Primary implantation of polyester-covered stent-grafts for transjugular intrahepatic portosystemic stent shunts (TIPSS): A pilot study

Purpose: To investigate whether placement of a polyester-covered stent-graft increases the primary patency of transjugular intrahepatic portosystemic stent shunts (TIPSS). Methods: Between 1995 and 1997 Cragg Endopro or Passager MIBS stent-grafts were used for the creation of TIPSS in eight male patients, 35–59 years of age (mean 48 years). All patients suffered from recurrent variceal bleeding and/or refractory ascites due to liver cirrhosis. Seven stent-grafts were dilated to a diameter of 10 mm, one to 12 mm. Follow-up was performed with duplex ultrasound, clinical assessment, and angiography. Results: The technical success rate for creation of a TIPSS was 100%. The mean portosystemic pressure gradient decreased from 25 mmHg to 12 mmHg. In seven of eight patients TIPSS dysfunction occurred between 2 days and 3 years after stent-graft placement. In one patient the TIPSS is still primarily patent (224 days after creation). The secondary patency rates are 31 days to 3 years. Conclusion: The primary use of polyester-covered stent-grafts for TIPSS did not increase primary patency rates in our small series.     

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.     

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.     

Endovascular treatment of a portal vein tear during TIPSS

During a transjugular portosystemic stent-shunt (TIPSS) procedure a portal vein laceration occurred with subsequent intraperitoneal hemorrhage. A PTFE-covered nitinol stent was successfully placed eliminating the leak and creating a functioning portosystemic shunt. This case demonstrates both the importance of portal vein puncture more than 1 cm from the bifurcation and the necessity of maintaining a stock of available stent-grafts.     

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.     

Treatment of TIPS Stenosis with ePTFE Graft-Covered Stents

Midshunt stenosis and recurrent variceal bleeding occurred in 2 patients after transjugular intrahepatic portosystemic shunts (TIPS). Repeat angioplasty was performed in both cases but recurrent stenosis again led to hemorrhage. Expanded polytetrafluoroethylene (ePTFE) graft-covered stents were expanded in each of the TIPS at the midshunt, reducing the portosystemic gradient for both patients. Variceal bleeding ceased, and follow-up studies showed no evidence of recurrent stenosis in either case.     

Balloon Occlusion Versus Wedged Hepatic Venography Using Carbon Dioxide for Portal Vein Opacification During TIPS

Balloon occlusion hepatic venography using carbon dioxide (CO₂) is proposed as a safer yet simpler alternative to wedged catheter techniques that have caused hepatic lacerations during the transjugular intrahepatic portosystemic shunt (TIPS) procedure. The image quality of CO₂ wedged catheter and balloon occlusion venograms was comparable in our small series, with no venographic-related complications occurring in the balloon occlusion group.     

Morphologic and clinical results of the transjugular intrahepatic portosystemic stent-shunt (TIPSS)

The concept of transjugular intrahepatic portosystemic stent-assisted shunt (TIPSS) using the Palmaz iliac stent has been successfully accomplished in 18 of 24 patients representing a technical success rate of 75%. Fourteen were male, 4 female with a mean age of 60 years (range 34–84 years). According to classification of Child’s and Turcotte, 6 were in stage A, 6 in stage B, and 6 in stage C. Five patients were treated on an emergency basis because of massive active bleeding. In 10 patients the portosystemic tract was created between the middle hepatic vein and the right main stem of the portal vein in 8, and the left main stem in 2 patients. In 8 patients, the shunt was established between the right hepatic vein and the right main branch of the portal vein. The portosystemic gradient in 18 patients was 29.9±6 mm Hg and dropped to an average of 16.9±4 mm Hg after shunt establishment. Within the early postprocedural period of 30 days, 1 patient died of direct complications of the procedure. Because of catheter dislocation, embolization of the percutaneous transhepatic approach to the portal vein after successful shunt “creation” could not be done and was followed by intraabdominal exsanguination. One patient died of an ARDS after TIPSS. A third developed pulmonary infection. In 13 patients, because of hematomas at the puncture site of the transhepatic approach, only the transjugular approach was elected for establishing TIPSS. The mean portosystemic gradient in 18 patients prior to TIPSS was 29±6 mm Hg (range 19–41 mm Hg), dropped to an average of 16.9±4 mm Hg (range 7–21 mm Hg), and showed no significant change 6 months after TIPSS with a pressure of 16±1.8 mm Hg. The 1-year survival rate was 75% (8/12); the 2-year rate was 50% (3/6).     

Recurrent TIPS failure associated with biliary fistulae: Treatment with PTFE-covered stents

Purpose: To evaluate the efficacy of covered stents for the treatment of transjugular intrahepatic portosystemic shunt (TIPS) obstruction in human subjects with identified or suspected biliary fistulae. Methods: Five patients were treated for early failure of TIPS revisions. All had mid-shunt thrombus, and four of these had demonstrable biliary fistulae. Three patients also propagated thrombus into the native portal venous system and required thrombolysis. TIPS were revised in four patients using a custom-made polytetrafluoroethylene (PTFE)-covered Wallstent, and in one patient using a custom-made PTFE-covered Gianturco Z-stent. Results: All identified biliary fistulae were successfully sealed. All five patients maintained patency and function of the TIPS during follow-up ranging from 2 days to 21 months (mean 8.4 months). No patient has required additional revision. Thrombosis of the native portal venous system was treated with partial success by mechanical thrombolysis. Conclusion: Early and recurrent failure of TIPS with mid-shunt thrombosis, which may be associated with biliary fistulae, can be successfully treated using covered stents. Stent-graft revision appears to be safe, effective, and potentially durable.     

Percutaneous transjugular intrahepatic portosystemic shunt (TIPS). The preliminary experience and proposal of a new method]

A new interventional procedure employing metallic stents has been recently suggested to perform percutaneous portosystemic shunts in the treatment of variceal bleeding in portal hypertension; the technique is called TIPSS (transjugular intrahepatic portosystemic stent shunt). This percutaneous treatment presents several advantages over surgery: the shunt diameter can be calibrated according to the degree of portal hypertension; moreover, TIPSS can be performed in patients waiting for liver transplantation because it does not alter the vascular anatomy of liver. The original technique employed transhepatic portography. In this paper the authors report on their personal experience and present their series of 4 patients with portal hypertension and variceal bleeding, in whom TIPSS was performed utilizing noninvasive US guidance. Variceal bleeding was successfully treated in all patients and variceal distension was also obtained.     

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.     

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.     

Treatment of a TIPS-Biliary Fistula by Stent-Graft in a 9-Year-Old Boy

We report a 9-year-old male cirrhotic patient with acute occlusion of a transjugular intrahepatic portosystemic shunt (TIPS) due to a biliary-to-TIPS fistula which occurred 9 hr after the TIPS procedure. Immediate TIPS revision was performed and the fistula was treated by placement of an endoluminal stent-graft. At 12-month follow-up color Doppler examination demonstrated a patent shunt.     

A new stent-graft for transjugular intrahepatic portosystemic shunts.

The transjugular intrahepatic portosystemic shunt (TIPSS) has become an effective method of treatment for the complications of portal hypertension, however shunt dysfunction is common. Covered stent-grafts have been tested in animal models, and customized or "home-made" devices have been deployed in several institutions. We report the use of a new commercially available TIPSS stent-graft in six patients undergoing primary shunting as well as two cases of revision or secondary TIPSS. The device has proved relatively easy to handle and appears to have the technical features likely to improve primary patency. Further follow-up is required to properly assess shunt patency and re-intervention rates.     

Percutaneous Transjugular Direct Porto-caval Shunt in Patients with Budd-Chiari Syndrome

The purpose of the study was to evaluate the feasibility and effectiveness of direct porto-caval shunts in patients with Budd-Chiari syndrome (BCS) in whom there is no access to the hepatic veins during transjugular intrahepatic portosystemic shunt (TIPSS). We included six consecutive patients with fulminant/acute Budd-Chiari syndrome (mean age: 35 years) in whom a conventional TIPSS was not possible due to inaccessible hepatic veins. We performed a direct porto-caval shunt via a transhepatic approach. Patients were followed up by means of clinical examination, laboratory investigations, and Doppler ultrasound. TIPSS implantation from the inferior vena cava (IVC) was successful in all six patients (100%). The median transhepatic shunt length was 9 cm (8–10 cm). No procedure-related complications were observed in our patients. Early shunt occlusion occurred in three out of six patients (50%). In all three of these patients, the stent used to stabilize the shunt ended 1–2 cm before reaching the IVC. All occlusions were successfully recanalized. One of these patients developed recurrent early shunt as well as mesenteric and splenic vein occlusions. She died 7 days after TIPSS placement due to an unmanageable coagulation disorder. The remaining five patients were followed up by planned clinical examination and laboratory investigations (mean follow-up time was 15 months; patient 1 was followed up for 13 months, patient 2 for 14 months, patient 3 for 15 months, and patients 4 and 5 for 16 months) and all displayed a complete and durable resolution of liver failure and ascites without reintervention. In patients with acute liver failure originating from BCS and inaccessible hepatic veins, a direct transhepatic porto-caval shunt can be performed safely and effectively under ultrasound guidance. Future studies in larger patient groups should investigate if the patency of transcaval TIPSS with long transhepatic shunt segments is similar compared to conventional TIPSS via the hepatic vein.     

经颈静脉肝内门体分流术对肝功能影响的初步研究

目的：观察ＴＩＰＳＳ对肝功能的影响。材料和方法：６０例普行ＴＩＰＳＳ的患者中择取１７例资料完整者作肝功能动态观察。结果：本组各例显示ＴＩＰＳＳ术后３５％患者有肝功能恶化，时间短暂其余病例肝功能无显著改变或有改善。结论：ＴＩＰＳＳ可有效地降低出生率，为降低ＴＩＰＳＳ的并发展和提高疗效，术前病例选择十分必要。     

Percutaneous transluminal angioplasty of peripheral bypass stenoses

Purpose: To assess the success of percutaneous transluminal angioplasty (PTA) in treating peripheral bypass stenoses. Methods: Patients who received a femoropopliteal or femorocrural bypass graft for limb ischemia were included in a duplex surveillance program. If duplex ultrasound revealed a short (<2 cm) severe (peak systolic velocity ratio ≥ 4.5) stenosis, patients were scheduled for arteriography and PTA. Fifty-eight peripheral bypass stenoses in 39 grafts in 37 patients were treated with PTA. The cumulative primary patency of treated stenoses was calculated. Results: During the first year after PTA 31 (53%) treated lesions remained patent, 15 (26%) lesions restenosed at a median interval of 5.0 (range 1–12) months and 4 (7%) bypasses occluded. The cumulative primary patency of 58 treated graft stenoses at 1 year was 60% [95% confidence interval (CI) 46%–74%] and 55% (95% CI 41%–70%) at 2 years. Graft body stenoses showed a better 2-year cumulative primary patency (86%; 95% CI 68%–100%) compared with juxta-anastomotic lesions (45%; 95% CI 29%–62%; p < 0.05). Conclusion: PTA is justifiable as the initial treatment of peripheral bypass stenoses. Nevertheless, the restenosis rate is rather high, especially in juxta-anastomotic lesions. Continuation of duplex surveillance after PTA and timely reintervention is recommended.     

经颈静脉肝内门体静脉内支架分流术术式改良的实验研究

目的：探讨建立改良式猪经颈静脉肝内门体静脉内支架分流术（TIPSS）模型的可行性及其意义。方法：11只家猪分成2组，7只采用改良术式（经肝段下腔静脉穿刺门脉）建立TIPSS模型，另4只行常规TIPSS作对照。共置入4枚进口覆膜镍钛合金支架，8枚国产覆聚氨酯膜支架。其中，改良组7只猪置入7枚支架（4枚进口支架，3枚国产支架）；对照组4只猪置入5枚国产覆膜支架（1只猪置入时支架发生移位，故加用1枚支架）。术后4周（5只），8周（2只）和12周（4只）进行门脉造影观察分流道通畅情况。动物处死后，行分流道大体和组织病理学检查。结果：术后4周，改良组2只分流道通畅（进口支架、国产支架各1枚），分流道表面均形成完整的假性内膜组织；另5只分流道在4至12周均闭塞，分流道内形成血栓，其中2只内支架伸入下腔静脉内不全，陷入肝实质内。常规组4只分流道在4、8和12周观察期内均闭塞。两组间分流道肝（下腔）静脉端，肝实质段和门静脉端各段的增生组织厚度对比差异均无显著性意义（t值分别为0．14、0．16和0．20，P值均＞0．05）。结论：改良式猪TIPSS模型的建立是安全和可行的。改良式TIPSS中应采用覆膜支架，并应有足够长度伸入至两端静脉内，有助于防止增生组织向分流道内长入。     

TIPSS术后肝性脊髓病（附5例报告）

目的：报告5例经颈静脉途径肝内分流术（TIPSS）后肝性脊髓病（HM）的临床表现。资料和方法：5例均有乙型肝炎和静脉曲张破裂出血病史。TIPSS术前影像学检查显示肝萎缩明显，术后分流道通畅。曾做脊髓MRI4例，1例做脊柱CT和脊髓造影。5例均行腰椎穿刺。结果：5例于TIPSS后4周－4个月出现进行性下肢痉挛性瘫痪，1例伴上肢无力，1例伴有尿失禁。5例术后有1次以上（1－6次）HE发作史。体验发现患者腱反射亢进，踝阵挛阳性，浅感觉正常，1例深感觉减退，除1例外，其余无明显肌莓缩表现。受累节段椎管影像学检查及腰椎穿刺脑脊液检查均无异常。5例均有术后持续高血低蛋白血症。结论：TIPSS术后出现进行性下肢痉挛性瘫痪、不伴有感觉障碍者应考虑HM。与TIPSS相关HM的高危因素有术前明显肝萎缩、术后持续高血氨及肝性脑病。     

Transjugular intrahepatic portosystemic shunt with an autologous vein-covered stent: results in a swine model.

PURPOSE: To investigate the feasibility, safety, and efficacy of an autologous vein-covered stent (AVCS) to prevent shunt stenosis in a porcine transjugular intrahepatic portosystemic shunt (TIPS) model. MATERIALS AND METHODS: TIPS were created with an AVCS in 12 healthy domestic swine and with a bare stent in 10 additional swine. Tissue response was compared with use of venography, histology, and computerized morphometry analysis 2 weeks after implantation. Differences between AVCS and noncovered stents (established by a t-test), as well as regional differences within a single stent (established by an f test), were considered significant at P <.05. RESULTS: Twenty of 22 TIPS procedures were technically successful. Ten of 12 shunts with an AVCS (83%) and two of 10 with bare stents (20%) remained patent (<50% diameter narrowing) at euthanasia 2 weeks later (P <.01). Histologic evaluation of harvested bare stents showed marked intimal hyperplasia (IH), composed of smooth muscle cells, myofibroblasts, and fibroblasts. In contrast, the AVCS were remarkably free of IH and thromboses. In patent TIPS in both groups, endothelial coverage of the luminal surface was present histologically. IH accounted for 57% (26.27/45.79) of total stent cross-sectional lumen area in the control group and 21% (8.34/39.54) in the AVCS group (P <.01), with no intrashunt differences (P >.05). CONCLUSION: Based on short-term follow-up, AVCS significantly improved TIPS patency by prevention of both IH and in-stent thrombosis. TIPS created with an AVCS was feasible and safe in our porcine model.