Left Atrail Appendage Closure: Peri-device Leaks
Conditions
Keywords
Left Atrial Appendage Closure, Central or peri-device leaks
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.
Interventions
OTHERleak closure with either detachable embolization coils, vascular plugs/CSO, or RFA
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.
Sponsors
Kansas City Heart Rhythm Research Foundation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Size of PDL After Leak Closure Procedure | Immediate postprocedural and 1 year follow-up | Size of leak in mm on TEE after leak closure procedure, immediately at the end of the procedure and at 1 year follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | From postoperative day 0 to day 7 | Periprocedural complications occurring from Postoperative days 0 - 7, including: device-related thrombus, pericardial effusion/pericardial tamponade requiring intervention and CVA. |
| Delayed Procedure-related Complications at 1 Year Follow-up | 1 year after procedure | Secondary Safety Endpoint: Delayed procedure-related complications at 1 year follow-up including device-related thrombus, pericardial effusion/ pericardial tamponade requiring intervention and CVA. |
Countries
United States
Participant flow
Recruitment details
Enrollment occurred between 2015 and 2021 in the US.
Participants by arm
| Arm | Count |
|---|---|
| Detachable Embolization Coils Group Patients who have an intervention for leak closure with detachable embolization coils
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: 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. | 64 |
| Vascular Plugs/Septal Occluders Group Patients who have an intervention for leak closure with vascular plugs/CSO
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: 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. | 36 |
| RF Ablation Group Patients who have an intervention for leak closure with Radio Frequency Ablation (RFA)
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: 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. | 60 |
| Total | 160 |
Baseline characteristics
| Characteristic | Detachable Embolization Coils Group | Vascular Plugs/Septal Occluders Group | RF Ablation Group | Total |
|---|---|---|---|---|
| Age, Continuous | 66.7 Years STANDARD_DEVIATION 9.8 | 71.4 Years STANDARD_DEVIATION 7.2 | 76 Years STANDARD_DEVIATION 7.2 | 72.2 Years STANDARD_DEVIATION 9 |
| History of CVA/TIA | 21 Participants | 12 Participants | 24 Participants | 57 Participants |
| Leak size prior to closure Mild (1-2 mm) | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Leak size prior to closure Moderate (3-4 mm) | 23 Participants | 27 Participants | 16 Participants | 66 Participants |
| Leak size prior to closure Severe (>5 mm) | 41 Participants | 9 Participants | 43 Participants | 93 Participants |
| Previous major bleeding Gastrointestinal | 11 Participants | 9 Participants | 23 Participants | 43 Participants |
| Previous major bleeding Intracranial hemorrhage | 7 Participants | 4 Participants | 6 Participants | 17 Participants |
| Previous major bleeding No previous major bleeding | 46 Participants | 23 Participants | 31 Participants | 100 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 13 Participants | 0 Participants | 33 Participants | 46 Participants |
| Sex: Female, Male Male | 51 Participants | 36 Participants | 27 Participants | 114 Participants |
| TIA/CVA after primary LAAC before leak closure | 9 Participants | 3 Participants | 6 Participants | 18 Participants |
| Vascular Disease | 33 Participants | 18 Participants | 15 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 36 | 0 / 60 |
| other Total, other adverse events | 0 / 64 | 0 / 36 | 0 / 60 |
| serious Total, serious adverse events | 0 / 64 | 0 / 36 | 0 / 60 |
Outcome results
Primary
Size of PDL After Leak Closure Procedure
Size of leak in mm on TEE after leak closure procedure, immediately at the end of the procedure and at 1 year follow-up
Time frame: Immediate postprocedural and 1 year follow-up
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Detachable Embolization Coils Group | Size of PDL After Leak Closure Procedure | Size of PDL at 1 year follow-up | Leak size - < 1 mm | 10 Participants |
| Detachable Embolization Coils Group | Size of PDL After Leak Closure Procedure | Size of PDL at 1 year follow-up | Leak size - 2-3 mm | 9 Participants |
| Detachable Embolization Coils Group | Size of PDL After Leak Closure Procedure | Size of PDL immediately at the end of the procedure | Leak size - 2-3 mm | 0 Participants |
| Detachable Embolization Coils Group | Size of PDL After Leak Closure Procedure | Size of PDL at 1 year follow-up | Leak size - > 3 mm | 0 Participants |
| Detachable Embolization Coils Group | Size of PDL After Leak Closure Procedure | Size of PDL immediately at the end of the procedure | Leak size - 0 mm | 0 Participants |
| Detachable Embolization Coils Group | Size of PDL After Leak Closure Procedure | Size of PDL immediately at the end of the procedure | Leak size - < 1 mm | 64 Participants |
| Detachable Embolization Coils Group | Size of PDL After Leak Closure Procedure | Size of PDL immediately at the end of the procedure | Leak size - > 3 mm | 0 Participants |
| Detachable Embolization Coils Group | Size of PDL After Leak Closure Procedure | Size of PDL at 1 year follow-up | Leak size - 0 mm | 45 Participants |
| Vascular Plugs/Septal Occluders Group | Size of PDL After Leak Closure Procedure | Size of PDL immediately at the end of the procedure | Leak size - 0 mm | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Size of PDL After Leak Closure Procedure | Size of PDL at 1 year follow-up | Leak size - < 1 mm | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Size of PDL After Leak Closure Procedure | Size of PDL immediately at the end of the procedure | Leak size - < 1 mm | 36 Participants |
| Vascular Plugs/Septal Occluders Group | Size of PDL After Leak Closure Procedure | Size of PDL at 1 year follow-up | Leak size - 2-3 mm | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Size of PDL After Leak Closure Procedure | Size of PDL at 1 year follow-up | Leak size - 0 mm | 36 Participants |
| Vascular Plugs/Septal Occluders Group | Size of PDL After Leak Closure Procedure | Size of PDL immediately at the end of the procedure | Leak size - > 3 mm | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Size of PDL After Leak Closure Procedure | Size of PDL at 1 year follow-up | Leak size - > 3 mm | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Size of PDL After Leak Closure Procedure | Size of PDL immediately at the end of the procedure | Leak size - 2-3 mm | 0 Participants |
| RF Ablation Group | Size of PDL After Leak Closure Procedure | Size of PDL at 1 year follow-up | Leak size - > 3 mm | 0 Participants |
| RF Ablation Group | Size of PDL After Leak Closure Procedure | Size of PDL immediately at the end of the procedure | Leak size - 0 mm | 0 Participants |
| RF Ablation Group | Size of PDL After Leak Closure Procedure | Size of PDL immediately at the end of the procedure | Leak size - < 1 mm | 60 Participants |
| RF Ablation Group | Size of PDL After Leak Closure Procedure | Size of PDL immediately at the end of the procedure | Leak size - 2-3 mm | 0 Participants |
| RF Ablation Group | Size of PDL After Leak Closure Procedure | Size of PDL at 1 year follow-up | Leak size - < 1 mm | 19 Participants |
| RF Ablation Group | Size of PDL After Leak Closure Procedure | Size of PDL immediately at the end of the procedure | Leak size - > 3 mm | 0 Participants |
| RF Ablation Group | Size of PDL After Leak Closure Procedure | Size of PDL at 1 year follow-up | Leak size - 0 mm | 31 Participants |
| RF Ablation Group | Size of PDL After Leak Closure Procedure | Size of PDL at 1 year follow-up | Leak size - 2-3 mm | 10 Participants |
Secondary
Delayed Procedure-related Complications at 1 Year Follow-up
Secondary Safety Endpoint: Delayed procedure-related complications at 1 year follow-up including device-related thrombus, pericardial effusion/ pericardial tamponade requiring intervention and CVA.
Time frame: 1 year after procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Detachable Embolization Coils Group | Delayed Procedure-related Complications at 1 Year Follow-up | Pericardial effusion/tamponade | 0 Participants |
| Detachable Embolization Coils Group | Delayed Procedure-related Complications at 1 Year Follow-up | DRT | 0 Participants |
| Detachable Embolization Coils Group | Delayed Procedure-related Complications at 1 Year Follow-up | Death | 0 Participants |
| Detachable Embolization Coils Group | Delayed Procedure-related Complications at 1 Year Follow-up | Vascular complications | 0 Participants |
| Detachable Embolization Coils Group | Delayed Procedure-related Complications at 1 Year Follow-up | No complications | 64 Participants |
| Detachable Embolization Coils Group | Delayed Procedure-related Complications at 1 Year Follow-up | CVA | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Delayed Procedure-related Complications at 1 Year Follow-up | No complications | 36 Participants |
| Vascular Plugs/Septal Occluders Group | Delayed Procedure-related Complications at 1 Year Follow-up | Vascular complications | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Delayed Procedure-related Complications at 1 Year Follow-up | Pericardial effusion/tamponade | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Delayed Procedure-related Complications at 1 Year Follow-up | CVA | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Delayed Procedure-related Complications at 1 Year Follow-up | Death | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Delayed Procedure-related Complications at 1 Year Follow-up | DRT | 0 Participants |
| RF Ablation Group | Delayed Procedure-related Complications at 1 Year Follow-up | DRT | 0 Participants |
| RF Ablation Group | Delayed Procedure-related Complications at 1 Year Follow-up | CVA | 0 Participants |
| RF Ablation Group | Delayed Procedure-related Complications at 1 Year Follow-up | Pericardial effusion/tamponade | 0 Participants |
| RF Ablation Group | Delayed Procedure-related Complications at 1 Year Follow-up | No complications | 60 Participants |
| RF Ablation Group | Delayed Procedure-related Complications at 1 Year Follow-up | Death | 0 Participants |
| RF Ablation Group | Delayed Procedure-related Complications at 1 Year Follow-up | Vascular complications | 0 Participants |
Secondary
Periprocedural Complications Occurring From Postoperative Day 0 - Day 7
Periprocedural complications occurring from Postoperative days 0 - 7, including: device-related thrombus, pericardial effusion/pericardial tamponade requiring intervention and CVA.
Time frame: From postoperative day 0 to day 7
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Detachable Embolization Coils Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | No complications | 62 Participants |
| Detachable Embolization Coils Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | CVA | 0 Participants |
| Detachable Embolization Coils Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | Vascular complications | 0 Participants |
| Detachable Embolization Coils Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | Pericardial effusion/tamponade | 2 Participants |
| Detachable Embolization Coils Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | Death | 0 Participants |
| Detachable Embolization Coils Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | Device-related thrombosis | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | Death | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | Vascular complications | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | Device-related thrombosis | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | No complications | 36 Participants |
| Vascular Plugs/Septal Occluders Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | Pericardial effusion/tamponade | 0 Participants |
| Vascular Plugs/Septal Occluders Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | CVA | 0 Participants |
| RF Ablation Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | No complications | 60 Participants |
| RF Ablation Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | Pericardial effusion/tamponade | 0 Participants |
| RF Ablation Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | Device-related thrombosis | 0 Participants |
| RF Ablation Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | CVA | 0 Participants |
| RF Ablation Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | Death | 0 Participants |
| RF Ablation Group | Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 | Vascular complications | 0 Participants |