Intravascular ultrasound-guided direct intrahepatic portacaval shunt: description of technique and technical refinements

PURPOSE: This is a prospective study designed to demonstrate the safety and feasibility of creating a direct inferior vena cava (IVC)-to-portal vein shunt with use of a new type of intravascular ultrasound (IVUS) to guide the puncture and completing the shunt with the use of a polytetrafluoroethylene (PTFE)-covered stent graft. MATERIALS AND METHODS: IVC-to-portal vein shunts were created in 31 sequential patients for ascites (n = 31) or bleeding (n = 8). Transfemorally placed IVUS transducers were positioned in the IVC to guide the puncture from the IVC to the portal vein, which was performed from a transjugular approach with a modified Rosch-Uchida liver access set. A 9-MHz axial imaging IVUS system was used for the first 11 patients, and a variable 5-10-MHz sagittal IVUS imaging system was used for the next 20 patients. The shunts were completed with the use of single (n = 11) or overlapping (n = 20) PTFE-covered Palmaz stent-grafts, deployed primarily at a diameter of 8 mm. Patients were followed clinically and with US, venography, and inspection at liver transplantation to establish 30-day patency rates. RESULTS: All direct intrahepatic portacaval shunts (DIPSs) were created successfully. Both IVUS systems were able to adequately guide the portal vein puncture. Resolution and operator confidence were subjectively superior with the sagittal IVUS imaging system compared to the axial IVUS system. Two extrahepatic portal vein punctures occurred during the procedures. Both were controlled by the placement of sheaths and subsequent placement of stent-grafts. Both patients remained asymptomatic, although one required transfusion of blood products. The mean portosystemic gradient was reduced from 24 mm Hg before DIPS creation to 10 mm after DIPS creation. Embolization of varices was also performed in eight patients with history of recent gastrointestinal bleeding. Two patients died in the first week of acute liver failure. Two patients with hepatocellular carcinoma refused further follow-up. Of the 27 remaining patients, patency was demonstrated in all DIPS at 30 days by US, venography, or direct inspection at liver transplantation. CONCLUSIONS: IVUS-guided direct IVC-to-portal vein shunts may be created successfully with minimal complications. The use of a stent-graft is recommended for this procedure. Modifications of current technique and IVUS systems are described.     

Intravascular US-guided direct intrahepatic portacaval shunt with a PTFE-covered stent-graft: feasibility study in swine and initial clinical results

PURPOSE: To determine the feasibility of the creation of a direct intrahepatic inferior vena cava (IVC)-to-portal-vein shunt with puncture guided by a transfemorally placed intravascular ultrasound (IVUS) probe and use of a polytetrafluoroethylene (PTFE)-covered stent-graft. MATERIALS AND METHODS: In five swine, transjugular access was used to perform a direct puncture from the IVC to the portal vein with use of a modified Rosch-Uchida Portal Access set directed with real-time IVUS (9 MHz) introduced from a transfemoral venous approach. The direct intrahepatic portocaval shunt (DIPS) was then created with single or overlapping PTFE-covered Palmaz stents placed through a 10-F sheath and dilated to a diameter of 8 mm. Follow-up was performed with transhepatic portography at 2, 4, and 8 weeks. Animals were killed when shunts occluded or at the termination of the study at 8 weeks. Gross and microscopic histologic study was performed on sacrificed animals. A similar technique was used to create DIPS in five patients with intractable ascites, with follow-up by US and venography. RESULTS: All experimental DIPS created in swine were created without complications. Portal vein punctures were achieved in four of five swine on the first or second pass of the needle. Follow-up transhepatic portography at 2 weeks demonstrated occlusion of two shunts, both explained by technical reasons at sacrifice. At 4 and 8 weeks, the remaining three shunts were patent on portography. Histology showed a thin neointimal lining with no significant tissue ingrowth or hyperplasia. Clinically, in five patients, successful puncture of the portal vein from the IVC was achieved in one to three passes. Creation of DIPS led to a reduction of mean portosystemic gradient from 18-29 mm Hg (mean, 24 mm Hg) to 9-10 mm Hg (mean, 9 mm Hg). One patient died of liver failure 2 days after creation of DIPS. The other four patients were doing well 2-15 months (mean, 8 months) after the procedure, with patency confirmed by US and venography. CONCLUSION: Creation of DIPS is technically feasible, and the direct IVC-to-portal-vein puncture can be done accurately with real-time IVUS guidance. Further studies and longer follow-up are necessary to determine if the short length of the PTFE-covered stent-graft and avoidance of the hepatic vein will increase the long-term patency compared to standard transjugular intrahepatic portosystemic shunt creation.     

Transjugular intrahepatic portosystemic shunt creation with the Viatorr expanded polytetrafluoroethylene-covered stent-graft

PURPOSE: To evaluate the midterm clinical results and patency of transjugular portosystemic shunts (TIPS) created with a commercially available expanded polytetrafluoroethylene (ePTFE)-covered stent-graft based on angiographic and ultrasonographic (US) criteria in a series of 71 patients. MATERIALS AND METHODS: Seventy-one patients (61 men, 10 women; mean age, 58.6 years, range, 25-78 years) were included in this series, which was performed in two centers. Indications for TIPS creation were refractory ascites (n = 44) and recurrent esophageal bleeding (n = 27). Ten patients had Child-Pugh class A liver cirrhosis, 43 had class B disease, and 18 had class C disease. Underlying liver diseases were alcoholic cirrhosis (n = 58), cirrhosis resulting from hepatitis (n = 9), cryptogenic cirrhosis (n = 3), and Budd-Chiari syndrome (n = 1). TIPS were created with commercially available ePTFE-covered stent-grafts in all patients. The diameters of the stent-grafts were 10 mm in 58 patients and 8 mm in the remaining 13 patients. Follow-up included clinical examination and color-coded US after 5 days, 1, 3, and 6 months, and every 6 months thereafter. Shunt angiograms were obtained every 6 months. Median follow-up was 16.3 months (range, 3.8-26.6 months). RESULTS: TIPS creation was successful in all patients without complications, and effective portal decompression was observed with a reduction of the mean portal gradient from 19 mm Hg to 6 mm Hg before and after TIPS creation. Four shunt occlusions were observed after 5 days, 2 months, 3 months, and 6 months. Shunt stenosis was observed in three patients at the hepatic vein, which was not fully covered by the stent-graft, after 6 months (n = 2) and 12 months, and at the portal side after 1 month in a patient who initially had portal vein thrombosis. The repeat intervention rate was 11.3%. The primary patency rates were 87.4% (95% CI, 77.7%-97.1%) after 6 months and 80.8% (95% CI, 68.2%-93.4%) after 12 months. The rate of de novo or deteriorated hepatic encephalopathy was 31%. The recurrent bleeding rate was 3.7% (one of 27), and ascites improved or resolved in 64% of patients after 1 month. CONCLUSION: TIPS patency can be significantly increased if the ePTFE-covered stent-graft is used for shunt creation. The increased shunt patency contributes to low repeat intervention and recurrent bleeding rates. The rate of hepatic encephalopathy is within the range of previously reported rates.     

Improved patency of transjugular intrahepatic portosystemic shunts in humans: creation and revision with PTFE stent-grafts

PURPOSE: To determine whether polytetrafluoroethylene (PTFE) stent-grafts yield longer patency for creation or revision of transjugular intrahepatic portosystemic shunts (TIPS). MATERIALS AND METHODS: Fourteen PTFE-covered Wallstents were placed in 13 patients with TIPS: seven at shunt creation and seven during revision of TIPS with one to five prior thromboses at 1 day to 1 year after initial TIPS formation. In six cases, prior to stent-graft placement persistent biliary-TIPS fistulas were demonstrated despite repeated shunt revisions with additional metallic stents. RESULTS: All but one graft-lined TIPS were widely patent at a mean duration of venographic follow-up of 19 months (median, 17 months; range, 5-32 months). The limiting percentage of stenosis within the grafted shunts was 0%-10%. One patient developed stent-graft thrombosis; the prior biliary-TIPS fistula was seen despite the graft. A second, parallel PTFE-lined transcaval shunt was created in this patient; it was widely patent at 11-month follow-up. In two asymptomatic patients, stenoses developed in the short, nongrafted portions of the outflow hepatic veins. CONCLUSION: PTFE stent-grafts can markedly prolong TIPS patency, potentially reducing the need for shunt follow-up and revision and the risk of recurrent symptoms associated with shunt stenosis or occlusion.     

Creation of transjugular intrahepatic portosystemic shunts with stent-grafts: initial experiences with a polytetrafluoroethylene-covered nitinol endoprosthesis.

PURPOSE: To evaluate the safety and performance of a recently developed expanded polytetrafluoroethylene (ePTFE)-covered nitinol stent-graft to create transjugular intrahepatic portosystemic shunt (TIPS) in patients with portal hypertension and related complications. MATERIALS AND METHODS: The ePTFE-covered nitinol stent-graft was used to create TIPS in 16 patients with recurrent variceal bleeding (n = 13) or refractory ascites (n = 3). Follow-up was performed with duplex ultrasonography, clinical assessment, and venography at 6 months. Technical success and portosystemic pressure gradients (PPGs) before and after stent-graft implantation and at follow-up were assessed. Two patients died during follow-up. Histopathologic follow-up data were available for one patient at autopsy and for the other after liver transplantation. RESULTS: The implantation technical success rate was 100%. Mean (+/- SD) PPG was reduced from 24 mm Hg +/- 5 to 9 mm Hg +/- 2. Histopathologic analysis of the explanted endoprostheses revealed no inflammatory response or neointima formation. The venographic follow-up data available for 10 patients demonstrated 100% in-graft patency (mean follow-up, 289 days +/- 26). Revisions with implantation of a new ePTFE-covered nitinol stent-graft or another commercially available stent in 10 patients were necessary because of hepatic vein stenosis above the grafted portion and/or relative diameter mismatch causing TIPS dysfunction. CONCLUSION: The ePTFE-covered nitinol stent-graft was used successfully to create TIPS and has the potential to prolong TIPS patency upon complete coverage to the hepatocaval junction.     

Experimental Percutaneous Extrahepatic Portacaval Shunt Creation by Transjugular Approach in Swine

The purpose of the study was to evaluate the feasibility of the creation of a percutaneous extrahepatic portacaval shunt (PEPS) in swine by a transjugular approach and to find a suitable stent-graft to use in PEPS. In 12 swine, the extrahepatic portal vein (PV) was entered from the inferior vena cava (IVC) by a needle system introduced from the transjugular approach. A catheter introduced through the transhepatic approach served as a target. Five types of stent-graft consisting of homemade Z stents and a polytetrafluoethylene cover were explored for PEPS creation. Eight animals had follow-up venograms up to 6 weeks or until the shunt became severely stenotic. Gross and histologic examinations were performed after the final follow-up venography. The PV punctures and stent-graft placement were difficult, but the PEPS was established in all animals. In four animals, the stent-graft failed to adequately cover the tract, causing severe hemorrhage. Only two shunts remained patent up to 6 weeks. The other shunts exhibited severe stenosis or occlusion. At gross examination, all shunts traversed the liver parenchyma of the caudate lobe surrounding the IVC. The extravascular PEPS portion was 4 mm to 2 cm long. All shunts entered the PV close to the splenomesenteric junction and exhibited neointimal formation. Shunt stenoses were caused by neointimal hyperplasia and occlusions by a superimposed thrombus. PEPS can be created by the transjugular approach in swine, but only the PV shunt entrance is extrahepatic. None of the tested rigid stent-grafts were suitable for PEPS creation. A short flexible stent-graft with flanged ends is suggested for further exploration.     

覆膜支架在经颈静脉门腔分流术中的应用

目的 评价经颈静脉肝内门腔分流术(TIPS)专用覆膜支架(Viatorr支架)在TIPS中的应用价值.方法 回顾性分析37例在美国俄勒冈州健康生命科技大学Dotter介入放射学研究所采用Viatorr支架行TIPS治疗的患者资料,随访时间为(15.2±9.3)个月(3-42个月).TIPS指征包括门静脉高压相关性的急慢性消化道出血,经药物及内镜治疗无效者17例;顽固性肝源性胸、腹水18例,Budd-Chiari综合征2例.采用配对t检验比较手术前后门腔静脉压力差(PSG)的变化,以Kaplan-Meier曲线分析支架开通率.结果 37例共置入41枚Viatorr支架,其中3枚直径为8 mm,38枚为10 mm,支架带膜长度为4～8 cm,无相关手术并发症.PSG由术前的(22.4±8.4)mm Hg(1 mm Hg=0.133 kPa)降为(8.1±3.2)mm Hg,差异有统计学意义(t=12.754,P<0.01).17例出血患者术后出血均停止,1例于术后17个月复发.18例严重顽固性腹水及肝性胸水患者中,4例术后腹水不消退,其余14例随访期间有2例腹水复发.2例(5.4%)发生分流道阻塞,Kaplan-Meier曲线分析结果显示1年的开通率为97.0%.术后1个月内无病死患者,2例分别于术后3个月及15个月死于多器官功能衰竭,晚期病死率为5.4%,死亡前1周内复查支架均通畅.肝移植患者5例(13.5%).结论 Viatorr支架能明显提高TIPS术后开通率,选择合适的支架,采用正确的释放技术能进一步提高疗效,但长期效果评价尚需验证.     

TIPS中8mm直径覆膜支架直用的临床研究

目的评价在TIPS中应用8mm直径覆膜支架的临床效果。方法对19例伴有食管胃底静脉曲张破裂出血和(或)难治性腹水的门脉高压症患者行TIPS术,术中应用8mm直径的覆膜支架,术后观察临床症状改善程度,并进行定期影像学和实验室检查,以评价疗效。结果所有患者均成功完成TIPS术,技术成功率100%,术中未出现并发症。术后平均随访13.5个月(2.7～28个月),1例(1/19,5.3%)原有肝性脑病加重;2例(10.5%)再次出血;腹水改善及治愈率为66.7%(12/18);16例患者进行了6个月的随访,初次开通率100%,8例患者随访12个月,初次开通率87.5%。结论在TIPS术中应用8mm直径覆膜支架在保证有效分流量,提高术后分流道开通率的同时,可以降低肝性脑病的发生率。     

Preliminary results of a new expanded-polytetrafluoroethylene-covered stent-graft for transjugular intrahepatic portosystemic shunt procedures.

OBJECTIVE: The purpose of our study was to evaluate the feasibility and the safety of transjugular intrahepatic portosystemic shunts (TIPS) with a new expanded-polytetrafluoroethylene-covered stent and the influence of the covering on occlusion rate. SUBJECTS AND METHODS: Twenty cirrhotic patients (57 +/- 11 years old) admitted with a history of esophageal variceal bleeding (n = 11), refractory ascites (n = 5), or both (n = 4) were included. Five of the patients were treated for TIPS revision, and 15 as de novo TIPS placements. The endoprostheses used were composed of a 2-cm noncovered nitinol stent and a 4- to 8-cm expanded-polytetrafluoroethylene graft covering, and were placed from the portal vein to the ostium of the hepatic vein. Patients underwent Doppler sonography at discharge and again at 1, 3, 6, 9, 12, and 15 months and underwent venography with portosystemic pressure gradient measurement at 6 months and whenever necessary. RESULTS: At the time of this writing, complications included three TIPS restenoses and one recurrent ascites successfully treated by balloon dilation, two cases of segmentary liver ischemia, and one patient with encephalopathy that required shunt reduction. After TIPS placement, the portosystemic pressure gradient dropped from 18 +/- 5 to 5 +/- 4 mm Hg. Primary and secondary patency rates were 80% and 100%, respectively, at 387 days. CONCLUSION: These results clearly show the feasibility of TIPS placement with the Gore TIPS endoprosthesis stent-graft and its improved patency compared with results in the literature for bare stents. These preliminary results must be certified further with randomized comparative trials between covered and noncovered TIPS stents.     

Results of a retrospective multicenter trial of the Viatorr expanded polytetrafluoroethylene-covered stent-graft for transjugular intrahepatic portosystemic shunt creation

PURPOSE: To report the results of a multicenter experience with the Viatorr expanded polytetrafluoroethylene-covered stent-graft for transjugular intrahepatic portosystemic shunt (TIPS) creation in which patency and clinical outcome were evaluated. MATERIALS AND METHODS: One hundred consecutive patients with portal hypertension, with a mean age of 52 years (range, 22-86 years), underwent implantation of the Viatorr TIPS stent-graft at one of three hospital centers. The indications for TIPS creation were variceal bleeding (n = 81) and refractory ascites (n = 19). Twenty patients had Child-Pugh class A disease, 46 had class B disease, and 34 had class C disease. Eighty-seven patients underwent de novo TIPS placements, with 13 treated for recurrent TIPS stenosis. Sixty-two patients were available for follow-up portal venography and portosystemic pressure gradient (PSG) measurement commencing 6 months after Viatorr stent-graft placement. RESULTS: The technical success rate was 100%. TIPS creation resulted in an immediate decrease in mean PSG (+/-SD) from 21 mm Hg +/- 6 to 7 mm Hg +/- 3. Acute repeat intervention (within 30 days) was required for portal vein thrombosis (n = 1), continued bleeding (n = 3), and encephalopathy (n = 1). The all-cause 30-day mortality rate was 12%. Two patients developed acute severe refractory encephalopathy, which led to death in one case. New or worsening encephalopathy was identified in 14% of patients. The incidence of recurrent bleeding was 8%. The cumulative survival rate at 1 year was 65%. Sixty-two patients available for venographic follow-up had a mean PSG of 9 mm Hg +/- 5 at a mean interval of 343 days (range, 56-967 days). There were four stent-graft occlusions (6%) and seven hemodynamically significant stenoses (11%), four within the stent-graft and three in the non-stent-implanted hepatic vein. The primary patency rate at 1 year by Kaplan-Meier analysis was 84%. CONCLUSIONS: This retrospective multicenter experience with the Viatorr stent-graft confirms the preliminary findings of other investigators of good technical results and improved patency compared with bare stents. Early mortality and symptomatic recurrence rates are low by historical standards. The theoretical increase in TIPS-related encephalopathy was not demonstrated. Longer-term follow-up will be required to determine whether the additional cost of the Viatorr stent-graft will be offset by reduced surveillance and repeat intervention.     

Aneurysms of Hemodialysis Access Grafts: Treatment with Covered Stents: A Report of Three Cases

Three patients with dialysis access graft shunts, having a symptomatic pseudoaneurysm and a hemodynamically significant stenosis at the anastomosis between the graft shunt and the subclavian vein, were treated with percutaneous transluminal angioplasty and insertion of a Wallstent. Pseudoaneurysms were excluded by percutaneous insertion of a Cragg Endo-Pro stent-graft with a diameter of 6 mm and a length of 6–10 cm. All three aneurysms were excluded successfully. In two patients, the stent-graft was punctured repeatedly during follow-up and the aneurysms recurred after 7 and 8 months, respectively. The patency of the dialysis shunt after stent-graft insertion was 8 (n= 1) and 9 months (n= 2). Due to the recurrence of the aneurysm (n= 2) or recurrent thrombosis (n= 1) the use of these shunts was discontinued.     

Dacron-covered stent-grafts in transjugular intrahepatic portosystemic shunts: initial experience

PURPOSE: To retrospectively review the authors' experience with use of a Dacron-covered stent-graft in transjugular intrahepatic postosystemic shunts (TIPS). MATERIALS AND METHODS: The need for internal review board approval was waived. Informed consent was obtained from all patients. The study was compliant with the Health Insurance Portability and Accountability Act. A retrospective analysis was performed of 16 patients who received a Dacron-covered stent-graft during revision or de novo creation of TIPS. There were 13 men and three women aged 44-80 years (mean age, 61 years). Primary unassisted and assisted patency rates and secondary patency rates were estimated. The primary unassisted patency of patients who underwent de novo placement of stent-grafts (n = 10) was compared with that of patients with stent-grafts placed during shunt revision (n = 6); in all patients, stent-grafts were placed within stents. Primary unassisted patency was also compared between patients in whom the covered stent was confined to the parenchymal tract (n = 7) and those in whom the stent extended 1 cm or more into the portal vein (n = 9). Patency was estimated with the Kaplan-Meier method, and group comparisons were performed with the log-rank test. RESULTS: Primary unassisted patency rates following stent-graft placement at 4, 12, and 24 months (+/- standard error) were 64% +/- 14, 54% +/- 15, and 40% +/- 16, respectively. The rates for primary assisted patency were 78% +/- 12, 67% +/- 14, and 67% +/- 14 and those for secondary patency were 91% +/- 9, 81% +/- 12, and 54% +/- 23. At 12 months, primary unassisted patency with de novo stent-graft placement was 90% +/- 9, whereas that with stent-grafts placed during TIPS revision was 17% +/- 15 (P = .005). At 12 months, the primary unassisted patency in patients with stent-grafts confined to the parenchymal tract was 75% +/- 22, and that of patients with stent-grafts extending at least 1 cm into the portal vein was 40% +/- 17 (P = .21). CONCLUSION: In this small series, satisfactory long-term patency was observed among patients in whom Dacron-covered stent-grafts were placed during revision or de novo creation of TIPS. More favorable outcomes were observed when the stent-graft was placed during de novo TIPS creation and when the device was confined to the parenchymal tract.     

内皮祖细胞种植支架在经颈静脉肝内门体分流术中应用的实验研究

目的 评价内皮祖细胞(EPC)种植支架在经颈静脉肝内门腔分流(TIPS)家猪动物模型中减少分流道再狭窄的疗效.方法 体外分离、培养、鉴定家猪外周血内皮祖细胞,并构建内皮祖细胞种植支架.15头家猪行TIPS介入手术,采用随机区组设计分为EPC种植支架组9头(实验组),裸支架组6头(对照组).术后14 d行直接门静脉造影,然后处死动物,作病理分析及免疫组织化学检查,记录分流道狭窄及阻塞率,并用图像处理软件计算TIPS分流道假性内膜厚度及面积.计数资料用Fisher精确概率法,计量资料行t检验,作统计学分析.结果 15头猪TIPS手术均成功.实验组分流道通畅5头,狭窄2头(狭窄率50%、70%),阻塞2头(共9头).对照组狭窄1头(狭窄率80%),阻塞5头(共6头).2组通畅率差异有统计学意义(P=0.03).实验组假性内膜增生的厚度(肝静脉、肝实质、门静脉段)显著小于对照组[分别为(1.0 ±0.6)、(0.9±0.5)、(1.0±0.4)mm和(1.2±0.4)、(1.3±0.5)、(1.5±0.4)mm,P值均＜0.05].免疫组织化学显示实验组中通畅的分流道有完整的内皮形成;再狭窄分流道的假性内膜主要由胶原纤维组成,而通畅分流道的假性内膜主要由细胞成分组成.结论 体外构建EPC种植支架是可行的,置入后促进了家猪模型TIPS分流道内皮化形成,可以提高分流道的通畅性.     

Stent-grafts for de novo TIPS: technique and early results

PURPOSE: To evaluate the potential benefits of placing a polytetrafluoroethylene (PTFE)-covered stent-graft during initial creation of a transjugular intrahepatic portosystemic shunt (TIPS) in clinical practice. MATERIALS AND METHODS: De novo TIPS were created with a PTFE stent-graft in four male and four female patients with symptomatic portal hypertension awaiting liver transplant. Their ages ranged from 35 to 62 (mean, 47) years. Patients were followed with TIPS ultrasound (US) and/or venography until liver transplantation or death; one remains under active study. Six recovered specimens underwent gross and microscopic evaluation. RESULTS: All TIPS placements were successful. Six shunts were primarily patent, with a mean patency of 289 days, through completion of the study. Five were found to be patent at transplant and one was found to be patent at autopsy. Explant evaluation revealed a smooth, thin layer of neointima and exclusion of biliary secretions. Three patients developed a total of four stenoses (one tandem lesion) during follow-up, leading to revision in two patients. Mean primary and total patency in these patients was achieved after 279 and 463 days, respectively. A previously occult moderate stenosis was detected after explant in another patient. Only one (nonsignificant) stenosis clearly developed in an area covered by PTFE. CONCLUSION: Placement of a de novo PTFE stent-graft during TIPS creation is feasible and may extend primary shunt patency. Appropriate positioning of the stent-graft is critical.     

TIPS with expanded polytetrafluoroethylene-covered stent: results of an Italian multicenter study

OBJECTIVE: Our objective is to describe the results of a multicenter prospective trial on the safety and efficacy of transjugular intrahepatic portosystemic shunts (TIPS) using the Viatorr stent-graft. SUBJECTS AND METHODS: From 2001 to 2003, 114 patients (75 men and 39 women; mean age, 59.3 years) with portal hypertension underwent TIPS with the Viatorr stent-graft. Indications for treatment were variceal bleeding (n = 49, 43.0%), refractory ascites (n = 52, 45.6%), hypertensive gastropathy (n = 10, 8.8%), Budd-Chiari syndrome (n = 1, 0.9%), and hepatorenal syndrome (n = 2, 1.7%). Eight patients (7.0%) had Child-Pugh class A cirrhosis; 60 (52.6%), Child-Pugh class B; and 46 (40.4%), Child-Pugh class C. Patients were monitored by color Doppler sonography and phlebography. RESULTS: The procedure was successful in 113 (99.1%) of 114 patients; in one patient, creation of the track was not feasible. The mean portosystemic pressure gradient decreased from 21.8 to 8.7 mm Hg. Three minor immediate complications (2.6%) occurred (two cases of self-limiting hemoperitoneum and one extrahepatic portal puncture requiring covered stenting). At a mean follow-up of 11.9 months, the overall mortality rate was 31.0% (35/113), with a 30-day mortality rate of 8.8% (10/113). Mortality was significantly higher in patients in Child-Pugh class C with refractory ascites and with post-procedural encephalopathy. Cumulative primary patency rates were 91.9%, 79.9%, and 75.9% at 6, 12, and 24 months' follow-up, respectively. Restenosis occurred in 15 patients (13.3%) within the stent (n = 8, 53.3%) or at the ends of the portal (n = 1, 6.7%) or hepatic (n = 6, 40%) veins and was solved by percutaneous transluminal angioplasty (n = 11), stenting (n = 3), or parallel TIPS (n = 1). The secondary patency rate was 98.2%. Post-procedural encephalopathy occurred in 27 patients (23.9%). CONCLUSION: The Viatorr stent-graft is safe and effective in TIPS creation, with high primary patency rates. Covering the entire track up to the inferior vena cava can increase patency.     

观察改良TIPS在治疗门静脉高压消化道出血中的应用

目的观察改良TIPS在胃食管出血应用中的技术可行性及临床效果。 方法收集接受改良TIPS治疗的肝硬化门静脉消化道出血的患者56例。操作技术改良是在线阵血管探头引导下穿刺右颈内静脉,引入导丝并将Rups-100穿刺系统送至肝右静脉,自肝静脉向门静脉穿刺成功后,引入加强硬度导丝至肠系膜上静脉,撤出Rups-100穿刺系统,直接将8 mm×40 mm球囊经12F鞘沿加硬导丝快速通过肝静脉-肝实质-门静脉,扩张球囊并保留球囊上肝静脉和门静脉切迹图像。支架技术改良是先释放1枚8 mm×60 mm的裸支架,根据球囊切迹,再释放1枚8 mm×40 mm的覆膜支架,覆膜部分覆盖实质全程而不阻挡同侧门静脉入肝血流,其余部分伸入肝静脉内,常规用弹簧栓子和明胶海绵栓塞胃冠状静脉。测量分流前后门静脉压力变化。 结果56例均获得技术性成功,成功率为100%。分流道建立前后门静脉压力分别为（31.20±3.98）mmHg和（17.36±3.48）mmHg,平均下降幅度为（13.839±2.585）mmHg（t=40.062,P<0.001）。随访1～3年。1、2、3年分流道通畅率分别为89.3%、75.0%、67.8%;再出血率分别为7.1%、12.5%、16.1%;肝性脑病发生率为12.5%。有1例术后第2天出现腹腔感染,抗感染治疗7天后好转;有7例于术后1～3年内因分流道完全闭塞而复发再出血,分别给予了介入开通和覆膜支架植入。所有病例均未出现其他严重并发症。5例在随访期间分别死于肝衰竭、肝癌和多器官衰竭。 结论通过对支架的改良,采用模拟Viatorr支架方法能够提高TIPS分流道的中远期通畅率,降低再出血率;简化TIPS操作步骤可减少与技术操作相关的并发症。     

Transjugular Intrahepatic Portosystemic Shunt Creation Using a Radiofrequency Wire: Prospective Clinical Safety and Feasibility Trial in Cirrhosis

PurposeTo assess the safety and feasibility of using a radiofrequency (RF) wire for portosystemic shunt creation.Materials and MethodsTen patients undergoing elective creation of a transjugular intrahepatic portosystemic shunt (TIPS) or a direct intrahepatic portosystemic shunt (DIPS) were prospectively enrolled. Primary outcomes were the safety and feasibility of RF wire used for the creation of TIPS and DIPS. Median age was 66.5 ± 6.1 years. Causes of liver disease included alcohol (n = 5), nonalcoholic steatohepatitis (n = 2), hepatitis C virus (n = 1), primary biliary cirrhosis (n = 1), autoimmune hepatitis (n = 1). The median score for model for end-stage liver disease was 11 ± 4.3. The Rosch-Uchida TIPS set was used with intravascular ultrasonography guidance in all cases. A 0.035-inch RF wire was used in lieu of the trocar needle through the 5-F TIPS set catheter to create a track between the hepatic vein and the portal vein. All shunts were created using stent grafts.ResultsTechnical success rate was 100%. In 7 of 10 patients, portal vein access was achieved with a single pass. A DIPS was created in 2 patients based on anatomic favorability. Median fluoroscopy time was 13.3 ± 3.8 min, and median total procedure time was 102 ± 19 min. The wire passed through parenchyma without subjective deflection. There was 1 case of extracapsular puncture with no clinical consequence. The RF wire was too stiff to curve into the main portal vein, requiring wire exchange in all but 1 case. Mean portosystemic gradient decreased from 13.9 ± 3.3 to 5.9 ± 2.1 mm Hg. No immediate complications were encountered. Shunt patency was 100% at 30 days.ConclusionsCreation of TIPS and DIPS using an RF wire was safe and feasible, enabling creation of an intrahepatic track without subjective deflection in cirrhotic patients.     

Polytetrafluoroethylene-covered nitinol stent-graft for transjugular intrahepatic portosystemic shunt creation: 3-year experience

PURPOSE: To prospectively evaluate the use of a recently developed expanded polytetrafluoroethylene (PTFE)-covered nitinol stent-graft in preventing the need for repeated intervention after transjugular intrahepatic portosystemic shunt (TIPS) creation. MATERIALS AND METHODS: Fifty-three consecutive patients underwent TIPS procedures between January 2000 and February 2002. Minimum patient follow-up was 9 months (mean, 16.3 months). Fifty-six stent-grafts were implanted in 53 patients; eight of the devices were 8 mm in diameter and 48 were 10 mm in diameter. The stent length varied from 4 to 7 cm. Indications for the procedure included recurrence of bleeding after sclerotherapy (28 patients with cirrhosis, one patient without), refractory ascites or hydrothorax (21 patients with cirrhosis, one patient without), and Budd-Chiari syndrome (two patients). RESULTS: A technical success rate of 100% was obtained, with an early clinical success rate of 96.2%. During the follow-up period, the recurrence rate was 3.4% (one of 29 patients) for bleeding and 9.0% (two of 22 patients) for ascites. Shunt malfunction occurred in nine of 53 patients (16.9%); in one of these nine patients, shunt occlusion was evident after revision, and a parallel shunt was created. The 1-year primary and secondary patency rates were 83.8% and 98.1%, respectively. In this series, the incidence of encephalopathy (included even as a single short-lived episode) was 47.1% (25 of 53 patients). The 30-day mortality rate was 3.8% (two of 53), and the late mortality rate was 17.3% (eight of 46), excluding seven patients who underwent transplantation. CONCLUSION: The new PTFE-covered nitinol stent-graft used appears to be excellent in preventing the need for repeated interventions. A primary patency rate of 83.8% and a secondary patency rate of 98.1% were achieved.     

Evaluation of MR/fluoroscopy-guided portosystemic shunt creation in a swine model

PURPOSE: To evaluate three different percutaneous portosystemic shunts created with magnetic resonance (MR) imaging and fluoroscopy guidance in a swine model. MATERIALS AND METHODS: In stage 1 of the experiment, an active MR intravascular needle system was created for needle tracking and extracaval punctures. Twenty inferior vena cava (IVC)/superior mesenteric vein (SMV)/portal vein (PV) punctures were performed in 10 swine (weight, 40-45 kg) in a 1.5-T short-bore interventional MR imager. With use of a real-time MR imaging sequence, the needle was guided through the IVC and into the SMV or PV (N = 20 punctures). After confirmation, a wire was advanced into the portal venous system under MR imaging guidance (N = 20). In stage 2, animals were transferred to the radiographic fluoroscopy suite for deployment of shunts. Three different shunts were evaluated in this study: (i) a commercial stent-graft, (ii) a prototype bridging stent, and (iii) a prototype nitinol vascular anastomotic device. Postprocedural necropsy was performed in all animals. RESULTS: Successful MR-guided IVC/SMV punctures were performed in all 20 procedures (100%). All three shunts were deployed. Stent-grafts had the poorest mechanism for securing a shunt. The vascular anastomotic device and the bridging stent had more secure anchoring mechanisms but also had higher technical failure rates (50% and 40%, respectively). When deployed successfully, the vascular anastomotic device resulted in no bleeding at the sites of punctures at necropsy. CONCLUSION: Percutaneous shunts and vascular anastomoses between the portal mesenteric venous system and IVC were successfully created with use of a combination of MR imaging and conventional fluoroscopy for guidance.     

Viatorr支架行TIPS术治疗门静脉高压性静脉曲张消化道出血效果评估

目的评价应用Viatorr支架行经颈静脉肝内门体分流术(TIPS)术治疗门静脉高压性静脉曲张消化道出血的可行性、安全性和临床效果。方法回顾性分析2015年10月至2018年11月收治的42例肝硬化门静脉高压性静脉曲张消化道出血患者临床资料,所有患者符合TIPS治疗指征,均接受Viatorr支架行TIPS术治疗。术中检测门静脉压力梯度(PPG)。术后1、3、6、12个月,之后每年随访超声或增强CT检查,评价分流道通畅情况,并通过电子病历、临床或电话随访患者肝功能、凝血4项、再出血、肝性脑病发生和生存时间。配对t检验分析术前、术后PPG、总胆红素、血清白蛋白和凝血酶原时间变化,Kaplan-Meier法分析分流道通畅率和生存率。结果 42例均成功施行TIPS术,技术成功率为100%。共植入直径8 mm Viatorr支架42枚。PPG均值由术前(26.85±6.00) mmHg(1 mmHg=0.133 kPa)降低为(11.62±4.54) mmHg(t=11.359,P<0.05),平均降低(55.63±16.77)%。与术前相比,术后3 d总胆红素浓度升高(P<0.05),血清白蛋白降低(P<0.05),凝血酶原时间延长(P<0.05)。术后1个月总胆红素、血清白蛋白和凝血酶原时间与术前水平差异均无统计学意义(P>0.05)。术后中位随访14.5(2~39)个月,再出血发生率为9.5%(4/42),其中1例接受分流道再通;肝性脑病发生率为19.1%(8/42)。术后1、2、3年分流道通畅率分别为91.9%、83.9%、77.4%,生存率分别为94.7%、89.4%、82.0%。肝硬化相关死亡率为9.5%(4/42),均于术后2~30个月死于终末期肝病伴多脏器功能衰竭。结论 Viatorr支架行TIPS术治疗肝硬化门静脉高压性静脉曲张消化道出血具有较高的技术成功率,术后分流道通畅率高,肝性脑病发生率低。