The S. Giovanni Battista Molinette Hospital Experience with Patent Foramen Ovale Transcatheter Closure

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1 The S. Giovanni Battista Molinette Hospital Experience with Patent Foramen Ovale Transcatheter Closure Paolo Scacciatella, MD Fulvio Orzan, MD Dipartimento Cardiovascolare e Toracico Università degli Studi di Torino

2 PFO CLOSURE in CARDIOVASCULAR DEPARTMENT CITTA della SALUTE e della SCIENZA di TORINO Procedure/anno

3 RIGHT to LEFT SHUNT as a basis of a Clinical Event

4 CLINICAL EVENT = INDICATION Pathophysiology Desaturation Paradoxic Embolism Pathology Platypnea Orthodeoxya Sleep Apnea Stroke, TIA Peripheral Arterial Embolism Decompression Illness Migraine (with aura)

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6 CAUSE-EFFECT RELATIONSHIP First publication to mention the possible relationship of a cerebrovascular event with the presence of PFO was reported in 1877 by Julius Cohnheim, a German pathologist who reported a case of a young woman died of a stroke. He hypothesized that the clot passed through the PFO

7 Hagen PT, Scholz DG, Edwards WD Mayo Clin Proceed 1984; 59 (1): autopsy specimens 263 exibited patency 1-10 mm diameter The size tended to increase with increasing age % Incidence , ,3 25,4 20, overall 1st-3rd decade 4th-8th decade 9th-10th decade

8 Problem of cause-effect relationship Direct e.g. myocardial infarction Indirect PFO - Stroke Local Istantaneous Static Curative Remote Sequential Dynamic Preventive

9 Association by chance or cause-effect relationship? CRITERIA in FAVOR of a CAUSE-EFFECT RELATIONSHIP I. Strength and consistency of association II. Biologic plausibility III. Risk of recurrence IV.Biological gradient Bias and Causal Associations in Observational Research

10 Strength and consistency of association PFO and CRIPTOGENIC STROKE are HIGHLY CORRELATED Handke et al. N Engl J Med 2007; 357: 2262 % of pts ,9 p<0,001 28,3 % of pts p<0,001 15,2 13, ,3 < 55 y 11,9 > 55 y Cryptogenic Known cause < 55 y 4,4 > 55 y Cryptogenic Known cause PREVALENCE OF PFO PREVALENCE OF PFO + ASA

11 Biologic plausibility

12 Risk of recurrence

13 Biological gradient

14 SECONDARY PREVENTION TREATMENT

15 EVIDENCE BASED MEDICINE Single-center series Case-control studies Meta-Analysis 2 prospective randomized clinical endpoint trial (CLOSURE I, RESPECT) More prospective randomized clinical endpoint trials in progress (PC, REDUCE, )

16 % p=0,30 Clinical end point at 2 years p=0,77 p=0,39

17 1. Follow up interval too short 2. Devices issues 3. Selection bias (enrollement 2 pts/center/year) 4. Exclusion of DVT and thrombophilia

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20 PFO CLOSURE in CARDIOVASCULAR DEPARTMENT CITTA della SALUTE e della SCIENZA di TORINO The Dangerous PFO Probability of ASSOCIATION - RECURRENCY Young (conventional cut-off 55 y) Deep vein thrombosis Pulmonary Embolism Thrombophylic disorders Multiple Ischemic events Recurrency despite OMT Atrial septal aneurysm Prominent Eustachian valve Severe basal shunt Wide tunnel

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25 PFO CLOSURE in CARDIOVASCULAR DEPARTMENT CITTA della SALUTE e della SCIENZA di TORINO Treated 369 patients Clinical Indication 340 EMBOLIC EVENTS 29 MIGRAINE MR - Clinical presentation 334 BRAIN 6 PERIPHERAL 133 TIA 195 STROKE 5 MIGRAINE RM+ 1 ASYMPTOM ATIC RM Single Multiple Single Multiple

26 Age 50 ± 14 y M 45,2% Atrial septum Aneurysm 51,8% Coag. Disorders 19,5% DVT/PE 11,7% PFO CLOSURE in CARDIOVASCULAR DEPARTMENT CITTA della SALUTE e della SCIENZA di TORINO ,2 single TIA Clinical presentation % 334 pts 9,6 recidivant TIA 49,4 single Stroke 9 recidivant Stroke 1,8 Migraine RM +

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29 PFO CLOSURE in CARDIOVASCULAR DEPARTMENT CITTA della SALUTE e della SCIENZA di TORINO Procedural imaging Local anestesia 41,3 58,7 ANGIO ECO TE Local anestesia + Sedation Hypnosis PROCEDURAL SUCCESS 99,7%

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33 PFO CLOSURE in CARDIOVASCULAR DEPARTMENT CITTA della SALUTE e della SCIENZA di TORINO The KISS rule Device % Keep It Simple for Safe 17,1 82,8 Amplatzer Others One of the most predictable and easy-to-deploy device Ease-of-use translate to fewer mistakes, shorter procedures, and fewer complications

34 PFO CLOSURE in CARDIOVASCULAR DEPARTMENT CITTA della SALUTE e della SCIENZA di TORINO % 0,35 0,3 0,25 0,2 0,15 0,1 0,05 0 Procedural Adverse Event 0, ,3 0,3

35 Procedural Complication of Percutaneous PFO Closure Whorle J. Lancet 2006; 368: studies, 1970 patients % 1,6 1,4 1,2 1 0,8 0,6 0,4 0,2 0 Adverse event 0,3 0, ,1 1,5

36 FOLLOW UP 6 months 12 years mean 37 ± 31 months PFO CLOSURE in CARDIOVASCULAR DEPARTMENT CITTA della SALUTE e della SCIENZA di TORINO Death 2,4% Ischemic recurrence 2,1% MACE 0,9% Repeat Procedure 10% Cardiac TIA Thrombosis Interventional 0,6% 2,1% 0,3% 8,8% Non Cardiac Stroke Erosion Surgery 1,8% 0% 0,3% 1,2% Endocarditis 0,3% Embolization 0% Pericardial effusion 0%

37 PFO CLOSURE in CARDIOVASCULAR DEPARTMENT CITTA della SALUTE e della SCIENZA di TORINO cardiac death - recurrent ichemia MACE repeat procedure 92% 92,6% Survival probability (%) Time

38 100 PFO CLOSURE in CARDIOVASCULAR DEPARTMENT CITTA della SALUTE e della SCIENZA di TORINO Recurrent ischemia (stroke, TIA) ,3% Survival probability (%) Time

39 PFO CLOSURE in CARDIOVASCULAR DEPARTMENT CITTA della SALUTE e della SCIENZA di TORINO months RESIDUAL SHUNT REINTERVENTION 72% (success 41%) CARDIAC SURGERY 2,5% MEDICAL TREATMENT 25,5%

40 PFO CLOSURE in CARDIOVASCULAR DEPARTMENT CITTA della SALUTE e della SCIENZA di TORINO cardiac death - recurrent ichemia MACE repeat procedure p=ns 92,7% vs 94,7% (p=ns) Survival probability (%) residual shunt N Y Time

41 Transcatheter PFO Closure is safe and effective in prevention of recurrence in patients with cryptogenic stroke It requires specific skills and clinical competence Procedural complication are rare and must be avoided Wide clinical indication to closure are expected in the next years on the basis of RCT results

42 TCT Congress Lectures on PFO topics - 6 Lectures on RESPECT trial TCT Late breaking trials (tonight) RESPECT Trial - Event driven - 85% basal shunt - 36% atrial septum aneurysm - 8 y data collection and follow up - Results in favour to transcatheter closure are expected

43 Transcatheter PFO Treatment Program Head Interventional PFO Treatment Program Paolo Scacciatella Fulvio Orzan Head Stroke Unit Paolo Cerrato Catheterization LAB Mauro Pennone Pierluigi Omedè Filippo Sciuto Head ECHO LAB Mauro Giorgi Mara Morello Clinical Follow up Gaetana Ferraro Anna Laura Fanelli Matteo Marchetti Elisa Pelloni Luigi Biasco Data Base Managent and Statistical analysis Ilaria Meynet

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