Fabien Praz, Andreas Wahl, Sophie Beney, Stephan Windecker, Heinrich P. Mattle*, Bernhard Meier

Transcription

1 Procedural Outcome after Percutaneous Closure of Patent Foramen Ovale using the Amplatzer PFO Occluder Without Intra-Procedural Echocardiography in 1,000 Patients Fabien Praz, Andreas Wahl, Sophie Beney, Stephan Windecker, Heinrich P. Mattle*, Bernhard Meier Cardiology and *Neurology, University Hospital Bern, Switzerland SW, HPM, BM: research grant and speaker bureau for AGA Medical

2 Background Percutaneous PFO closure is safe and feasible using various closure devices Clinical efficacy for secondary prevention of paradoxical embolism appears favorable compared to medical treatment PFO closure is generally performed using simultaneous fluoroscopic and TEE or ICE guidance TEE requires sedation or general anesthesia and intubation to avoid aspiration ICE is costly and adds risk (additional vascular access, rigid, unguided intravenous catheter) Both lengthen the procedure considerably, increasing the risk of clot formation in or on the catheters

3 Objectives To assess the safety, feasibility, and clinical efficacy of percutaneous PFO closure Using the Amplatzer PFO Occluder (APFO) Without intra-procedural echocardiography APFO APFO seen from RA (cadaver heart)

4 Amplatzer PFO Occluder AGA Medical Corp, Plymouth, Minnesota, USA Self-expanding double-disc device, fully recoverable before final release Nitinol wire with polyester fabric Commercially available in sizes mm Selected based on size and mobility of PFO and interatrial septum Can be implanted without intra-procedural echocardiography by relying on the Pacman sign

5 Methods 1,000 consecutive and unselected patients 844 presumed paradoxical embolism (94% cerebral, 6% other) 74 embolic event with concurrent etiology 53 diving 25 migraine 4 other (pulmonary embolism, planned neurosurgery, ) Local anesthesia and fluoroscopic guidance only No echocardiographic guidance TEE prior to intervention for initial diagnosis of PFO Acetylsalicylic acid 100 mg/d for 5-6 months and clopidogrel 75 mg/d for 1-6 months

6 Patient Demographics 1,000 consecutive unselected patients 11/98 07/08 Age (years) 52±13 (13-84) Male gender 60% Height (cm) 172±9 Weight (kg) 76±16 Left atrial size (mm) 36±10 Cardiovascular risk factors - Arterial hypertension 32% - Diabetes mellitus 5% - Smoking history 33% - Total cholesterol (mmol/l) 5.0±1.1

7 Atrial Septal Anatomy Indications for Closure 30% had more than 1 event

8 In-Hospital Outcome All implantation procedures successful 8 procedural complications (0.8%) - 6 (0.6%) arteriovenous fistulae at puncture site - 5 in patients with concomitant coronary angiography - elective surgical closure in 5-1 (0.1%) TIA with visual symptoms - 1 (0.1%) air embolism with transient symptoms - No deaths, no long-term sequelae - Similar complication rates in all subgroups

9 Total procedure time, including incidental coronary angiography in 790 patients: 43±22 min (median: 39 min) Total fluoroscopy time 8±7 min (median: 6 min) Patients undergoing solely PFO closure mean procedure time 16±9 min fluoroscopy time 5±5 min Procedural Data

10 Late Echocardiographic Outcome PFO mediated right-to-left shunt during contrast TEE Before PFO Closure n=1,000 6 Months after PFO Closure n=855 3% 19% 6% 3% 1% 78% Grade 0 Grade 1 Grade 2 Grade 3 90%

11 Predictors of Residual Shunt Presence of residual shunt at 6 months was independently predicted by Device size of more than 30mm (OR 5.5; 95%-CI: ; p<0.001) Baseline shunt grade 3 (OR 2.2, 95%-CI: ; p=0.048) Presence of an ASA (OR 1.7, 95%-CI: ; p=0.033)

12 A clinical follow-up could be obtained in 810/844 patients (96%) with cryptogenic stroke 2.5±1.9 years of follow-up (median: 2.2 years; total 2,059 patient-years): - 9 deaths (3 accident, 2 cancer, 2 ventricular fibrillation, 1 infection, 1 coma due to prolonged hypoglycemia) - 9 TIAs - 5 ischemic strokes Clinical Outcome During long-term follow-up, the risk of recurrent events after transcatheter treatment of PFO with or without associated ASA was <1% per year

13 Clinical Outcome II The presence of multiple clinical embolic events prior to PFO closure was a risk factor for recurrence (HR: 3.8; 95% CI: 1.6 to 8.7; p=0.001)

14 Conclusions APFO affords excellent safety and long-term clinical efficacy of percutaneous PFO closure without intra-procedural echocardiography High feasibility Low complication rate: 0.8% No long-term sequelae No further complications during long-term follow-up Residual shunt rate 10% depending on device size Low rate of recurrent events