Roy L. Gordon

Two-year outcome following transjugular intrahepatic portosystemic shunt for variceal bleeding: Results in 90 patients

BACKGROUND/AIMS Transjugular intrahepatic portosystemic shunt (TIPS) is a new therapy for variceal bleeding. Immediate technical and short-term clinical results have been reported. This study was undertaken to evaluate mid-term outcome after TIPS in patients who successfully underwent the procedure for variceal bleeding. METHODS Ninety patients were followed up prospectively by clinical examination and radiological shunt evaluation including Doppler sonography and transjugular portal venography. RESULTS The average follow-up in surviving patients was 2.2 years. The cumulative survival rate was 60% at 1 year and 51% at 2 years. The rate of cumulative rebleeding was 26% at 1 year and 32% at 2 years. A shunt abnormality was noted in all rebleeding patients. Rebleeding was successfully controlled in all but 1 of the patients who underwent shunt revision. Cumulative detection of stenosis or occlusion was 31% at 1 year and 47% at 2 years. Thirty-eight percent of shunt abnormalities were detected by routine surveillance. Percutaneous shunt revision was attempted in 22 patients and was successful in 21 (95%). CONCLUSIONS Although mid-term primary patency is limited in many patients by the development of a shunt stenosis or occlusion, shunt function can be maintained in most patients by careful surveillance and periodic percutaneous intervention.

Endoscopic Sclerotherapy Compared with Percutaneous Transjugular Intrahepatic Portosystemic Shunt after Initial Sclerotherapy in Patients with Acute Variceal Hemorrhage: A Randomized, Controlled Trial

During the past 15 years, endoscopic sclerotherapy and, more recently, band ligation and such pharmacologic agents as octreotide have eclipsed surgical shunting as the preferred method for controlling acute variceal hemorrhage. The status of sclerotherapy for the long-term management of patients with bleeding varices, however, remains controversial. In a previous controlled clinical trial comparing endoscopic sclerotherapy with surgical portacaval shunting [1], we enrolled 64 adult patients with Child class C cirrhosis and active hemorrhage from esophageal varices. At the index hospitalization, patients randomly assigned to sclerotherapy required less blood transfusion and fewer days of hospitalization than did those randomly assigned to shunt surgery. During the initial follow-up period, which extended for a mean of 530 days after randomization, 75% of the patients treated with sclerotherapy were hospitalized for recurrent variceal hemorrhage but none of the patients who had had shunt surgery were rehospitalized [1]. Although patients treated with sclerotherapy had longer hospital stays and received more blood transfusions during short-term follow-up, a longer follow-up study [2] showed no difference in survival or overall health care costs between patients treated with sclerotherapy and those treated with surgical shunt. The transjugular intrahepatic portosystemic shunt (TIPS) procedure is a nonsurgical procedure in which an expandable metal prosthesis is used to connect an intrahepatic portal vein with an adjacent hepatic vein [3, 4]. In our initial report on 100 patients having this procedure [3], TIPS stent placement was technically successful in 96 patients and variceal hemorrhage was controlled in 88 of 94 patients [3]. Furthermore, the 30-day mortality rate was only 13% in patients treated with TIPS. These data, as well as those of other researchers who used radiographically placed portosystemic stents, suggest that TIPS might be more cost-effective than sclerotherapy; however, data comparing the two procedures are limited [5-10]. Therefore, we did a randomized, controlled trial in patients with massive acute variceal hemorrhage in an effort to compare the two therapies for the prevention of recurrent variceal hemorrhage. Methods From November 1991 through December 1995, we enrolled 49 adults who had cirrhosis and endoscopically documented bleeding from esophageal varices. We excluded an estimated additional 250 patients with bleeding varices whom we had seen during the study period (vide infra). Our study protocol was approved by the Committee on Human Research of the University of California, San Francisco. Patients who were admitted to San Francisco General Hospital, University of California Medical Center, and Veterans Affairs Medical Center (all located in San Francisco, California) with massive or submassive acute gastrointestinal tract hemorrhage from large esophageal varices were approached for consent and randomization within 24 hours of admission. Massive hemorrhage was defined as bleeding associated with shock (systolic blood pressure < 80 mm Hg). Submassive hemorrhage was defined as hemorrhage associated with postural vital sign changes (upright pulse rate increased by 20 beats per minute compared with supine pulse rate; upright systolic blood pressure decreased by 20 mm Hg compared with supine blood pressure). The 250 excluded patients were excluded for the following reasons: They were prisoners; they were younger than 18 or older than 75 years of age; they had had a cerebrovascular accident within 3 months before the onset of bleeding; they refused to accept blood products; or they had gastric variceal hemorrhage, electrocardiographic changes compatible with acute myocardial infarction, a Po 2 less than 70 mm Hg or an arterial pH of 7.20 or less on room air at the time of evaluation for eligibility, a serum creatinine level of 221 mol/L or more, a prothrombin time at least 5 seconds longer than control (despite the use of fresh frozen plasma), a platelet count less than 50 109/L, stage IV hepatic encephalopathy, cancer other than skin cancer, the acquired immunodeficiency syndrome (AIDS) or advanced AIDS-related complex, sepsis, pneumonia, peritonitis, clinical evidence of alcoholic hepatitis, a serum bilirubin concentration of 7 mg/dL or more, thrombosis of the portal vein, thrombosis of the hepatic veins, or thrombosis of the inferior vena cava as determined by Doppler ultrasonography. All patients received endoscopic sclerotherapy at the time of the initial endoscopic procedure that established the source of hemorrhage as esophageal varices. Patients were deemed eligible for participation if they presented with hemodynamically submassive or massive hemorrhage and were found to have large (>1 cm across) distal esophageal varices with cherry red spots, hematocystic spots, or red wale signs. Before randomization, all patients had patency of the portal venous system (main, right, and left portal veins and the splenic vein) and hepatic veins determined by real-time color and pulse-wave Doppler ultrasonography. After we obtained informed consent, we used serially numbered, sealed, opaque envelopes to randomly assign patients either to repeated sclerotherapy or to TIPS. If neither the patient nor the patients next of kin was able to give informed consent, a patient advocate was designated to consider the invitation to participate. Patients randomly assigned to sclerotherapy received treatment every 2 to 7 days during the initial hospitalization; treatment consisted of 0.5- to 2.0-mL injections of ethanolamine oleate solution per varix. Repeated endoscopy and sclerotherapy treatments were done weekly after discharge from the initial hospitalization. As much as 30 mL of ethanolamine oleate solution was used per treatment session. All visible varices were injected within the distal 7 to 10 cm of the esophagus. In patients who developed sclerotherapy-associated ulcers, repeated endoscopy was scheduled to be done 2 to 7 days after the notation of ulcers to assess interval healing. Patients assigned to the TIPS group had the procedure within 48 hours of randomization; the procedure was performed by one of six radiologists skilled in this procedure, as described elsewhere [3]. Catheterization of the hepatic vein was done through the right internal jugular vein. A tract between a suitable hepatic vein and a suitable portal vein was established by needle set (Ring TIPS set, Cook, Inc., Bloomington, Indiana), dilated with a balloon over a guidewire, and then maintained by one or more expandable metal mesh stents (Wallstent, Schneider, Inc., Minneapolis, Minnesota). The adequacy of the portosystemic shunt was documented by contrast injection and manometric measurement at the time of the initial procedure. A target portal vein-to-hepatic vein pressure gradient of 12 mm Hg or less was achieved in all cases. Persistent varices opacified at portal venography after adequate stenting were occluded by using embolization coils. Preprocedural data recorded prospectively included sex, age, vital signs at admission, physical examination findings at admission (including presence of encephalopathy and ascites), nutritional status, results of laboratory tests, and Child-Pugh score [11]. Prospectively identified outcome variables after randomization included death, rebleeding, liver transplantation, total transfusion requirements, onset and presence of encephalopathy, cost of managing variceal hemorrhage after randomization, total duration of hospitalization for variceal hemorrhage and any related encephalopathy, and complications of therapy. Nutritional status was defined as malnourished if the patient had gross muscle wasting, had cachexia, or had lost at least 10% of body weight during the previous 6 months. Bleeding after randomization was defined as bloody or coffee grounds emesis (hemetemesis, melenemesis) or liquid black stools (melena) with a decrease in hematocrit sufficient to warrant transfusion. Hepatic encephalopathy was defined clinically by the presence of asterixis, gross disorientation or agitation, or frank somnolence or coma in the absence of another identifiable cause. Presence of ascites was determined by both ultrasonography and clinical assessment (shifting dullness, fluid wave, gross distention) for all patients initially and for patients in the TIPS group having follow-up Doppler ultrasonography. For patients assigned to sclerotherapy, presence of ascites was subsequently determined by clinical criteria alone. Follow-up information was obtained through face-to-face interviews, telephone interviews, or chart reviews and was obtained from the patient, family, physician, or all three sources. The total cost of health care per patient was calculated as the sum of all real costs for inpatient and outpatient hospital care, including hospital expenditures and costs for professional services from the day of randomization until death or the last follow-up visit. In addition, all outpatient costs for endoscopic sclerotherapy, Doppler ultrasonography, and stent revision during the follow-up period were included. We used the actual cost to the hospital or medical staff, or both, of providing a service or procedure (rather than billing charges or collections). For example, the cost of an endoscopic sclerotherapy session was determined by summating the following: 1 hour of a gastroenterologists time plus benefits (derived from personnel pay records); 2 hours of a registered nurses time plus benefits; the invoice cost of disposable sclerotherapy catheters, bite blocks, and intravenous tubing; the pharmacy costs of all drugs, including the sclerosant agent; the estimated depreciation of an Olympus GIT-IT100 videoendoscope (Lake Success, New York); endoscopic processing costs; 1 hour of recovery room personnel time; and costs of recovery supplies. Outcome variables were compared, using the intention-to-tre

Using Transjugular Intrahepatic Portosystemic Shunts to Control Variceal Bleeding before Liver Transplantation

OBJECTIVE To determine the safety and efficacy of transjugular intrahepatic portosystemic shunts (TIPS) in controlling bleeding from esophageal varices in patients awaiting liver transplantation. DESIGN Prospective, uncontrolled trial. SETTING University medical center with an active liver transplant program. PATIENTS Thirteen patients referred for liver transplantation with either active variceal hemorrhage or recurrent variceal hemorrhage despite sclerotherapy; four patients had been previously treated with surgical portosystemic shunts. INTERVENTION An intrahepatic portosystemic shunt created via a transjugular approach to the hepatic veins using expandable, flexible metallic stents. MEASUREMENTS Portal pressures before and after the creation of the shunt, the direction of portal blood flow at differing diameters of the shunts, procedure-related complications, and outcome in terms of survival, liver transplantation, and recurrent variceal bleeding. MAIN RESULTS The transjugular intrahepatic portosystemic shunt was placed successfully in 13 patients, and bleeding was controlled acutely in all 13. After the procedure, the mean portal pressure decreased from 34 +/- 8.9 cm H2O to 22.4 +/- 5.4 cm H2O (P less than 0.001). No complications were associated with the procedure; however, two patients died of causes unrelated to the procedure. Seven patients subsequently underwent liver transplantation and are doing well, and three patients are being managed conservatively. Bleeding recurred in one patient 102 days after the procedure secondary to shunt occlusion caused by neointimal proliferation. CONCLUSION Placement of a transjugular intrahepatic portosystemic shunt is apparently safe and effective therapy for variceal hemorrhage in patients referred for liver transplantation.

An Endovascular System for Thoracoabdominal Aortic Aneurysm Repair

Purpose: To describe a stent-graft system for endovascular repair of thoracoabdominal aortic aneurysm (TAAA) that preserves side branch perfusion. Technique: The modular endograft system includes 3 components. The primary stent-graft is custom-made from conventional graft fabric and Gianturco Z-stents. Covered nitinol Smart Stents are used for the visceral and renal extensions, and the distal extension is made from a modified Zenith system. With the supine patient under general anesthesia, the components are delivered sequentially through surgically exposed femoral and right brachial arteries in an operation that requires prolonged periods of magnified high-resolution imaging. This system was first used in a 76-year-old man with a contained rupture of a supraceliac ulcer and a large abdominal aortic aneurysm ending proximally at the celiac artery. The endograft was implanted successfully, but the patient developed paraplegia on day 2; imaging documented an excluded aneurysm and excellent flow through the endograft and all prosthetic branches. Discussion: Endovascular repair of TAAA appears to be feasible. If there are no serious, specific, unavoidable complications, the potential advantages are enormous.

Selective arterial embolization for the control of lower gastrointestinal bleeding

BACKGROUND Transcatheter embolization is accepted as a safe method for treating acute bleeding from the upper gastrointestinal (GI) tract. Hesitancy persists using this technique below the ligament of Treitz, based on the belief that the risk of intestinal infarction is unacceptably high, despite mounting clinical evidence to the contrary. METHODS A series of 17 consecutive patients with angiographically demonstrated small intestinal or colonic bleeding was retrospectively reviewed. The success and complication rate of subselective embolization was assessed. RESULTS Bleeding was stopped in 13 of 14 patients (93%) in whom embolization was possible, and in 13 of 17 patients (76%) where there was an intention to treat. Sufficiently selective catheterization to permit embolization could not be achieved in 3 patients. No clinically apparent bowel infarctions were caused. CONCLUSION Subselective embolization is a safe treatment option for lower GI bleeding, suitable for many patients and effective in most. Careful technique and a readiness to abandon embolization when a suitable catheter position cannot be achieved are important.

Histopathologic Study of Stenotic and Occluded Transjugular Intrahepatic Portosystemic Shunts

PURPOSE A detailed histopathologic analysis of three stenotic and two occluded transjugular intrahepatic portosystemic shunts was performed to evaluate the nature and cause of each shunt abnormality. PATIENTS AND METHODS The study group consists of five patients who developed a shunt stenosis or occlusion and subsequently underwent liver transplantation or autopsy. Shunt specimens were examined grossly and microscopically. RESULTS The pseudointima was composed of granulation tissue, which was generally denser and more cellular near the luminal surface. Pseudointima was thicker in the parenchymal portion of the shunt than at the venous ends. A contiguous single layer of endothelial-like cells lined the majority of the luminal surface of each shunt. Scattered debris and clot covered 10%-15% of the luminal surfaces. Transected bile ducts were noted in three cases. Bile staining was detected around the transected ducts, and bile pigment was incorporated into the developing pseudointima. CONCLUSIONS Pseudointimal hyperplasia appears to be the causative lesion in these obstructions. An inflammatory reaction incited by bile extravasation may have contributed to pseudointimal proliferation in three cases.

Endovascular aneurysm repair in high-risk patients☆☆☆★★★

PURPOSE The purpose of this study was to evaluate the role of endovascular aneurysm repair in high-risk patients. METHODS The elective endovascular repair of infrarenal aortic aneurysm was performed in 116 high-risk patients with either custom-made or commercial stent grafts. The routine follow-up examination included contrast-enhanced computed tomography (CT) before discharge, at 3, 6, and 12 months, and annually thereafter. Patients with endoleak on the initial CT underwent re-evaluation at 2 weeks. Those patients with positive CT results at 2 weeks underwent endovascular treatment. RESULTS Endovascular repair was considered feasible in 67% of the patients. The mean age was 75 years, and the mean aneurysm diameter was 6.3 cm. The American Society of Anesthesiologists grade was II in 3.4%, III in 65.5%, IV in 30.1%, and V in 0.9%. There were no conversions to open repair. Custom-made aortomonoiliac stent grafts were implanted in 77.6% of the cases, custom-made aortoaotic stent grafts in 11.2%, and commercial bifurcated stent grafts in 11.2%. The 30-day rates of mortality, major morbidity, and minor morbidity were 3.4%, 20.7%, and 12%, respectively, in the first 58 patients and 0%, 3.4%, and 3.4%, respectively, in the last 58. The late complications included five cases of stent graft kinking, two cases of femorofemoral graft occlusion, and three cases of proximal stent migration, one of which led to aneurysm rupture. At 2 weeks after repair, endoleak was present in 10.3% of the cases. All the type I (direct perigraft) endoleaks underwent successful endovascular treatment, whereas only one type II (collateral) endoleak responded to treatment. The technical success rate at 2 weeks was 86.2%, and the clinical success rate was 96.6%. The continuing success rate was 87.9%. Seventeen patients died late, unrelated deaths. CONCLUSION Endovascular aneurysm repair is safe and effective in patients at high risk, for whom it may be the preferred method of treatment.

Percutaneous Transhepatic Portal Vein Angioplasty and Stent Placement after Liver Transplantation: Early Experience☆

In four patients who underwent liver transplantation, portal vein thrombosis was associated with esophageal varices and significant gastrointestinal bleeding. In a fifth liver transplant patient, portal vein stenosis was suspected when evidence of hepatic ischemia was revealed at liver biopsy. Four patients were treated with percutaneous transhepatic portal vein angioplasty. Percutaneous recanalization was precluded by technical factors in the remaining patient. Early in the series, one patient required surgical excision of what proved to be a thick cuff of fibrous tissue and lymph nodes after angioplasty failed to widen the stenosis significantly. Later, a patient with residual stenosis was treated successfully by means of intravascular stent placement. Of the four patients treated, three eventually died secondary to multiple problems unrelated to the percutaneous procedure. This early experience suggests that transhepatic portal vein interventions are feasible in patients who have received liver transplants and may prove useful at least in the early postprocedure period.

The transjugular intrahepatic portosystemic shunt: an update.

OBJECTIVE The purpose of this article is to review the indications, outcomes, complications, patient selection, and technical aspects of creating a transjugular intrahepatic portosystemic shunt (TIPS). CONCLUSION The best available evidence supports the use of TIPS in secondary prevention of variceal bleeding and in refractory ascites, although TIPS is also commonly used for other indications such as Budd-Chiari syndrome, hepatic hydrothorax, and acute variceal hemorrhage. The TIPS procedure was revolutionized by the introduction of covered stents, which dramatically improved long-term shunt patency.

Successful Reversal of Hepatic Encephalopathy with Intentional Occlusion of Transjugular Intrahepatic Portosystemic Shunts

PURPOSE To establish a safe and effective method for occluding a transjugular intrahepatic portosystemic shunt (TIPS) in patients who develop uncontrollable, disabling encephalopathy. PATIENTS AND METHODS The study population consisted of five patients who developed refractory encephalopathy following TIPS. The indication for TIPS was bleeding in four patients and ascites in one. Wallstents that were 10 mm in diameter and 68 mm long were used to bridge the hepatic parenchyma in all patients. The onset of encephalopathy from the time of the TIPS procedure ranged from 24 hours to 210 days. Because encephalopathy was not responsive to conventional medical management, shunt thrombosis was induced by means of temporary inflation of an 11.5-mm-diameter latex occlusion balloon within the midportion of the stent. RESULTS All shunts were successfully thrombosed when the balloon was inflated for 12 hours or more. Encephalopathy resolved in four patients and improved in the remaining patient. One patient experienced recurrent bleeding within 24 hours of the TIPS occlusion that was controlled medically. CONCLUSION Temporary occlusion of a TIPS with latex balloons successfully induces shunt thrombosis and improves encephalopathy. However, the patient is again exposed to risks related to complications of portal hypertension.