Objectives: Evaluation of the immediate and long-term efficacy of a novel method of transvenous closure of the patent ductus arteriosus was the purpose of this study.
Background: In 1981 at the First Moscow Hospital, a new method of transvenous patent ductus arteriosus closure with the Botallooccluder was developed.
Methods: Transvenous closure of the patent ductus arteriosus with the Botallooccluder was carried out in 273 patients. All patients were regularly followed up as outpatients at intervals of 3, 6 and 12 months after intervention. A total of 171 patients were examined at a mean of 3.2 +/- 1.1 years (range 1 to 8) after the procedure. Late evaluation with cardiac catheterization was performed in 62 patients (36%); 50 (29%) of these 62 also underwent right heart catheterization.
Results: Successful implantation was achieved in 266 patients (97%). The late follow-up findings testify to the favorable clinical course, with disappearance of the continuous murmur and regression of the electrocardiographic signs of ventricular overloading in the vast majority of patients. In no case after complete patent ductus arteriosus closure was a late ductus recanalization observed. No patient had even a minor degree of postprocedural lower extremity venous damage. In 29 patients (24%), the femoral artery was imaged by ultrasonography at late follow-up, without evidence of any vascular abnormality.
Conclusions: The clinical data suggest high long-term efficacy and reliability of this technique. Introducer sheaths (12F to 16F outer diameter) did not cause any long-term entry site sequelae.