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.     

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.     

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.     

Transjugular intrahepatic portosystemic shunt patency and clinical outcome in patients with Budd-Chiari syndrome: covered versus uncovered stents

PURPOSE: To retrospectively compare primary patency and reintervention rates, clinical outcome, and improvement in hepatic dysfunction (Child-Pugh score) in patients with Budd-Chiari syndrome treated with transjugular intrahepatic portosystemic shunt (TIPS) using bare stents or expanded polytetrafluoroethylene (PTFE)-covered stents. MATERIALS AND METHODS: Approval of study and treatment protocol and waiver of informed consent for the retrospective study were obtained from institutional review board. Informed consent was obtained from each patient before procedure. Four male and nine female consecutive patients (mean age, 35.7 years) with Budd-Chiari syndrome treated with TIPS from January 1994 to November 2003 were included. In six patients, TIPS creation was performed with bare stents (group A). After April 2001, TIPS creation was performed in seven patients with expanded PTFE-covered stent-grafts (group B). Follow-up (group A mean, 22.7 months +/- 10.53 [standard deviation]; group B mean, 23.1 months +/- 7.81) was performed at 7 days, 30 days, and 3 months and subsequently every 3 months. Liver function was evaluated every 3 months. Primary end points were 6- and 12-month TIPS patency rates. Secondary end points were reintervention rate and clinical outcome. Patency rates were estimated (Kaplan-Meier method) and compared (log-rank test). Continuous (Mann-Whitney U test) and categoric (chi(2) test) data were compared. Significant differences before and after treatment were determined (Wilcoxon test). RESULTS: Mean primary patency duration was 4.46 months +/- 3.40 in group A and 22.29 months +/- 8.15 in group B. In group B, a significant increase in primary patency rate (100% and 85.7% vs 16.7% and 0% at 6 and 12 months; P < .001, log-rank test) and a decrease in reintervention rate (0.29 +/- 0.49 vs 6.17 +/- 1.72, P < .001) were observed. Both groups had a significantly decreased Child-Pugh score; group B had a more persistent and significantly higher reduction. CONCLUSION: Expanded PTFE-covered stent-grafts significantly increased primary patency rate of TIPS in patients with Budd-Chiari syndrome, with reduced reintervention rate and prolonged clinical improvement.     

Polyurethane-coated dacron-covered stent-grafts for TIPS: results in swine

Purpose: To evaluate shunt patency after placing a new polyurethane-coated Dacron-covered spiral Z stent-graft to create a transjugular intrahepatic portosystemic shunt (TIPS). Methods: TIPS stent-grafts were placed in six young swine, using polyurethane-coated, Dacron-covered spiral Z stent-grafts. Animals were followed weekly by transhepatic portal venography until shunt occlusion or up to 6 weeks, then were sacrificed for gross and histologic evaluation. Results: Five of six TIPS stent-grafts were found to be occluded by 3 weeks and none were patent at 6 weeks. Histologic evaluation demonstrated a marked foreign body reaction with superimposed thrombosis occluding the graft lumen. Conclusion: Polyurethane-coated Dacron-covered stent-grafts do not improve TIPS patency.     

Dr. Gary J. Becker young investigator award: comparison of small-diameter type 1 collagen stent-grafts and PTFE stent-grafts in a canine model--work in progress

PURPOSE: To report an in-progress experiment in a canine model in which two types of small-diameter stent-grafts-one constructed of polytetrafluoroethylene (PTFE) and the other of a new, type 1 collagen material-were compared regarding vessel patency, intimal hyperplasia formation, and tissue reaction. MATERIALS AND METHODS: Six mongrel dogs weighing 30-35 kg were used. Stent-grafts of 4-mm diameter and 20-mm length were constructed with use of balloon-expandable stainless-steel stents wrapped with either PTFE or a new type 1 collagen graft. Stent-grafts were placed in deep femoral arteries bilaterally (PTFE on one side, collagen on the other). Animals were followed for 2 weeks (n = 2), 6 weeks (n = 2), or 12 weeks (n = 2). Percent stenosis based on angiographic findings as well as thickness and area of neointimal hyperplasia were compared at each time point and compared with use of the Student t test. RESULTS: All devices were patent in the immediate postimplantation period. Five of six collagen stent-grafts and five of six PTFE implants were patent at follow-up. In-stent stenosis was undetectable angiographically in all five patent collagen stent-grafts. All five patent PTFE stent-grafts showed demonstrable in-stent stenosis (10%-60%), indicating a trend toward improved patency in collagen stent-grafts versus PTFE stent-grafts (P = .07). Neointimal hyperplasia was absent at 2 weeks in the collagen stent-grafts. Neointimal thickness increased to a maximum of 360 microm at 12 weeks in the collagen stent-grafts. For PTFE stent-grafts, neointimal hyperplasia was present in all samples and reached a maximum of 770 microm at 12 weeks (P = .03). CONCLUSIONS: Even in small-diameter vessels, type 1 collagen stent-grafts demonstrate excellent patency rates and favorable histologic findings. The type 1 collagen stent-graft technology merits further developmental efforts in preclinical models.     

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.     

Added Value of Covered Stents in Transjugular Intrahepatic Portosystemic Shunt: A Large Single-Center Experience

Purpose

Transjugular intrahepatic portosystemic shunts (TIPS) were historically placed using uncovered bare-metal stents. Current practice has now shifted toward the use of polytetrafluoroethylene (PTFE)-covered stents, given the improved primary patency seen with these stents. The aim of this study was to determine whether there is any added value, such as overall survival or stent patency, when using covered stents versus uncovered stents in TIPS placement in a large cohort.

Materials and Methods

From April 1995 to June 2012, a total of 744 consecutive adult patients underwent de novo TIPS placement (378 receiving uncovered stents, 366 receiving covered stents). Information was obtained on demographics, baseline clinical variables, and outcomes after TIPS placement. Data were collected, compared, and analyzed to assess outcomes including mortality, primary patency (determined via repeat intervention), and secondary patency (determined via ultrasound parameters).

Results

Covered stents were associated with significantly improved primary patency (P < 0.001) and secondary patency (P < 0.001) when compared with uncovered stents in TIPS procedures. Additionally, covered stents were associated with higher estimated overall survival rates and higher survival rates when TIPS was performed emergently and in patients with higher Model for End-Stage Liver Disease (MELD) scores. For example, in patients with MELD scores between 11 and 18, there was a predicted survival of 59.2% with covered stents versus 42.8% with uncovered stents at 1 year.

Conclusion

This study demonstrated that covered stents offer the additional value of higher estimated overall survival and higher estimated survival in patients undergoing TIPS emergently and in those with higher MELD scores when compared to uncovered stents.

     

Bile resistance of coated transjugular intrahepatic portosystemic shunt stents in a flow-model

PURPOSE: We sought to test the bile resistance of transjugular intrahepatic portosystemic shunt (TIPS) stents with 3 different coatings. MATERIALS AND METHODS: Three stents with different coating materials (monolayer polyethylene terephthalate [PETP], monolayer polytetrafluoroethylene [PTFE], and double layer [PTFE]) were tested in a flow model. After testing the sealing of the system with isotonic saline solution, fresh human bile was circulated. Constant pressure was 50 cm H2O. Bile resistance of the stent membranes was analyzed. RESULTS: Two of the 3 stents proved completely resistant to water. Only the PETP stent was resistant to bile. The PTFE-coated stents were not bile resistant. CONCLUSION: The bile resistance of coated TIPS stents and, thus, the dependency of TIPS shunt patency is called into question. The stent with the reported superior patency rates does not show experimental bile resistance.     

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.     

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.     

经皮经肝门腔静脉分流术

目的介绍一种经皮治疗门静脉高压症的新方法,评价其安全性和可行性,探讨其潜在的临床意义。方法19例门静脉高压患者行经皮经肝门腔静脉分流术(PTPS)。其中食管胃底静脉曲张出血16例,难治性腹水2例,肝肺综合征1例;Child’sB级4例、C级15例。经皮经肝穿刺门静脉左支再穿刺肝段下腔静脉,经皮经肝方向植入PTFE覆膜支架于门静脉左支与腔静脉之间。结果19例经肝段下腔静脉PTPS分流术均获成功,技术成功率100%,未出现术中技术相关并发症,术后门腔静脉压力梯度平均下降13cmH2O,平均随访216d,所有患者未发生再出血,难治性腹水得到有效控制。1年内初步开通率94.8%,明显高于传统TIPS。结论经皮经肝途径建立门腔静脉分流是安全可行的,1年内支架初步开通率明显高于传统TIPS。     

Intravascular ultrasound-guided direct intrahepatic portacaval shunt: midterm follow-up

PURPOSE: To describe the midterm patency and clinical results of the intravascular ultrasound (US)-guided direct intrahepatic portacaval shunt (DIPS) procedure for the treatment of intractable ascites and variceal bleeding. MATERIALS AND METHODS: From February 23, 1999, to December 18, 2002, inferior vena cava (IVC)-to-portal vein (PV) shunts were created in 40 patients for ascites (n = 35) and bleeding (n = 5). Intravascular US was used to guide direct puncture from the IVC to the PV. The shunts were completed with the use of single (n = 15) or overlapping (n = 25) polytetrafluoroethylene (PTFE)-covered Palmaz stents. These stent-grafts were deployed primarily at diameters of 8 mm. The diameter of the shunt was increased in three cases to achieve a target portosystemic gradient (PSG) of 15 mm Hg or lower. All patients were followed clinically and with portography with manometry. RESULTS: All DIPSs were created successfully. Mean PSGs were reduced from 23 mm Hg before DIPS creation to 9 mm afterward. During the follow-up period of a maximum of 38 months, 22 of 40 patients died or underwent liver transplantation (mean follow-up, 9 months; median, 6 months). At the time of this report, 18 of 40 patients remain living after follow-up ranging in duration from 8 to 38 months (mean, 22 months; median, 16.5 months). During the follow-up period, there was one stent-graft occlusion and three stenoses. These four patients were successfully treated by additional stent-graft placement. In addition, two patients developed IVC stenosis cephalad to the DIPS, which required IVC stent placement. The primary patency rates by Kaplan-Meier analysis were 100% at 6 months and 75% (95% CI, 53%-97%) at 12 months. CONCLUSION: Intravascular US-guided direct IVC-to-PV shunts may be created successfully with minimal complications. Primary patency of the shunt is greater than that with conventional TIPS with a bare wire stent and appears equal to that with TIPS with a PTFE-covered stent-graft.     

Pull-Through Technique for Recanalization of Occluded Portosystemic Shunts (TIPS): Technical Note and Review of the Literature

Transjugular intrahepatic portosystemic shunt (TIPS) dysfunction is an important problem after creation of shunts. Most commonly, TIPS recanalization is performed via the jugular vein approach. Occasionally it is difficult to cross the occlusion. We describe a hybrid technique for TIPS revision via a direct transhepatic access combined with a transjugular approach. In two cases, bare metal stents or polytetrafluoroethylene (PTFE)-covered stent grafts had been placed in TIPS tract previously, and they were completely obstructed. The tracts were inaccessible via the jugular vein route alone. In each case, after fluoroscopy or computed tomography-guided transhepatic puncture of the stented segment of the TIPS, a wire was threaded through the shunt and snared into the right jugular vein. The TIPS was revised by balloon angioplasty and additional in-stent placement of PTFE-covered stent grafts. The patients were discharged without any complications. Doppler sonography 6 weeks after TIPS revision confirmed patency in the TIPS tract and the disappearance of ascites. We conclude that this technique is feasible and useful, even in patients with previous PTFE-covered stent graft placement.     

Transjugular intrahepatic portosystemic shunts in the treatment of refractory ascites: results in 48 consecutive patients

PURPOSE: To assess the efficacy, morbidity, and mortality involved in the creation of transjugular intrahepatic portosystemic shunts (TIPS) in the treatment of patients with refractory ascites in Child-Pugh classes B and C. MATERIALS AND METHODS: Forty-eight consecutive patients with refractory ascites were treated with TIPS creation in a tertiary care institution. They were followed for a median of 337 days (range, 3-1376 d). RESULTS: TIPS significantly decreased the portohepatic pressure gradient (20.7 +/- 5.9 mm Hg vs. 6.8 +/- 4.1 mm Hg; P < .0001). Seventy-three percent of patients had complete or partial response. One year after TIPS creation, survival was 73% in Child class B patients and 56% in Child class C patients. Thirteen patients experienced procedural complications (portal vein thrombosis, peritoneal bleeding, acute renal failure, pneumothorax, hemoptysis, spontaneous bacterial peritonitis, and heart failure) and TIPS creation was considered the cause of death in five patients (10.4%). Primary patency was 65% at 3 months and 23% at 1 year, but shunt obstruction was accessible for a second intervention. Ten patients (21%) had de novo encephalopathy after TIPS creation. CONCLUSIONS: This series suggests that TIPS is an effective treatment for refractory ascites; however, it is a challenging procedure and serious complications--usually renal and heart failure--can be seen. A careful selection of patients is mandatory.     

经颈静脉门腔分流术中Fluency覆膜支架应用的临床观察

目的 评价Fluency覆膜支架在经颈静脉门腔分流术(TIPS)中的临床效果.方法 搜集21例采用Fluency覆膜支架行TIPS治疗患者的临床病例资料进行回顾性分析.本组患者随访时间2.0～24.0个月,平均(10.1±4.6)个月;均为门静脉高压上消化道大出血,其中原发性肝癌门静脉主干癌栓伴大出血1例,布加综合征1例.分析患者术后支架开通情况,门静脉压力及肝功能变化情况.对手术前后门静脉压力及肝功能变化情况的比较采用配对t检验.结果21例患者共放支架25枚,均成功放置,支架直径10 mm 2枚、8 mm为23枚;覆膜支架长度6～8 cm.所有患者术后上消化道出血停止;门静脉压力由术前平均(25.4±3.5)mm Hg(1mm Hg=0.133 kPa)降为(15.4±2.8)mm Hg,手术前后差异有统计学意义(t=12.495,P<0.01).随访期间,1例原发性肝癌伴门静脉主干癌栓患者于术后4个月死亡,1例随访期间发现原发性肝癌的患者术后24个月死亡,1例门静脉高压上消化道大出血患者于术后2个月死于多器官功能衰竭,1例于术后15个月出现肝静脉端狭窄,行第2枚支架治疗效果良好,余17例随访7～17个月支架无狭窄.患者死亡前1周复查超声示支架均通畅.3例术后出现一过性肝性脑病前驱症状,经对症处理后好转.存活6个月以上的19例患者,术前Child肝功能评分(6.3±1.4)分,术后6个月评分(6.4±1.9)分,两者差异无统计学意义(t=0.645,P>0.05).结论采用Fluency覆膜支架行TIPS术,能明显提高TIPS术后开通率,但长期效果及肝性脑病的评价尚需验'证.     

Transjugular Intrahepatic Portosystemic Shunt (TIPS): Current Status and Future Possibilities

Since the insertion of the first TIPS in 1989 much has been learned about this therapeutic procedure. It has an established role for the treatment of some complications of portal hypertension: prevention of recurrent variceal bleeding and rescue of patients with acute uncontrollable variceal bleeding. In addition TIPS is useful for Budd-Chiari syndrome, refractory ascites and hepatorenal syndrome, although its specific role in these indications remains to be definitively established. However, the decrease in sinusoidal blood flow induced by TIPS can lead to the patient developing hepatic encephalopathy and liver failure in some cases. Therefore, TIPS should be used with caution in patients with very poor liver function. From a technical point of view, successful placement of TIPS is achieved in more than 98% of cases by experienced groups. At present, evaluation of TIPS dysfunction based on morphology probably leads to an overdiagnosis of this complication since most of these cases are not associated with clinical manifestations (recurrent bleeding or refractory ascites). The major disadvantage of TIPS remains its poor long-term patency requiring a mandatory surveillance program. The indicator for shunt function/malfunction should be the portosystemic pressure gradient, which is best assessed by intravascular measurements. Shunt obstructions may be prevented or reduced by the use of stent-grafts in the future.     

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.     

Early and long-term clinical and radiological follow-up results of expanded-polytetrafluoroethylene-covered stent-grafts for transjugular intrahepatic portosystemic shunt procedures

The purpose of this study was to assess the therapeutic efficacy and immediate and long-term safety of expanded-tetrafluoroethylene covered stent-grafts for transjugular intrahepatic portosystemic shunts in patients with portal hypertension-related complications. A cohort of 56 patients suffering from severe portal hypertension-related complications underwent implantation of an expanded-polytetrafluoroethylene-covered stent-graft. All patients suffered from severe liver cirrhosis graded Child-Pugh A (n=8; 16%), B (n=13; 21%) or C (n=35; 63%). In 44 patients, the stent-graft was placed during the initial TIPS procedure (de novo TIPS); in the other 12 patients, the stent-graft was placed to repermeabilize the previously placed bare stent (TIPS revision). Follow-up was performed with clinical assessment, duplex ultrasound and, if abnormal or inconclusive, with invasive venography and pressure measurements. Per- en immediate post-procedural complications occurred in four patients (4/56, 7%). None of them was lethal. During follow-up, stent occlusion appeared in one patient and stenosis in two; no recurrence of bleeding was noted in all patients treated for variceal bleeding (n=28), and 24 of the 28 patients (86%) suffering from refractory ascites and/or hepatic hydrothorax were free of regular paracenteses and/or drainage of pleural effusion after shunt creation. The 30-day and global mortality for the total study population (n=56) was, respectively, 7% (n=4) and 28.5% (n=16). In the patient subgroup with variceal bleeding (n=28), 30-day mortality was 3.5% (n=1) and global mortality 14.2% (n=4). In the ascites and/or hydrothorax subgroup (n=28), 8.1% (n=3) mortality at 30 days was found and global mortality was 32.4% (n=12). In 10 patients of the 56 studied patients (18%), isolated hepatic encephalopathy occurred, which was lethal in 4 (Child C) patients (7%). Three of these four patients died within the 1st month after TIPS placement. A very high primary patency rate of TIPS can be obtained long-term after implantation of an e-PTFE-covered stent-graft, leading to a definitive resolution of portal hypertension-related complications. The incidence of TIPS-induced hepatic encephalopathy is acceptable.     

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.