Endocardial LAA Occlusion: Which Device for Which Patient?
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1 Endocardial LAA Occlusion: Which Device for Which Patient? Roy Beinart, MD Davidai Arrhythmia Center The Leviev Heart Center Sheba Medical Center Sheba Medical Center Tel Hashomer The Leviev Heart Center
2 Disclosures None Sheba Medical Center Tel Hashomer The Leviev Heart Center
3 LAA Closure Devices Watchman, Boston Scientific ACP, St Jude Medical Flexible LAA, Coherex Medical
4 Watchman Device A self expanding system with a nitinol frame covered with a permeable 160 mm polyethylene terephthalate fabric on the LA side of the device. Ten active fixation hooks are placed around the circumference Sheba Medical Center Tel Hashomer The Leviev Heart Center
5 ACP Device Made of a flexible braided nitinol mesh. 2 major components: Distal lobe with 6 pairs of hooks Proximal disc (covers the ostium) A second-generation (Amulet) allows for larger LAAs to be treated: Has a slightly larger disc The waist and the lobe are longer The number of stabilizing wires is increased for improved device flexibility and stability. Sheba Medical Center Tel Hashomer The Leviev Heart Center
6 LAA Occlusion which device? The Anatomy Lesson of Dr. Nicolaes Tulp Rembrandt, Canvas, 1632
7
8 WATCHMAN Evidence-Based Medicine N=3394
9 Rate per 100 patient years PROTECT AF 4 Year: Results % lower 32% lower 60% lower P S = 96% P N > 99% P S = 99% * Primary Efficacy All Stroke CV or Unexplained Death 63% lower P S = 98% Disabling Stroke WATCHMAN N=463 P N = Posterior Probability for Non-Inferiority Ps = Posterior Probability for Superiority Disabling or fatal strokes were those with an MRS of 3-6 post stroke. Non-disabling were those with an MRS of 0-2 post stroke. For Bayesian analysis, a posterior probability of 97.5% represents non-inferiority; 95% represents superiority. * Warfarin N=244 All stroke (ischemic & hemorrhagic), cardiovascular death (limited to any cardiovascular & unexplained death), and systemic embolism Reddy, VY et al. JAMA. 2014; 312(19):
10 FDA Panel October WATCHMAN Periprocedural adverse events 12.0% 10.0% N= % Success: 88%-95% N Total : 2,902 Patients with Safety Event (%) 8.0% 6.0% 4.0% N= % N=566 N=269 N= % 4.1% 3.8% N= % 2.0% 0.0% PROTECT AF CAP PREVAIL CAP2 EWOLUTION 1 st Half 2 nd Half All Device and/or procedure-related serious adverse events within 7 Days including composite of vascular complications such as cardiac perforation, pericardial effusion with tamponade, ischemic stroke, device embolization, and other vascular complications such as PE not necessitating intervention, AV fistula, major bleeding requiring transfusion, pseudoaneurysm, hematoma and groin bleeding 1
11 ACP Periprocedural adverse events Success: 97%-100% N Total : 1, % 10.0% Patients with Safety Event (%) 8.0% 6.0% 4.0% 2.0% 0.0% N= % Haburg-Bern N= % Italian registry N= % Initial European Experince N= % N=20 0.0% Bern regisrty Initial Asian Experince N=52 4.0% Canadian registry N= % ACP EU N=35 0.0% Spanish registry N= % Tzikas All Device and/or procedure-related serious adverse events within 7 Days including composite of vascular complications such as cardiac perforation, pericardial effusion with tamponade, ischemic stroke, device embolization, and other vascular complications such as PE not necessitating intervention, AV fistula, major bleeding requiring transfusion, pseudoaneurysm, hematoma and groin bleeding 1 FDA Panel October 2014.
12 WATCHMAN ACP Success 88%-95% 97%-100% Efficacy (Compared to Warfarin) All Stroke/CV Death/CE: RR 0.60 All cause mortality: RR 0.66 CV Mortality: RR 0.40 * NA Safety Events 2.8%-9.9% 0%-7% * PROTECT AF
13 LAA Anatomy
14 LAA Anatomy There are considerable variations in its size, shape, and relationship with adjacent cardiac and extra cardiac structures. The orifice of the appendage is usually oval. Round, triangular, and water-drop shapes are also observed. The distribution of number of lobes varies: 3 lobes 23% 4 lobes 3% 2 lobes 54% 1 lobes 20%
15 LAA Anatomy (2) The shapes of the LAA in patients with drug-refractory AF were classified into 4 morphological types: Chicken wing Cauliflower Windsock Cactus JACC Cardiovasc Imag 2014
16 LAA Anatomy (3) Cauliflower Windsock Cactus Chicken wing JACC Cardiovasc Imag 2014
17 LAA by TEE JACC Cardiovasc Imag 2015
18 DEVICE SIZING FOR ENDOLUMINAL OCCLUSION DEVICES JACC Cardiovasc Imag 2015
19 Specific Considerations With Regard to LAA Closure Size: Too small Too Large Main anchoring lobe long enough Shape: Severe angulation Specific morphologies ( Chicken wing ) Lobes that separate close to ostium ( Ostial Lobes )
20 A very large or very small LAA may be problematic for device placement
21 A very large or very small LAA may be problematic for device placement
22 A very large or very small LAA may be problematic for device placement. Watchman ACP Required landing zone diameters mm (Available Sizes: mm) mm (Available Sizes: mm)
23 The main anchoring lobe needs to be long enough to accommodate the selected device.
24 The main anchoring lobe needs to be long enough to accommodate the selected device. Watchman ACP Required depth of main anchoring lobe (in the axis of the device) 19 mm for the smallest device size (21 mm) The length of the device progressively increases as device diameter increases 10 mm
25 Specific morphologies (e.g., a chicken wing morphology)/ severe angulation between the ostium and the neck may need specific implantation strategies
26 Specific morphologies (e.g., a chicken wing morphology)/ severe angulation between the ostium and the neck may need specific implantation strategies ACP maybe superior to Watchman in severe angulation, due the flexibility of the central pin that allows a misalignment between the disc and the lobe.
27 A lobe that originates very close to the ostium may stay unsealed.
28 A lobe that originates very close to the ostium may stay unsealed.
29 A lobe that originates very close to the ostium may stay unsealed. In very ostial lobes ACP maybe superior due to the pacifier principle (Improved sealing with the disc)
30 Device size (mm) Lin s concordance correlation coefficient of (95% confidence interval (CI) , 0.680; P=0.203) Device size (mm) Printed MDCT 3D models for prediction of LAAO size 3 experienced interventional cardiologists, were asked to use printed 3D LAA models in order to choose the appropriate device size. Watchman (N=16) ACP: (N=12) correlation coefficient : correlation coefficient : Average estimate (mm) Average estimate (mm) reduced major axis line of perfect concordance reduced major axis line of perfect concordance Sheba Medical Center Tel Hashomer The Leviev Heart Center
31 Conclusions LAA morphology / geometry and size are variable, and therefore choosing the right device and right size maybe challenging. Inherent 3D modalities (3D echocardiography, MRI and MDCT) could be beneficial. 3D printing (based on MDCT datasets) may have a potential role of in pre-procedural planning.
32 Conclusions (2) The ACP and the Watchman devices have both shown efficacy and relative safety. The Watchman device was studied in more patients, and in a more robust way (a randomized controlled trial - PROTECT AF). There are hardly any anatomical contraindications for an attempt at LAA occlusion with an ACP. LAA anatomy dictates which device to choose - ACP maybe superior in very small/large LAAs / severe angulation/ Ostial lobes
33 Thank you Sheba Medical Center Tel Hashomer The Leviev Heart Center
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Left Atrial Appendage Occlusion: A Valid Option to Anticoagulation for Long-term Prevention of Stroke Saibal Kar, MD
Left Atrial Appendage Occlusion: A Valid Option to Anticoagulation for Long-term Prevention of Stroke Saibal Kar, MD Director of Interventional Cardiac Research Cedars Sinai Medical Center Disclosure Statement
Left Atrial Appendage Closure: The Rationale
Left Atrial Appendage Closure: The Rationale JOHN D. HUMMEL, MD DIRECTOR OF CLINCAL ELECTROPHYSIOLOGY RESEARCH PROFESSOR OF CLINICAL INTERNAL MEDICINE OHIO STATE UNIVERSITY WEXNER MEDICAL CENTER 1 Disclosures
Percutaneous Left Atrial appendage occlusion and anticoagulation therapy Nicolas Lellouche, MD, PhD
Percutaneous Left Atrial appendage occlusion and anticoagulation therapy Nicolas Lellouche, MD, PhD Fédération de Cardiologie Hôpital Henri Mondor Créteil Atrial Fibrillation is a major cause of Stroke
Medical Policy Manual. Topic: Left-Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation. Date of Origin: December 2011
Medical Policy Manual Topic: Left-Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation Date of Origin: December 2011 Section: Medicine Last Reviewed Date: October 2013 Policy No:
Watchman and Structural update..the next frontier. Ari Chanda, MD Cardiology Associates of Fredericksburg
Watchman and Structural update..the next frontier Ari Chanda, MD Cardiology Associates of Fredericksburg Different Left Atrial Appendage (LAA) morphologies Watchman (the device) Fabric Anchors Device structure
Percutaneous Epicardial LAA Closure: When Does it Make Sense?
Percutaneous Epicardial LAA Closure: When Does it Make Sense? Petr Neuzil, MD,PhD, FESC Professor of Medicine Cardiology department Na Homolce Hospital, Prague, Czechia petr.neuzil@gmail.com Disclosures
Feel the rhythm of the beat! Imaging the left atrium: What the electophysiologist wants to know
Feel the rhythm of the beat! Imaging the left atrium: What the electophysiologist wants to know Anna Shmukler MD, Anna S Bader MD MS, Narmadan Kumarasamy MD, Eric Bader MD, Linda B Haramati MD MS Disclosure
Left atrial appendage closure for thromboembolism prevention in patients with atrial fibrillation: advances and perspectives
Review Article Left atrial appendage closure for thromboembolism prevention in patients with atrial fibrillation: advances and perspectives Bin Kong 1,2, Yu Liu 1,2, He Huang 1,2, Hong Jiang 1,2, Congxin
Manuel Castellá Cardiovascular Surgery Hospital Clínic, Universidad de
When not to exclude the LAA Manuel Castellá Cardiovascular Surgery Hospital Clínic, Universidad de Barcelona mcaste@clinic.ub.es @mcastellamd Normal hearts Patient in sinus rhythm Patient in AF (with
Left Atrial Appendage Closure for Stroke Prevention in Patients with Atrial Fibrillation
Left Atrial Appendage Closure for Stroke Prevention in Patients with Atrial Fibrillation Issam D. Moussa, MD Professor of Medicine Mayo Clinic College of Medicine Chair, Division of Cardiovascular Medicine
Atrial fibrillation (AF) is associated with a high
Echo Essentials for Endoluminal LAA Closure Echocardiography is the imaging modality of choice for this new interventional technique. By Nina C. Wunderlich, MD; Martin J. Swaans, MD; Harald Küx, MD; Roy
The evolving role of left atrial appendage occlusion
ORIGINAL ARTICLE 288 A high-volume single-centre experience The evolving role of left atrial appendage occlusion Raffael A. Ghenzi, Slayman Obeid, Francesco Maisano, Maurizio Taramasso, Ronald Binder,
Medical Policy An independent licensee of the Blue Cross Blue Shield Association
Percutaneous Left Atrial Appendage Closure Device Page 1 of 22 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Percutaneous Left Atrial Appendage Closure Devices
Primary Care Atrial Fibrillation Update: Anticoagulation and Left Atrial Appendage Occlusion. Greg Francisco, MD, FACC
Primary Care Atrial Fibrillation Update: Anticoagulation and Left Atrial Appendage Occlusion Greg Francisco, MD, FACC DISCLOSURES None to declare Estimated 33.5million have AF worldwide (6-7million in
Left atrium appendage closure: A new technique for patients at high hemorrhagic risk
Left atrium appendage closure: A new technique for patients at high hemorrhagic risk Victoria Martin Yuste MD PhD ITC. Cardiology Department. Hospital Clinic. Barcelona SITE. Barcelona, Juin-9-2013 NON
Hands on workshops. 08:00-10:15 Session 1 - LAA morphology and imaging Moderator: Saibal Kar, MD / Shakeel A. Qureshi, MD / Bushra Rana, MD
Friday, November 20th, 2015 07:00-18:30 Registration 07:00-08:00 Welcome coffee Hands on workshops 08:00-10:15 Session 1 - LAA morphology and imaging Moderator: Saibal Kar, MD / Shakeel A. Qureshi, MD
16th ANGIOPLASTY SUMMIT-TCTAP TCTAP 2011 Seoul, Korea, April 27 29, 2011 Left Atrial Appendage Closure State of the Art Horst Sievert, Nina Wunderlich, Maik Gonzaga, Annkathrin Braut, Ilona Hofmann CardioVascular
EP Clinical Research Program Summary. Daniel L Lustgarten MD PhD Associate Professor The University of Vermont School of Medicine
EP Clinical Research Program Summary Daniel L Lustgarten MD PhD Associate Professor The University of Vermont School of Medicine Financial Disclosures Consultant and/or Research Support: Medtronic Biosense
TREATMENT OF STROKE PATIENTS THAT ARE TAKING NOVEL ANTICOAGULANTS. Jesse Weinberger, MD The Icahn School of Medicine at Mount Sinai
TREATMENT OF STROKE PATIENTS THAT ARE TAKING NOVEL ANTICOAGULANTS Jesse Weinberger, MD The Icahn School of Medicine at Mount Sinai Acknowledgement Many of the slides for this presentation were obtained
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 10, NO. 21, 2017 ª 2017 PUBLISHED BY ELSEVIER ON BEHALF OF THE
ª 2017 PUBLISHED BY ELSEVIER ON BEHALF OF THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 1936-8798/$36.00 http://dx.doi.org/10.1016/j.jcin.2017.06.072 STRUCTURAL: ATRIAL INTERVENTION FOCUS Percutaneous