Chapter 76 Left Atrial Appendage Closure: Indication and Technique

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Chapter 76 Left Atrial Appendage Closure: Indication and Technique RANJAN SHETTY INTRODUCTION Atrial fibrillation (AF) is one of the most common cardiac arrhythmias, which affects around 3% 5% of the

1 Chapter 76 Left Atrial Appendage Closure: Indication and Technique RANJAN SHETTY INTRODUCTION Atrial fibrillation (AF) is one of the most common cardiac arrhythmias, which affects around 3% 5% of the population between 65 and 75 years of age. The prevalence increases to 8% in those aged more than 80 years 1. Stroke risk in patients with nonvalvular AF (NVAF) is around 3% 5% per year. Overall, AF accounts for up to 30% of stroke in patients over 80 years of age 2. Oral anticoagulation (OAC) is the standard treatment for stroke prevention in patients with NVAF with CHA2DS2-VASc stroke risk score 1 (see ref 3). OAC, including novel OAC (NOAC), are indeed effective in stroke prevention. However, the higher rate of bleeding events reported in several patients is a significant limitation in considering OAC for chronic prophylaxis of stroke 4, 5. Percutaneous left atrial appendage (LAA) occlusion is a new and emerging therapy which provides an alternative to OAC in patients with high stroke risk and contraindication to OAC. RATIONALE The LAA which has been regarded as the most lethal human attachment is the major site in the left atrium (LA) accounting for more than 90% of thrombi formation in patients with NVAF, in contrast to the patients with valvular AF generating only 60% of thrombi in LAA as detected by transoesophageal studies 6. Generally, LAA actively contracts with a distinct pattern of emptying in sinus rhythm, as detected by both transoesophageal echocardiography (TEE) and cardiac magnetic resonance imaging studies. However, in patients with AF, the blood flow velocity in LAA frequently decreases, resulting in stasis and pooling of blood associated with an increased rate of thrombus formation. Hence, the rationale behind occluding LAA is that it can reduce 90% of thrombi formation in patients with NVAF. Currently, LAA closure has been given a class IIB recommendation in recent AHA/ESC guidelines. EVIDENCE Percutaneous left atrial appendage transcatheter occlusion (PLAATO) device was the first approved technology with a self-expanding Nitinol cage covered with a polymeric membrane for percutaneous transcatheter LAA occlusion which was evaluated by two multicentric prospective studies with positive results on 5-year follow-up 7, 8. Later, the feasibility and early experience using the WATCHMAN Left Atrial Appendage System, a self-expanding Nitinol device for percutaneous implantation to seal the LAA, was reported in Importantly, the WATCHMAN is the first and only device that has been evaluated in prospective randomized control trials (RCTs). Most of the evidence for LAA closure as an effective alternative to OAC and NOAC come from two RCTs, the PROTECT AF trial, and the PREVAIL study, and some registry data 9, 10. Details are summarized in Table INDICATIONS Based on the EHRA/European Association of Percutaneous Cardiovascular Interventions expert consensus statement on catheter-based LAAO (THE EP WIRE STUDY), the following patient categories need to assessed to determine the possible indication to LAA closure ( Table 76-2 ). TECHNIQUE The two most commonly used devices for LAA closure are the WATCHMAN and the Amplatzer 641

2 642 SECTION VIII Cardiac Electrophysiology TABLE 76-1 SUMMARY OF REGISTRIES AND RANDOMIZE CONTROLLED TRIALS CONDUCTED IN LEFT ATRIAL APPENDAGE CLOSURE WITH WATCHMAN DEVICE Study (Ref. #) Design PROTECT-AF 9, 11 RCT, N 707: 2 WM; 1 warfarin PREVAIL 10 CAP 12 ASAP 13 RCT, N 407: 2 WM; 1 warfarin Registry, N 460 Registry, N 150 CHADS2, Mean SD Procedural Success (%) Follow-Up Duration pt-yrs (mean 1.8 years) 1588 pt-yrs (mean 2.3 years) 2621 pt-yrs (45 months) Efficacy Events Primary end point: stroke, systemic embolism, CV death: 3.0% WM, 4.9% warfarin per 100 pt-yrs; RR: 0.62; met Primary end point: 3.0% WM, 4.3% warfarin per 100 pt-yrs; RR: 0.71; met Primary end point: 2.3% WM, 3.8% warfarin per 100 pt-yrs; RR: 0.6; met noninferiority and superiority criteria months Stroke, systemic embolism, CV and unexplained death at 18 months: both groups, RR: 1.07; did not meet ( 90 patients, at 18-month follow-up); ischaemic stroke or systemic embolism 7 days; met no inferiority criteria: WM; warfarin Median 0.4 year months All-cause stroke and systemic embolism 2.3%/year; observed ischaemic stroke rate was 77% lower than expected Important Safety Issues with WM Serious pericardial effusion 4.8%, procedural stroke 1.3%, device embolization 0.6%, major bleeding 3.5% (4.1% warfarin), haemorrhagic stroke 0.2% (2.5% warfarin) Major bleeding 4.8% (7.4% warfarin), haemorrhagic stroke 0.6% (3.7% warfarin). 7-day death, ischaemic stroke, systemic embolism and procedure complications met (2.2% WM). Pericardial effusion needing pericardiocentesis, window or surgery 1.9%; procedure stroke 0.4%; device embolization 0.8% Procedural stroke 0%, serious pericardial effusion 2.2% Serious procedure or device-related events 8.7%; pericardial effusion with tamponade 1.3%, device embolism 1.3%, device thrombus 4.0% (with 0.7% causing stroke) Note: ASAP, ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology; CAP, Continued Access Protocol; CHADS2, congestive heart failure history, hypertension history, age 75 years, diabetes mellitus history, stroke or transient ischaemic attack symptoms previously; CV, cardiovascular; PREVAIL, Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation vs. Long-Term Warfarin Therapy; PROTECT-AF, WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation; pt-yrs, patient-years; RCT, randomized controlled trial; RR, risk ratio; WM, WATCHMAN. Source: (Reprinted from JACC: Cardiovascular Interventions, 7/11, Jacqueline Saw, Mathieu Lempereur, Percutaneous Left Atrial Appendage Closure, , with permission from Elsevier by the American College of Cardiology Foundation.)

3 Chapter 76 Left Atrial Appendage Closure: Indication and Technique 643 TABLE 76-2 INDICATIONS TO LEFT ATRIAL APPENDAGE CLOSURE 1. CHA2DS2-VASc 2 but contraindicated to OAC (ICH/ life-threatening bleeding) 2. CHA2DS2-VASc 2 and HAS-BLED 3 3. Embolic events despite OAC (excluding other plausible causes such as carotid artery disease) 4. CHA2DS2-VASc 2 and ESRD (CrCl: ml/min) 5. CHA2DS2-VASc 2 and triple anticoagulant therapy 6. CHA2DS2-VASc 2 and pulmonary vein isolation 7. Alternate to OAC in patients with no increased risk for bleeding 8. Patients 60 years of age in whom the potential side effects and complications of long-term OAC therapy are thought to be more serious than LAAO. Note: CrCl, creatine clearance; ESRD, end-stage renal disease; ICH, intracranial haemorrhage; LAA, left atrial appendage occlusion; OAC, oral anticoagulants. Cardiac Plug (ACP). Here, the technique with ACP is discussed in detail. IMAGING Ideally, a preprocedure TEE should be done to assess the LAA anatomy and feasibility for device occlusion. TEE is done during the procedure to assess LAA anatomy, size of the ostium and size of landing zone which is needed to determine the device size. Ostium of the LAA is measured at the level of the left circumflex artery (LCX) and the left upper pulmonary vein (LUPV). The measurement of landing zone is taken 10 millimetres (mm) inside the ostium perpendicular to the neck of the LAA ( Fig ). The size of the landing zone determines the size of the lobe of ACP being used. ACCESS AND TRANS-SEPTAL PUNCTURE TECHNIQUE The procedure can be done under conscious sedation or general anaesthesia. The site for septal puncture is depicted in Fig The right femoral vein is cannulated using Seldinger technique and 10 French (Fr) sheath is placed. Soft Terumo wire is passed up to the superior vena cava (SVC). 10 Fr sheath is removed and 8 Fr Mullen s sheath with dilator passed over the wire to the SVC. A Brockenbrough septal puncture needle is passed inside the Mullen s sheath and the trans-septal puncture is done under TEE guidance. The important step in this trans-septal procedure which differs from other trans-septal puncture for balloon mitral valvotomy (BMV) is that it is done posterior and inferior to the fossa ovalis under continuous TEE guidance ( Fig ) in order to align the Mullen s sheath with the LAA. The Mullen s sheath is then passed over the puncture needle in the LA and the puncture needle and Mullen s sheath dilator are removed and 6 Fr sizing pigtail catheter is then passed inside the Mullen s sheath into the LA. ANGIOGRAPHY The Mullen s sheath and the pigtail are then guided into the LAA body by anticlockwise torque on the pigtail. Once the pigtail is inside the body of the LAA, angiographic views in right anterior oblique (RAO) 20 degrees and cranial 20 degrees were taken by contrast injections through the Mullen s sheath. LAA ostium measurements and landing zone measurements are done ( Fig ). If required, additional views such as RAO caudal are taken to Transcatheter mitral valve repair (Black X). Left atrial appendage closure (White X), and balloon mitral valvotomy (Blue X) RA = right atrium LA = left atrium IVC = inferior vena cava MV = mitral valve LAA = left atrial appendage RA LA MV LAA Figure TEE showing the LAA and the measurements to be taken (A, ostium of LAA; B, measurement of the landing zone which is 10 mm inside the ostium perpendicular to neck of LAA; C, LUPV; D, LCX). IVC Figure Site for septal puncture for various procedures.

644 SECTION VIII Cardiac Electrophysiology Figure 76-5. The Amplatzer Cardiac Plug and the pacifier principle. Figure 76-3.

Angiography in right anterior oblique view opacifying the LAA and the measurements to be taken (A, ostium of the LAA; B, distance between the ostium and the landing zone for the device in LAA [10

After angiographic measurements in different views and comparing with TEE measurements, appropriate size of the device is chosen.

4 644 SECTION VIII Cardiac Electrophysiology Figure The Amplatzer Cardiac Plug and the pacifier principle. Figure TEE-guided trans-septal puncture which is posterior and inferior to the fossa ovalis (A, tenting of the atrial septum; B, Brockenbrough needle). Figure Angiography in right anterior oblique view opacifying the LAA and the measurements to be taken (A, ostium of the LAA; B, distance between the ostium and the landing zone for the device in LAA [10 mm]; C, measurement of the landing zone for the lobe of the device). delineate the LAA anatomy clearly. After angiographic measurements in different views and comparing with TEE measurements, appropriate size of the device is chosen. The device is selected based on the lobe size of ACP and measurement of the landing zone, the lobe size should be 3 6 mm more than the measurements of the landing zone. an Inoue dilator is used to dilate the skin and soft tissues and the interatrial septum. This step has not been described in any of the reviews from other countries and is a novel modification from our experience of doing percutaneous BMV. This step of dilating the soft tissue and interatrial septum allows easy passage of the delivery sheath for device deployment. After dilatation, the delivery sheath is introduced over the super stiff wire to the LUPV. The delivery sheath comes with the device and comes in three sizes 9, 10 and 13 Fr and is selected according to the size of the device. The device is then loaded inside the delivery cable and is flushed under water to remove any air. The device with the delivery cable is then passed inside the delivery sheath and taken to the end of the sheath. The delivery sheath which was resting in the LUPV is then pulled back slightly, which allows it to face the LAA ostium. The device is then pushed out of the delivery sheath till it forms a ball shape, after which the whole system is pushed inside the body of the LAA and continuous monitoring with the help of TEE is done. Once on TEE, it is confirmed that two-third of the lobe is beyond the LCX artery, an anticlockwise torque to the delivery sheath is given and the device is further pushed out till the lobe of ACP is deployed. This anticlockwise torque helps to align the ACP perpendicular to the neck of the LAA. The lobe should attain a shape of a tire before further deployment of the device. Once satisfactory shape and location of the lobe are confirmed on TEE, the disc of the device is deployed by pulling back the delivery sheath and maintaining traction on the delivery cable (Fig. 76-5). TECHNIQUE OF ACP DEVICE IMPLANTATION CHECKLIST BEFORE FINAL RELEASE OF THE DEVICE (CONFIRMED ON TEE) (Fig. 76-6) After angiography, the pigtail is removed and an exchange length super stiff wire is placed in the LUPV and the Mullen s sheath is removed. Then 1. Tire shape of the lobe. 2. Good separation between the lobe and disc. 3. Disc is concave in shape.

Chapter 76 Left Atrial Appendage Closure: Indication and Technique Barbs 645 Double Curve Single Curve PTFE 30mm 24mm 33mm 27mm 21mm Preformed curve shapes guide position in LAA Figure 76-7.

(Reprinted from JACC: Cardiovascular Interventions, 7/11, Jacqueline Saw, Mathieu Lempereur, Percutaneous Left Atrial Appendage Closure, 1205 20, with permission from Elsevier.

5 Chapter 76 Left Atrial Appendage Closure: Indication and Technique Barbs 645 Double Curve Single Curve PTFE 30mm 24mm 33mm 27mm 21mm Preformed curve shapes guide position in LAA Figure WATCHMAN device and delivery sheath. (Reprinted from JACC: Cardiovascular Interventions, 7/11, Jacqueline Saw, Mathieu Lempereur, Percutaneous Left Atrial Appendage Closure, , with permission from Elsevier by the American College of Cardiology Foundation.) Figure Fluoroscopic image showing the final deployed device. 4. Disc seals off the ostium of the LAA. This is confirmed by angiography via injection of contrast through the delivery sheath. It can also be confirmed by colour Doppler on TEE. Jet width up to 3 mm on TEE is accepted across the device. 5. Two-third of the lobe should be inside the LCX artery on TEE. 6. ACP should parallel the LAA neck. 7. If the disc is not sitting at the ostium properly than the delivery cable is pulled slightly and then released, which allows the disc to cover the ostium completely. After confirming all these points, the device is finally released by rotating the delivery cable in anticlockwise manner till the device is finally released. The delivery cable and sheath are taken out and local haemostasis is achieved by local compression at the puncture site. WATCHMAN SIZING AND IMPLANTATION STEPS The sizing for WATCHMAN device is based on the maximum LAA ostium diameter. To be able to accommodate available devices, the LAA ostium diameter should be between 17 and 31 mm (Fig. 76-7). Approximately 9% 25% oversizing from the widest LAA diameter is recommended to ensure adequate device compression and good device hold. This generally corresponds a difference of 2 4 mm. Once the appropriate size device is selected, the prepared delivery system containing the compressed device is introduced into the access sheath. The delivery system is advanced until both the distal marker bands of the delivery system and access sheath are aligned. The device is then unsheathed slowly without forward advancement of the device, while asking the patient to hold breath to allow stable deployment. Once the device is fully unsheathed, the device position is assessed on fluoroscopy and TEE. If the device appears to be too distal, it may be partially recaptured and the access system is withdrawn slightly. The unsheathing process is then reattempted in the new position. On the other hand, if the device seems to be too proximal (or sizing/position is suboptimal), the device may have to be fully recaptured, and a new device and delivery system may have to be used through the existing 14F sheath. Before device release, the four PASS criteria should be met: (1) Position (device distal or at LAA ostium, protrusion of shoulder by 40% to 50% of device depth is acceptable) (2) Anchor (testing stability by retracting the deployment knob and letting go, to assess return to original position) (3) Size (device shoulder compressed 8% 20% of original size on TEE) (4) Seal (assess TEE for any residual flow, must be 5 mm before release) When these criteria are met, the device may be released with a counter-clockwise rotation of the core wire for three to five turns. Final angiography and TEE assessment are then performed. POSTPROCEDURE TREATMENT AND FOLLOW-UP Postprocedure dual antiplatelet is to be continued for 6 months, during which the device completely

6 646 SECTION VIII Cardiac Electrophysiology endothelizes, after which a single antiplatelet is continued indefinitely if no contraindication. Postprocedure TEE is done before discharge to look for early device embolization. Repeat TEE is done at 6 weeks to see for embolization and device endothelization. POSSIBLE COMPLICATIONS 1. Cardiac perforation and pericardial effusion due to trans-septal puncture or due to the device itself in which case it can perforate the LAA. Cardiac perforation up to 7 days is reported due to the device. 2. Pericardial effusion and cardiac tamponade. 3. Device embolization (early and late). 4. Device thrombosis. 5. Stroke/TIA thromboembolism, air embolism. 6. Vascular complications haematoma, bleeding. OUR EXPERIENCE A total of 77 patients aged 65 years with a CHA2DS2- VASc score of 2 and contraindicated to OACs with a HAS-BLED score of 3 were directed for percutaneous LAA closure. Thirty-eight patients were operated in the primary care centre and the rest 39 cases proctored. Gender wise distribution revealed female predominance (52.6%) over male (47.4%) patients eligible for LAA closure. ACP device was used more commonly (73) than WATCHMAN (2). The success rate of the procedure was reported to be around 97.4% with the device being successfully implanted in 75 patients. LAA closure was aborted in two patients on observing that one of the patients presented with LAA anatomy unfavourable for the occlusion and the other had pericardial effusion while attempting to close with a 20 mm ACP. These two cases were part of the initial 15 cases being studied critically, which we believe is a part of the learning curve. Nevertheless, the success rate of the procedure was 100% following these two cases. Post-LAA closure follow-up revealed one case of on-table device embolization, wherein the device was retrieved and repositioned without any complications. All the patients with LAA closure devices are being followed up. REFERENCES 1. Wolf, P. A., Abbott, R. D., & Kannel, W. B. ( 1991 ). Atrial fibrillation as an independent risk factor for stroke: The Framingham Study. Stroke, 22, Kannel, W. B., Wolf, P. A., Benjamin, E. J., & Levy, D. ( 1998 ). Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: Population-based estimates. American Journal of Cardiology, 82, 2N 9N. 3. Camm, A. J., Lip, G. Y., De Caterina, R., Savelieva, I., Atar, D., Hohnloser, S. H., et al. ( 2012 ) focused update of the ESC guidelines for the management of atrial fibrillation: An update of the 2010 ESC guidelines for the management of atrial fibrillation developed with the special contribution of the European Heart Rhythm Association. Europace. 14, Glader, E. L., Sjölander M., Eriksson, M., & Lundberg, M. ( 2010 ). Persistent use of secondary preventive drugs declines rapidly during the first 2 years after stroke. Stroke, 41, Landmesser, U., & Holmes, D. R., Jr. ( 2012 ). Left atrial appendage closure: A percutaneous transcatheter approach for stroke prevention in atrial fibrillation. European Heart Journal, 33, Blackshear, J. L., & Odell, J. A. ( 1996 ). Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Annals of Thoracic Surgery, 61, Ostermayer, S. H., Reisman, M., Kramer, P. H., Matthews, R. V., Gray, W. A., Block, P. C., et al. ( 2005 ). Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with nonrheumatic atrial fibrillation: Results from the international multi-center feasibility trials. Journal of the American College of Cardiology, 46, Block, P. C., Burstein, S., Casale, P. N., Kramer, P. H., Teirstein, P., Williams, D. O., et al. ( 2009 ). Percutaneous left atrial appendage occlusion for patients in atrial fibrillation suboptimal for warfarin therapy: 5-year results of the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) Study. JACC Cardiovascular Interventions, 2, Holmes, D. R., Reddy, V. Y., Turi, Z. G., Doshi, S. K., Sievert, H., Buchbinder, M., et al. ( 2009 ). Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: A randomised non-inferiority trial. Lancet, 374, Holmes, D. R., Jr., Kar, S., Price, M. J., Whisenant, B., Sievert, H., Doshi, S. K., et al. ( 2014 ). Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL trial. Journal of the American College of Cardiology, 64, Reddy, V. Y., Doshi, S. K., Sievert, H., Buchbinder, M., Neuzil, P., Huber, K., et al. ( 2013 ). Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-year follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation, 127, Reddy, V. Y., Holmes, D., Doshi, S. K., Neuzil, P., & Kar, S. ( 2011 ). Safety of percutaneous left atrial appendage closure: Results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation, 123, Reddy, V. Y., Möbius-Winkler, S., Miller, M. A., Neuzil, P., Schuler, G., Wiebe, J., et al. ( 2013 ). Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: The ASAP study (ASA Plavix Feasibility Study with Watchman Left Atrial Appendage Closure Technology). Journal of the American College of Cardiology, 61,

Atrial fibrillation (AF), one of the

Atrial fibrillation (AF), one of the Hellenic J Cardiol 2013; 54: 408-412 Case Report Left Atrial Appendage Occlusion with the Amplatzer Amulet for Stroke Prevention in Atrial Fibrillation: The First Case in Greece Apostolos Tzikas, Lambros