Comparison of Outcomes after Device Closure with Transseptal Puncture and Standard Technique in Patients with Patent Foramen Ovale and Ischemic Events.
OBJECTIVE
The purpose of this study was to compare the effectiveness of device closure with the transseptal puncture and standard technique in patients with patent foramen ovale (PFO) and ischemic events.


METHODS
Eighty-two consecutive patients (men: 60 patients, mean age: 45.2 years) who underwent PFO closure with the Amplatzer PFO Occluder were enrolled. PFO closure with the transseptal puncture was performed in 22 patients (transseptal puncture technique, group I). In the remaining patients (n = 60), PFO closure was performed with the standard technique (group II). The co-primary end points were the incidence of significant residual shunt on follow-up transesophageal echocardiography (TEE) and a composite of death, stroke, transient ischemic attack (TIA), and peripheral embolism.


RESULTS
Baseline characteristics were similar between the two groups. On TEE, despite similar grade of interatrial right-to-left shunt, shunt at rest/septal hypermobility was less common in group I than in group II (40.9% vs. 72.9%, P < 0.010). The device was successfully implanted in all patients. On follow-up TEE, significant residual shunt was more common in group I than in group II (28.6% vs. 4.3%, P = 0.021). In addition, composite of death, stroke, TIA, or peripheral embolism was more common in group I than in group II (13.6% vs. 0%, P = 0.017) during the follow-up period (mean 25.4 months).


CONCLUSIONS
Compared to the standard technique, PFO closure with the transseptal puncture technique showed higher incidence of residual shunt and ischemic events. Therefore, this technique might be considered in only highly selected patients as the last option.
Cardiology Division, Department of Internal Medicine, Gachon Cardiovascular Research Institute, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Jeonggeun
J
Moon
Cardiology Division, Department of Internal Medicine, Gachon Cardiovascular Research Institute, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Woong Chol
WC
Kang
Cardiology Division, Department of Internal Medicine, Gachon Cardiovascular Research Institute, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Sihoon
S
Kim
Cardiology Division, Department of Internal Medicine, Gachon Cardiovascular Research Institute, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Myeong Gun
MG
Kim
Cardiology Division, Department of Internal Medicine, Gachon Cardiovascular Research Institute, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Pyung Chun
PC
Oh
Cardiology Division, Department of Internal Medicine, Gachon Cardiovascular Research Institute, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Yae Min
YM
Park
Cardiology Division, Department of Internal Medicine, Gachon Cardiovascular Research Institute, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Wook-Jin
WJ
Chung
Department of Pediatrics, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Deok Young
DY
Choi
Department of Anesthesiology, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Ji Yeon
JY
Lee
Department of Neurology, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Yeong-Bae
YB
Lee
Department of Radiology, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Hee Young
HY
Hwang
Department of Anesthesiology, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Taehoon
T
Ahn
D000328:Adult; D002545:Brain Ischemia / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D006328:Cardiac Catheterization / Q000379:methods; D017548:Echocardiography, Transesophageal / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000175:diagnosis / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care / Q000706:statistics & numerical data; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods / Q000706:statistics & numerical data; D056910:Republic of Korea / Q000453:epidemiology; D055989:Septal Occluder Device / Q000009:adverse effects*