The Clinical Research Of The New-type Ceramic Occluder To Treat The Secundum Atrial Septal

Purpose: Contrast and analyze the relevant clinical information of the New-type ceramic occluder and the ordinary NITIoccluder and the surgery to treat the secundum atrial septal; discuss the security, the validity and the superiority of New-type ceramic occluder to treat the secundum atrial septal.Method: Survey the patients of Heart Internal Medicine Transcatheter occluded ASD from January 2008 to December 2009. For the New-type ceramic occluder are 20 cases, for ordinary NITI occluder are 22 cases, meanwhile the patients are on operation in our heart surgery to treat secundum atrial septal are 18 cases. Collect their clinical information (sex, age, weight, the size of defect by TTE, the waist diameter of occluder), operation time, extracorporeal circulation, blood transfusion, the success rate of operation, the death rate, the complication date, the time in hospital, the Nickel concentration and so on. At the same time, contrast and analyze the group of the New-type ceramic occluder and the ordinary NI occluder and the surgery.Results:1.The New-type ceramic occluder group is 20 cases, 5 men and 15 women, the age is 3-59 years old, average age is 29.5士16.17 years old, the weight is 15-52kg, average weight is 36.52士18.15Kg, the size of the defect by TTE is 23.2士7.8mm. The operation time is about 35-80 minutes, average time is 46.62士18.34 minutes, the occluder waist diameter is 8-32mm, average diameter is 26.6士11.8mm.2. The ordinary NI occluder is 22 cases, 7 men and 15 women; the age is 4-50 years old, average age is 28.6士15.22 years old, the weight is 14-61kg, average weight is 34.74士16.36Kg, the size of defect is 22.2士6.9mm. Among these patients, double ASD (Atrial Septal defect) is 1 case, incorporate PS (Pulmonary stenosis) is 1 case. The operation time is about 30-86 minutes, average time is 47.3士20.79 minutes, the occluder waist diameter is 8-36mm, average diameter is 27.6士13.5mm, the time is in the hospital 3-8 days, average time is 4.8-2.6 days.3. The surgery group is 18 cases, 5men and 13 women, the age is 3-55 years old, average age is 24.36士18.23 years old, the weight is 12-65kg, the average weight is 38.92-18.03kg, the ASD diameter by TTE is 29.0士4.8mm, after operation the ASD diameter is 29.4士9.7mm. Among these patients, mixed type is 1 case, up oral cavity(口腔) is 1 case, down oral cavity is 1 case, middle one is 15 cases. The operation time is 99-201 minutes, average time is 124.32士23.86minutes, extracorporeal circulation time is 25-60 minutes, average time 40士15 minutes. The rate of blood transfusion is 125-600ml, average rate is 377-191ml. The time is in the hospital is 9-16 days, average time is 12.90士3.19 days.4. The New-type ceramic occluder group and the ordinary NI occluder group.①No obvious difference in clinical information, operation time, the success rate of operation, death rate, and the complication rate (P>0.05), ②No obvious difference on the blood concentration of Nickel before operation (P>0.05), the difference appears after operation(P<0.05)in one or three months, no difference six months later (P>0.05). When the blood Nickel rate is lower in biologic ceramic occluder than ordinary NI occluder, it is expressing highly significance that biologic ceramic occluder reduces the Nickel to be separated out. Comparing with the two groups, the difference appears after operation of the new ceramic occluder (P<0.05), no difference six months later after operation (P>0.05), it is hinting that one month later after operation, Nickel rate is up to the peak, gradually it begins to decrease, six months later after operation the blood Nickel rate is up to the level of preoperative; the ordinary NI occluder has the same changing, it is expressing that the Nickel is separated out after operation, but gradually low down one months later, six months later the blood Nickel rate decreases to the level of preoperative.5. The new ceramic occluder group and the surgery group.①In the contrary of the ordinary clinical treatment, it is significant that the difference of the defect size by TTE at preoperative (P<0.05), the defect size in the surgery group is greater than the new ceramic occluder group.②It has statistics significance in operation time, extracorporeal circulation, blood transfusion, and the time in hospital(P<0.05). It is expressing that the operation time is less in the new ceramic occluder group than in the surgery group; it is no blood transfusion and extracorporeal circulation, but half patients of the surgery group accept blood transfusion; the time in the hospital is obvious less in the new ceramic occluder group than the surgery group.Conclusion:1.It is more secure and valid to treat the secundum atrial septal by the new ceramic occluder, it is no obvious difference to the ordinary NI occluder. After operation, in the earlier period the rate of Nickel separated is decreased obviously.2.Compare for the surgery, the ceramic occluder has the advantages of little hurt, without extracorporeal circulation and blood transfusion, recover soon and little time in the hospital.