Trombocitopenia severa inducida por un oclusor para DAP: reporte de caso en tecnovigilancia

Introducción: El ductus arterioso persistente (DAP) es una cardiopatía congénita de especial interés. La oclusión intervencionista es el tratamiento de elección, no obstante, el dispositivo médico "oclusor para DAP", usado en este procedimiento, puede dar lugar a la aparición de eventos adversos de rara frecuencia como hemorragia, trombocitopenia, entre otros. Reporte de caso: Se presenta un caso de una paciente pediátrica con trombocitopenia severa posterior a la intervención. Durante su hospitalización, la paciente mantuvo niveles bajos de plaquetas hasta que logra su recuperación y sale de alta sin una nueva manifestación hematológica. El caso fue reportado como sospecha de incidente adverso asociada al oclusor para DAP. Conclusión: Al realizarse el análisis causa-raíz, se concluye que el tamaño del oclusor para DAP podría ser la principal causa de la trombocitopenia. El presente caso es una muestra que los dispositivos médicos pueden causar eventos adversos severos, por lo que, es necesaria la implementación de tecnovigilancia, principalmente a los dispositivos médicos de alto riesgo.

Introduction: Patent ductus arteriosus (PDA) is a congenital heart condition of special interest. Interventional occlusion is the treatment of choice; however, a PDA occlude, used in this procedure, is a medical device that rarely could lead to adverse events such as hemorrhage, thrombocytopenia, etc. Case report: We present a case of a pediatric patient with severe thrombocytopenia after surgery. During her hospitalization, platelet levels remained lower and, finally, she was fully recovered without any hematological manifestation. The case was reported as a suspected adverse incident related to PDA occlude. Conclusion: After performing a cause-root analysis, we concluded that the size of the PDA occlude may be the main cause of thrombocytopenia. This case demonstrates that medical devices could lead to adverse events. Thus, it is important for clinicians to implement medical device surveillance, mainly for high-risk medical devices.

Development of an Occluder Device for Closure of Patent Ductus Arteriosus

BACKGROUND: Surgical correction of patent ductus arteriosus (PDA) is relatively safe and effective since it does not remain in the category of open-heart-surgery. Although the surgical practice for PDA is performed in almost all hospitals, they contain the problems of anxiety of patients, remained surgical wounds on patients' chests and complications of surgery and general anesthesia. Recently non-surgical methods for the obstruction of PDA have been developed and some of them including buttoned devices are used now. The success rates of these methods approach to 84%. But the problems of embolization, incomplete closure, hemolysis, stenosis of aorta and left pulmonary artery have been reported. We invented new PDA occluder , using stainless steel wire and polyurethane foam. Therefore we investigated the efficacy of occluding blood flow with the new PDA occluder in the vessels of experimental animals. METHOD: Using 304 stainless steel wire which is self-expandable stent, two star-shaped frames were made, each frame forming cone and facing the other's tip. And in the center of the frames polyurethane foam was inserted. 316L stainless steel wire was used to fix the elements described above and some portion of the wire was extracted outside of the frames, shaping hook or round loop with which the occluder could be pulled out in case of misplacement. To create the similar situation to PDA, we made shunts from artery to vein between carotid arteries and jugular veins with surgical bypass grafts or made shunts of direct artery to vein connections without grafts in 4 dogs and 1 pig. Through 8F sheath, we deployed the occluders into the shunts made of 5 grafts or made of 3 arterial ends. Also the occluders were inserted into the femoral artery of dog and iliac artery of pig. After deployment of occluders, angiograms were performed to obscure the efficacy of blocking blood flow and follow-up angiogrms were done in one and two weeks. The animals were sacrificed in one and two weeks to get the tissues including occluders inside. Gross findings were checked about thrombi formation in and around polyurethane foam. RESULTS: The 10 occluders were placed successfully except one site due to misplacement. The occluders successfully blocked the blood flows in all 10 sites within 3 - 60 minutes. Each follow-up angiogram for occluders in one and two weeks revealed good maintenance of blockade in blood flow. Observed gross findings on tissues were packed thrombi formation in the polyurethane foam and membrane formation along the occluder. CONCLUSIONS: This newly developed device revealed good efficacy for occlusion of blood flow including shunts in immediate and follow-up study. Practical method for the delivery of the device and some design modification for proper fitting into the PDA especially for small patients would be required. Longer period of follow-up with more animal experiments for other possible complications including distal embolization would be required also before clinical trial.

Transcatheter Closure of Patent Ductus Arteriosus with the Rashkind PDA Occluder System

PURPOSE: This study was perfomed to evaluate the success rate and complications of transcatheter closure of patent ductus arteriosus with the Rashkind PDA Occluder System (USCI). METHODS: Between February 1993 and January 1996, 24 patients (6 men and 18 women, median age 4 years, range 10 months to 51 years) were treated with the Rashkind PDA Occluder System for occlusion of patent ductus arteriosus at Dong-A University Hospital. The rate of presence of residual shunt and complications associated with the ductus occlusions in these patients were investigated. RESULTS: At pre-occlusion cardiac catheterization, mean Qp/Qs was 1.49+/-0.48 and mean pulmonary artery pressure was 18.1+/-4.93mmHg. The narrowest diameters of ductus ranged from 1.2mm to 6mm (mean 2.8+/-1.3mm). The most frequently encountered ductal shape was Krichenko type A (16 patients, 66.6%). Three patients required dilatation of ductus with 3mm balloon catheter to cross with 8Fr long sheath. Seventeen 12mm and seven 17mm devices were successfully placed in twenty-four patients. Mean pulse pressure was decreased from 45.5+/-7.11mmHg to 38.8+/-8.98mmHg (p<0.05). After occlusion, the continuous murmurs were disappeared from all but one. From the immediate (20 minute) postocclusion aortogram, 12 of 24 patients (50%) had evidence of residual left to right shunt through the ductus. Four of these 24 patients (17%) demonstrated residual shunt by echocardiogram which performed within 2 weeks after the procedure. Of 20 patients with 3 patients who had residual shunt at previous study, having returned for follow up echocardiogram at 6 months after occlusion, only one (5%) had residual shunt. There were no significant differences in incidence of residual shunt according to size of devices or ductal shape. In 2 patients, Doppler study revealed mild pressure gradient at origin of left pulmonary artery. CONCLUSIONS: In selective candidates, transcatheter closure of the patent ductus arteriosus using the Rashkind PDA Occluder System is a safe and effective method in the nonsurgical management of patent ductus arteriosus.

Transcatheter Closure of Patent Ductus Arteriosus with the Rashkind PDA Occluder System

PURPOSE: This study was perfomed to evaluate the success rate and complications of transcatheter closure of patent ductus arteriosus with the Rashkind PDA Occluder System (USCI). METHODS: Between February 1993 and January 1996, 24 patients (6 men and 18 women, median age 4 years, range 10 months to 51 years) were treated with the Rashkind PDA Occluder System for occlusion of patent ductus arteriosus at Dong-A University Hospital. The rate of presence of residual shunt and complications associated with the ductus occlusions in these patients were investigated. RESULTS: At pre-occlusion cardiac catheterization, mean Qp/Qs was 1.49+/-0.48 and mean pulmonary artery pressure was 18.1+/-4.93mmHg. The narrowest diameters of ductus ranged from 1.2mm to 6mm (mean 2.8+/-1.3mm). The most frequently encountered ductal shape was Krichenko type A (16 patients, 66.6%). Three patients required dilatation of ductus with 3mm balloon catheter to cross with 8Fr long sheath. Seventeen 12mm and seven 17mm devices were successfully placed in twenty-four patients. Mean pulse pressure was decreased from 45.5+/-7.11mmHg to 38.8+/-8.98mmHg (p<0.05). After occlusion, the continuous murmurs were disappeared from all but one. From the immediate (20 minute) postocclusion aortogram, 12 of 24 patients (50%) had evidence of residual left to right shunt through the ductus. Four of these 24 patients (17%) demonstrated residual shunt by echocardiogram which performed within 2 weeks after the procedure. Of 20 patients with 3 patients who had residual shunt at previous study, having returned for follow up echocardiogram at 6 months after occlusion, only one (5%) had residual shunt. There were no significant differences in incidence of residual shunt according to size of devices or ductal shape. In 2 patients, Doppler study revealed mild pressure gradient at origin of left pulmonary artery. CONCLUSIONS: In selective candidates, transcatheter closure of the patent ductus arteriosus using the Rashkind PDA Occluder System is a safe and effective method in the nonsurgical management of patent ductus arteriosus.