• LAA Closure: Lessons Learned : Tips and Tricks

    Ramon Quesada, MD, FACP,FACC, FSCAI Medical Director, Interventional Cardiology & Cardiac Research Baptist Cardiac & Vascular Institute, Miami, Florida Clinical Associate Professor of Medicine, Florida International University Herbert Wertheim School of Medicine I/we have no real or apparent conflicts of interest to report. Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial RelationshipCompany Grant/Research SupportNone Consulting Fees/HonorariaAbbott, Cordis, St. Jude, W.L. Gore, NMT Medical, Terumo & Boston Scientific Corporation Major Stock Shareholder/EquityNone Royalty IncomeNone Ownership/FounderNone Intellectual Property RightsNone Other Financial BenefitNone Available sizes- 21, 24, 27, 30, 33 mm (diameter) 10 Fixation barbs around device perimeter engage LAA tissue Contour shape accommodates most LAA anatomy Fabric Cap- (PET) Fabric Polyethyl terephthalate Prevents harmful emboli from exiting during the healing process 160 micron filter Barbs PET fabric Experience with WATCHMAN LAA Closure Device Threaded Insert *European enrollment sites only Data from PROTECT AF Intent-to-Treat- Primary Safety Results Reflects the risks of the Intervention Higher upfront risk associated with the procedure Higher relative risk in terms of safety Primary Safety Kaplan-Meier Estimates 1500 Patient-year Analysis Procedure Related Pericardial Effusion / Tamponade Procedure-related stroke Device embolization Bleeding events (mostly associated with Control Group) Intracranial or GI bleeding requiring transfusions 1 bleeding event on device arm while patient was on Coumadin post implant PROTECT AF vs. CAP *From tests comparing the PROTECT AF cohort with CAP ±From tests for differences across three groups (early PROTECT AF, late PROTECT AF, and CAP) Implant success defined as attempted case resulting in successful implantation *From tests comparing the PROTECT AF cohort with CAP ±From tests for differences across three groups (early PROTECT AF, late PROTECT AF, and CAP) The 5 procedure related strokes were air embolisms during procedure Reduced to 0% in CAP from improved air management techniques Primary Safety Kaplan-Meier Estimates CAP PROTECT AF Late PROTECT AF Early Transeptal crossing Advancement into LAA Device deployment and recapture Periprocedural Stroke Inappropriate Device Placement Poor Seal of LAA Device Embolization Procedural Risks- We know what they are and we’ve learned techniques to reduce their incidence Technical Improvements Device made shorter, reducing the need to cannulate as deep into LAA New sheath developed Softer tip Markers for guidance into appendage Optimized Transeptal access Strict use of pigtail catheter for cannulation of LAA Proper device manipulation Patient Management Reduced ACT levels during procedure Discontinued use of post procedure LMWH Mid to superior and posterior stick for best approach into LAA Use available imaging tools for safe crossing. TEE in most cases ICE if that is the operator’s comfort level Getting across difficult septums RF energy for crossing Use of the Pigtail catheter Start contrast injection at ostium for full visualization of LAA Use multiple imaging planes to understand the anatomy and plan the approach Distinguish separate lobes to determine optimal placement Using only one view may have them overlap on Cine Angiographic Assessment in Two Views RAO Caudal and Cranial Careful deployment by not advancing into LAA Watch distal tip of device during deployment and recapture Risk- Periprocedural Stroke Data indicates that it is preventable Has been reduced to 0% in CAP. Requires proper flushing of sheaths. Additionally Must watch for clots during procedure Proper anticoagulation during procedure Avoiding these scenarios requires understanding of LAA and device imaging Improper seal of LAA Device embolization During baseline screening After device deployment and prior to release Requires Understanding the Anatomy Long axis view of device Face at ostium Stable position Proper seal Canted position Barbs disengaged! Off axis position En face view of device Example of inadequate position in posterior lobe Final device placement in anterior lobe High angle showing proper orientation at ostium Coaxial Position Canted position Significant Shoulder Much of device is in the left atrium Device in improper position Final, stable position and good seal Inappropriate Placement Tines compressed distally Rapid filling of contrast into LAA through gaps Inferior shoulder protrusion Final Device Placement Device opened up allowing barbs to make contact Slow filling of contrast through filter cap Releasing a device with poor placement could lead to device not sealing the ostium and risk of future embolization Use of 3D imaging reveals a final big picture Ensure slow filling of LAA through filter cap Tug test- Very important step prior to release If available use 3D Ultrasound for confirmation of proper seal around ostium Review of Event Relative Risk Reduction Over Time 79 YR old female with a history of Chronic Atrial Fibrillation with a high risk for anticoagulation due to two episodes of GI bleeding, one episode while on coumadin and the 2nd episode on Pradaxa. Most recent hospitalization for lower GI bleeding. PMH- previous embolic CVA with no major sequelae HTN, no Diabetes, non-smoker Patient was referred for LAA occlusion vs exclusion Patient did not qualify for the PREVAIL study (currently in randomization ~ coumadin vs Watchman device) Therefore patient was offered LAA exclusion with the Lariet device suture delivery device Remote suture delivery device compatible with access >4.3mm 40mm pre-tied, “0” polyester suture loop mounted on collapsible snare Unique open / close capabilities allow control & precise placement Includes SofTIP & TenSURE accessories TM TM TM guide wire system .025” & .035” torque guide wires with N-S magnet tips Designed to easily find each other when in close proximity (4-5mm) Intended for two-way delivery of catheters TM large occlusion balloon Low profile, 15mm compliant balloons, >8.5F introducer compatible Excellent echogenic properties for identifying anatomic references Angiography performed through side holes distal to balloon TM Compatible with FindrWIRZ Confirm origin, shape, size & trajectory of target is compatible with LARIAT Identify exclusions such as thrombus, adhesions or other anatomic factors Access Delivery Capture Close Remove PRE-PROCEDURE Confirm absence of anatomical factors for delivery, e.g. adhesions Access Delivery Capture Close Remove ACCESS AP View AP View Lateral View Lateral View Courtesy of Miguel Valderrábano, MD Courtesy of Miguel Valderrábano, MD Delivery Capture Close Remove IDENTIFY Appendage Echo Probe Guide wire in sac 8.5f transseptal catheter Heart Diaphragm Close Remove CONFIRM Capture Exclusion location satisfactory? No Open snare and reposition Yes Move to “release of suture” Delivery Remove Delivery Capture Close CONFIRM Before After Left Atrium Appendage Pericardium Delivery Capture Close Pre-LARIAT exclusion Remove 30 day TEE Acute LARIAT exclusion Offers Immediate & Complete Exclusion Nothing Left Inside that can Break, Move, Infect Traditional Procedure – New Approach Data shows that the therapy is effective Avoids Risks Associated with Anticoagulants- Continual bleeding risk from drugs Systemic effects of medication Patient compliance issues Difficulties with anticoagulation reversal when needed Long term, these problems continue to increase Benefit of Device Therapy-

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Review our Privacy Policy for more details