All rights reserved. 11/18/2020
Risk factors for AF 13 Beacon Watchman Prgram 11/18/2020
Goals of treatment of AF 1. Treatment of risk factors 2. Symptom control 3. Prevention of thromboembolism 14 Beacon Watchman Prgram 11/18/2020
Atrial fibrillation Ablation – Pulmonary Vein Isolation 15 Beacon Watchman Prgram 11/18/2020
Effects of Successful Radio-Frequency Ablation within the Superior Pulmonary Veins in Two Patients. 16 Beacon Watchman Prgram 11/18/2020
Cryoballoon ablation 17 Beacon Watchman Prgram 11/18/2020
New Balloon Technologies 18 Beacon Watchman Prgram 11/18/2020
Pulmonary Vein Isolation Luminize (Apama) balloon Heliostar ü 28 mm OTW ü Irrigated RF balloon. ü 18 open irrigated RF ablation electrodes. ü Works with Carto system. ü In built camera allows visualization of contact. ü compliant 28 mm balloon ü Initial data promising 19 Beacon Watchman Prgram ü 10 irrigated gold plated electrodes. 11/18/2020
New Ablation technology 1. Pulsed field ablation or electroporation 2. Irreversible Electroporation(IRE) occurs when strong pulsed electrical field(PEF) is applied across cell membrane. Causes cell permeabilization leading to cell disruption and death. 3. FDA approved for tumor ablation. 4. Tissue specific, non thermal and cardiac myocytes have a low threshold for PEF. , 5. PEF is created by high voltage DC between 2 or more electrodes. Once the electrical field is applied, charge is established across the lipid bilayer. Once threshold is reached(depends on transmembrane voltage), electroporation occurs. 6. Cellular effects observed depend on applied electrical field(which depends on pulse duration, voltage, frequency and polarity). Low intensity fields cause reversible effects. 20 Beacon Watchman Prgram 11/18/2020
Electroporation 21 Beacon Watchman Prgram 11/18/2020
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FARAPULSE ablation catheter 23 Beacon Watchman Prgram 11/18/2020
Managing Stroke Risk in AF Pharmacological and non-pharmacological strategies 11/18/2020
AF is a Growing Problem Associated with Greater Morbidity and Mortality AF= most common cardiac arrhythmia, and growing ~5 M People in AF in U. S. expected to more than double by 2050 12 M 25 < 5 x Greater risk of stroke with AF 5 M ‘ 15 ‘ 20 ‘ 30 AF increases risk of stroke ’ 40 ‘ 50 Beacon Watchman Prgram • Higher stroke risk for older patients and those with prior stroke or TIA • 15 -20% of all strokes are AF related • AF results in greater disability compared to non AF related stroke • High mortality and stroke recurrence rate In AF, >90% thrombus formed in left atrial appendage 11/18/2020
Why OAC may not work for some patients: 1. Bleeding risk 2. Life style 3. Occupation 4. Insurance 5. Compliance Not available any more 26 Beacon Watchman Prgram Thoracoscopic LA clip or Concurrent OHS 11/18/2020
Patients are worried about Bleeding risk 27 Beacon Watchman Prgram Physicians are worried about Stroke risk 11/18/2020
Bleeding risk Bleeding Risks on Anticoagulants Compound Over Time 70 60 50 40 30 20 10 0 0 1 2 3 HAS-BLED* Score Estimated 10 -Year Bleeding Risk (%) 28 Beacon Watchman Prgram 4 5 Annual % Bleed Risk 11/18/2020
Bleeding risk CAD and AF 29 Beacon Watchman Prgram 11/18/2020
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The sweet spot – Coumadin is not a candy! 31 Beacon Watchman Prgram 11/18/2020
Despite Increasing Usage of DOACs, Gaps in Care Remain Data from the NCDR PINNACLE Registry shows that the rate of overall OAC use increased from 52. 4% to 60. 7% with the introduction of DOACs Still, nearly 40% of OACeligible patients are not receiving OAC therapy. 32 Beacon Watchman Prgram 11/18/2020
Less than Half of Patients on DOACS are Adherent A retrospective study of 64, 661 patients found that only 47. 5% of patients on DOACS had ≥ 80% adherence during a median follow-up period of 1. 1 years 100% 90% 80% Adherence* 70% 60% 52. 1% 50% 47. 6% 45. 9% 38. 7% 40% 30% 20% 10% 0% *Predicted probability of adherence; reported adherence rates adjusted for confounders Apixaban Rivaroxaban Dabigatran Warfarin DOAC adherence was higher than warfarin Yao X et al. J Am Heart Assoc. 2016; 5: e 003074 SH-603802 -AB
The Risk is real and life threatening in some cases Nuisance 34 Beacon Watchman Prgram Death 11/18/2020
Challenges of Oral Anticoagulation 83% of patients with AF would be willing to try a different treatment to help reduce their risk of stroke 1
National Direct-to-Patient Campaign will reach 93% of Patients SH-630609 -AA MAY 2019
WATCHMAN Clinical Timeline More than 6, 000 patients ad over 15 years of experience 2002 Pilot N=66 Non-randomized Feasibility and Safety 2008 CAP Registry N=566 Non-randomized Add’l patients and follow-up Mar 2015 FDA Approval 2010 PREVAIL N=407 Randomized Comparison: warfarin 2017 ASAP TOO N= Up to 888 Randomized US Indication Expansion Worldwide study 2012 CAP 2 Registry N=579 Non-Randomized Add’l patients and follow-up 2002 2005 PROTECT AF N=707 Randomized Comparison: warfarin 2019 OPTION N=1600 Randomized Comparison: OAC FLX Device** *trial design in development 2017 WATCH-TAVR N=312 Randomized TAVR+WATCH MAN 2018 2013 2009 ASAP N=150 Non-randomized Patients Contra-indicated to warfarin* 2013 EWOLUTION, WASP Registries N=1020, N=201 Non-randomized Real-world, All comers 2017 SALUTE N= 42 Non-randomized Japanese Approval Study 2016 US NESTed NCDR LAAO Registry N=2000 Post-approval statistical analysis 2018 PINNACLE FLX N=400 Non-randomized FLX Device** US IDE *Not US Indication 38 The WATCHMAN Beacon FLX™ Watchman Prgram device and restricted by **Caution: is an investigational Federal law to investigational use only. Not available for sale in the US. CE Marked. 11/18/2020
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Patient Level Meta-Analysis PROTECT AF, PREVAIL 5 Years 41 Beacon Watchman Prgram 11/18/2020
WATCHMAN studies have shown that WATCHMAN is safe, effective, and enables patients to discontinue OAC medications. A robust body of evidence, including long-term data from numerous clinical studies (PROTECT AF, CAP Registry, PREVAIL, CAP 2 Registry), supports the WATCHMAN implant U. S. Food and Drug Administration (FDA) approval and the subsequent Centers for Medicare and Medicaid Services (CMS) national coverage decision for therapy in the U. S. , as well as approval and licensing of the WATCHMAN implant in 75 countries. In a real-world, post-approval analysis, the WATCHMAN implant has demonstrated high rates of procedural success and low rates of complication for patients with non-valvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy. 1. Varosy PD, Masoudi FA, Reisman M, et al. Procedural Safety of WATCHMAN Implantation: The U. S. NESTed Post Approval Study. A Report from the NCDRR Left Atrial Appendage Occlusion (LAAO) Registry. R. ACC 2018. 2. Reddy VY, Doshi SK, Kar S, et al. 5 -Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J. Am Coll Cardiol. 2017; SH-603802 -AB 3. Holmes, DR et al. JACC 2014; 64(1): 1 -12. 4. Price, M. J. , V. Y. Reddy, et al. , JACC: CV Interventions 2015; 8(15): 1925 -1932 *Two strokes in PREVAIL are excluded because the baseline MRS score was unavailable
Patient Case - High Bleeding Risk 74 yr female Past medical Hx: HTN, Diabetes, Vascular Disease (PCI, CAD) arthritis, COPD, atrial fibrillation, obesity, arthritis, gastric ulcer, TIA (remote-? event) EKG: atrial fibrillation, rate controlled for several years CHADS 2 -VASC=5 (1) age, (1) HTN, (1) gender (1) diabetes (1) vascular disease (PCI/CAD) Current meds: Diltiazem 120 mg, Breo, Prednisone daily, Xarelto 20 mg daily Social Hx: former smoker, no illicit drugs, no alcohol use Suffered multiple bleeding episodes including GI bleed, right knee bleeding, eye bleeding and multiple minor skin bleeding. 44 Beacon Watchman Prgram 11/18/2020
3 Mensio Work-up from Boston Scientific - Pre - Planning - Referral Consultation Pre – Planning Imaging Shared decision making Heart team approach Procedure Post procedure care Follow up Imaging Stopping of Oral anticoagulation 45 Beacon Watchman Prgram 11/18/2020 You can participate by identifying patients at risk / Referrals
Angiography device deployment 46 Beacon Watchman Prgram 11/18/2020
Intra-Op TEE post-Watchman placement 47 Beacon Watchman Prgram 11/18/2020
45 - Day Post Watchman TEE 48 Beacon Watchman Prgram 11/18/2020
Timeline of Adjunctive Pharmacotherapy in Device Patients Warfarin + ASA (81 mg) daily Implant 49 Beacon Watchman Prgram Clopidogrel (75 mg) + ASA (325 mg) 45 days* ASA (325 mg) daily 6 months *if leak >5 mm, patients remained on warfarin + ASA until seal documented, skipping the clopidogrel + ASA pharmacotherapy 11/18/2020
Beacon Watchman Program A strong collaboration between Memorial and Elkhart campuses at Beacon All patients are evaluated by Heart team (EP, IC, NP, RN, Echo tech and MD, Rad techs, Radiology, Reps, National experts) Community and provider educational events 2 successful years in running – with excellent outcomes Next frontiers Patient education events Watchman Flex Patients DO NOT have to choose between Risk of stroke and Bleeding 50 Beacon Watchman Prgram 11/18/2020
Beacon Watchman Program results N=67 51 Beacon Watchman Prgram 11/18/2020
National Trends 52 Beacon Watchman Prgram 11/18/2020
WATCHMAN Continues to Grow 50+% AVG. ANNUAL GROWTH 120, 000+ Global Implants 590+ Medical Education Programs 1, 300+ Trained Implanters 650+ Trained Coordinators 35, 000+ Referring Physicians Reached per year SH-630609 -AA MAY 2019
Thank You ! 54 Beacon Watchman Prgram 11/18/2020
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