Offenes Foramen ovale (PFO)

2018 Update

Bernhard Meier

Universitätsklinik für Kardiologie

Inselspital

Bern, Schweiz

Interessenkonflikte: Honorare von Abbott

Principle of Percutaneous PFO Closure

SP

Weshalb ist ein PFO gefährlich?

Del Grande Mirko, 25.07.1956, 15.07.1956, 21.09.2011, 19.03.2012, Hirslanden ZH

PFO and Atrial Septal AneurysmDiagnosis by Transthoracic Echocardiography (TTE)

30/30 Amplatzer PFO occluder implanted

TEE at 6 mo: complete closure

Zinsli Annemarie 08.11.1941, 05.07.2010 Baden

ASA

PFO

ASA

PFO

LA

RA

LA

RA

PFO and ASATEE Angiography

Eustachian Valve

Entwicklungsgeschichte kathetergestützter Herzeingriffe

1953 Rubio-Alvarez Pulmonalklappenstenose Drahtaufdehnung beim Kind

1966 Rashkind Atriale Septostomie beim Kind

1966 Porstmann Ductus Botalli Verschluss

1972 Galiano Koronare Drahtrekanalisation bei akutem Herzinfarkt

1975 King Vorhofseptumdefekt Verschluss mit Implantat

1977 Grüntzig Koronararterie Ballondilatation

1981 Singer Isthmusstenose Ballondilatation

1982 Gallagher His Bündel Ablation

1983 Lababidi Aortenstenose Ballondilatation beim Kind

1984 Inoue Mitralstenose Ballondilatation

1986 Puel Koronararterie Stentimplantation

1987 Simpson Koronararterie Atherektomie

1990 Palacios Perikard Balloneröffnung

1994 Sigwart Alkoholseptumablation bei hypertropher Kardiomyopathie

1998 Waxman Perikardzugang durch das Herzohr für Medikamentengabe

2000 Bonhoeffer Pulmonalklappenersatz

2001 Sievert Vorhofohrverschluss (Antikoagulationsalternative bei Vorhofflimmern)

2002 Cribier Aortenklappenersatz

2003 Feldman Mitralklappen Clip-Reparatur bei Insuffizienz

2012 Sondergaard Mitralklappenersatz

Di Giorgio Roberto, 30.05.1977, 24.07.2011 Pilgrim

PFO-Death in Healthy 34-Year-Old Man, 1 Day after a Soccer Bruise to the ThighSudden collapse: cardiogenic shock --> catheterization under cardiac massage Pilgrim T, J Invasive Cardiol 25:162-164, 2013

Huge infarction Femoralveinthrombusatbruise

PFO

Pulmonaryembolusalsofound

Culprit

Autopsy

Cicero

29. März 2016

†45jährig

Jedes

PFO

sollte

verschlossen

werden!

The only good PFO

is a closed PFO!

zu deutsch:

Wo Loch da zu!

Intricacy of Adult Interventional Cardiology Procedures

PFO Closure LAA Closure Paravalvular(Mitral) Leak

ClosureMitraClipTAVI

PCI

• Prevention• Therapy

ASD Closure

CardioSEAL STARFlex BioSTAR

NMT

Solysafe

Amplatzer PFO Occluder

PFx

CIERRA

SeptRxPremere

St. Jude

Gore Septal OccluderINTRASEPT

CARDIA

HeartStitchSUTURA

St. Jude Abbott

SWISSIMPLANT

FlatStent

Buttoned Device

INTERSEPT

CARDICA

Stealth Custom Medical Devices

COHEREX

Gore

CARAG

Bioabsorbable

Occluder

NobleStitch and KwiKnot

HeartStitch

Clinically Used Devices

Amplatzer PFO Occluder

Figulla PFO OccluderCera Occluder

Cocoon OccluderHyperion Occluder

Comed

St. Jude Abbott

Cardi-O-Fix Occluder

Starway Medical TechnologyIrisFIT

Vorkommen von PFO gemäss Alter

Alter (Jahre)

PFO in 263/965 Autopsien (Durchschnitt 27%)

Hagen PT, Mayo Clin Proc 1984; 59: 17-20

%

Y =35-0.12x

R2

=0.6, p=0.008

PFO as Predictor of Adverse Outcome in

Patients With Major Pulmonary EmbolismKonstantinides S et al. Circulation 1998;97:1946-1951

• 139 patients with major pulmonary

embolism undergoing TEE

• 35% with PFO

• 59±17 (17 - 89) years

• Clinical endpoints

• death

• cerebral embolism

• arterial thrombo-embolism

• major bleeding

- PFO: independent predictor of mortality

- Suggested mechanism: paradoxical embolism

PFO-Death in Healthy 46-Year-Old Woman after Face Lifting

Wiestner Marianne 31.01.196701.05.2013 Diehm, Nietlispach, Kadner

Multiple coronary artery occlusions (under ECMO support)

Multiple pulmonary embolisms

PFO

Cardiogenic shock and death4 days

after emergency heart surgery

LA

RA

0,4%

1,1%

PFO Closure

Medical Treatment

P=0.03

1,872 patient-years

1,394 patient-years

PFO with device

PFO without device

Wahl A, Circulation 2012, 125:803-812

Death per Year(≥ 10 years of follow-up)

PFO Closure Versus Medical Therapy (Meta-Analysis)

Schulze V, Clin Res Cardiol 2018

Mortality

PC and RESPECT Combined (Patient Level)

Kent DM, J Am Coll Cardiol 2016;67:907–17

Device

Medical

Constructed Individual Patient Meta-Analysis

Giacoppo D, BMJ 2018

No Stroke

PC Trial Meier B, NEJM 2013;368:1083-1091Percutaneous Closure of Patent Foramen Ovalein Cryptogenic Embolism

StrokesFU (years) Closure Control

4.1 1/204 (0.5%) 5/210 (2.4%)

Number needed to treat (NNT)

to prevent 1 stroke

RESPECT Trial Long-Term

Saver JL, N Engl J Med 2017;377:1022-32

Recurrent Stroke

Patti G, Am J Cardiol 2015;115:837-843

Antiplatelet or Anticoagulantfor Patients With Cryptogenic Stroke and Patent Foramen Ovale

Recurrent Stroke

Patti G, Am J Cardiol 2015;115:837-843

Antiplatelet or Anticoagulantfor Patients With Cryptogenic Stroke and Patent Foramen Ovale

Antiplatelet AnticoagulantMajor Bleeding

Primary efficacy outcome (recurrent stroke)

The relative size of the data markers indicates the weight of the sample size from each study.

CI = confidence interval; RR = risk ratio

PFO closure better PFO closure worse

Mojadidi MK, JACC Cardiovasc Interventions 2017;10:2228-2230

Primary safety outcome (atrial fibrillation)

PFO Closure and Atrial Fibrillation (Meta-Analysis)

Sie hatte seit 10 Jahren unter schwerer Migräne gelitten!

Pflegefachfrau mit 2 Teenager-Buben, 39jährigwird nie mehr sprechen wegen eines Hirnschlags

Migraine and risk of cardiovascular diseasesDanish population based matched cohort study

PFO mentioned but no recommendation to screen for it

Adelborg K, BMJ 2018;360:k296

• 51 032 patients with migraine• 510 320 people from the general population in Denmark, matched on age, sex, and calendar year

Years Years

Editorial

Migraine and risk of cardiovascular disease

"Action to reduce risk is long overdue!"

Kurth T, BMJ 2018;360:k275

Reduction in migraine days

Responder rate (%)

Primary Endpoint Secondary Endpoint

* 80 pts, Mattle H, Eur Heart J 2016;37:2029-2036

** 220 pts, Tobis JM, J Am Coll Cardiol 2017;70:2766–2774

Effect ofAmplatzer PFO Closureon Migrainein Randomized Trials

*

*

**

**

Courtesy: Luiz Carlos Simões, MD, Brazil

Embolism to fingers through PFO45-year-old woman with two previous embolic brain events and long known PFO

• Bypass surgery for left main stem disease 7,000• Betablocker after infarction 10,000• Invasive strategy for coronary artery disease 10,000• Cervical cancer screening 12,000• Treatment of hypertension 13,000• Statin therapy, secondary prevention 24,000• TPA instead of streptokinase for infarction 33,000• Hemodialysis 35,000• Percutaneous aortic valve replacement 50,000• PTCA for acute myocardial infarction 52,000• Heart transplantation 54,000• Fourth day of monitoring for acute infarction 105,000• Statin therapy, primary prevention 150,000• Seat belt 150,000• Smoke detector 239,000• Radiation control 834,000• Air bag 1,500,000

Cost for Year of Life Saved (US$)

*Frei A, Kardiovask Med 7:174-180, 2004

0

•Sekundärprävention- Hirnschlag oder TIA

- Herzinfarkt

- Sonstige systemische Embolie

- Tauchzwischenfall

- Höhenkrankheit

•Primärprävention- Gefährliche Art des PFO

- Neigung zu Venenthrombosen

- Lungenembolie

- Schrittmacher oder Defibrillator

- Gewisse Operationen

- Geplante Schwangerschaft

•Therapie- Migräne

- Atemnot im Sitzen

- Atemnot bei Anstrengung

- Schlafapnoe

•Beruf oder Freizeit- Taucher

- Hochalpinist, Hochländer

- Blasmusiker

- Glasbläser

- Bodennleger

- Militärpilot oder Astronaut

- Busfahrer oder Linienpilot

Gründe (Indikationen) für PFO Verschluss

PFOSehen wir nur die Spitze des Eisbergs?

2. kryptogener Hinschlag

Jeder Hirnschlag oder TIA

Embolischer Herzinfarkt

Periphere Embolie

Migräne (mit Aura)

Schlafapnoe

Platypnoea orthodeoxia

Belastungshypoxie

Tauchen

Hochalpinismus

Lungenembolie

Tiefe Venenthrombose

Schrittmacher-/Defibrillatorelektroden

Emboliegefährdete Chirurgie

- Orthopädie

- Neurochirurgie, sitzend

Gefährliches PFO

- Gross

- Septumaneurysma

- Eustachsche Klappe

- Chiari Netzwerk