Atrial Fibrillation Post PFO Closure and New PFO

Devices

Dr. Alonso José Luis: Hospitales J.P.Garrahan Bs.As. J.D.Perón de Formosa

NO CONFLICTS

Argentina
Atrial Fibrillation Post PFO Closure and New PFO Devices

PFO CLOSURE IS A PROCEDURE THAT IN OUR COUNTRY BEGAN TO SLOWLY

DEVELOP NEARLY 10 YEARS LATER THAN IN THE REST OF THE WORLD WHERE ARE
CENTERS WITH EXPERIENCE IN THOUSANDS OF CASES.

ALMOST EVERYTHING IS WRITTEN AND OUR CONTRIBUTION MAY BE OUR LITTLE

EXPERIENCE OF LESS THAN 150 CASES (136p) AND ON WHAT HAS BEEN
PUBLISHED
Atrial Fibrillation Post PFO Closure and New PFO Devices

Atrial fibrillation is the most common sustained cardiac

arrhythmia in the general population. In Spain, the latest
data indicate that in over 40 years the prevalence of atrial
fibrillation may be 4%.

Rev Esp Cardiol Supl. 2016;16(A):2-7 - Vol. 16 Núm.Supl.A

DOI: 10.1016/S1131-3587(16)30007-3
Epidemiología de la fibrilación auricular
Juan José Gómez-Dobla
Atrial Fibrillation Post PFO Closure and New PFO Devices

136 PFO CLOSURE 3 Pre-Closure AF

Residual Shunt: minimum 1 P 0.73%
Devices Amplatzer PFO/ASD/VSD Occluders 122 (90%) Others Helex –Atriasept-
Solisafe.
Complications:
Major: 2 P 2,72%
1 P Intracardiac Erosion 1 P 0.73% TCT 2015
1 Device embolization.
Minor: 9p 6.6% transient supraventricular arrythmias self limited.
5 p new onset AF 6.8% early after closure
All over 50 years old, with bad anatomy
 Atrial Fibrillation Post PFO Closure and New PFO Devices
Over a mean follow-up period of 38.1 +/- 28 months, 53 (3.9%) patients developed new
onset atrial fibrillation, which is higher compared with an age-matched population. Of
these, 33 (62.3%) patients developed atrial fibrillation within 4 weeks and 8 (15%) within 6
months following PFO closure (totally 77% from 0 to 6 months). The event consisted of a

PFO CLOSURE GUILTY

single paroxysm lasting less than 48 hr in 23 patients, resolving either spontaneously or with
cardioversion. 40 (75.5%) patients were symptomatic at the time of diagnosis. Thirty
(56.6%) patients developed chronic atrial fibrillation.
On multivariate analysis, advanced age and use of the STARFLEX device predicted atrial
fibrillation.

Catheter Cardiovasc Interv. 2009 Nov 15;74(6):889-95. doi: 10.1002/ccd.22172.

New onset atrial fibrillation after patent foramen ovale closure.
Staubach S1, Steinberg DH, Zimmermann W, Wawra N, Wilson N, Wunderlich N, Sievert H.
Predictors of AF
The following parameters showed to bear no relation to the new onset of AF after
closure of an IASC: residual shunt, hypertension, body mass index, coronary artery
disease, gender, age, and left atrial size.

Significance for right atrial size as a predictor for AF was narrowly missed (P = 0.08).
The only significant predictor of AF was found to be device size . Four out of seven
patients experiencing post closure AF had right atrial enlargement. Of the 68
patients studied, 62 (91.2%) had a patent foramen ovale (PFO) and 6
(8.8%) an ASD.

Of the latter, one patient (17%) experienced AF after defect closure, the other six
patients developing AF had a PFO (9.6%; P = ns). Frequent atrial ectopics had been
found in two patients that developed AF after IASC, and in four patients that
remained free of AF (P = ns). Clin Res Cardiol (2010) 99:507–510
Recurrent neurological events after PFO closure are rare, usually
noncryptogenic and associated with conventional vascular risk factors or AF
related in 15% of patients .
After transcatheter PFO closure, lifelong strict vascular risk factor control is
warranted.

Elisabetta Mariucci et al Hindawi Cardiology Research and Practice

Volume 2017, Article ID 9849425, 10 pages Published 21 December 2017
 Atrial Fibrillation Post PFO Closure and New PFO Devices
Atrial fibrillation occurred with a similar frequency whether the patent
foramen ovale/atrial septal defect was successfully percutaneously closed or
was medically managed. 7.6% vs 7.8%
The presence of a large patent foramen ovale was the only significant
predictor of AF occurrence during follow-up.

PFO CLOSURE NOT GUILTY

Incidence of atrial fibrillation after percutaneous closure of patent foramen ovale and
small atrial septal defects in patients presenting with cryptogenic stroke
Feb 2010 International Journal of Stroke
Robert F BonviniRoman SztajzelP-A Dorsaz[...]J Sztajzel
 Atrial Fibrillation Post PFO Closure and New PFO Devices
Recurrent embolic events after device closure of patent foramen
ovale (PFO) have been related to incomplete closure. Another cause

PFO CLOSURE NOT GUILTY

could be atrial fibrillation (AF).
In multivariate analysis, the presence of an occluder device was not
an independent risk factor for AF.
The incidence of AF is high after device closure of a PFO in stroke
patients and similar to that in patients with stroke of non-PFO
etiology and, hence, with no device.

Atrial Fibrillation following Device Closure of Patent Foramen Ovale

March 2008Cardiology 111(1):47-50
DOI10.1159/000113427
Atrial Fibrillation Post PFO Closure and New PFO Devices

The high prevalence of arrhythmias detected before and after PFO

closure may be related to an increased atrial electrical vulnerability in
patients with atrial septal abnormalities

PFO CLOSURE NOT GUILTY JACC Vol. 62, No. 25, 2013
December 24, 2013:2449–56
 Atrial Fibrillation Post PFO Closure and New PFO Devices
Clinical Key Point: The PFO closure produced no adverse events or recurrent strokes during
the 2-year follow-up.
Important finding: has produced no adverse events or strokes in the Group of device
more medication, compared with six events in the medication-only group.
Details of the study: the data come from DEFENSE-PFO, a randomized trial of 120 adults
with a history of high-risk PFO and cryptogenic stroke. Disclosures: DEFENSE-PFO was
supported by the Cardiovascular Research Foundation in Seoul, South Korea. Dr. Song had
no financial conflicts to reveal.

Fuente: Song J. ACC 2018.

In the 30 Day Event Monitoring Belt for Recording Atrial Fibrillation After a Cerebral Ischemic
Event (EMBRACE) randomized controlled trial
The authors found a significantly higher prevalence of atrial fibrillation in the cryptogenic
stroke patients monitored for 30 days versus those monitored for only 24 hours after stroke
(16.1 % versus 3.2 %; 95 % CI: 8.0–17.6; p<0.001). Thus, whether a PFO is present or not, it
is important to carefully monitor for paroxysmal atrial fibrillation in cryptogenic stroke
patients and initiate appropriate anticoagulation for the prevention of recurrent stroke.

Update on the Management of Patent Foramen Ovale in 2017:

Indication for Closure and Literature Review. Kimberly Atianzar, MD,1 Peter Casterella, MD,1
Ming Zhang, MD, PhD,1 Rahul Sharma, MD1,2 and Sameer Gafoor, MD1,3
1. Swedish Heart and Vascular Institute, Seattle, WA; 2. Carilion Clinic, Roanoke, VA; 3.
Cardiovascular Center Frankfurt, Frankfurt, Germany © RADCL I F F E CARDIOLOGY 2 0
 Atrial Fibrillation Post PFO Closure and New PFO Devices
The Risk of Paradoxical Embolism (RoPE) study devised a predictive model to determine the likelihood
that an initial stroke was due to a PFO and recurrent stroke risk. However, is likely multifactorial.
For example, atrial fibrillation and atrial flutter are established preventable ischemic stroke risk
factors; therefore, the development of these arrhythmias in cryptogenic stroke patients with a PFO may
increase the likelihood of stroke recurrence.

Leidraad PFO-sluiting Guideline for the Closure of Patent Foramen Ovale

NEDERLANDSE VERENIGING VOOR CARDIOLOGIE 8 maart 2017 Opgesteld door:
Projectgroep PFO
Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke: Meta-Analysis of
Five Randomized Controlled Trials with 3440 Patients (1829 PFO closure)
The Problem of Atrial Fibrillation After the Procedure The rate of new-onset atrial fibrillation was
significantly higher in the PFO closure group than in antiplatelet group in our meta-analysis, with most
cases detected within 1 month after the procedure — a finding that suggests that the procedure itself
induces atrial fibrillation. Indeed, in the closure group, most of the observed cases of atrial fibrillation
were periprocedural.
The risk of stroke from atrial fibrillation induced by PFO closure has not been determined in the CLOSE[7]
trial. In the REDUCE[8] trial, atrial fibrillation was more commonly reported in the PFO closure group, but
it was usually transient and the clinical relevance of atrial fibrillation related to closure and overall risk of
stroke requires further investigation. In the CLOSURE I[11] trial, a quarter of the strokes in the closure
group were ascribed to atrial fibrillation, and in two of these cases, the patients had device associated
thrombus on transesophageal echocardiography.

This meta-analysis found that stroke rates are lower with percutaneously implanted device closure than
with medical therapy alone, being these rates modulated by the rates of effective closure.
Braz J Cardiovasc Surg 2018;33(1):89-98
Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic
Stroke: Meta-Analysis of Five Randomized Controlled Trials with 3440 Patients
(1829 PFO closure)

What is New? After the publication of the two new RCTs (CLOSE and REDUCE), the
pooled results of our meta-analysis with the five RCTs confirmed that PFO closure
reduced the rates of stroke, but also reinforced the problem of atrial fibrillation
after the procedure, whose impact remains unknow. This meta-analysis revealed
that the more effective the closure, the lower the risk of stroke.
Braz J Cardiovasc Surg 2018;33(1):89-98

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The main finding of our study is that percutaneous PFO closure is not per se an inductor
for post-procedural atrial arrhythmias; indeed, the only predictor of post-procedural
arrhythmias appear to be the presence of arrhythmias before PFO closure.
Indeed, at multivariate analysis we could not identify any predictors of post-procedural
arrhythmias except preclosure arrhythmias. In particular, residual RLS, device type and
size, atrial and PFO anatomical features were not predictive of postprocedural
arrhythmias.
An interesting ancillary finding of this study, albeit non conclusive for the lack of a control
group, is that the prevalence of atrial arrhythmias, including atrial fibrillation, in patients
with PFO is unexpectedly higher than that estimated in the general population
JACC Vol. 62, No. 25, 2013
December 24, 2013:2449–56
 Atrial Fibrillation Post PFO Closure Conclusion I

1) Incidence of AF after PFO closure is high compared with general population

2) Increase with age.

3) No differences between PFO Closure or Medical Therapy alone.

4) Relationship with any device (shape or size) is not clearly defined.

 Atrial Fibrillation Post PFO Closure Conclusion II

5) Electric disturbances asociated to Interatrial Septal Defects.

6) Anatomy of the PFO may be?

7) The relationship between stroke recurrence, PFO closure and AF remains

unknown. Longlife controls are mandatory.

8) More studies are necessary to answer those questions.

 PFO closure device?
• There will be no "best device"
• Each PFO has its own best device
• The tailored approach is the way to go

Sometime the decision is suggested by the anatomy of

the PFO and
Sometimes on patient conditions (clothing disorders,
atrial fibrilation).
Red de Chiari
New Devices and Developements

a) Double disc Devices

b) Bioabsorvable Devices

c) Tunnel Shape devices

d) Suture based devices

e) Non device closure

A –double disc self expandable Devices
FDA aproved PFM

Amplatzer Cardia

Comed hiperion Lifetech Iris /spider

Pre-oxidised Nitinol Gore Cardioform
d- SUTURE BASED DEVICES
NOBLESTICH

J O U R NA L OF T H E AME R I C A N C O L L E G E O F C A R D I O L O G Y , V OL . 7 0 , N O . 1 8 , S U P P L B , 2 0 1 7
Thanks for joining me
till the end