Clinical trial NCT05131308: Multimodality Evaluation of LAA Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry
Official title: Comparison of the Efficacy of Successful Leak Closure Between Available Leak Closure Methods for Clinically Relevant and Persisting Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Atrail Appendage Closure: Peri-device Leaks
Keywords: Left Atrial Appendage Closure
Central or peri-device leaks
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients at risk for stroke or thromboembolism that demonstrated any degree of the significant leak on follow up TEE imaging at least 4-6 weeks following either epicardial, endocardial, or surgical LAAC were included in this study population. All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.

Brief summary: Closure of peri-device leaks (PDL) after incomplete LAAC have shown early feasibility, however no comparison study of all the leak closure modalities exists. Therefore, this is an attempt to report the first 3-way observational comparison study to date, with results in 160 total patients in 3 arms including detachable embolization coils, vascular plugs/septal occluders and Radiofrequency ablation.

Detailed description: Left Atrial Appendage (LAA) Closure (LAAC) is a potent technique of LAA isolation and exclusion for stroke prevention in patients with atrial fibrillation, with evidence from the PROTECT-AF and PREVAIL-AF trials, including their 5-year follow-up assessments, solidifying LAAC as a viable option in these patients with comparable stroke reduction in comparison to oral anticoagulation (OAC) as well as a reduction in bleeding risk, hemorrhagic CVA, and mortality. However, the surge in the multiple methods of LAA exclusion has also brought to attention postprocedural complications specific to LAAC, namely, peri-device leaks (PDL). The stroke implication and classification of PDL itself still lacks consensus, with an increased thromboembolic (TE) potential due to PDL seen in patients with LARIAT and surgical ligation procedures, yet no statistically significant relationship seen in percutaneous and endocardial LAA closure approaches. PDL \> 5mm has been widely accepted as clinically significant, although there remains limited data with no current established guidelines. Placement of a septal occluder device such as Amplatzer Vascular Plug, Detachable embolization coils, Gore Cardioform Septal Occluder (CSO; W.L. Gore and Associates, Newark DE), and radiofrequency ablation (RFA) have all emerged as options to resolve residual PDL and post-surgical/ligation leaks. However, there exists no head-to-head comparison between these modalities. Given their emergence, this is a proposed a multi-center observational study to further assess and evaluate these three treatment modalities for their efficacy for leak closure, assessment of pre-, peri- and post-procedural characteristics after leak closure, TE events, and bleeding risk, and complication rates.

Eligibility criteria: Inclusion Criteria:

1. Patients at risk for stroke or thromboembolism that demonstrated any degree of the significant leak on follow up TEE imaging at least 4-6 weeks following either epicardial, endocardial, or surgical LAAC
2. Patients undergoing any form of eccentric or centric/central leak closure with available modalities (detachable embolization coils, vascular plus/septal/ASD occluders, or RF Ablation). Criteria for this was made based on the judgement of the operator, with no specific cutoffs for leak size, follow-up time from LAAC to leak closure, etc)
3. Age greater than 18 years

Exclusion Criteria:

1. Patients not undergoing leak closure after incomplete LAAC
2. Patients unable to complete 45 day follow-up imaging for reevaluation of LAA leak
3. Patients unable to consent

Primary outcomes:
measure: Size of PDL After Leak Closure Procedure
timeFrame: Immediate postprocedural and 1 year follow-up
Secondary outcomes:
measure: Periprocedural Complications Occurring From Postoperative Day 0 - Day 7
timeFrame: From postoperative day 0 to day 7
measure: Delayed Procedure-related Complications at 1 Year Follow-up
timeFrame: 1 year after procedure
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
Study officials:
affiliation: Kansas City Heart Rhythm Institute
name: Dhanunjaya Lakkireddy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. 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. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X.
citation: Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029.
citation: 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.
citation: Nguyen A, Gallet R, Riant E, Deux JF, Boukantar M, Mouillet G, Dubois-Rande JL, Lellouche N, Teiger E, Lim P, Ternacle J. Peridevice Leak After Left Atrial Appendage Closure: Incidence, Risk Factors, and Clinical Impact. Can J Cardiol. 2019 Apr;35(4):405-412. doi: 10.1016/j.cjca.2018.12.022. Epub 2018 Dec 21.
citation: Sahore A, Della Rocca DG, Anannab A, Mohanty S, Akella K, Murtaza G, Trivedi C, Gianni C, Chen Q, Bassiouny M, Ahmadian-Tehrani A, Macdonald B, Al-Ahmad A, Tarantino N, Cirone D, Horton RP, Romero J, Lakkireddy D, Di Biase L, Natale A. Clinical Implications and Management Strategies for Left Atrial Appendage Leaks. Card Electrophysiol Clin. 2020 Mar;12(1):89-96. doi: 10.1016/j.ccep.2019.11.010.
citation: Albaghdadi, M., et al., Peri-Device Leaks after Percutaneous Left Atrial Appendage Closure: Clinical Significance and Unmet Diagnostic Needs. Structural Heart, 2020. 4(6): p. 475-481
citation: Mohanty S, Gianni C, Trivedi C, Gadiyaram V, Della Rocca DG, MacDonald B, Horton R, Al-Ahmad A, Gibson DN, Price M, Krumerman AK, Palma EC, Di Biase L, Lakkireddy D, Natale A. Risk of thromboembolic events after percutaneous left atrial appendage ligation in patients with atrial fibrillation: Long-term results of a multicenter study. Heart Rhythm. 2020 Feb;17(2):175-181. doi: 10.1016/j.hrthm.2019.08.003. Epub 2019 Aug 7.
citation: Aryana A, Singh SK, Singh SM, O'Neill PG, Bowers MR, Allen SL, Lewandowski SL, Vierra EC, d'Avila A. Association between incomplete surgical ligation of left atrial appendage and stroke and systemic embolization. Heart Rhythm. 2015 Jul;12(7):1431-7. doi: 10.1016/j.hrthm.2015.03.028. Epub 2015 May 18.
citation: Turagam MK, Velagapudi P, Kar S, Holmes D, Reddy VY, Refaat MM, Di Biase L, Al-Ahmed A, Chung MK, Lewalter T, Edgerton J, Cox J, Fisher J, Natale A, Lakkireddy DR. Cardiovascular Therapies Targeting Left Atrial Appendage. J Am Coll Cardiol. 2018 Jul 24;72(4):448-463. doi: 10.1016/j.jacc.2018.05.048. Epub 2018 Jun 26.
citation: Jang SJ, Wong SC, Mosadegh B. Leaks after Left Atrial Appendage Closure: Ignored or Neglected? Cardiology. 2021;146(3):384-391. doi: 10.1159/000513901. Epub 2021 Mar 18.
citation: Della Rocca DG, Horton RP, Di Biase L, Bassiouny M, Al-Ahmad A, Mohanty S, Gasperetti A, Natale VN, Trivedi C, Gianni C, Burkhardt JD, Gallinghouse GJ, Hranitzky P, Sanchez JE, Natale A. First Experience of Transcatheter Leak Occlusion With Detachable Coils Following Left Atrial Appendage Closure. JACC Cardiovasc Interv. 2020 Feb 10;13(3):306-319. doi: 10.1016/j.jcin.2019.10.022. Epub 2020 Jan 15.
citation: Della Rocca DG, Horton RP, Tarantino N, Van Niekerk CJ, Trivedi C, Chen Q, Mohanty S, Anannab A, Murtaza G, Akella K, Gianni C, Bassiouny M, Ahmadian-Tehrani A, Al-Ahmad A, Burkhardt JD, Natale VN, Price M, Gallinghouse GJ, Gibson DN, Lakkireddy D, Di Biase L, Natale A. Use of a Novel Septal Occluder Device for Left Atrial Appendage Closure in Patients With Postsurgical and Postlariat Leaks or Anatomies Unsuitable for Conventional Percutaneous Occlusion. Circ Cardiovasc Interv. 2020 Oct;13(10):e009227. doi: 10.1161/CIRCINTERVENTIONS.120.009227. Epub 2020 Sep 18.