title: Feasibility of patent foramen ovale closure with no-device left behind: first-in-man percutaneous suture closure.
abstract: OBJECTIVE
  This study evaluated the feasibility of percutaneous patent foramen ovale (PFO) closure using a transcatheter suture (Superstitch), leaving no device behind.
  
  
  BACKGROUND
  PFO has been implicated in cryptogenic strokes and migraine with auras. Percutaneous PFO closure, being less invasive than surgical closure, is increasingly performed. There are, however, early and long-term risks including device embolization, fracture, thrombosis, or infection, erosions into the free atrial wall and aorta, arrhythmias, and death. Furthermore, device implantation may complicate future percutaneous access to the left atrium. Partially reabsorbable devices and tissue welding to close PFO have recently been introduced. The first-in-man transcatheter suture closure of a PFO in an 18-year-old female with chronic migraine with aura and a well documented stroke is described.
  
  
  METHODS
  The right femoral vein was cannulated under mild sedation and local anesthesia. Using intracardiac echocardiography imaging, bubble study demonstrated a right-to-left shunt through the PFO at rest. A Superstitch device was advanced across the PFO and sutures were delivered through the septum primum and secundum. The sutures were exteriorized and a knot was advanced to the right atrial septum and cut.
  
  
  RESULTS
  Bubble study confirmed successful PFO suture closure. Transesophageal and transthoracic echocardiograms with bubble studies at 1 and 2 months, respectively showed complete closure with no right-to-left shunt even during Valsalva maneuver. At 6 months, the patient remained free of symptoms or migraine episodes.
  
  
  CONCLUSIONS
  Percutaneous transcatheter suture closure of a PFO can be successfully achieved with no residual shunt and leaving no device behind. Technological refinements are required for wider scale use.
authors.affiliation: Department of Cardiac and Vascular Interventional Services, Lenox Hill Heart and Vascular Institute of New York, New York, USA. cruiz@lenoxhill.net
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Ruiz
authors.forename: Nicholas
authors.initials: N
authors.lastname: Kipshidze
authors.forename: Paul T L
authors.initials: PT
authors.lastname: Chiam
authors.forename: Irakli
authors.initials: I
authors.lastname: Gogorishvili
mesh_terms: D000293:Adolescent; D006328:Cardiac Catheterization; D006348:Cardiac Surgical Procedures / Q000295:instrumentation*; D002908:Chronic Disease; D017548:Echocardiography, Transesophageal; D004867:Equipment Design; D005260:Female; D005471:Fluoroscopy; D054092:Foramen Ovale, Patent / Q000150:complications / Q000473:pathology / Q000601:surgery*; D006801:Humans; D020325:Migraine with Aura / Q000209:etiology* / Q000601:surgery; D020521:Stroke / Q000209:etiology* / Q000601:surgery; D013528:Surgical Staplers; D013536:Suture Techniques / Q000295:instrumentation*; D016896:Treatment Outcome