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 Grant support: Boston-Scientific Inc, Coherex /Biosense-Webster Inc, Sentreheart Inc Grant support / Consultant: St Jude Medical Inc
LAA Anatomy
Thrombus Formation (TEE)
Surgical LAA Exclusion LAA ligation or exclusion is regular part of mitral valve surgery. 1,2 Long term follow-up: Results of MAZE procedure 2 indicate significant reduction of strokes/tia in the case of concomitant LAA closure/exclusion Complete ligation is critical: Katz et al documeted during TEE incomplete LAA closure in 18/50 (36%) patients. 1 Authors indicate residual communication between LAA and rest of LA as increase risk for thromboembolic events. 1 1.Katz et al. Surgical LAA Ligation if Frequently Incomplete: A transesophageal Echocardiographic Study. J AM Coll Cardiol 2000;36:468-71. 2. Ad N, Cox JL.. Stroke prevention as an indication for the Maze procedure in the treatment of atrial fibrillation. Semin Thorac Cardiovasc Surg 2000.
Surgical LAA Incomplete Closure
LAA clip occlusion device Atriclip Atricure: Self-closing implantable clip LAA closure regardless of LAA anatomy CT before and at 3-year follow-up after implantation Emmert MY at al: Eur J Cardio-Thorac Surg 2014,45:127.
LAA clip occlusion device Emmert MY at al: Eur J Cardio-Thorac Surg 2014,45:127.
Stroke Prophylaxis: Alternatives to Drugs Novel Anticoagulants Thrombin Inhibitors Dabigatran Factor Xa Inhibitors Apixaban Rivaroxaban Edoxaban LA Appendage Closure Surgical Epicardial Vascular PLAATO Amplatzer Cardiac Plug Wavecrest Watchman Blackshear and Odell, Ann Thoracic Surgery 1996
PLAATO LAA Occlusion Homolka Experience Watchman Amplatzer Cardiac Plug [ACP] WaveCrest Coherex Watchman Flex 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Watchman Gen 3 Lariat endo/epi Amplatzer Amulet
LAA Occlusion Homolka Experience 60 CHADS 2, Ø=2.79 Coherex; Lariat Total 239 implants 40 20 Amulet W 35% 0 60 0 1 2 3 4 5 6 CHA 2 DS 2 VASc, Ø= 3.84 ACP PLAATO M 65% 40 20 Watchman 0 0 1 2 3 4 5 6 7 8 9 Other Occluder Watchman 100 80 60 40 20 0 Age in time of procedure 2004 2015 Age < 37 Age > 89 Average 71.4 First half 68 Second half 74 Younger > 50 years 3 Registr OLAA NNH, 2015
PLAATO: Long-Term Outcomes 23 pts followed for 58 ± 9 mos Age: 68 ± 5 years CHADS 2 score: 3.6 ± 0.6 Hx CVA/TIA: All pts Long-Term follow-up: 58 ± 9 mos 2 deaths: cancer and CHF 4/23 (3.4%/yr) with CVA/TIA Time-to-event: 29.7 ± 10 mos All recovered w/o major sequelae CT/TEE: Leaks in 3/4 pts (75%) Do leaks predict strokes? LAA LEAK PLAATO With Stroke/ TIA Without Stroke/ TIA Age 61.8 ± 6.7 61.2 ± 5.7 CHADS 2 3.6 ± 0.6 3.5 ± 0.5 Leak? 3/4 (75%) 7/9 (78%) P.Neuzil & V.Reddy, JICE, 2012
Do peri-device leaks portend worse prognosis? Leak at 12mo in Primary Event Rate PROTECT AF (Events / 100 pt-yrs) cohort No Leak 67,9% 67.9% 2,5 2.5 Leak ( 5 mm) 32,1% 32.1% 2,1 2.1 J.Viles-Gonzales / V.Reddy, JACC
Epicardial LAA Ligation Electrocardiogram Guided Approach A B Friedman PA at al: J Cardiovasc Electrophysiol, 2009, 20: 909.
Stroke Prophylaxis: LAA Epicardial Exclusion Novel Anticoagulants Thrombin Inhibitors Dabigatran (RELY) Factor Xa Inhibitors Apixaban (AVERROES) Rivaroxaban (ROCKET AF) Sternum RV Liver LV LA Appendage Closure Surgical Epicardial Vascular PLAATO Amplatzer Cardiac Plug Wavecrest Watchman Modified from slide from: E Sosa, M Scanavacca, A d Avila
Lariat Epicardial LAA Ligation Components Bartus K at al: JACC 2013, 62:108-18.
Lariat Epicardial LAA Ligation Os Landmark Proximal LAA Closure
Lariat Epicardial LAA Ligation Melzer Knot Pre-confirm Control of Suture Atraumatic Suture Release
LAA Suture Ligation: Pre-Clinical Work Endocardial Balloon: Not Used Residual LAA Remnant: 3 / 4 (75%) S.Singh / A.d Avila / S.Dukkipati / V.Reddy, Heart Rhythm 2010
LAA Suture Ligation: Pre-Clinical Work Endocardial Balloon: Used Residual LAA Remnant: 0 / 5 (0%) S.Singh / A.d Avila / S.Dukkipati / V.Reddy, Heart Rhythm 2010
Clinical LAA Suture Ligation
Clinical LAA Suture Ligation
Clinical LAA Suture Ligation
Clinical LAA Suture Ligation Pre-Ligation Post-Ligation LAA
Lariat Incomplete LAA Suture Di Biase at al: Heart Rhythm 2014,11:1087-88.
LARIAT Epicardial LAA Ligation multicenter clinical experiences Study included 41 patients (4 centers) - LAA closure with the LARIAT system. RESULTS Ø age was 75 ± 10 years, Ø mean CHADS 2 score was 3.0 ± 1.3, Ø HAS-BLED score was 4.4 ± 1.4. Accumulated 24.6 person-years of follow-up. Acute LAA closure was achieved in 38 patients (93 %). 3.3 ± 0.8 m. after the procedure LAA leakage demonstrated by TEE or CT in 24 % pts. 1 pt (2 %) TIA, 8 (20 %) pericardial effusions requiring pericardiocentesis. 4 (9 %) were complicated by perforation of the LAA, with 2 of these patients requiring open surgical correction. Miller MA at al: Heart Rhythm 2014, 11:1853-59.
LARIAT Epicardial LAA Ligation multicenter clinical experiences Anticoagulation/Antiplatelet therapy pre and post Lariat Miller MA at al: Heart Rhythm 2014, 11:1853-59.
LARIAT Epicardial LAA Ligation first clinical experiences Single center non-randomized trial 85/89 (96%) patients IMPL/INCL 81 pts complete closure immediatelly 3 pts >2 mm residual leak 1 pt >3 mm residual leak At 1+3 months 81/85 + 77/81 (95%) complete closure After 1 year 65 (98%) complete closure included 1 with previous leak COMPLICATIONS: Access related 3, pericardial effussion 2 / late 1, SCD 2, late stroke 2 Bartus K at al: JACC 2013, 62:108-18.
LARIAT Epicardial LAA Ligation first clinical experiences Bartus K at al: JACC 2013, 62:108-18.
LARIAT Epicardial LAA Ligation first clinical experiences 3D CT reconstruction Bartus K at al: JACC 2013, 62:108-18.
LARIAT Epicardial LAA Ligation first clinical experiences Fluoroscopic guidance to assist in the closure of the LAA Bartus K at al: JACC 2013, 62:108-18.
LARIAT Epicardial LAA Ligation first clinical experiences Bartus K at al: JACC 2013, 62:108-18.
LARIAT Epicardial LAA Ligation first clinical experiences Pericardial access approach Bartus K at al: JACC 2013, 62:108-18.
LARIAT Epicardial LAA Ligation Intraoperative Multimodality Imaging TEE guidance of LARIAT balloon placement Laura DM at al: JASE 2014, 27:704.
LARIAT Epicardial LAA Ligation Intraoperative Multimodality Imaging Fluoroscopy guidance of wires connection and snare placement Laura DM at al: JASE 2014, 27:704.
? Price M J at al: JACC 2014, 64: 569.
FINAL THOUGHTS 1. Epicardial LAA exclusion is more independent on its anatomy 2. There is no any device implanted 3. Stop anticoagulation after procedure 4. Less thrombogenic 5. Permanent occlusion?
Computed tomography findings at twelve-, twenty-, and thirty-six month follow-up after LAA clip surgery Emmert MY at al: LAA clip occlusion device. Eur J Cardio-Thorac Surg 2014,45:129.
Adverse events after LAA closure using the LARIAT device Miller MA at al: Safety of LAA closure with the LARIAT device. Heart Rhythm 2014, 11:1856.
Percutaneous Appendage Closure. Background: Pharmacologic therapies to prevent stroke in atrial fibrillation (AF) have numerous limitations, prompting the development of device-based therapies. We investigated whether an electrogram-based approach using a novel hollow suture can safely capture and ligate the left atrial appendage (LAA). Methods and Results: A novel system for closure of the LAA within the confines of the closed pericardium with a single sheath puncture was tested in 4 dogs. The tool used to grasp the appendage was fitted with electrodes and utilized electrical navigation to identify and confirmlaacapture. Ahollowsuture preloaded with a mechanical support wire to permit its manipulation and fluoroscopic visualization was advanced over the grasper, and the wire removed after the suture was positioned. The LAA was successfully closed in all dogs. In 2 dogs, after closure, a thoracotomy was performed and the LAA amputated without bleeding, confirming closure integrity. Necropsy confirmed closure in all animals. Conclusions: Using electrical navigation, percutaneous epicardial LAA ligation with a remotely tightened suture was performed successfully within the confines of the intact pericardial space. This technique may allow decreasing the risk of stroke in AF patients without the need for thoracotomy or an endocardially placed prosthetic device. left atrial appendage, atrial fibrillation, stroke, epicardial, electrograms Friedman PA at al.:percutaneous appendage closure. J Cardiovasc Electrophysiol, 2009,, 20, :908-915.
Necropsy evaluation of left atrial appendage (LAA closure) Friedman PA at al: Percutaneous appendage closure. J Cardiovasc Electrophysiol, 2009, 20: 913.