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