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CLINICAL RESEARCH: TREATMENT OF PATENT FORAMEN OVALE

Transcatheter treatment of atrial septal aneurysm associated with patent foramen ovale for prevention of recurrent paradoxical embolism in high-risk patients

Andreas Wahl, MD^*, Ulrike Krumsdorf, MD, Bernhard Meier, MD^*, Horst Sievert, MD, Stephan Ostermayer, MD^,*, Kai Billinger, MD, Markus Schwerzmann, MD^*, Ulf Becker, MD^*, Christian Seiler, MD^*, Marcel Arnold, MD, Heinrich P. Mattle, MD and Stephan Windecker, MD

^* Cardiology
Neurology, University Hospital, Bern, Switzerland
Cardiovascular Center, Frankfurt, Germany

Manuscript received June 28, 2004; accepted October 18, 2004.

^* Reprint requests and correspondence: Dr. Stephan Windecker, Director, Invasive Cardiology, Swiss Cardiovascular Center, Bern University Hospital, CH-3010, Bern, Switzerland (Email: stephan.windecker{at}insel.ch).

OBJECTIVES: This study sought to investigate the safety and efficacy of transcatheter treatment of atrial septal aneurysm (ASA) associated with patent foramen ovale (PFO).

BACKGROUND: Patients with both ASA and PFO are at high risk for recurrent paradoxical embolism.

METHODS: The procedural, echocardiographic, and clinical outcomes of 141 patients with ASA + PFO and 1 paradoxical embolic event undergoing transcatheter treatment were compared with 220 patients with PFO alone.

RESULTS: Device success (ASA + PFO, 99.3%; PFO alone, 99.5%; p = 0.75) and procedural complications (ASA + PFO, 0.7%; PFO alone, 3.2%; p = 0.12) were similar in both groups. Maximal atrial septal excursion in patients with ASA + PFO decreased from 16 ± 4 mm before to 4 ± 3 mm after the intervention (p < 0.0001). At 6 months follow-up, right-to-left shunt was abolished in 120 (86%) patients with ASA + PFO, compared to 187 (85%) patients with PFO alone (p = 0.80). Freedom from recurrent transient ischemic attack, stroke, and peripheral embolism at 4 years was 95% (ASA + PFO) and 94% (PFO alone, p = 0.70), respectively. A residual right-to-left shunt after the intervention was the only predictor for recurrence (hazard ratio [HR] 6.9; 95% confidence interval [CI] 1.3 to 36.9, p < 0.03) in patients with ASA + PFO.

CONCLUSIONS: Transcatheter treatment of ASA + PFO is safe and effective in patients with paradoxical embolism. The procedure effectively abolishes right-to-left shunt and decreases atrial septal mobility. Long-term prevention of recurrent events appears favorable when compared to patients with PFO alone.

Abbreviations and Acronyms   ASA = atrial septal aneurysm   CI = confidence interval   HR = hazard ratio   PFO = patent foramen ovale   TEE = transesophageal echocardiography   TIA = transient ischemic attack

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