MILAAC: The Role of Multimodality Imaging in Left Atrial Appendage Closure
Study Details
Study Description
Brief Summary
The aim of the present prospective, randomized single-centre study is to determine the utility of multimodal imaging in percutaneous left atrial appendage closure. The investigators are planning to examine the success rate, safety, operative burden and long-time outcome of the procedure after multimodal and standard preprocedural imaging. Multimodal procedural guidance and postoperative assessment is going to be used. The investigators aim to compare the sensitivity of different imaging techniques in detecting postoperative complications.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Left atrial appendage closure (LAAC) is an increasingly used non-pharmacologic strategy to prevent stroke in patients with atrial fibrillation who have absolute or relative contraindications to long-term oral anticoagulant therapy, mainly due to previous major bleeding or high bleeding risk. As the candidates of the procedure are mainly aged and multimorbid, the reduction of procedural burden is of huge significance for them. More comprehensive data about the optimal imaging of LAAC may contribute in finding the most accurate and least invasive way to plan and guide the procedure and to follow up the patients.
The aim of the present prospective, randomized, single-centre study is to examine the potential advantages of preoperative multimodal imaging in percutaneous left atrial appendage closure. The investigators are going to assess the success rate, safety and long-term outcome of LAAC procedures, and determine the procedural burden (total radiation dose, procedure time, fluoroscopy time, contrast amount) of the interventions after preprocedural multimodal (2D/3D transesophageal echocardiography /TOE/ and multidetector computed tomography /MDCT/) and standard (2D/3D TOE or MDCT) appendage characterization and device sizing. Multimodal procedural guidance (2D/3D TOE, fluoroscopy-angiography) and multimodal postprocedural imaging (2D/3D TOE, MDCT) is going to be used to reveal complications (peri-device leak, thrombus). The investigators are planning to compare the accuracy and additive value of different postoperative imaging techniques, and ascertain the additive value of echocardiographic contrast agents in detecting postoperative complications.
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Multimodal imaging Preoperative 2D/3D TOE AND MDCT for appendage characterisation and sizing Operative 2D/3D TOE and fluoroscopy/angiography for guiding and checking the procedural events and success Postoperative 2D/3D TOE and MDCT to assess the complications (peri-device leak, thrombus) |
Diagnostic Test: Multimodal imaging
Preoperative 2D/3D TOE and MDCT, operative 2D/3D TOE and fluoroscopy/angiography, postoperative 2D/3D TOE and MDCT
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| Experimental: Standard imaging Preoperative 2D/3D TOE OR MDCT for appendage characterisation and sizing Operative 2D/3D TOE and fluoroscopy/angiography for guiding and checking the procedural events and success Postoperative 2D/3D TOE and MDCT to assess the complications (peri-device leak, thrombus) |
Diagnostic Test: Standard imaging
Preoperative 2D/3D TOE or MDCT, operative 2D/3D TOE and fluoroscopy/angiography, postoperative 2D/3D TOE and MDCT
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Outcome Measures
Primary Outcome Measures
- Total radiation dose [Periprocedural (1 month) interval]
Total radiation dose of the patient resorbed during LAAC imaging and intervention (uGym2)
Secondary Outcome Measures
- Fluoroscopy time [during the procedure]
during LAAC procedure (min)
- Procedure time [during the procedure]
of LAAC procedure (min)
- Contrast media amount [during the procedure]
used during LAAC procedure (ml)
- Rate of successful implantations [during the procedure]
left atrial appendage occluder successfully deployed and released
- Rate of patients with adequate seal of closure device [6 weeks post-procedure]
Adequate seal defined as no leak or residual leak< 5 mm established by postoperative TOE
- Rate of procedural complications [within 30 days post-procedure]
Thromboembolic events, myocardial infarction, bleeding events, vascular complications, pericardial effusion, tamponade, infections, allergic reactions, renal insufficiency, device/air embolism, mortality
- Rate of clinical events [5 years post-procedure]
Composite endpoint of thromboembolic events (ischemic stroke, TIA, systemic embolism)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients, who have clinical indication to LAAC and are undergoing percutaneous LAAC procedure in Gottsegen National Cardiovascular Center from 10.03.2021 to 31.12.2025
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Age above 18 years
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Informed consent
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Legal capacity
Exclusion Criteria:
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Age under 18 years
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Pregnancy
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Incapacitation
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Absence of consent
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Esophageal stenosis or diverticulum
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Active esophageal bleeding
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CT-contrast agent allergy
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Severe chronic kidney disease (GFR<15 ml/min/1,73 m2)
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Appendage thrombus (mobile/with significant embolic risk)
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Life expectancy shorter than 12 months
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Active infection
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Significant mitral valve stenosis
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Mechanical heart valve
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Open heart surgery is indicated
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center) | Budapest | Hungary | 1096 |
Sponsors and Collaborators
- Hungarian Institute of Cardiology
Investigators
- Principal Investigator: Anita Zadori, MD, PhD, 0036303837011, zadori.anita@kardio.hu
Study Documents (Full-Text)
None provided.More Information
Publications
- Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27.
- Nucifora G, Faletra FF, Regoli F, Pasotti E, Pedrazzini G, Moccetti T, Auricchio A. Evaluation of the left atrial appendage with real-time 3-dimensional transesophageal echocardiography: implications for catheter-based left atrial appendage closure. Circ Cardiovasc Imaging. 2011 Sep;4(5):514-23. doi: 10.1161/CIRCIMAGING.111.963892. Epub 2011 Jul 7.
- Osmancik P, Tousek P, Herman D, Neuzil P, Hala P, Stasek J, Haman L, Kala P, Poloczek M, Branny M, Chovancik J, Cervinka P, Holy J, Vancura V, Rokyta R, Taborsky M, Kovarnik T, Zemanek D, Peichl P, Haskova S, Jarkovsky J, Widimsky P; PRAGUE-17 Investigators. Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study). Am Heart J. 2017 Jan;183:108-114. doi: 10.1016/j.ahj.2016.10.003. Epub 2016 Oct 11.
- Qamar SR, Jalal S, Nicolaou S, Tsang M, Gilhofer T, Saw J. Comparison of cardiac computed tomography angiography and transoesophageal echocardiography for device surveillance after left atrial appendage closure. EuroIntervention. 2019 Oct 20;15(8):663-670. doi: 10.4244/EIJ-D-18-01107.
- Rajwani A, Nelson AJ, Shirazi MG, Disney PJS, Teo KSL, Wong DTL, Young GD, Worthley SG. CT sizing for left atrial appendage closure is associated with favourable outcomes for procedural safety. Eur Heart J Cardiovasc Imaging. 2017 Dec 1;18(12):1361-1368. doi: 10.1093/ehjci/jew212.
- Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.
- Sievert H, Lesh MD, Trepels T, Omran H, Bartorelli A, Della Bella P, Nakai T, Reisman M, DiMario C, Block P, Kramer P, Fleschenberg D, Krumsdorf U, Scherer D. Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk patients with atrial fibrillation: early clinical experience. Circulation. 2002 Apr 23;105(16):1887-9.
- MILAAC