PFO (Patent Foramen Ovale): Smoking Gun or an Innocent Bystander?

Transcription

1 PFO (Patent Foramen Ovale): Smoking Gun or an Innocent Bystander? J Thompson Sullebarger, M.D. Florida Cardiovascular Institute University of South Florida

2 Kris Letang

3 Tedy Bruschi

4 Bret Michaels

5 The Atrial Septum Formation

6 Incidence and Clinical Importance: PFO Decreasing incidence with age First 3 decades 33% 4th-8th decade 25% Insignificant hemodynamic burden Associations with paradoxical shunt CVA and TIA Refractory hypoxemia Decompression illness Migraine with aura Platypnea-orthodeoxia

7 Recurrence Rate in Cryptogenic Stroke 12/01 PFO and ASA

8 PFO and Cryptogenic Stroke: Risk of Recurrent Cerebrovascular Events Annual Recurrence Rate Stroke Stroke or TIA French Study Group 1.2 % 3.4 % PFO/ASA, 1995 Lausanne Study, % 3.8 % Stone et al % Comess et al % Wahl %

9 Prevalence of PFO in patients with "cryptogenic" stroke Cryptogenic Stroke Control p Lechat % 10% < 0.01 Webster % 15% < 0.01 De Belder % 3% < 0.01 Di Tullio % 4% < 0.01 Hausmann % 11% < 0.01 Cabanes % 18% < 0.01

10 Diagnosis of PFO Transesophageal ECHO Transthoracic ECHO with contrast Transcranial Doppler with contrast Ear Oximetry with contrast Sensitivity is best with femoral contrast injection Cardiac Cath

11 Risk Factors for Paradoxical Embolus Larger PFO Presence of Atrial Septal Aneurysm Associated Coagulation Abnormality History of DVT or PE History of Migraine Large R to L shunt on bubble study

12 Hypercoagulable Workup Lupus Anticoagulant Protein C, S deficiency Factor V Leiden Prothrombin 20210A Hormone Replacement Oral Contraceptives COX-2 inhibitors

13 Indications for Closure of PFO Paradoxical embolism Desaturation

14 Surgical Therapy for PFO Mayo Clinic 91 patients in series Simple Suture in 90% Patch closure in 10% 8% recurrent TIA at 4 years 0% recurrent strokes

15 Complications After ASD Surgery Study % Complications Cowley, % Jones, % Galal, % Pastorek, %

16 Complications After ASD Surgery (Mayo) Atrial Fibrillation or Flutter 12% Pericardial Tamponade 5% Reexploration for Bleeding 4% Infection 1%

17 Starflex Septal Occluder Nitinol Medical Technologies (NMT) Double umbrella patch design Components Metal frame : MP35N Fabric: Dacron 10F delivery sheath Large clinical experience >10,000 pt yrs

18 Amplatzer PFO Occluder Nitinol skeleton with absorbant material Two randomized trials

19 Helex Septal Occluder W.L. Gore and Associates Double circular low profile patch design Components Single strand nitinol wire eptfe membrane 9 F delivery catheter No sheath in LA Repositionable, removable Even after release Wire frame eptfe

20 Complications of Septal Closure Atrial fibrillation Infection Thrombosis Incomplete deployment Embolization Perforation

21 Closure I (STARFlex for PFO and TIA or Stroke (JACC 2014) 909 Subjects, STARFlex not superior to medical therapy Patients with recurrent events had a higher body mass index (30.2 vs 28.3 p=0.03) and more frequently had diabetes (19.2% vs 7.1% p=0.0016), hypertension (46.2% vs 30.1% p=0.015, and ischemic heart disease 3.8% vs 0.9% p=0.05) AF predicted recurrence p=0.0003

22 RESPECT Trial 980 Patients randomized with Amplatzer vs antiplatelet (74.8%) or warfarin (25.2%) No benefit based on intention to treat Closure group had lower risk of stroke in as treated analysis p=0.03 No increase in AF

23 Udell et al, Canadian J Cardiology 2014 Analysis of three randomized controlled trials involving 2303 subjects 3.7% vs 5.2% risk of recurrent TIA or stroke (p=.10) Increased risk of AF 3.8% vs 1.0% (p<0.0001) No identified risk based on patient age or sex, shunt size, ASA or device used.

24 European Heart Journal 2015 Meta-analysis of Stortecky et al Four clinical trials with Amplatzer, STARFlex, Helex Amplatzer reduced risk of stroke vs medical therapy No differences for STARFlex and Helex No difference in TIAs New onset AF more common with STARFlex (RR 7.67) vs Amplatzer (2.14) and Helex (1.3)

25 Capodano et al, Eurointervention 2014 Three randomized trials and 11 observational studies Amplatzer trials showed reduced stroke risk STARFlex showed increased AF and thrombus PFO closure reduced stroke risk but not TIA

26 Pickett et al, Texas Heart Inst J 2014 Three randomized trials meta-analysis Closure was associated with reduced risk of stroke with number needed to treat of 167 Risk of AF was increased with device closure

27 Pineda et al, Cathet Cardiovasc Intev 2013 Meta-analysis of three randomized trials Trend to benefit 3.7% vs 5.3% p=0.08 No difference in TIA, CVA Increased risk of AF p=0.08

28 Nagaraja et al 2013 Meta-analysis of three randomized controlled trials Odds ratio for stroke and TIA did not confer a benefit for PFO closure Age, gender, shunt size and atrial septal aneurysm did not influence the treatment effect

29 Recent randomized controlled trials examining reduction of risk for secondary prevention of stroke and or transient ischemic attack and for the elimination of migraine have underscored the message to restrain the temptation to intervene on a PFO; adversity appears to increase without accrued benefit from such an intervention Landzberg and Khairy, Can J Cardiol 2013 July;29(7)890-2

30 Conclusions There is likely still a subgroup of high risk patients who may benefit from PFO closure for stroke prevention. Further studies are needed. PFO closure may still be indicated for platypnea orthodeoxia The Amplatzer device appears to be superior to STARFlex for PFO closure.