Clinical Cases in LAA Occlusion Indication, Techniques, Devices, Implantation Martin W. Bergmann Apostolos Tzikas Nina C. Wunderlich 123 Clinical Cases in LAA Occlusion Martin W. Bergmann • Apostolos Tzikas Nina C. Wunderlich Clinical Cases in LAA Occlusion Indication, Techniques, Devices, Implantation Martin W. Bergmann Nina C. Wunderlich Standort Wandsbek Kardiovaskuläres Zentrum Darmstadt Cardiologicum Hamburg Darmstadt Hamburg Germany Germany Apostolos Tzikas AHEPA University Hospital Interbalkan European Medical Center Thessaloniki Greece ISBN 978-3-319-51429-1 ISBN 978-3-319-51431-4 (eBook) DOI 10.1007/978-3-319-51431-4 Library of Congress Control Number: 2017939628 © Springer International Publishing AG 2017 This work is subject to copyright. 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Printed on acid-free paper This Springer imprint is published by Springer Nature The registered company is Springer International Publishing AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland Contents 1 Background: Stroke Prevention in Patients with Atrial Fibrillation . . 1 1.1 Rationale for LAA Closure in 2017: Background . . . . . . . . . . . . . . . 1 1.2 Stroke Prevention in Patients with Atrial Fibrillation: Role of Pulmonary Vein Isolation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.3 Reality of Oral Anticoagulation in 2017 . . . . . . . . . . . . . . . . . . . . . . 2 1.4 Risk of Bleeding with Oral Anticoagulation . . . . . . . . . . . . . . . . . . . 6 1.5 S troke Prevention in AF Patients Following Acute Coronary Syndromes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1.6 I ndications for LAA Occlusion in 2017 . . . . . . . . . . . . . . . . . . . . . . . 8 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 2 S afety and Efficacy of LAA Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 2.1 R andomized Trials on LAA Closure with the  Watchman Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 2.2 P rospective Registry Data on LAA Closure with the  Watchman Device from the US . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 2.3 Prospective Registry Data on LAA Closure with the  Watchman Device from Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 2.4 Registry Data on LAA Closure with the ACP and Amulet from Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 3 Anatomy and Imaging of the LAA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 3.1 Important Anatomical and Histological Aspects with Regard to LAA Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 3.1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 3.1.2 Important Surrounding Structures . . . . . . . . . . . . . . . . . . . . . 26 3.1.3 The Left Atrial Appendage. . . . . . . . . . . . . . . . . . . . . . . . . . . 27 3.1.4 The Atrial Septum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 v vi Contents 3.2 Pre-Procedural Imaging of the LAA . . . . . . . . . . . . . . . . . . . . . . . . . 30 3.2.1 Transthoracic Echocardiography . . . . . . . . . . . . . . . . . . . . . . 30 3.2.2 Transesophageal Echocardiography . . . . . . . . . . . . . . . . . . . 31 3.2.3 Computed Tomography and Magnetic Resonance Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 3.3 Intraprocedural Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 3.3.1 Transseptal Puncture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 3.3.2 Positioning of the Delivery Sheath and Device Deployment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 3.3.3 Assessment of the Final Result . . . . . . . . . . . . . . . . . . . . . . . 49 3.3.4 Monitoring of Complications . . . . . . . . . . . . . . . . . . . . . . . . . 51 3.4 Post-Procedural Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 4 Access to the Left Atrium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 4.1 Preparation of Transseptal Puncture . . . . . . . . . . . . . . . . . . . . . . . . . 59 4.2 Puncture of the Fossa Ovalis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 4.3 Handling of Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 4.4 T echnical Modifications of Left Atrium Access . . . . . . . . . . . . . . . . 61 5 P ractical Watchman Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 5.1 Device Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 5.2 Sheath Exchange . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 5.3 Sizing the LAA Watchman Landing Zone . . . . . . . . . . . . . . . . . . . . . 73 5.4 Watchman Implantation Step-by-Step . . . . . . . . . . . . . . . . . . . . . . . . 76 5.5 Release Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 5.6 S heath Removal and Hemostasis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 5.7 P ost-Procedural Care and Drug Regimen . . . . . . . . . . . . . . . . . . . . . 79 6 Practical Watchman Implantation: Case Examples . . . . . . . . . . . . . . . 81 6.1 Case Examples for the Watchman LAA Occluder . . . . . . . . . . . . . . . 81 6.1.1 Shallow LAA: Watchman Implantation with “Shoulder” (Case 1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 6.1.2 Dual Lobe LAA (Case 2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 6.1.3 LAA with Inferior Take-off (Case 3) . . . . . . . . . . . . . . . . . . . 87 6.1.4 LAA with Chicken Wing Morphology (Case 4) . . . . . . . . . . 92 6.1.5 LAA with Dual Lobe Anatomy (Case 5) . . . . . . . . . . . . . . . . 93 6.1.6 LAA with Single Lobe (Case 6) . . . . . . . . . . . . . . . . . . . . . . 95 6.1.7 Multilobe LAA (Case 7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 6.1.8 Multilobe, Large LAA and Transseptal Puncture (Broccoli-Type, Case 8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 6.1.9 Large LAA Closed by Two Devices (“Kissing Watchman”, Case 9) . . . . . . . . . . . . . . . . . . . . . . 103 Contents vii 7 Amplatzer Amulet Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 7.1 Device Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 7.2 Step by Step . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 7.2.1 Before Puncture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 7.2.2 Vascular Access: Transseptal Puncture . . . . . . . . . . . . . . . . 111 7.2.3 Device Sizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 7.2.4 Device Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 7.2.5 Stiff Wire: Sheath Exchange . . . . . . . . . . . . . . . . . . . . . . . . 113 7.2.6 Device Introduction and Deployment . . . . . . . . . . . . . . . . . 113 7.2.7 Signs of Device Stability, Evaluation of  Complete LAAO, Tug Test, and Device Release . . . . . . . . . 114 7.2.8 Device Recapture: Change . . . . . . . . . . . . . . . . . . . . . . . . . . 115 Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 8 Amplatzer Amulet Implantation: Case Series . . . . . . . . . . . . . . . . . . . 117 8.1 Closure of a Large LAA with a 34 mm Amulet device . . . . . . . . . . 117 8.2 Closure of a Shallow, Double Lobe LAA with Embolization . . . . . 119 8.3 LAA with Two Proximal Lobes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121 8.4 LAA with Chicken Wing Morphology . . . . . . . . . . . . . . . . . . . . . . 125 8.5 Cauliflower LAA with Short Depth . . . . . . . . . . . . . . . . . . . . . . . . . 128 8.6 LAA with a Chicken Wing Morphology and an Additional Proximal Lobe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 8.7 Closing a LAA with a Close Proximity to the  Pulmonary Artery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136 9 Prevention and Management of Complications . . . . . . . . . . . . . . . . . . 141 9.1 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141 9.1.1 Pericardial Effusion/Tamponade . . . . . . . . . . . . . . . . . . . . . 141 9.1.2 Thrombus Formation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 9.1.3 Device Embolization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 9.1.4 Air Embolism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152 9.1.5 Device Thrombosis During Follow Up . . . . . . . . . . . . . . . . 156 9.1.6 Late Pericardial Effusion/Tamponade . . . . . . . . . . . . . . . . . 157 9.1.7 Device Embolization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159 10 C ombined Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161 10.1 L AA Closure and Transcatheter Aortic Valve Implantation (TAVI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161 10.2 L AA Closure and MitraClip Implantation . . . . . . . . . . . . . . . . . . . 162 10.3 L AA Closure and Percutaneous Coronary Interventions (PCI) . . . 162 10.4 L AA Closure and Pulmonary Vein Isolation (PVI) . . . . . . . . . . . . 163 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165 Acknowledgments We acknowledge the contribution of the following authors: Jennifer Franke Department of Cardiology, University of Heidelberg, Heidelberg, Germany Siew Yen Ho Cardiac Morphology Unit, Royal Brompton Hospital, London, England Robert James Siegel The Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA Kevin P. Walsh Mater Misericordiae University Hospital, Dublin, Ireland ix Chapter 1 Background: Stroke Prevention in Patients with Atrial Fibrillation 1.1 Rationale for LAA Closure in 2017: Background When starting or expanding a LAA closure program, the imminent question cer- tainly raised by referring physicians, and possibly even by some patients, is: why go for a potentially risky cardiac intervention if a well proven drug therapy like NOAC is available? Many patients prefer a single 2–3 days hospital stay with a low risk cardiac intervention similar to pulmonary vein isolation or PFO closure, over a long-term therapy which increases sensitivity to skin bruises, gastro-intes- tinal bleeding and other side effects. Non-interventional general practitioners or other colleagues not close to the field may argue that evidence is not sufficient as the number of patients included in prospective trials is low and only available for the Watchman device. Randomized trials and prospective registries in over 500,000 patients treated with NOAC’s are available. In the absence of a random- ized trial comparing NOAC therapy to LAA closure, in-depth discussion of the available data is necessary to achieve consensus. This chapter focusses on a criti- cal appraisal of NOAC study data and provides a simple algorithm incorporating both US and European guidelines regarding indication for LAA closure. 1.2 Stroke Prevention in Patients with Atrial Fibrillation: Role of Pulmonary Vein Isolation Atrial fibrillation (AF), regardless if paroxysmal, persistent, long-standing persis- tent or permanent, confers a five-fold risk of stroke overall 5 times higher than in patients without atrial fibrillation. Individual risk is calculated on the basis of the CHA2DS2−VASc score with a score ≥1 indicating the need for oral anticoagulation; this means that, aside from younger (<65 years) patients without cardiovascular risk © Springer International Publishing AG 2017 1 M.W. Bergmann et al., Clinical Cases in LAA Occlusion, DOI 10.1007/978-3-319-51431-4_1 2 1 Background: Stroke Prevention in Patients with Atrial Fibrillation factors, all patients with AF should receive a therapeutic measure for stroke preven- tion. CHA DS VASc score calculators are available in many smartphone APP’s 2 2− and should be documented in every AF patient. From a European perspective, CHADS is no longer in use. Patients with lone atrial fibrillation are often symp- 2 tomatic even on one or more drugs meant for rhythm control. These patients will likely be eligible for pulmonary vein isolation (PVI) [1]. However, according to the guidelines and published data, the indication for oral anticoagulation even after PVI is strictly linked to the CHA DS VASc score as the current interpretation of the 2 2− effect of PVI in most patients is to convert symptomatic AF to asymptomatic AF. Whereas PVI reduces the burden of AF more efficiently than available drug therapies (i.e. from 3.6 to 0.3 h per day in one study), only 21% of patients were completely free of any AF episode during a follow up of 41.4 ± 15.1 months employing an implantable monitoring device. AF may also reoccur after long-last- ing (>1 year) episode-free intervals [2]. Nonetheless, patients with a CHA DS VASc 2 2− of ≤1 were found to have a lower risk of stroke after PVI [3]. In summary, PVI is the treatment of choice in patients younger than 65 with no comorbidities. If suc- cessful, no long term oral anticoagulation is required. The majority of patients with a history of AF are in need of a life-long therapeutic strategy for stroke prevention independent of the treatment strategy chosen for AF itself, including PVI. Unlike the treatment of other medical conditions like hypertension, stroke prevention needs to be more aggressive and intense with increasing age, as the risk of stroke and clinical impact of a stroke increases. 1.3 Reality of Oral Anticoagulation in 2017 Although the guidelines recommend oral anticoagulation with warfarin in patients with AF and a CHADS score >1 for many years, many patients still do not receive 2 adequate stroke prevention. The Canadian stroke network found that 90% of patients admitted to their stroke units with known atrial fibrillation and no known contraindi- cation for anticoagulation were not receiving adequate medical stroke prevention: 29% presented with an INR <2, 29% were on platelet inhibition only, 2% were on dual antiplatelet therapy and 29% did not receive any form of anticoagulation [4]. The situation in Europe is comparible; in 2005, a Euro Heart Survey study on atrial fibril- lation found oral anticoagulation to be prescribed in only 67% of patients [5]. More recently, the European PREFER in AF and the GARFIELD AF registries reported approximately 80% of hospitalized AF patients to be receiving oral anticoagulation with Vitamin-K antagonists or NOAC’s [6]; However, around 20% mostly high risk (CHADs-VASc ≥3) patients still do not receive adequate stroke protection [4]; the number of patients receiving inadequate reduced dose of NOAC’s is unknown. Currently four non-Vitamin K antagonists (NOAC) are available throughout the EU. These anticoagulants, namely dabigatran, rivaroxaban, apixaban and edoxaban, have been studied in large randomized trials which also provided new insights into stroke and bleeding risk in patients with AF. Several extensive reviews are available