Clinical Study Of Pipeline Embolization Device In The Treatment Of Complex Intracranial Aneurysms

Background and PurposeIntracranial aneurysms are common,and the prevalence rate is about 2%~7%.Once the aneurysm ruptures,the morbidity and mortality is high,and only about 1/3 of the patients have a good clinical outcome.The traditional treatment of intracranial aneurysms includes intravascular coil embolization and microsurgical clipping.Compared with surgical clipping,endovascular interventional therapy can reduce the probability of death or dependency,and improve the prognosis.It has become the first choice for some kind of intracranial aneurysms.For some kinds of complex intracranial aneurysms,such as wide neck,large or giant,fusiform,dissecting and blister aneurysms,the risk of rupture are higher.However,for the treatment of complex intracranial aneurysms,the traditional treatment is difficult to achieve a satisfactory effect.In recent years,the appearance of a new flow diversion(FD),represented by Pipeline Embolization Device(PED),has changed the situation of the low cure rate of complex intracranial aneurysms.The flow diversion device is innovated with the reconstruction of the parent artery,by reducing the volume and speed of the blood flow into the aneurysm sac,and accelerating the thrombus formation in the sac and the endothelialization at the neck of the aneurysm,to achieve the curative effect of the sac and the parent artery from relative isolation to absolute isolation.Most of studies abroad have confirmed the safety and effectiveness of the FD for the treatment of intracranial aneurysms.However,the application of FD in the treatment of intracranial aneurysms interiorly is still in its infancy,with less experience.The aim of this study is to evaluate the safety and efficacy of PED in the treatment of complex intracranial aneurysms in Chinese patients,and analyze the related influencing factors.MethodsRetrospective analysis the clinical and imaging data of patients with complex intracranial aneurysms treated with PED from January 2015 to October 2016,in the Intervention treatment Center of the Zhengzhou University People’s Hospital.All of the 53 patients(70 aneurysms)were implanted with PED at the parent artery through the femoral artery under general anesthesia,and followed up to March 2018.The data of patients and perioperative adverse events were recorded.Clinical follow-up was performed 3,6,12,24 months after the operation and the prognosis was evaluated by mRS score.The imaging follow-up were performed 6,12,24 months after operation,and the degree of aneurysm occlusion was assessed by OKM scale.Relevant statistical methods were used to analyze the related factors that affect the incidence of complications and the complete occlusion of aneurysms.Results1.53 patients(70 aneurysms)were treated with 58 PEDs,and the placement was technically successful in all patients.45 aneurysms(include multiple aneurysms with 1 parent artery)were treated with PED alone,and 25 aneurysms were treated with PED assisted coil embolization.1 aneurysms were overlapped with 2 PED,and the remaining 69 aneurysms were implanted with 1 PED.Severe complications occurred in 2 patients(3.8%,2/53).2.43patients(58 aneurysms)have imaging follow-up visit 3-19 months after operation,47aneurysms(81.0%,47/58)are complete and subtotal occlusion,with no aneurysm recurrence.47 patients have clinical follow-up visit 13-33 months after operation,the mRS score was 0-2 points in 46 patients(97.9%,46/47),and the curative effect was significant compared with the preoperative(P < 0.01).3.Severe complications that cause death and disability occurred in 2 patients(3.8%,2/53).Subarachnoid hemorrhage occurred in 1 cases on third days after operation,and acute cerebral infarction occurred in 1 cases 1 days after operation.4.Multivariate logistic regression analysis shows that whether the aneurysm is located on the convex part of the parent artery(P=0.008)is a factor affecting the complete occlusion of aneurysm,suggesting that the aneurysm located on the convex surface is more difficult to get complete occlusion.Multivariable logistic regression analysis shows that whether the aneurysm is located on the convex part of the parent artery(P=0.643),the location of the aneurysm(P=0.499),the type of aneurysm(P=0.261),aneurysm size(P=0.295)have no significant difference with the occurrence of complications.Conclusion1.The result shows that the treatment of complex intracranial aneurysms with PED is effective in mid-term follow-up,the rate of occlusion is high,and with no aneurysm recurrence.But serious complications remain to be noted.Further safety and efficacy assessed by long-term follow-up is still required.2.The result shows that the treatment of complex intracranial aneurysms with PED is safe,with low severe complications rate..3.The result shows that aneurysms located on the convex part of the parent artery may be one of the factors that affect the complete occlusion of aneurysms.It suggests that the preoperative imaging features may help to estimate the effect and guide the clinical operation.