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22—LEFT ATRIAL APPENDAGE OCCLUSION 263
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Fig. 22.8 Once in the LAA, perform angiography in a
RAO (20 to 30 degrees to visualize the mid-distal
LAA) and caudal (20 to 30 degrees to visualize the
ostium) angulation, which allows visualization of the
distal lobes before advancing the sheath farther.
The LAA should be fully evaluated with a TEE sweep in
all angles, especially 135 degrees, when advancing the
sheath distally.
Fig. 22.9 It is important to always have a pigtail in
front of the sheath when advancing to avoid damage
to the LAA wall.
Fig. 22.10 The prepped Watchman delivery system
along with the compressed device is advanced
through the sheath until both the distal marker bands
of the sheath and delivery system are aligned. The
device is deployed by unsheathing slowly, without any
forward movement, and preferably with apnea for stable
deployment.

264 6—LEFT ATRIAL INTERVENTIONS
Watchman FLX Watchman
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Fig. 22.11 Once deployed, the device needs to be thoroughly evaluated on TEE and fluoroscopy for
“PASS” criteria.
The incidence of pericardial effusion is 1% to 2% and can result in tamponade requiring
pericardiocentesis or even surgical repair of a perforation. Care should be taken to never advance
the sheath without a pigtail in front of it in the LAA, visualize the distal LAA with TEE and
angiography before advancing, and avoid forward movement of the device anchors/feet during
deployment.
A newer iteration of the device (Watchman FLX) (Fig. 22.12) is currently under investigation and is expected to further improve procedural safety besides allowing more LAA
anatomies to be treated. Device embolization is rare (0.5% to 1%) and can be retrieved percutaneously in many cases using a snare and sheath that are at least 2F sizes larger than the
implanting sheath. Larger devices or those trapped in papillary muscle/trabeculations might
require surgical removal.
Partial deployment can be advanced into LAA
Fig. 22.12 The newer-generation Watchman FLX device currently in trial phase. (Permission received
from Boston Scientific.)
Closed distal end with fluoro marker–
Shorter device length and
wider use matrix to treat
more LAA anatomies
18 anchors
with increased
fixation strength

22—LEFT ATRIAL APPENDAGE OCCLUSION 265
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Postprocedural Follow-Up
Patients should undergo follow-up TEE in ≈6 weeks to evaluate device stability, presence of re-
sidual leaks, and any thrombus. Formation of thrombus on the atrial side of the device has been
reported in ≈2% to 5% of the cases, especially in patients who were not anticoagulated according
to device manufacturer recommendations.
20,21
These predominantly occur over nonendothelialized device protrusions, such as the threaded insert. A deep implant with associated cul-de-sacs
or uncovered proximal LAA trabeculations should thus be avoided. If noted, the patient should
be continued on anticoagulation for another 8 to 12 weeks, followed by a repeat TEE.
The randomized trials of LAA occlusion using the Watchman device both used ,5 mm residual flow into the LAA as the criteria for successful closure. The presence of a perileak can
plausibly enhance platelet adhesion and thrombus formation on the device and/or within the
LAA due to turbulent blood flow adjacent to the device. Small residual leaks are unlikely to have
clinical significance, as it would be difficult for the thrombus behind the device to embolize
through a small perileak into the LA. On the other hand, a large perileak with a larger diameter
aperture may allow such thrombus to escape the LAA into the systemic circulation. Previous
studies have not revealed an increased event rate with persistent perileaks, although data are
12,22
limited.
at 6 months, and 32% at 12 months.
A perileak was present in 41% of patients in the PROTECT AF trial at 45 days, 34%
23
Approximately a third of patients had a perileak .3 mm
in diameter. There was no difference in clinical outcomes in patients with a perileak compared
with those with complete closure. However, clinicians were aware of the TEE results, and the
majority of patients with a significant perileak remained on warfarin long term.
Summary and Take-Home Points
n
LAAO using the Watchman device provides an alternative for embolic risk reduction in a
large patient population with nonvalvular AF who are not suitable candidates for long-term
anticoagulation.
n
Preprocedural planning along with a meticulous intraprocedural approach will allow the
procedure to be completed safely and efficiently.
n
Newer iterations of the Watchman device and alternative LAAO devices are currently
being tested and are expected to further improve the safety of this procedure.
References
1. Chugh SS, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a Global Burden
of Disease 2010 Study. Circulation. 2014;129(8):837-847. doi: 10.1161/CIRCULATIONAHA.113.005119.
2. Fang MC, Stafford RS, Ruskin JN, Singer DE. National trends in antiarrhythmic and antithrombotic
medication use in atrial fibrillation. Arch Intern Med. 2004;164(1):55-60. doi: 10.1001/archinte.164.1.55.
3. Kakkar AK, Mueller I, Bassand JP, et al. Risk profiles and antithrombotic treatment of patients newly
diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational,
prospective GARFIELD registry. PLoS One. 2013;8(5):e63479. doi: 10.1371/journal.pone.0063479.
4. Glader EL, Stegmayr B, Norrving B, et al. Large variations in the use of oral anticoagulants in stroke
patients with atrial fibrillation: a Swedish national perspective. J Intern Med. 2004;255(1):22-32.
5. O’Brien EC, Holmes DN, Ansell JE, et al. Physician practices regarding contraindications to oral
anticoagulation in atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Am Heart J. 2014;167(4):601-609 e1. doi: 10.1016/j.
ahj.2013.12.014.
6. Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial
fibrillation. Ann Thorac Surg. 1996;61(2):755-759. doi: 10.1016/0003-4975(95)00887-X.

266 6—LEFT ATRIAL INTERVENTIONS
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7. Services CgCfMM. Decision memo for percutaneous left atrial appendage (laa) closure therapy (CAG00445N) [cited 2017 Jun 25]. Available from https://www.cms.gov/medicare-coverage-database/details/
nca-decision-memo.aspx?NCAId5281.
8. Administration USFD. WATCHMAN LAA Closure Technology - P130013 [cited 2017 Jan 12]. Available
from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/
Recently-ApprovedDevices/ucm440621.htm.
9. Holmes DR, Reddy VY, Turi ZG, et al. 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;374(9689):534-542. doi: 10.1016/S0140-6736(09)61343-X.
10. Holmes DR Jr., Kar S, Price MJ, et al. 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;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029.
11. Holmes DR Jr., Doshi SK, Kar S, et al. Left atrial appendage closure as an alternative to warfarin for stroke
prevention in atrial fibrillation: a patient-level meta-analysis. J Am Coll Cardiol. 2015;65(24):2614-2623.
doi: 10.1016/j.jacc.2015.04.025.
12. Tzikas A, Shakir S, Gafoor S, et al. Left atrial appendage occlusion for stroke prevention in atrial fibrillation:
multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention. 2016;11(10):1170-1179.
doi: 10.4244/EIJY15M01_06.
13. ClinicalTrials.gov. AMPLATZER™ Amulet™ LAA Occluder Trial (Amulet IDE) 2017 [cited 2017
April 4]. Available from https://clinicaltrials.gov/ct2/show/NCT02879448.
14. Lakkireddy D, Afzal MR, Lee RJ, et al. Short and long-term outcomes of percutaneous left atrial appendage suture ligation: results from a US multicenter evaluation. Heart Rhythm. 2016;13(5):1030-6. doi:
10.1016/j.hrthm.2016.01.022.
15. Ailawadi G, Gerdisch MW, Harvey RL, et al. Exclusion of the left atrial appendage with a novel device:
early results of a multicenter trial. J Thorac Cardiovasc Surg. 2011;142(5):1002-1009. doi: 10.1016/j.
jtcvs.2011.07.052.
16. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients
with atrial fibrillation: executive summary: a report of the American College of Cardiology/American
Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation.
2014;130(23):2071-2104. doi: 10.1161/CIR.0000000000000040.
17. Matsuo Y, Neuzil P, Petru J, et al. Left atrial appendage closure under intracardiac echocardiographic
guidance: feasibility and comparison with transesophageal echocardiography. J Am Heart Assoc. 2016;5(10).
doi: 10.1161/JAHA.116.003695.
18. Fassini G, Dello Russo A, Conti S, Tondo C. An alternative transseptal intracardiac echocardiography
strategy to guide left atrial appendage closure: the first described case. J Cardiovasc Electrophysiol.
2014;25(11):1269-1271. doi: 10.1111/jce.12480.
19. Desimone CV, Asirvatham SJ. ICE imaging of the left atrial appendage. J Cardiovasc Electrophysiol.
2014;25(11):1272-1274. doi: 10.1111/jce.12536.
20. Dukkipati SR, Kar S, Holmes DR, et al. Device-related thrombus after left atrial appendage closure.
Circulation. 2018;138(9):874-885. doi: 10.1161/CIRCULATIONAHA.118.035090.
21. Fauchier L, Cinaud A, Brigadeau F, et al. Device-related thrombosis after percutaneous left atrial appendage occlusion for atrial fibrillation. J Am Coll Cardiol. 2018;71(14):1528-1536. doi: 10.1016/j.jacc.
2018.01.076.
22. Saw J, Tzikas A, Shakir S, et al. Incidence and clinical impact of device-associated thrombus and peridevice leak following left atrial appendage closure with the Amplatzer Cardiac Plug. JACC Cardiovasc
Interv. 2017;10(4):391-399. doi: 10.1016/j.jcin.2016.11.029.
23. Viles-Gonzalez JF, Kar S, Douglas P, et al. The clinical impact of incomplete left atrial appendage closure
with the Watchman Device in patients with atrial fibrillation: a PROTECT AF (Percutaneous Closure
of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial
Fibrillation) substudy. J Am Coll Cardiol. 2012;59(10):923-929. doi: 10.1016/j.jacc.2011.11.028.

e1
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Abstract: Atrial fibrillation (AF) affects more than 33 million people worldwide. AF accounts for a majority of cardioembolic strokes, especially in elderly individuals. Although
anti-coagulation reduces the risk of embolic stroke, there are a significant proportion of AF
patients who have relative or absolute contraindications to anti-coagulation. Imaging studies
have previously documented that >90% of embolic strokes in non-valvular AF originate from
the left atrial appendage (LAA). This might be secondary to specific anatomy of pectinate
muscles as well as inflammation and fibrosis involving the LAA. This therefore makes
therapies targeted at LAA occlusion (LAAO) appealing. LAAO using the WATCHMAN
device provides an alternative for embolic risk reduction in a large patient population with
non-valvular AF who are not suitable candidates for long term anti-coagulation. This chapter
will focus on patient selection, pre-procedural planning along with a meticulous intra-procedural
approach for LAAO using the WATCHMAN device.
Keywords: Atrial Fibrillation, Left atrial appendage Occlusion, WATCHMAN

CHAPTER 23
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Pulmonary Vein Stenosis:
Management and Outcomes
R. Jay Widmer David R. Holmes Jr.
Introduction
Pulmonary vein stenosis (PVS) is a relatively infrequent yet detrimental complication of atrial
fibrillation (AF) ablation thought to be related to intimal thermal or barotrauma of the pulmonary veins (PV).
in PVS rates of over 40%.
severe PVS has decreased and is now reported between 0.32% and 3.4%.
specific frequency of PVS, however, has become more difficult because current Heart Rhythm
Society (HRS) consensus statements do not recommend routine postablation screening, and
some providers now forgo surveillance imaging.
fact that when PVS occurs, the diagnosis is often delayed or missed. Symptomatic patients may
come to attention months after the initial AF ablation procedure during which time the stenosis has continued to develop or may have even progressed to complete occlusion related to
scarring and contracture of the PV itself, making interventions very difficult with associated
with a less-than-optimal outcome.
1-3
Early AF ablative techniques focusing specifically on the PV ostia resulted
4,5
However, with improved ablation techniques, the incidence of
11
These recommendations have resulted in the
1,2,6-10
Ascertaining the
INITIAL PRESENTATION AND DIAGNOSTIC WORKUP
The diagnosis and management of PVS have been previously described in a large series of
124 patients, which demonstrates the challenge of diagnosing PVS. This challenge relates to the
fact that patients with PVS often present with nonspecific symptoms, including dyspnea, fatigue,
chest pain, cough, and even hemoptysis (Table 23.1). Some patients present with findings consistent with bronchitis both clinically and radiographically—and are treated for this—with
further delays to diagnosis. As many of these symptoms (except for hemoptysis) can be associated
with the recurrence of AF or other nonspecific conditions, there may be a multimonth delay
(median of over 4 months) between symptom onset and correct diagnosis. Once the diagnosis is
suspected, a number of tests are usually performed. Conventional chest radiography may identify
areas of infiltration, or infarction, or sometimes nodularity. Conventional transthoracic echocardiography (TTE) may not be diagnostic. The most accurate modality is dedicated computed
tomography (CT) imaging, specifically CT angiography with contrast enhancement timed for
opacification of the PVs before the index AF ablation (Fig. 23.1). Careful preprocedure evaluation
with CT includes analysis of multiple components, including the pulmonary parenchyma for signs
of hemorrhage or infarction, detailed evaluation of the PVs (specifically the number of veins),
the distribution, whether there is a common antrum of the left superior and left inferior PVs, the
diameter of each vein, its branching pattern, if it is occluded, the length of the occlusion and
the diameter of the veins distal to the occlusion, the severity of the stenosis, the presence of
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268 6—LEFT ATRIAL INTERVENTIONS
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TABLE 23.1 n Symptoms at Presentation
Variable, n (%) Patients (n 5 124)
Any symptom 101 (83%)
Dyspnea at rest 62 (67%)
Exertional dyspnea 71 (69%)
Cough 46 (45%)
Fatigue 47 (45%)
Decreased exercise tolerance 46 (45%)
Chest pain (pleuritic) 23 (22%)
Chest pain (exertional) 40 (38%)
Hemoptysis 28 (27%)
Flulike 10 (10%)
Diagnosis
Time from ablation to symptom onset (months) 4.0 6 3.0
Time from onset of symptoms to PVS diagnosis
(months)
Number of patients initially misdiagnosed, n (%) 41 (35%)
PVS, Pulmonary vein stenosis.
4.4 6 5.4
abnormalities which suggest thrombus, and the size of the right atrium (RA) and the location of
the veins within it. For reasons that are still unclear, we note a higher incidence of left-sided PVS.
After diagnosis, patients typically should undergo transesophageal imaging to assess venous
anatomy and pulsed-wave Doppler assessment, as well as ventilation/perfusion (V/Q) ratio,
which generally shows defects corresponding to the affected PV (Fig. 23.2). Cardiac magnetic
resonance can also be used to evaluate PVS; however, this is less well clinically validated and
awaits future evaluation and study. Once symptomatic PVS is identified, the time course of subsequent evaluation and treatment should be based on the severity of the stenosis. Very severe
stenoses may progress rapidly to complete occlusion, which then renders attempted intervention
considerably more difficult. We generally define severe PVS as greater than 75% PV obstruction
as assessed by dedicated CT scan or angiography (if available) on preintervention imaging. If
severe or subtotal stenoses are identified, invasive evaluation should be considered urgently. After
Fig. 23.1 Computed tomography (CT) angiography is performed to assess the location
and severity of pulmonary vein stenosis to
aid with procedural planning.

23—PULMONARY VEIN STENOSIS: MANAGEMENT AND OUTCOMES 269
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Fig. 23.2 Ventilation/perfusion (V/Q) scan demonstrat-
ing poor perfusion in the right upper zone of the lung.
the initial PVS intervention, patients are followed at a regular interval with repeat CT angiograms
and V/Q scans guided by clinical symptoms.
PERCUTANEOUS INTERVENTION
Our practice is to preload patients with 325 mg chewable aspirin and 600 mg clopidogrel by
mouth on the day of the procedure. Vitamin K antagonists can be continued up to the date of the
procedure at a reduced dose to achieve an international normalized ratio (INR) less than 2. For
severe PVS and elevated CHADS
bridging with low-molecular-weight heparin (LMWH). However, direct oral anticoagulants
(DOACs) should be held for an appropriate period, as there is not only a risk of vascular injury
with larger-bore sheaths in the femoral veins but also risk of cardiac perforation and subsequent
pericardial effusion/tamponade. There is no role for bridging with LMWH and DOACs. Postpro-
cedural antiplatelet and anticoagulation therapy will be discussed later in the chapter.
Patients are brought to the catheterization laboratory in the fasting state and maintained
under light sedation throughout the procedure if intracardiac echocardiogram (ICE) is to
be used, or general anesthesia should transesophageal echocardiography (TEE) be utilized.
The choice of imaging should be operator and institution dependent; however, working and
successful images can be obtained with both modalities complete with Doppler color and
velocity measurements. Imaging is crucial not only to visualize and access the affected PVs
but also to assist with the transseptal puncture. Biplane fluoroscopic imaging is preferred if
available.
Vascular access is established utilizing two venous sheaths (8F and 9 to 11F) placed in the
right and left femoral veins and a 4F arterial line either in the femoral or radial artery. ICE (we
commonly use a four-direction, steerable 64-element 10F ICE catheter) is inserted in the left
venous site. We usually prefer the larger, 10F system; however, a 9F system is available and can
be found in 8F or 9F sizes, necessitating a long (30 cm) and one F size larger sheath. For example, an 8F ICE catheter would be best delivered through a 9F 3 30 cm sheath. The ICE
catheter not only can aid in transseptal puncture but is also used to identify the PV ostium and
quantify the severity of PVS by direct measurement of the ostial diameter and Doppler assessment
of blood flow velocity. In some patients, assessment of full right heart pressures is helpful—for
example, in patients in whom symptoms may be related to pulmonary hypertension, or a noncompliant left atrium (LA). In occasional cases a subselective pulmonary angiogram with delayed
imaging of left atrial emptying may be used if the relevant PV appears to be occluded.
-VA Sc score (especially with prior stroke), one can consider
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LEFT ATRIAL ACCESS AND PULMONARY VEIN ENGAGEMENT
Transseptal access is discussed in a previous chapter; however, it can be obtained in a variety of
methods. Importantly, the use of ICE and TEE has allowed for crossing the septum in a specific
location. As the PVs are quite posterior in the LA, an anterior transseptal puncture can be useful
to approach both the left- and right-sided veins. For transseptal access, typically either an 8F
transseptal sheath (St. Jude, SL1) is used to cross to the LA or an Agilis sheath, and wire position
is established in the LA with an Amplatz stiff or Inoue wire placed through the sheath that was
used to initially cross the septum. Once in the LA, heparin should be administered as needed to
maintain an activated clotting time (ACT) between 250 and 350 seconds, generally at a dose of
200 units per kilogram. At this point, with the wire position firmly established in the LA, a steerable sheath such as an Agilis or, alternatively, Dexterity sheath can be introduced into the LA for
more precise movement and positioning. In patients with a thickened fibrotic septum, if there are
problems associated with needle entry into the LA, a Safe-Sept wire or radiofrequency delivered
to the needle may be of value. Should the steerable sheath not readily cross the septum, dilation
with either the Inoue dilator or even a coronary or peripheral set of wire/balloon can be used to
readily gain access to the LA with the larger, steerable sheath. Certainly, a larger guiding catheter
such as a 6F to 8F multipurpose catheter can be used to directly access and engage the affected
PV. A conventional coronary guiding catheter is usually used in the event that intravascular ultrasound (IVUS) is needed to assess the lesion more carefully. Without the steerable sheath,
however, this creates some difficulty in terms of support as well as maintaining access to the LA
while switching out equipment. Either along or through the steerable sheath, we commonly use
a 6F multipurpose catheter to intubate the affected PV, using clockwise maneuvering for posterior
positioning and counterclockwise movements to position the sheath more anteriorly. Engagement
with the orifice of the affected PV can be confirmed by brief contrast injection on fluoroscopic
angiography or with ICE guidance using the venous jet.
WIRE CROSSING
To cross the stenotic PV, one can use a 0.0350 Stork guidewire, similar diameter (0.0350) or
pediatric (0.0250) hydrophilic Glidewire, a 0.0180 V-18 wire, or even a 0.0140 coronary wire,
depending on the degree and character of the stenosis. Wire position across the stenosis
should be confirmed with angiography in multiple planes as well as echocardiography (TEE
or ICE). If no microchannel can be identified on CT scan, the ICE catheter can be used to
interrogate the LA for a velocity representing flow. In addition, focused contrast injections
could be used to try to identify a “beak” representing the site of occlusion. Often, despite a
diagnosis of complete PV occlusion on CT, in up to 40% of the time there is a microchannel
able to be crossed when the patient is taken to the catheterization laboratory. This places a
premium on CT scanning as the initial diagnostic modality with subsequent hemodynamic
catheterization with PV angiography to confirm complete occlusion. If no potential site or
microchannel can be identified, the PV could be considered chronically occluded and the
procedure aborted at this point because even with careful probing, there may be damage to
the vein or LA itself.
PULMONARY VEIN INTERVENTION: DILATION AND STENTING
Once across the stenosis, one should not lose the wire position; it will be important to maintain
access and upgrade the wire for more support to deliver balloons and stents. If possible, advance
the multipurpose catheter into the PV for simultaneous PV/LA pressure measurements
(see Fig. 23.3). LA pressure can either be obtained with a second catheter (4F multipurpose)

23—PULMONARY VEIN STENOSIS: MANAGEMENT AND OUTCOMES 271
The mean gradient is 15 mmHg.
PV to LA pressure gradient after dilation.
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80
40
PV
LA
0
PV to LA pressure gradient before dilation.
80
40
PV
LA
0
Fig. 23.3 Pressure tracing of PV/LA gradient preprocedure and postprocedure.
in the LA or through the sidearm of the steerable catheter. In our series, higher-pressure gradients portend more difficult procedures requiring more devices and higher balloon/stent inflation
pressures. Any pressure gradient between the PV/LA is abnormal and should be intervened upon
if the patient is symptomatic. Along those lines, this is also an excellent postprocedural method—
along with IVUS—to assess the intervention, as the post-balloon/stent gradient should be as low
as possible. Higher residual pressure gradients also portend higher rates of restenosis.
If the multipurpose catheter can be passed across the stenosis, then the crossing wire can be
exchanged for a stiff Amplatz wire, which can then be used to deliver over-the-wire peripheral
balloons and stents, depending on the size of the PV, which can be assessed on the preprocedure
CT or with ICE. It is important to place the largest stent that the vein will tolerate. Our standard
goal is placement of a 10-mm-diameter stent, as this is associated with a lower subsequent restenosis rate. If the disease process is advanced with the finding of a 4- to 6-mm vessel, coronary
stents may be used, but the long-term outcomes are characterized by recurrent events.
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