Background: At present, the exclusion for percutaneous pulmonary valve implantation for free pulmonary regurgitation after tetralogy of Fallot repair includes an unfavourably large right ventricular outflow tract. Objective: To report feasibility and early experience with a recently developed transcatheter heart valve, Venus P-valve TM , implanted in six patients with severe pulmonary regurgitation with large right ventricular outflow tracts. Patients: There were two female patients and four male patients. The median age of the patients was 18.5 years, and the mean body weight was 53.8 kg. All the patients were in NYHA class II and had severe pulmonary regurgitation after previous transannular patch repair of tetralogy of Fallot. The median time after the last surgical operation was 13.5 years. Results: The Venus P-valve TM was successfully implanted in all the patients with implanted valve diameters ranging from 24 to 32 mm. The mean fluoroscopy time was 29.8 minutes. None of the patients had significant outflow tract gradient or pulmonary regurgitation immediately after valve implantation. Only one patient had unexpected mild proximal valve migration to the right ventricular body during withdrawal of the delivery system. It caused mild paravalvar leak and significant tricuspid regurgitation. At 6 months follow-up, the median of right ventricular end-diastolic volume indices decreased from 146 to 108 ml/m 2 (p-value = 0.046). The Doppler systolic peak gradient across the valve ranged from 4 to 40 mmHg, and there was no evidence of stent fracture on fluoroscopy or structural valve failure. Conclusion: The Venus P-valve TM can be implanted successfully and effectively in patients with severe pulmonary regurgitation and a large right ventricular outflow tract. The early results with this valve are encouraging.
The Occlutech(®) Figulla(®) septal occluder (OFSO) is a later-generation double-disk device with few reports of its success rates and complications compared with the Amplatzer(®) septal occluder (ASO), which is the worldwide standard device in percutaneous atrial septal defect (ASD) closure. We recruited and compared the results in 149 patients (76.5 % female) who underwent ASD device closure in our center between January 2003 and June 2012. The patients ranged in age from 2.3 to 77.2 years. There were no statistically significant differences between the two groups regarding patient baseline characteristics and procedure variables. The success rate using either device was excellent (ASO 94.4 % and OFSO 97.4 %; p = 0.43). Although the diameter of the ASD and the pulmonary arterial pressure in the OFSO group were slightly higher than in the ASO group, the median fluoroscopic time in the OFSO group was significantly shorter (ASO 13.7 min; OFSO 9.0 min; p < 0.001). The overall median follow-up time was 3.6 years (interquartile range 2.1-9.0 years). There were no significant differences between the major and minor complications when comparing the two devices. Both devices were safe and effective for percutaneous ASD closures. The OFSO had the benefit of a shorter fluoroscopic time.
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