Role of Imaging in Complex LAA Closure Anatomies

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Role of Imaging in Complex LAA Closure Anatomies Sameer Gafoor 1,2 1 Swedish Heart and Vascular: Ming Zhang, Paul Huang, Darryl Wells, Adam Zivin, John Petersen II, Madalena Petrescu, Nimish Muni, Eric Lehr, Robert Bersin, Glenn Barnhart, Irina Penev,Amanda Ray, Cale Peterson, Julia Antonyuk, Thearry Deap, Zachary Newhart, David Mazza 2 CVC Frankfurt: Jennifer Franke, Simon Lam, Stefan Bertog, Laura Vaskelyte, Ilona Hofmann, Markus Reinartz, Horst Sievert Swedish Heart and Vascular: Swedish Medical Center, Seattle, WA, USA CVC: CardioVascular Center Frankfurt, Frankfurt, Germany

Potential conflicts of interest Speaker's name: Sameer Gafoor I do have a potential conflict of interest: Consulting for Boston Scientific and Siemens Speaker for Boston Scientific

Patient History 77 year old male with embolic stroke with hemorrhagic transformation. ECG showed paroxysmal atrial fibrillation. Now with mild gait ataxia at risk for falls. Neurology judged him to be at high risk for bleeding, so was referred for LAA closure. PMH: embolic stroke with hemorrhagic transformation, paroxysmal atrial fibrillation PSH: none Meds: aspirin 81 CHADS2 score: 3 due to age and stroke (5.9% risk stroke if no coumadin) CHADS-VASc score: 4 due to age, stroke (4.8% stroke, 6.7% stroke/tia/embolism)

LAA Types The Wind Sock Type LAA is an anatomy in which one dominant lobe of sufficient length is the primary structure. The Chicken Wing Type LAA is an anatomy whose main feature is a sharp bend in the dominant lobe of the LAA anatomy at some distance from the perceived LAA ostium. The Broccoli Type LAA is an anatomy whose main feature is an LAA that has limited overall length with more complex internal characteristics. SC2000 PRIME SC2000 PRIME

Watchman device Minimally Invasive, Local Solution Available sizes: 21, 24, 27, 30, 33 mm diameter 160 µm PET fabric cap Intra-LAA design Avoids contact with left atrial wall to help prevent complications Nitinol Frame Conforms to unique anatomy of the LAA to reduce embolization risk 10 active fixation anchors for stability Proximal Face Minimizes surface area facing the left atrium to reduce post-implant thrombus formation 160 micron membrane PET cap designed to block emboli and promote healing 98.5% implant success rate in EWOLUTION trial (Boersma LVA, et al. HRS2017) Anchors Nitinol frame

% of Patients 7-Day Procedure/Device Related SAEs 10.0% 8.0% 6.0% 4.0% 2.0% 0.0% 8.7% n=39 4.1% 4.2% n=23 n=12 Kaplan-Meier SAE rate 2.8% n=26 PROTECT AF CAP PREVAIL EWOLUTION Composite of vascular complications includes cardiac perforation, pericardial effusion with tamponade, ischemic stroke, device embolization, and other vascular complications 1 1 Includes observed PE not necessitating intervention, AV fistula, major bleeding requiring transfusion, pseudoaneurysm, hematoma and groin bleeding Boersma LVA, et al. HRS2017; Late Breaking Clinical Trials: Chicago IL, USA.; PROTECT AF/CAP: Reddy et al. Circulation 2011; PREVAIL: Holmes et al. JACC 2014

Benefit of imaging LAA closure is an imaging-guided preventive procedure When do we use imaging Pericardial effusion Transseptal puncture LAA measurement Post-procedural device stability & compression Complication assessment and management

Normal vs. Next-Generation Normal: TEE approach General anesthesia Radial line Post-anesthesia recovery (ICU/PACU) Next-day discharge Next-generation ICE approach Conscious sedation Floor recovery Same-day discharge We have already done it in TAVR

Siemens Imaging Suite Artis Zee Dedicated cardiology system for all applications ClearChoice helps choose image preference Outstanding quality and dose reduction capacity Acuson SC2000 TEE Real-time true volume non-stitch 3D imaging Image fusion capacity for fluoroscopy Automated valve measurements AcuNAV V ICE Catheter 3D ICE Capacity

Pericardial Effusion Check Angiography ICE TEE Siemens Imaging Support: Artis zee angiography system system is in the RV ACUSON SC2000 PRIME TEE - AcuNav V ICE catheter - RV near the top, LV near the bottom

Imaging for Transseptal Puncture Angiography ICE TEE Siemens Imaging Support: Artis zee angiography system ACUSON SC2000 PRIME TEE AcuNav V ICE catheter based in RA

transseptal focus TEE ICE Can easily see where transseptal can be performed different location for different procedures 3D will be the new gold standard for transseptal puncture

Placing the ICE catheter in the LAA Can be done after the transseptal sheath has been removed and stiff wire is in the LUPV

Other ICE Measurements LV LV Ao Ao Can mimic many of measurements of TEE

45 / 135 Baseline LAA Assessment 90 LAA measurements excellent match ICE TEE: Width: largest 24 mm in 0 degrees Depth: largest 28-32 mm Device choice: Watchman 30 mm device Siemens Imaging Support: Artis zee angiography system ACUSON SC2000 PRIME TEE AcuNav V ICE catheter

Delivery Sheath in LAA Angiography ICE TEE LAA measurements: 0 degrees: width 24 length 28 90 degrees: width 21.5, length 31 45 degrees: width 22 length 29 135 degrees: width 22, length 29 Siemens Imaging Support: Artis zee angiography system ACUSON SC2000 PRIME TEE AcuNav V ICE catheter

Watchman Device Delivery Device delivery fluoroscopy is key Siemens Imaging Support: Artis zee angiography system ACUSON SC2000 PRIME TEE AcuNav V ICE catheter

Position, Anchor, Size, Seal

Position Device distal to or at ostium of the LAA (LCx) Siemens Imaging Support: Artis zee angiography system ACUSON SC2000 PRIME TEE AcuNav V ICE catheter

Anchor Siemens Imaging Support: Artis zee angiography system ACUSON SC2000 PRIME TEE AcuNav V ICE catheter Pull test stability checked to make sure fixation barbs engaged

Size Compression at least 8-20% of original size (30 mm) 0 degrees: 23 mm 90 degrees: 22 mm 45 degrees: 20.4 mm 135 degrees: 22.1 mm Good compression with Watchman device

Seal Angiography ICE TEE Seal device spans ostium, minimal leak allowed Good seal with Watchman device Siemens Imaging Support: Artis zee angiography system ACUSON SC2000 PRIME TEE AcuNav V ICE catheter

Release of Watchman device Placed on aspirin/plavix per ASAP protocol

Patient Result Successful placement of Watchman 30 mm device Started aspirin/plavix per ASAP protocol Conclusion Excellent imaging is sine qua non for LAA closure TEE and ICE are both useful modalities for successful LAA closure ICE is the future of LAA closure, but now also the present