JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO.

6, 2023

ª 2023 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

PUBLISHED BY ELSEVIER

STATE-OF-THE-ART REVIEW

Peridevice Leak After Left Atrial

Appendage Occlusion
Incidence, Mechanisms, Clinical Impact, and Management

Mohamad Alkhouli, MD,a Ole De Backer, MD, PHD,b Christopher R. Ellis, MD,c Jens Erik Nielsen-Kudsk, MD,d
Horst Sievert, MD,e Andrea Natale, MD,f Dhanunjaya Lakkireddy, MD,g David R. Holmes, MDa

ABSTRACT

Left atrial appendage occlusion is an increasingly adopted stroke prevention strategy in patients with atrial fibrillation.
However, peridevice leaks after the procedure are not infrequent and have recently been shown to confer a higher risk for
subsequent ischemic events. In this paper, the authors review the available research on the frequency, mechanisms,
clinical significance, and management of peridevice leak after percutaneous left atrial appendage occlusion.
(J Am Coll Cardiol Intv 2023;16:627–642) © 2023 by the American College of Cardiology Foundation.

L eft atrial appendage occlusion (LAAO) has

emerged as a feasible stroke prevention strat-
egy for selected patients with atrial fibrillation
(AF).1 In the past decade, numerous studies have sup-
management.3,5,14,15 In this paper, we provide an up-
to-date review of the incidence, mechanisms, clinical
impact, and management of PDL after percutaneous
LAAO.
ported the safety and efficacy of LAAO, but a few
have revealed remaining issues that warrant further FREQUENCY OF PDL
investigation. 2-11 One of these issues is incomplete
LAAO, often described synonymously as peridevice The left atrial appendage (LAA) is the source of
leak (PDL). Initial data from the pivotal LAAO trials thrombi in most patients with nonvalvular AF.16
and prospective observational registries did not show The proposed mechanism of action of LAAO is
an association between PDL and adverse events.12,13 that the exclusion of the trabeculated LAA cavity
Hence, the presence of PDLs (especially small ones) from the systemic circulation lowers the risk
has largely been considered benign. However, for thromboembolic events. Historical data from
recent studies documented a relationship between surgical research show that incomplete LAAO was
PDLs and subsequent thromboembolic events frequent after surgical LAA exclusion, raising con-
leading to a renewed interest in PDLs and their cerns about its efficacy in mitigating the risk for

From the aDepartment of Cardiology, Mayo Clinic School of Medicine Rochester, Minnesota, USA; bDepartment of Cardiology, The
Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; cVanderbilt University Medical Center,
Nashville, Tennessee, USA; dDepartment of Cardiology, Aarhus University Hospital, Skejby, Denmark; eCardiovascular Center
Frankfurt, Frankfurt, Germany; fTexas Cardiac Arrhythmia Institute, St. David’s Medical Center, Austin, Texas, USA; and the
g
Kansas City Heart Rhythm Institute, Overland Park, Kansas, USA.
Ignacios Amat-Santos, MD, served as Guest Editor for this paper. Lars Søndergaard, MD, served as Guest Editor-in-Chief for this
paper.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’
institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information,
visit the Author Center.

Manuscript received October 2, 2022; revised manuscript received November 11, 2022, accepted December 5, 2022.

ISSN 1936-8798/$36.00 https://doi.org/10.1016/j.jcin.2022.12.006

628 Alkhouli et al JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023

Peridevice Leak After LAAO MARCH 27, 2023:627–642

ABBREVIATIONS stroke or thromboembolism. 17 Similarly,

AND ACRONYMS HIGHLIGHTS
several studies have shown that incomplete
closure is common after transcatheter LAAO,  PDL after LAAO are common and are
AF = atrial fibrillation
albeit with considerable variability in the associated with an increased risk of
CT = computed tomography
definitions, surveillance timing, detection thromboembolic events.
LAA = left atrial appendage
methods, and availability of core laboratory
LAAO = left atrial appendage  Comprehensive assessment of a PDL
adjudication across these studies (Figure 1).18
occlusion should consider not only its dimensions
In the PROTECT AF (Watchman Left Atrial
NCDR = National but also its potential mechanisms.
Appendage System for Embolic Protection in
Cardiovascular Data Registry

PDL = peridevice leak

Patients With Atrial Fibrillation) trial, any  Closure of PDL can be performed using
PDL and PDL >3 mm were present on 45-day plugs, occluders, coils, or radiofrequency
TEE = transesophageal
echocardiography
transesophageal echocardiography (TEE) in ablation. However, long-term data on
40.9% and 13.3% of patients, respectively. 13 these approaches are limited.
In the Amulet IDE (Amplatzer Amulet Left Atrial
 Novel devices, steerable sheaths, and
Appendage Occluder Randomized Controlled Trial),
computational simulation may aid in
the incidence rates of any PDL and PDL $3 mm at
mitigating the risk of PDL in the future.
45 days were 37.0% (296 of 801) and 11.2% (90 of
801) among patients treated with the Amulet device
A temporal change in PDL incidence and size has
(Abbott Vascular) and 53.9% (427 of 792) and
also been documented in up to 1 in 4 patients with
25.9% (205 of 792) among patients treated with
detectable leaks on the first imaging surveillance af-
the Watchman 2.5 device (Boston Scientific),
ter LAAO. In PROTECT AF, any PDL decreased from
respectively. 8 The differences in PDL between the
40.9% to 32.1% at 1 year. 13 In the Amulet IDE trial,
Watchman and Amulet devices may in theory
although the incidence of PDL $3 mm decreased be-
contribute to different rates of ischemic events.
tween 45 days and 1 year from 25.9% (205 of 792) to
However, in the Amulet IDE trial, the rates of
21.7% (134 of 618) with Watchman, and from 11.2% (90
ischemic stroke or systemic embolism at 18 months
of 801) to 9.5% (64 of 673) with Amulet, “new”
were identical with both devices (2.8% vs 2.8%),
PDLs $3 mm were identified at 1 year in 8.3% and
despite the higher incidence of PDL with the
4.2% in the Watchman and Amulet arms, respec-
Watchman device. 8 Notably, prospective registries
tively.14 In PINNACLE FLX, any PDL decreased from
reported lower PDL rates than the rates reported in
17.4% at 45 days to 10.5% at 1 year.21 In a computed
randomized clinical trials with both devices. In
tomography (CT)–based study of LAAO using the
EWOLUTION (Registry on Watchman Outcomes in
Amplatzer devices, the rate of contrast patency in the
Real-Life Utilization), 8.4% of the 835 patients
LAA declined from 66% to 47% between 2 months and
enrolled were reported to have any PDL at 45 days. 19
1 year.23 The size of the leak is an important deter-
Similarly, in the global Amulet observational study
minant of the likelihood of its temporal regression.
(which enrolled 1,088 patients treated with the
Afzal et al15 showed that PDLs #3 mm tend to regress
Amulet device), the rate of any core laboratory–
over time, whereas those >3 mm remained un-
adjudicated PDL at 45 days was only 9.9%. 20 Data
changed. Whether these temporal changes in PDL
from >50,000 patients in the U.S. National Cardio-
incidence and diameter are due to interobserver
vascular Data Registry (NCDR) showed that any PDL
variations in leak detection and reporting or repre-
after LAAO with the Watchman 2.5 device was pre-
3 sent a true change due to atrial remodeling remains
sent in 26.6% on 45-day follow-up TEE. Although
uncertain.24
the newer generation Watchman FLX device has not
been assessed in a randomized trial, data from the
PINNACLE FLX (Protection Against Embolism for DETECTION AND MECHANISM OF PDL
Nonvalvular AF Patients: Investigational Device
Evaluation of the Watchman FLX LAA Closure Tech- There is no consensus on the definition of PDL or the
nology) registry (n ¼ 400 patients) showed a lower optimal method of its detection and sizing. In the
incidence of PDL with the FLX device (any PDL 17.4% published research, PDL has been defined as a resid-
at 45 days). 21 The SURPASS (Real-World Safety and ual communication between the left atrium and the
Efficacy of Watchman FLX) registry, which included LAA as determined on TEE or cardiac CT.10 However,
16,048 patients treated with the Watchman FLX de- the issue of PDL is highly nuanced, and uncertainties
vice, demonstrated a comparable rate (18.0%) of any and controversies surrounding its detection and
PDL at 45 days.22 reporting remain.
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023 Alkhouli et al 629
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F I G U R E 1 Incidence of Peridevice Leak in Randomized Trials and National and Prospective Core Laboratory–Adjudicated Registries

Amulet IDE ¼ Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial; EWOLUTION ¼ Registry on Watchman Outcomes in Real-Life
Utilization; LAAO ¼ left atrial appendage occlusion; NCDR ¼ National Cardiovascular Data Registry; PINNACLE FLX ¼ Protection Against Embolism for Nonvalvular AF
Patients: Investigational Device Evaluation of the Watchman FLX LAA Occluder; PRAGUE-17 ¼ Left Atrial Appendage Closure vs Novel Anticoagulation Agents in
High-Risk Atrial Fibrillation Patients; PROTECT AF ¼ Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation;
SURPASS ¼ Real-World Safety and Efficacy of Watchman FLX; SWISS-APERO ¼ Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left
Atrial Appendage Closure.

First, the reported rate of PDL varies considerably Indeed, “micro-PDLs” that are not visible on routine
according to the imaging modality selected for sur- imaging have been proposed as an alternative expla-
veillance. Although TEE was used to detect PDL in nation to this phenomenon. Whether the lack of LAA
clinical trials, 8-10 several studies have shown that CT thrombosis without a discernable leak on CT or TEE
is a more sensitive method to evaluate PDLs carries a similar clinical significance as PDL is uncer-
compared with TEE (Figure 2). 12,25-27 CT provides a tain and warrants further research. 28 It is important
detailed perspective of the shape, size, and mecha- to avoid “overdiagnosis” of PDL when CT is used for
nism of a PDL compared with TEE, on which only the surveillance considering the unknown implications of
dimensions of the PDL are typically reported on the fabric leaks or microleaks and the attendant risks of
basis of the width of the color Doppler jet. In one prolonged anticoagulation or interventional leak
study, among 346 patients who underwent TEE and closure.
CT at 8 weeks after LAAO with an Amplatzer device Third, there are important differences in PDL
(Amplatzer Cardiac Plug or Amulet), a visible gap was morphology among percutaneous LAA occluders.
detected in 110 patients (32%) on TEE and in 210 pa- With plug-type occluders (eg, Watchman devices), a
tients (61%) on CT. 12 The timing of surveillance PDL usually indicates the presence of flow between
(6 weeks vs 8 weeks vs 12 weeks) could also influence the left atrium and the distal part of the LAA. How-
PDL rates, considering the documented temporal ever, with disc-and-lobe devices (eg, Amplatzer), a
change in PDL in several studies.13-15 PDL could represent flow between the left atrium and
Second, the LAA is not thrombosed in a sizable the distal part of the appendage or flow between the
cohort of patients despite the absence of a visible left atrium and the space between the disc and the
communication between the left atrium and LAA. lobe.29 The clinical relevance of the different types of
This phenomenon has been attributed to “fabric PDLs with disc-and-lobe devices has not yet been
leak,” although this remains an area of debate. adequately studied.
630 Alkhouli et al JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023

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F I G U R E 2 Peridevice Leak Assessment on Transesophageal Echocardiography vs Computed Tomography

(A) A 45 transesophageal echocardiographic view of a Peridevice leak. The width of the color Doppler jet is recorded as the peridevice leak
size. On cardiac computed tomography, a 2-chamber long-axis view (B) and short-axis view (C) are obtained with the axes aligned with the
disc of the device (red line “disc”), creating an en face view of the disc for assessment of leak size (D). A similar approach is performed at the
proximal (L1), mid (L2), and distal (L3) parts of the device lobe. The red arrow marks the position of the peridevice leak. Contrast patency is
present in the appendage (asterisk). Reproduced with permission from Korsholm et al.12 Ao ¼ aorta; LA ¼ left atrium; Pa ¼ pulmonary
artery; Pv ¼ pulmonary vein; RA ¼ right atrium.

Fourth, in the published research, PDLs are typi- thromboembolic events after LAAO is low. Therefore,
cally classified on the basis of their size, with little discerning an independent impact of PDL requires a
consideration of their location or mechanism. This very large sample cohort and/or long-term follow-up.
approach could be problematic, as a 3- to 4-mm leak Second, the cutoff of what is potentially significant
could entail the presence of a small uncovered non- PDL is arbitrary and varies across different sites ($3,
trabeculated proximal LAA tissue but could also >3, and >5 mm). Third, the mechanism of PDL was
represent a conduit to a completely uncovered tra- not considered in most studies. Fourth, patients with
beculated lobe (Figure 3). A more complete descrip- large leaks often remain on anticoagulation or un-
tion of PDL should include not only its size but also its dergo PDL closure, and hence assessing the impact of
potential mechanism. The Central Illustration depicts residual leak in these patients is confounded by a
the different mechanisms of PDL with plug-type and significant treatment bias. Because of these limita-
disc-and-lobe occluder devices. tions, most published studies on the clinical impact of
PDL have been underpowered and/or inconclusive.
CLINICAL IMPLICATIONS OF PDL However, 3 recent studies suggested that PDLs might
not be as benign as previously believed.
Investigators who sought to assess the clinical impact The first is an analysis from the NCDR LAAO Reg-
of PDL faced several challenges. First, the rate of istry of >50,000 patients who underwent LAAO in the
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023 Alkhouli et al 631
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F I G U R E 3 Limitation of the Current Definition of Peridevice Leak Based on Size Only

(A to D) Transesophageal echocardiography (TEE) after Watchman deployment showing adequate compression and <5-mm leak (0 , 50 , 95 , and 138 ). (E to H) TEE
at 45-day follow-up depicting a large leak with an open posterior lobe (0 , 42 ,95 , and 123 ). Reproduced with permission from Alkhouli et al.44 AL ¼ anterior lobe;
PL ¼ posterior lobe.

United States between 2016 and 2019. In that study, Amulet IDE trial that assessed the association
large leaks (>5 mm) were infrequent (<1%), but about of leaks $3 mm in diameter with adverse events
25% of patients had small residual leaks (defined as among 1,593 patients who had evaluable TEE at
those <5 mm) on 45-day TEE. Small PDLs were asso- 45 days.14 The study found that the presence
ciated with higher odds of stroke, transient ischemic PDL $3 mm on 45-day TEE was associated with
attack, or systemic embolization (HR: 1.15; 95% CI: higher odds of the composite endpoint of ischemic
1.02-1.29), major bleeding (HR: 1.11; 95% CI: 1.03-1.12), stroke, systemic embolization, or cardiovascular
and major adverse events (HR: 1.10; 95% CI: 1.05- death (8.1% vs 4.7%; HR: 1.66; 95% CI: 1.02-2.69). In
1.16). 3 The second is a long-term (5-year) analysis of aggregate, the differential negative impact of PDL
1,054 patients who underwent LAAO with the consistently shown in these studies seems to settle
Watchman device in the PROTECT AF and PREVAIL the uncertainty on the clinical significance of PDL
(Evaluation of the Watchman LAA Closure Device in (Figure 4).
Patients With Atrial Fibrillation Versus Long Term PDLs have also been associated with a higher
Warfarin Therapy) randomized trials and their incidence of bleeding events. In the NCDR LAAO
continuous access registries.30 In this study, small Registry, patients with small (<5 mm) leaks had a
leaks (>0 and <5 mm) that persisted at 1 year post- higher incidence rate of major bleeding at 1 year
LAAO were associated with a 2-fold increase in compared with those with no leaks (8.57 [8.07-9.07]
stroke or systemic embolization (9.9% vs 5.1%; vs 7.58 [7.3-7.86]) despite similar rates of anticoagu-
P ¼ 0.008; HR: 1.94; 95% CI: 1.15-3.29), driven by lant use after the procedure.3 In the Amulet IDE trial,
higher odds of nondisabling stroke (HR: 1.97; 95% CI: patients with large (>5 mm) leaks had a numerically
1.03-3.78). 5 The third is a subgroup analysis of the higher incidence of major bleeding at 18 months,
632 Alkhouli et al JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023

Peridevice Leak After LAAO MARCH 27, 2023:627–642

C E NT R AL IL L U STR AT IO N Residual Leaks Following LAA Occlusion

Mechanism of Leak With Plug Occluders Mechanism of Leak With Lobe-and-Disc Occluders

Edge leak Uncovered Leak between Leak into

lobe disc and lobe distal LAA

Uncovered
proximal
LAA tissue
Fabric leak
Uncovered Fabric leak
proximal
LAA tissue
Alkhouli M, et al. J Am Coll Cardiol Intv. 2023;16(6):627–642.

(Left) Mechanisms of residual leaks after left atrial appendage (LAA) occlusion with a plug-type occluder. (Right) Mechanisms of residual leaks after LAA occlusion
with a disc-and-lobe occluder.

although this was not statistically significant (12.9% Amulet IDE trial, a higher CHA2DS 2-VASc score and
vs 6.5%; HR: 2.07; 95% CI: 0.76-5.62; P ¼ 0.15).14 the use of the Watchman 2.5 (vs Amulet) were inde-
Further research is needed to discern the etiology of pendently associated with PDL $3 mm. 14 In the NCDR
this association, especially considering its impact on LAAO Registry, patients with PDLs had larger LAA
the selected management strategy. It is plausible that orifice diameters (21.1  4.2 mm vs 22.3  4.3 mm), a
patients who develop PDL are higher risk patients higher prevalence of nonparoxysmal AF and cardio-
with more advanced vascular disease, remodeling, myopathy, and higher CHA 2DS2-VASc scores
and bleeding tendencies, although this notion needs compared with patients with no PDL.3 Although
to be further studied. speculative, the association between these factors
and PDL may be mediated by advanced vascular dis-
PREVENTION OF PDL ease and atrial myopathy. For example, patients with
long-standing persistent AF have been found to have
To mitigate the risk for PDL, it is important to identify significantly larger LAA ostial diameter and depth, to
factors that are associated with its occurrence. require larger LAA occluders, and to develop more
Several studies discerned independent predictors of moderate or severe PDLs after LAAO than patients
PDL, although most were nonmodifiable. In the with paroxysmal AF. 31 Other key determinants of PDL
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023 Alkhouli et al 633
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F I G U R E 4 Summary of Recent Studies Documenting an Association of PDL With Ischemic Events

Ischemic events include ischemic stroke or systemic embolization (Amulet IDE trial); stroke, transient ischemic attack, or systemic
embolization (NCDR LAAO Registry); and ischemic stroke or systemic embolization (Watchman trials). PDL ¼ peridevice leak; other
abbreviations as in Figure 1.

include complex LAA anatomy (eg, multilobar LAA), Computational modeling, steerable sheaths, newer
inability to gain coaxial access to the LAA (eg, anterior generation, and novel LAA occluders may potentially
chicken wing anatomy, suboptimal transseptal mitigate the risk for PDL. The FEops HEARTguide
puncture), and undersizing of the occluder device (FEops) is a cloud-based platform that combines the
(Table 1). 3,31-34 Notably, operator or center procedural advantages of digital twins with artificial intelligence
volume and the use of intracardiac echocardiography technology for planning LAAO and other structural
have not been found to be associated with a greater heart interventions. The HEARTguide uses pre-
risk for developing PDL after LAAO.3,22 procedural CT to provide manual “rigid-device over-
lay,” allowing operators to understand how a specific
implant interacts with a patient’s anatomy (Video 1).
The FEops HEARTguide has been shown to facilitate
T A B L E 1 Factors Associated With Peridevice Leak
accurate device sizing and achieve better LAA seal
Nonmodifiable factors
(Figure 5). In a recent randomized study (PREDICT-
Sex
LAA [Value of FEops HEARTguide Patient-Specific
Left ventricular cardiomyopathy
Computational Simulation in the Planning of Percu-
Nonparoxysmal AF
taneous Left Atrial Appendage Closure With
High CHA2DS2-VASc score
the Amplatzer Amulet Device]), patients who
Large LAA diameter
Complex LAA anatomy (eg, multilobar LAA)
underwent LAAO guided by the FEops HEARTguide
Potentially modifiable factors (n ¼ 100) had higher rates of complete LAAO
Device undersizing (compression < 10%) compared with those who had standard computed
Single-lobe LAAO devices tomographic procedural planning (n ¼ 100) (61.1% vs
Noncoaxial access to the LAA 44.0%; relative risk: 1.44; 95% CI: 1.05-1.98;
P ¼ 0.03). 35 In addition, use of HEARTguide computer
AF ¼ atrial fibrillation; LAA ¼ left atrial appendage; LAAO ¼ left atrial appendage
occlusion. simulations resulted in improved procedural effi-
ciency with the use of fewer Amulet devices and
634 Alkhouli et al JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023

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F I G U R E 5 Usefulness of Computational Modeling in Predicting Peridevice Leak After Left Atrial Appendage Occlusion

The FEops HEARTguide was used to depict the implantation of various Amulet left atrial appendage occluders in a single patient. The software
provides important insights into device compression and the likelihood of residual peridevice leak (red arrows) with various device sizes and
implant locations. (A) A 25-mm Amulet device implanted distally. (B) A 28-mm Amulet device implanted proximally. (C) A 25-mm Amulet
device implanted proximally. (D) A 31-mm Amulet device implanted proximally.

fewer device repositioning attempts in the computed eliminate the risk for PDL (eg, Laminar [Laminar]
tomographic simulation group. Steerable sheaths and Appligator [Append Medical]).
may facilitate coaxial access to the LAA and hence
allow tilt-free device deployment, but their differ-
ential impact on PDL has not been studied TREATMENT OF PDL
(Figure 6). Newer generation LAAO devices have
demonstrated lower rates of PDL compared with Once a PDL is diagnosed, the conundrum is whether
first-generation devices (eg, Watchman FLX vs leaks should be managed with watchful observation
Watchman 2.5). In addition, a large portfolio of and frequent imaging, with long-term anti-
novel LAAO devices are being evaluated in preclin- coagulation, or with prophylactic PDL closure. The
ical and early clinical investigations. 36 Some of these decision is further complicated by the lack of
devices allow better sealing of challenging anato- consensus on which leaks are clinically significant
mies, such as the LAmbre device (Lifetech) and (any leaks, leaks >3, $3, >5, and $5 mm), the absence
Conformal (Conformal Medical) devices.37 Others of long-term efficacy data on PDL closure procedures,
use novel occlusion mechanisms (invagination or and the heightened risk for bleeding among these
infolding of the LAA), could in theory completely patients. Furthermore, a large proportion of patients
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023 Alkhouli et al 635
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F I G U R E 6 Steerable Delivery Sheath of the Amplatzer Amulet Device

Deflection: (A) 45 , (B) 120 , and (C) 0 . Reproduced with permission from Cruz González I, Antúnez Muiños PJ, López Tejero S, et al. Left
atrial appendage occlusion using the novel Amplatzer steerable delivery sheath combine with FEops HEARTguide. J Am Coll Cardiol Intv.
2021;14(21):e301-e304.

undergo LAAO because of absolute contraindication steerable sheath in the left atrium (eg, Agilis, Abbott),
to anticoagulation, especially outside the United a coronary guide (eg, multipurpose guide), and an
States. Hence, initiating or prolonging anti- angled Glidewire (Terumo). A 6-F coronary guide al-
coagulation in these patients may not be a viable lows the delivery of any Amplatzer Duct Occluder and
option. The choice of management strategy is further of up to a 12-mm Amplatzer Vascular Plug II, which is
complicated with the observed temporal regression in adequate for closing most leaks. These occluders do
PDL in 20% to 40% of patients, especially among not have stabilizing anchors. Therefore, their stability
those with leaks <5 mm.15 Interventional approaches relies on adequate oversizing ($50%) and sufficient
to close larger PDLs include the use of vascular plugs compression by the LAA wall and the LAA occluder
and cardiac occluders, detachable coils, radio- device. Multiple plugs can be deployed simulta-
frequency ablation, or a combination of more than neously or sequentially to cover larger or crescentic
one technique (Figure 7).38-42 Herein, we summarize leaks (Figure 8). Very large leaks or completely un-
these reported techniques and the relevant published covered lobes can also be closed with a second LAA
data on their safety and efficacy. occluder using standard LAAO techniques.34 Pre-
The most common devices used to close PDL are procedural computed tomography planning can be
the Amplatzer Vascular Plug II and Amplatzer Duct instrumental in accurate sizing and characterization
Occluder (Abbott Vascular) because of their low pro- of the leak and selecting the optimal fluoroscopic
file and deliverability. 39,41,43,44 Prior experience with angels for the procedure.
using these devices for transcatheter closure of par- Endovascular coils are used in the closure of cere-
avalvular leaks can be extrapolated to closure of bral aneurysms and arteriovenous malformations and
PDL.45,46 Typically, the leak is accessed with a in treating congenital and iatrogenic shunts.
636 Alkhouli et al JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023

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F I G U R E 7 Interventional Strategies for Peridevice Leak Closure

LAAO ¼ left atrial appendage occlusion.

Recently, the use of detachable coils in PDL closure they should occupy the LAA behind the occluder de-
after LAAO has been described (Figure 9). Coils can be vice to eliminate the potential reservoir for thrombus.
delivered via 4- to 5-F catheters or even micro- Because of concerns about coil prolapse, most oper-
catheters. Hence, they are ideal for leaks with shallow ators opt for the latter approach.40 The most common
or narrow landing zones where vascular plugs or coiling system used is the Azur system (Terumo). In
occluders could not be accommodated. A key limita- most cases, PDL closure is achieved with a combina-
tion of endovascular coils, however, is the need for a tion of the Azur framing coils, which establish a base
defined physical boundary to ensure safe deployment that outlines the lumen, and the Azur HydroCoils,
and avoid embolization. Therefore, uncovered lobes which expand 4 to 5 times their original size in the
or wide PDL necks are often not suitable for closure presence of blood to create a mechanical occlusion
with endovascular coils. Another uncertain area is the base. If needed, the Azur cross-sectional coils can
whether coils should be placed at the site of the leak be also used to fill smaller residual spaces within the
(ie, PDL neck), aiming at its obliteration, or whether leak cavity. Other systems that are often used include
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023 Alkhouli et al 637
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F I G U R E 8 Closure of Peridevice Leak Using Amplatzer Vascular Plugs

Illustration of peridevice leak due to an off-axis implantation in a patient with an anterior chicken wing anatomy. (A) Left atrial appendage
(LAA) angiography showing the Watchman sheath accessing the LAA at a significant angle (B) Following device implantation, a significant
posterior leak was observed on 45-day transesophageal echocardiography and confirmed during LAA angiography. (C) Leak closure with
2 Amplatzer Vascular Plug II devices. (D) Three-dimensional echocardiography showing the plugs sealing the posterior peridevice leak.
Reproduced with permission from Alkhouli et al.34 MV ¼ mitral valve.

the Interlock-35 fibered occlusion system (Boston Catheter [Biosense Webster], TactiCath CF-sensing
Scientific) and the Concert Helix and Axium coil sys- [Abbott]). The ablation catheter can be advanced to
tems (Medtronic. the atrial side of the leak through a steerable sheath
Radiofrequency energy is used in a variety of under fluoroscopic or echocardiographic guidance.
medical applications to promote thermally induced Repeated (15-20 seconds) energy treatments are then
collagen matrix contraction. Recently, its utility in applied with a power range of 40 to 47 W and tip
treating PDL after LAAO has been explored.38,42 The temperature of #42  C.38 Caution should be used to
procedure is performed under moderate sedation or limit the radiofrequency treatment to the atrial side
general anesthesia using standard 8-F radiofrequency of the leak and avoid wedging of the ablation catheter
ablation catheters (eg, ThermoCool SmartTouch SF in the tunnel between the occluder and the left atrial
638 Alkhouli et al JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023

Peridevice Leak After LAAO MARCH 27, 2023:627–642

F I G U R E 9 Closure of Peridevice Leak Using Detachable Endovascular Coils

(Top left) Intraprocedural transesophageal echocardiographic images of left atrial appendage (LAA) closure with leak at baseline. (Top right)
Reduction in leak after coiling. (Bottom left) Fluoroscopy demonstrating catheter positioned behind the appendage and contrast injection
demonstrating a nonthrombosed LAA. (Bottom right) Fluoroscopy demonstrating coils behind the appendage. Reproduced with permission
from Musikantow et al.40 LSPV ¼ left superior pulmonary vein.

wall. A wedged catheter may result in an increase approach, 43 patients with PDLs $4 mm (median
contact force that can lead to a steam pop (intramural 5 mm; range: 4-7 mm) underwent radiofrequency
gas eruption from myocardial tissue due to excessive ablation using open irrigated-tip ablation catheters.
heating), pericardial effusion, or left atrial perfora- After ablation, PDL size was reduced by 95%, result-
tion. Limiting contact force to <15 g and close moni- ing in no or minor (1-2 mm) residual leaks in 100% of
toring for an abrupt decrease in impendence can help patients. Sudden decreases in impendence occurred
mitigate this potential complication. 38 Less aggres- in 12 of 43 patients (28%) as the catheter tip made
sive ablation could be attempted for simple leaks to contact with the Nitinol frame of the Watchman
further maximize the safety of the procedure. device, but pericardial effusion occurred in only
Another consideration with this technique is the po- 1 patient.38
tential impact of reversible tissue edema on adequacy A review of the published studies on PDL closure
of closure and recurrence rate. The ablation proced- using coils, radiofrequency ablation, or occluders re-
ure could induce a volumetric effect due to acute veals several important observations: 1) the indica-
tissue edema, which upon resolution can lead to PDL tion for PDL closure varied considerably among sites
recurrence. It is therefore recommended to apply and countries and across specialties; 2) interventional
overlapping runs of radiofrequency ablation adjacent leak closure remains infrequent (<400 cases reported
to the ostium of the LAA after acute closure is ach- in published research), especially considering
ieved.38 In the first published experience with this the large number of LAAO procedures performed
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023 Alkhouli et al 639
MARCH 27, 2023:627–642 Peridevice Leak After LAAO

T A B L E 2 Published Studies on Peridevice Leak Closure After Left Atrial Appendage Closure

First Author (Ref. #) Population Intervention Outcomes

39
Killu et al 72 patients (Watchman, n ¼ 53; AVP-II 18% Acute procedural success (defined as no or mild
surgery, n ¼ 19) ADO-II 25% leak) 94%
Coils 55.5% MACE 3%
Second Watchman 1.5% Any residual leak at follow-up 13%
Della Rocca et al38 43 patients who underwent LAAO RF ablation 100% (index procedure in Acute procedural success (defined as #1 mm
(Watchman) 19 [44%], subsequent in 24 [56%]) residual leak) 100%
MACE 2.3%
Any residual leak at follow-up 34.9%
Piayda et al41 95 patients who underwent LAAO Coils 42.3% Acute procedural success (defined as device
(Watchman/FLX, n ¼ 68; Lariat, n ¼ 17; AVP-II 29.8% deployment without tamponade or stroke)
Amulet/ACP, n ¼ 4; other, n ¼ 6) ADO-II 17.3% 100%
MACE 1.1%
Any residual leak at follow-up 18.9% (PDL
diameter decreased from 6.1  3.6 mm to
2.5  1.3 mm)
Della Rocca et al52 30 patients who underwent LAAO Coils 100% Acute procedural success (defined as <3-mm
(Watchman, n ¼ 25; Amulet, n ¼ 2; residual leak) 93.3%
Lariat, n ¼ 3) MACE 6.1%
Any residual leak at follow-up 23.3%
Musikantow et al40 20 patients who underwent LAAO Coils 100% Acute procedural success (defined as LAA access
(Watchman) and coil deployment) 95%
MACE 5%
Any residual leak at follow-up 39%
Charate et al42 160 patients who underwent LAAO Plugs 22.5% Acute procedural success (defined as <1-mm
(Watchman/FLX, n ¼ 116; Amulet, Coils 40% residual leak) 100%
n ¼ 3; Lariat, n ¼ 26; surgery, n ¼ 15) RF ablation 37.5% MACE 1.3%
Any residual leak at follow-up 30% (0% after plugs,
48.3% after RF ablation, 29.7% after coils)

ACP ¼ Amplatzer Cardiac Plug; MACE ¼ major adverse cardiovascular event(s); RF ¼ radiofrequency; other abbreviations as in Table 1.

worldwide and the number of potential candidate these studies support the potential efficacy of PDL
patients with PDL; 3) acute procedural success of PDL closure, the small number of studied patients and the
closure, although varied in definition, was consis- short follow-up duration precludes solid conclusions.
tently high, and the rates of major complication were Furthermore, the impact of placing multiple devices
low regardless of the technique used; 4) although the in the LAA on the development of device related
leak’s size decreased significantly in most patients, thrombus needs to be investigated.
13% to 39% had persistent flow into the LAA on
follow-up surveillance imaging; and 5) the type of FUTURE DIRECTIONS AND
closure device may have a differential impact on the SUGGESTED APPROACH TO PDL
adequacy and durability of PDL closure. In a multi-
center registry of 160 patients who underwent PDL Addressing PDL requires a holistic approach that
closure, vascular plugs were more likely to provide primarily focuses on its prevention but also in-
complete LAAO compared with endovascular coils or corporates the emerging data on its various treatment
radiofrequency ablation.42 The characteristics and options. Computer simulation software has now been
outcomes of the published studies on PDL closure are shown to aid in mitigating PDL and should be
summarized in Table 2. routinely used for preprocedural planning when
Uncertainties remain regarding the long-term feasible. 35 Selection of an LAA occluder should
management of patients undergoing interventional consider the likelihood of achieving complete seal
PDL closure. For example, there are no standardized with that particular device. For example, an LAA with
protocols for postprocedural imaging surveillance or proximal LAA tissue may be challenging to close with
antithrombotic therapy after PDL closure. In the a plug-type device, and a disc-and-lobe device may be
published research, most patients who underwent more appropriate for such an anatomy. Very large or
PDL closure were treated with antiplatelet agents and multilobed LAAs that may not be adequately sealed
underwent a single follow-up imaging study. with percutaneous occluders should be considered
Although the low rates of ischemic events reported in for epicardial clipping or continuous anticoagulation
640 Alkhouli et al JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023

Peridevice Leak After LAAO MARCH 27, 2023:627–642

F I G U R E 1 0 Proposed Algorithm for the Diagnosis and Management of PDLs

LA ¼ left atrium; LAA ¼ left atrial appendage; OAC ¼ oral anticoagulation; PDL ¼ peridevice leak; RFA ¼ radiofrequency ablation; Tx ¼ treatment.

if surgical and bleeding risks are not prohibitive. empirical approach to the classification and treat-
During the procedure, optimizing the transseptal ment of PDL (Figure 10). We suggest that the
puncture and using steerable sheaths would ensure assessment of a PDL consider both the leak’s di-
coaxial alignment with the LAA, reducing the chance mensions and its mechanism. If the leak is deter-
of significant PDL.47,48 Adequate imaging guidance is mined to be “clinically relevant,” decisions on
also key to avoid PDL. Although the use of intracar- anticoagulation or PDL closure should consider the
diac echocardiography has not been shown to individual ischemic vs bleeding risks and the limited
engender PDL, caution should be used to avoid the long-term data on PDL closure. Furthermore,
possibility of missing leaks when limited views of the framing of those risks should reflect both the relative
LAA could be obtained.49,50 and absolute rates of ischemic events associated
Despite best efforts, PDLs may still occur, and with PDL reported in the published research.3,14,30,51
their optimal management requires a careful
consideration of the various available strategies. A CONCLUSIONS
standardized nomenclature should be used to
describe PDL. The lack of a visible communication Despite recent advances and increasing adoption,
between the left atrium and the LAA without a certain issues with LAAO remain. The frequency of
thrombosed LAA cavity suggests the presence of PDL and the documented association of PDL with
either a micro-PDL or a fabric leak. If a true PDL tract adverse events have fueled a renewed interest in
can be discerned, determining the potential clinical understanding its mechanisms, mitigation strategies,
significance of the leak is essential but can be chal- and optimal management. Several studies have sug-
lenging. Current research suggests that any PDL may gested the safety and efficacy of interventional PDL
be clinically relevant but remains inconclusive on closure, but long-term outcomes data are limited.
whether there is a proportional relationship between Novel LAAO devices with enhanced sealing or inno-
PDL size and the risk for ischemic events. Further- vative closure mechanisms, steerable delivery
more, the impact of PDL mechanisms on clinical sheaths, and simulation software may aid in lowering
outcomes has not been studied. We propose an the risk for PDL.
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023 Alkhouli et al 641
MARCH 27, 2023:627–642 Peridevice Leak After LAAO

FUNDING SUPPORT AND AUTHOR DISCLOSURES Recor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics,
Vivasure Medical, Venus, and Veryan. Dr Natale is a consultant for
Abbott, Biosense Webster, Boston Scientific, Baylis, Biotronik, and
Dr Alkhouli has served on the advisory board for and received
Medtronic. Dr Holmes is a member of the advisory board of Boston
research grant support (institutional) from Boston Scientific and
Scientific; and has received an institutional research grant from
Philips; and has received consulting fees from Abbott and Biosense
Boston Scientific. Dr Lakkireddy has received research and educa-
Webster. Dr De Backer has received research grants (institutional)
tional grants to the institution from Abbott, Atricure, Alta Thera,
from Abbott and Boston Scientific. Dr Ellis is an advisory board
Medtronic, Biosense Webster, Biotronik, and Boston Scientific; and
member for Atricure, Abbott Medical, Boston Scientific, and Med-
has received speaker honoraria from Abbott, Medtronic, Biotronik,
tronic; and has received research grant support (institutional) from
and Boston Scientific.
Boston Scientific, Medtronic, and Boehringer Ingelheim. Dr Nielsen-
Kudsk is a consultant and proctor for Abbott and Boston Scientific.
Dr Sievert has served as a consultant for 4tech Cardio, Abbott, Abla-
tive Solutions, Ancora Heart, Bavaria Medizin Technologie, Bio- ADDRESS FOR CORRESPONDENCE: Dr Mohamad
ventrix, Boston Scientific, Carag, Cardiac Dimensions, CeloNova,
Alkhouli, Mayo Clinic, 200 First Street SW, Rochester,
Cibiem, CGuard, Comed, Contego, CVRx, Edwards Lifesciences,
Endologix, Hemoteq, InspireMD, Lifetech, Maquet Getinge Group, Minnesota 55905, USA. E-mail: alkhouli.mohamad@
Medtronic, Mitralign, Nuomao Medtech, Occlutech, pfm Medical, mayo.edu.

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Interv Cardiol Clin. 2018;7:253–265. catheter and surgical management of mitral please see the online version of this paper.