This document summarizes information about patent foramen ovale (PFO) closure procedures. It begins by describing a PFO and conditions it can be associated with like cryptogenic stroke. It then discusses devices used for closure like the Amplatzer PFO Occluder and the procedure. Risks include air embolism or device migration. The document also reviews trials that have evaluated PFO closure for stroke prevention. While some trials were negative, a meta-analysis showed a trend favoring closure, particularly in high-risk groups. Ongoing trials aim to provide more clarity around PFO closure benefits.

3. Patent foramen ovale (PFO) is
a flaplike opening between the
atrial septa primum and
secundum at the location of
the fossa ovalis.

4. Complete occlusion occurs in most populations but in
approximately 25% the fusion is incomplete, giving rise to
PFO.
Probe patent PFO’s of 0.2 to 0.5 cm.

5.  Cryptogenic Stroke
 Systemic embolization.
 Platypnea-orthodeoxia syndrome
 Decompression Sickness
 Migraine Headaches.

6.  In 35-40% of patients with stroke the cause
cannot be identified even after thorough
evalution, such CVAs are called
cryptogenic.
 Higher prevalence of PFO has been found
in patients of cryptogeic stroke as compared
to patient with identifiable causes.

7.  The reported recurrence rate of cryptogenic 1.2 %
to more than 16%, but most commonly 2%.
 Related to PFO size, Patency, Shunt severity, and
the presence of Atrial septum Aneurysm.

8.  Currently, there is no consensus on the
superiority of antiplatelet or oral
anticoagulation therapy for patients with
cryptogenic strokes and PFO.
 The only series that compared medical
therapy to percutaneous closure in patients
with PFO’s and cryptogenic strokes was
published by Windeker and Colleagues.
 With its inherent limitations this study
demonstrated an advantage of percutaneous
closure.

9.  Percutaneous closure of the PFO in patients
who experienced recuurrent CVA despite being
on medical therapy carries a class Iib
indication[AHA/ACC].
 The FDA has permitted use of Amplatzer and
Cardioseal Septal Occluders Only for patients
who have experienced recurrent CVAs while on
conventional medical therapy (oral
anticoagulation with a therapeutic INR)

10.  People with migraine have twice the risk of stroke
and the risk increases to 3.5 for patients younger
than 35 years.
 ANZOLA and COWORKERS: the incidence of
PFO was significantly higher among the
migraineurs with aura compared to those without
aura or controls./ those who went for PFO closure
also reported less incidence of attacks with
aura(80%) and complete resolution in 56%.

11.  MIST Trial :- The migrain intervention with
STARflex Technology: The primary end point of
cessation of attacks was not met.
 However reduction in attacks was seen in PFO
closure group.
 MIST 2 AND ESCAPE were discontinued due to
slow enrollment.
 Until further results are available, PFO closure
should not be considered for the treatment of
migraine with Headache with aura.

12.  Is caused by nitrogen bubbles that come out of
solution in blood as the ambient pressure decreases.
 In a case control study, GERMONPRE et al found
odds ratio of 2.25 for the development DCS in divers
with PFO.
 TORTI et al found that divers with PFO had a higher
risk of developing DCS, required treatment, and had
symptoms for more than 24 hrs.
 Currently, PFO closure to prevent DCS is not
indicated because of low overall incidence and
ease of avoidance.

13.  TTE
 TEE
 TCD( Transcranial Doppler; Middle cerebral artery)
 Recently 3DE, CT and MRI.
•Agitated Saline is used to Diagnose right to left shunts,
it is generally accepted that a right to left shunt is
diagnosed if at least 3 microbubbles appear in the left
atrium, either spontaneously or after provocative
maneuvers, within 3 cycles of complete opacification of
right atrium.

14.  While evaluating the patients with
cryptogenic stroke and PFO: size, degree
of shunting and tunnel length
should be taken into account when
evaluating a patient.
 TEE has been shown to correlate very well
with autopsy findings (sens. & specf.
Approaching 100%) : GOLD STANDARD.

15.  AMPLATZER PFO OCCLUDER
 STARFlex
 PREMERE PFO CLOSURE SYSTEM.
 OFF LABEL WITH ASD CLOSURE
DEVICES
› HELEX SEPTAL OCCLUDE
› AMPLATZER ATRIAL SEPTAL OCCLUDER
› AMPLATZER MULTIFENESTRATED OR
CRIBRIFORM ASO

16.  The APO :self expanding,double-disk device
made from 0.005 inch nitinol wire, with a polyester
fabric sewn into both disks.
 In the APO, the left atrial disk is smaller than the
right atrial disk except for the 18- and 30-mm
devices, which have matched disk sizes.
 Device size represents the right atrial disk
diameter.
 Device sizing depends on the measurement from
the foramen ovale to the SVC and from foramen
ovale to aorta.

17.  The right disk radius should not exceed the
shortest distance obtained.
 FUTURE DEVICES:-
THE GORE SEPTAL OCCLUDER.
BioSTAR and BioTREK.
COHEREX DEVICE
SeptRX.

18. Parameters Closure 1 Respect Pc
Device Starflex septal closure
system
Amplatzer pfo occlude
device
Amplatzer pfo occlude
device
Patients 909 patients with
cryptogenic stroke and
TIA
980 with cryptogenic
stroke
414 with cryptogenic
stroke
Methodolgy Medical therapy vs
transcatheter pfo
closure
Medical therapy vs
transcatheter pfo
closure
Medical therapy vs
transcatheter pfo
closure
Difference in
outcome
Nil Statistically significant Recurrent stroke was
less in device group
but not stat signif.
Limitation Not deal pt population
Longer follow up
Stringent inclusion

19.  The primary end points for the completed
trials have been negative.
 However , a meta analysis of the completed
randomized controlled trials for secondary
prevention of cryptogenic stroke shows a
statistically significant trend favouring
transcatheter PFO closure.

20.  There are “signals” pointing towards benefit
with closure, particularly in select group of
patients at HIGH RISK, such as those with
ASA (atrial septal aneurysm) and LARGE
SHUNTING.
 Upcoming trials:-
› CLOSE
› DEFENSE-PFO
› REDUCE

21. This is a summary of the American Academy of Neurology (AAN) practice advisory, “Recurrent
Stroke with Patent Foramen Ovale,” which was published in Neurology ® online on July 27, 2016,
and appears in the August 23, 2016, Neurology print issue.

22.  Percutaneous closure for refractory
hypoxemia related to R>L shunt across PFO
is still available under humanitarian device
exemption or by off label application of
cribriform(AGA Medical) or Helex( gore)
occluder.

23.  Percutaneous closure is performed under
ultrasound and fluoroscopic guidnace.
 Adequate hydration decreases the risk of air
embolism.
 Femoral venous access provide favourable
entry: 7-8 Fr short sheath.
 A second venous sheath is placed for ICE. ;8
OR 10 Fr

24.  An end hole MP catheter is advanced over a stiff 0.035 inch,
1.5mm long J tipped guidewire.
 On arrival at the Junction of right atrium and IVC the wire is
advanced towards IAS at the level of aortic valve.
 Septal puncture is performed.
 In LA guidewire is advanced to left pulmonary veins, extending
beyond the left main bronchus.
 After passage across foramen ovale sytemic anticoagulation is
done with heparin : target ACT >200sec

25.  Delivery sheath is inserted, dilator and
guidewire removed, and the sheath is
connected to manifold while ensuring the air
bubbles are cleared.
 Device positioning and release.

26.  Additional fenestrations
 Long rigid PFO tunnel
 Unavailablity of Femoral Venous access

27.  Defects clustered in fossa ovale can be
treated with large device.
 If the distance between the defects large,
additionaL devices can be placed during the
same procedure.
 Hence while putting more than one device,
an additional femoral venous access and
cross the main PFO and distal defect with
Seperate catheters and wires.

28.  If the septum primum is inflexible and and
the overlap of septum primum and
secundum is long (>1cm) it may be difficult
to withdraw the closure device far enough
into the tunnel to successfully open the right
atrial occluder, resulting in partial opening of
right atrial occluder or extraction over the left
occluder.

29.  TRANSSEPTAL PUNCTURE TECHNIQUE
 BALLOON DETUNNELIZATION.

30.  DUE to previous intrumentation, thrombosis or
an IVC filter.
 Transhepatic route.
 Right Internal Jugular Route.
because of the orientation of the PFO’s flap valve, the catheter from
the SVC impacts the septum on the wrong angle to cross the defect. In
such cases deflectable electrophysiology sheath is used. Such
sheaths can be deflected up to 270 deg in RA. A 5 Fr multipurpose
catheter can be advanced and to left upper pulmonary vein. A stiff
guide wire is exchanged and placed in LV apex, measuring pressures
through pullback tech, so that mitral valve is not compromised, device
is delivered in usual fashion.

31.  Procedural Complications occur in 4-7% patients,
usually mild.
Procedure related
complications
• Air Embolus.
Device Related
• Device Migration
• Device arm fracture
• Device thrombosis
• Transient Arrhythm
• Nickel allergy
• Endocarditis

32.  It is the most common source of cardioembolic
stroke in AF as LAA thrombus is present in up to
15% of patients in AF and 90% of thrombus
formation in nonvalvular AF is in LAA.

33.  The LAA is responsible for several functions:
 it acts as a reservoir during left ventricular
systole, a conduit for blood transiting from
the pulmonary veins to the left ventricle
during early diastole,
 an active contractile chamber that augments
left ventricular filling in late diastole,
 and a suction source that refills itself in early
systole

34.  The LAA also has an endocrine role: it
contains stretch-sensitive receptors that are
able to influence heart rate and natriuretic
peptides secretion in response to change in
atrial pressure.
 A quantitative analysis of atrial natriuretic
peptides (ANP) in excised LAAs revealed a
content of approximately 30% of all cardiac
ANP

35.  Three LAA flow patterns have been
described:
 (1)type I, characterized by a regular biphasic
emptying pattern, occurring in sinus rhythm;
 (2)type II, characterized by a saw-tooth
emptying pattern, occurring in some patients
with atrial fibrillation;
 (3)type III, without any active emptying
pattern, typically occurring during AF. This is
associated with the highest incidence of
spontaneous echo-contrast and thrombus

36. entire atrial coronary circulation as being
provided by the left circumflex and right
coronary arteries from their course in the left
and right atrioventricular sulci

37. 
Measurements of the left atrial appendage (LAA) in an anatomic specimen. The LAA is outlined in
black. The echocardiographic orifice (Oe) is somewhat larger than the anatomic orifice (Oa). The
length (L) of the appendage is a curvilinear distance (dashed line) from Oa to the tip of the tail,
whereas the maximal width (W) is a straight-line measurement. Nearly all appendages in the adult
contain pectinate muscles >1 mm in diameter. Oe is usually measured from the junction of the left
superior pulmonary vein (LSPV) entering the left atrium (LA) to the junction of the LA and LAA.

38. A, Diagram of a left atrial appendage
(LAA) shows lobes (1, 2, and 3). Each
distinct protrusion from the
windsocklike body represents a lobe,
as does the tail itself. Bends in the tail
do not necessarily produce new lobes
at the point of flexion. B, Gross
anatomic specimen of LAA with two
distinct lobes (1 and 2). LA indicates
left atrium; LIPV, left inferior
pulmonary vein; LPA, left pulmonary
artery; and LSPV, left superior
pulmonary vein.

39. Distribution of number of lobes (1 to 4) of left atrial appendage. The most frequent
(54%) occurrence was a two-lobe left atrial appendage.

40.  EXCLUSION
 EXCISION

41.  Percutaneous left atrial Appendage Transcatheter
Occlusion System.(PLAATO)
 Watchman Occluder.
 Transcatheter Left Atrial Appendage Ligation with
the Lariat Device.
 Wavecrest Occluder.

42.  First Device to be evaluated.
 Self expanding Nitinol cage covered with an
occlusive expanded polytetrafluoroethylene
membrane.
 Delivered through 14 Fr delivery sheath, with TEE
and fluoroscopy.
 The major procedural complication is cardiac
tamponade.
 PLAATO experience serves as “proof for principle”
for transcatheter occlusion of LAA.

44.  Parachute shaped.
 Nitinol frame, polyethylene terphthalate (PET) fabric
membrane cap that faces the body of the left atrium.
 Device size corresponds to the diameter of the device
measured at the proximal shoulders, which is its
widest portion.
 Size: 21-33 mm
 Oversizing of device by 08-10 % is recommended

45.  The device length is equal to its diameter.
 IMPLANTATION PROCEDURE:-
A 14 Fr access sheath is carefully placed deep within the
LAA and often telescoped over a diagnostic pigtail catheter to
prevent laceration or perforation of the thin walled friable
LAA. The device which is provided preloaded in a delivery
system and attached to a delivery cable, is advanced to the
tip of the access sheath, after which the sheath is withdrawn
and the device is deployed.

47. Studies of left atrial appendage occlusion with the Watchmann Device for stroke
Prevention in Nonvalvular Atrial Fibrillation
STUDY STUDY DESIGN N PATIENTS
PILOT Prospective multicenter
registry
66 OAC ELIGIBLE
PROTECT AF Randomized Clinical Trial 707 OAC ELIGIBLE
PREVAIL Randomized Clinical Trial 407 OAC ELIGIBLE
CAP Continued Access
Registry
460 OAC ELIGIBLE
CAP2 Continued Access
Registry
579 OAC ELIGIBLE
ASAP Prospective Multicenter
Registry
150 OAC INELIGIBLE

48.  In PROTECT AF and PREVAIL TRIAL
patients with watchman device was
continued with following algorithm:-
Implant – 45 days
Warfarin Dosage to achieve INR 2.0-3.0 , ASPIRIN :81mg while on
warfrin, clopidogrel- NO
45D- 6MONTHS
WARFARIN: NO
ASPIRIN:325MG
CLOPIDOGREL: YES
45D- 6MONTHS
WARFARIN: YES
ASPIRIN:81MG
CLOPIDOGREL: NO
LAA SEAL (TEE) NO LAA SEAL (TEE)

49. 6 MONTHS – 5 YEAR
WARFARIN :NO
ASPIRIN 325MG
CLOPIDOGREL: NO
6 MONTHS – 5 YEAR
WARFARIN :Discontinued when
seal is adequate
ASPIRIN 81 mg on warfarin
Off warfarin 325mg aspirin
CLOPIDOGREL: NO

50.  In PROTECT AF trial, watchman LAA was
non inferior and superior to warfarin for the
primary efficacy end point.
 The rate of fatal and disbling stroke was less
in the device group without any difference in
rates of total events.
 Quality of life measurements were
significantly improved in the device group.

51.  AIM: to confirm procedural safety.
 Procedural complications were less as compared
to PROTECT AF.
 A MEAN FOLLOW UP of approx 1 year, primary
safet efficacy end point of stroke, systemic
embolism or cardiovascular death was simialr in
both the groups, but did not achieve non inferiority
criteria.

52.  The WATCHMAN LAA occluder has been
approved by FDA for use within United
states .
 It is indcated to reduce the risk of
thromboembolism from the LAA in patients
with AF who are at increased risk of stroke or
embolism based on CHADS2 OR
CHA2DS2VASc and are recommended for
anticoagulation; are deemed by their
physicians to be suitable for warfarin: and
have an appropriate rationale to seek a non
pharmacological alternative to warfarin.

53.  SELF EXPANDING nitinol mesh with a swen
polyster patch.
 Distal lobe and proximal disc.
 Distal lobe has hooks around its circumference
that anchors the device in the LAA and proximal
disc covers the mouth of LAA from within the
left atrium.
 The device sizing is based on the maximum
diameter of the distal lobes landing zone, which
is measured 10mm distal to the LAA orifice.

56.  For the second generation ACP or amulet,
the landing zone is measured approximately
12 to 15 mm from the LAA orifice.
 Most studies, evaluated the device in
patients with intolerance or contraindications
to OAC, and patients were usually treated
with a limited course of antiplatelet therapy
after device implantation.

57.  The rates of successful LAA closure are
excellent.
 The most frequent procedural complication
appears to be pericardial effusion( similar
rates with Watchman device).

58.  Cleared By FDA for soft tissue approximation.
 Accomplished through both Transpericardial
(subxiphoid) and transseptal approach.
 Anatomic Eligibilty by CT scan.
 A large (2nd Gen) device may allow closure of upto
45 mm dia appendage

59.  14 Fr sheath is inserted into anterior percardial
spaceusind an epidural or micropuncture needle
under fluoroscopy.
 8.5 Fr trans septal sheath is introduced into left
atrium.(inferoposterior location is preferred).
 A rail is formed by approximating the two magnet
tipped guidewires, over which Lariat snare is
delivered.

60.  Lariat snare is advanced through pericardial
sheath.
 Snare contains prelaoded tied surgical suture.
 Suture tensioning device is used to tie the knot.
 Drain is placed for 4-6 hours.

63.  Diameter greater than 40 mm
 Lobes behind Pulmonary artery
 Lobes with posterior orientation

64.  Successful closure is defined as a residual
leakage of less than 1mm in dia.
 Pericardial effusion and pericarditis are major
complication.
 Rarely LAA perforation is seen.
 AF burden is reduced as Lariat can have
antiarrhythmic effect.

65.  Expanded polytetrafluoroethylene cap and
self expanding nitinol cage.
 Foam skirt enhances sealing.
 When the device is implanted, occluder is
positioned to occlude LA , set of anchors are
then deployed in seperate step.

67.  Less traumatic.
 More flexibility in closing irrespective of LAA
depth.

68.  INDIVIDUAL RISK FOR THROMBO
EMBOLISM.
 LONG TERM RISK OF OAC
 SHORT TERM PROCEDURAL RISK OF
DEVICE IMPLANTATION.

69. RECOMMEDNDATION FOR LEFT ATRIAL APPENDAGE CLOSURE
SOCIETY GUIDELNES CLASSIFICATION RECOMMENDATION
AHA/ACC/HRS 2014 II B SURGICAL EXCISION OF
LAA MAY BE
CONSIDERED IN
PATIENS UNDERGONG
CARDIAC SURGERY
ESC 2012 II B
IIB
SURGICAL EXCISION OF
LAA MAY BE
CONSIDERED IN
PATIENS UNDERGONG
OPEN HEART SURGERY
INTERVENTIONAL,
percutaneous LAA closure
may be considered in
patients with a high stroke
risk and contraindication
for long term OAC