One-wire technique for performance of balloon aortic valvuloplasty.

BACKGROUND: We present a new one-wire technique for balloon aortic valvuloplasty and discuss possible advantages of this technique over other techniques. METHODS: The records of 16 patients who underwent 18 procedures were reviewed. TECHNIQUE: A floppy-tipped, nitinol wire (Ultra-Select, Microvena Corp., White Bear Lake, MN) is placed across the aortic valve through a guide/measurement catheter positioned in the aortic root. The guide catheter is then removed, and the balloon catheter is positioned. Balloon dilation is then performed. RESULTS: Pre-dilation all patients had 0-1+ aortic insufficiency (AI). Four of 18 procedures resulted in an increase of >1 grade of AI, leaving 14 of 18 with < or =1 grade increase in AI. The mean gradient reduction achieved was 65%. FOLLOW-UP: Eighty-seven percent of the procedures have required no further intervention. CONCLUSION: The ease and simplicity of the procedure may reduce the risk of increasing AI, decrease fluoroscopy time, and arterial access time.

Five-year clinical and echocardiographic evaluation of the Das AngelWings atrial septal occluder.

BACKGROUND: The late outcome of patients treated with atrial septal occluder devices remains incompletely defined. The purpose of this study was to assess the late outcome (range 4-7 years postprocedure) of patients in whom the Das AngelWings septal occluder device was implanted in the atrial septum. We report the clinical and echocardiographic outcome, at an average of 5 years following the procedure, of patients treated with the Das AngelWings device used to close either a secundum atrial septal defect (ASD) or a patent foramen ovale (PFO). METHODS: Thirty-two patients underwent successful percutaneous closure of an atrial septal closure, patent foramen ovale, or fenestration in the lateral tunnel of their Fontan with the Das AngelWings device between June 1995 and March 1998 at Duke University Medical Center. Two of the 32 patients were lost to follow-up. The remaining 30 patients were divided into 3 groups based on indication for device implantation. Group 1 consisted of 14 patients with a secundum ASD and predominantly left-to-right atrial shunting. Group 2 consisted of 8 patients who had a PFO and who suffered a thromboembolic event. Group 3 (compassionate use) consisted of 10 patients with multiple comorbid medical problems with predominantly right-to-left shunting at the atrial level causing hypoxemia. Eight of the patients in group 3 were severely ill at the time of device implantation. The 2 remaining patients in group 3 underwent AngelWings implantation for closure of right-to-left shunting through a Fontan fenestration. Mean follow-up was 59 months. RESULTS: There was no device embolization. No patient in the ASD or PFO/stroke group had a clinical complication. By radiographic examination, 2 of 27 patients had evidence of fracture of the nitinol framework at 2-year follow-up. Residual shunting was present in 44% at 24 hours, 20% at 1 year, and 18.8% at 2 years by use of Doppler color flow imaging and/or microcavitation echocardiographic studies. Mild mitral regurgitation caused by the AngelWings device occurred in 1 patient. One patient in the compassionate use group had a subsequent neurologic event. Five of the 10 patients in the compassionate use group died of comorbid illnesses in follow-up, none directly related to device complications. CONCLUSION: The late clinical outcome of secundum ASD and PFO/stroke patients in this study demonstrates that Das AngelWings closure of the atrial septum is effective and safe. These data are encouraging with respect to the expanding use of other percutaneously implanted ASD occlusion devices, although late clinical safety and efficacy data are needed for the specific devices being implanted.

Cost implications of closure of atrial septal defect.

We sought to evaluate the relative cost of surgical and device closure of atrial septal defect. Device closure for atrial septal defects is becoming an alternative to surgical closure. We examined the hospital-generated cost data in 13 patients who underwent surgical repair and 15 patients who underwent device closure of an atrial septal defects (ASD) or patent foramen ovale (PFO) during a prospective clinical trial of the device. The cost of device closure of ASD was 7,837 dollars less on average than surgical closure when the cost of the occlusion device was excluded (device closure cost 7,397 dollars +/- 2,822 dollars, surgical closure cost 15,234 dollars +/- 3,851 dollars; P < 0.001). When adjusted for a 5% failure rate of device closure, the cost savings was 7,076 dollars. Device closure of ASD results in substantial hospital-related cost savings that will be an important consideration once new devices are approved for clinical use.