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Annals of Internal Medicine | 1997

Transjugular Intrahepatic Portosystemic Shunts Compared with Endoscopic Sclerotherapy for the Prevention of Recurrent Variceal Hemorrhage: A Randomized, Controlled Trial

Arun J. Sanyal; Arthur M. Freedman; Velimir A. Luketic; Preston P. Purdum; Mitchell L. Shiffman; Patricia E. Cole; Jaime Tisnado; Sharon Simmons

Variceal hemorrhage results directly from portal hypertension. Therefore, the advent of portal decompressive shunt surgery held great promise for the treatment of variceal hemorrhage. This potential was not realized, however, and controlled trials showed no improvement in survival despite markedly decreased rebleeding rates [1-4]. This outcome has been attributed to the morbidity and mortality associated with general anesthesia, major surgery, and post-shunt encephalopathy [5, 6]. Transjugular intrahepatic portosystemic shunts (TIPS) [7-9] function like side-to-side portacaval shunts but avoid the risks associated with anesthesia and major surgery. This has led to renewed interest in portosystemic shunting as therapy for variceal hemorrhage [8, 9]. In two large initial uncontrolled studies [10, 11], TIPS were effectively used to control bleeding in patients with refractory variceal hemorrhage. However, no controlled studies have compared the utility of TIPS with that of currently available treatments for the prevention of recurrent variceal hemorrhage. In the absence of treatment, variceal hemorrhage recurs in approximately 70% of patients after the index bleeding episode [5, 12, 13]. This risk is greatest in the first 48 hours after initial hemostasis and gradually subsides thereafter [13-15]. The long-term course is punctuated by recurrent bleeding episodes, hepatic decompensation, and, eventually, death [13, 14]. Thus, rebleeding episodes may occur early (within a few days) or late (weeks to months) after an episode of variceal hemorrhage. The primary objective of our randomized trial was to compare the efficacy and safety of TIPS with those of repeated endoscopic sclerotherapy for the prevention of late variceal rebleeding in clinically stable persons who survived an episode of esophageal variceal bleeding. Methods Patients Active variceal hemorrhage was defined as emesis of coffee-ground material or bright red blood with or without melena or hematochezia, along with a decrease in hemoglobin level of at least 2 g/dL caused by bleeding varices. Bleeding was considered variceal in origin if actively bleeding varices or varices with stigmata of bleeding [16, 17] were seen during endoscopy and if no other lesions were noted that could explain the bleeding. Survivors of an episode of active esophageal variceal hemorrhage were considered for inclusion if they were clinically stable and were not actively hemorrhaging (absence of hemorrhage was indicated by a stable hemoglobin level and no need for transfusions) for at least 72 hours. Before randomization, all patients were assessed clinically and by Doppler ultrasonography. We excluded patients who had portal venous thrombosis, ultrasonographically evident hepatoma, and end-stage cancer or systemic diseases that would limit a patients life span to less than 1 year. Other exclusion criteria were failure to obtain informed consent, pregnancy, and a history of noncompliance with treatment. Randomization Therapy with -blockers was discontinued in all patients who were taking these agents before study entry. Patients who met entry criteria were randomly assigned to either TIPS or sclerotherapy. Patients were not stratified in any manner before being randomly assigned in a 1:1 ratio, which was done by using a computer-generated randomization code. Randomization was performed by selecting a sealed opaque envelope that contained the code for the study group. The study groups were balanced for every 20 randomly assigned patients. For all patients, the primary intervention was initiated within 72 hours of randomization. Primary Interventions Transjugular Intrahepatic Portosystemic Shunts Transjugular intrahepatic portosystemic shunts were created with Wallstents (Schneider, Inc., Plymouth, Minnesota) using standard techniques described elsewhere [10, 18]. Special care was taken to ensure that only the central portions of the right or left branches of the portal vein were used for creation of the intrahepatic tract in order to optimize hemodynamics and minimize turbulence in the stent. After the TIPS were created, the stents were dilated with an 8-mm balloon catheter. By using methods described in previous reports [18, 19], pressures were measured in the inferior vena cava; hepatic vein; and proximal, middle, and distal stent and portal vein before and after TIPS were created. If the portosystemic gradient did not decrease to less than 12 mm Hg or the completion portogram did not demonstrate excellent flow through the stent, the stent was dilated to 10 mm and pressure was measured again. If the gradient was less than 12 mm Hg, the stent was dilated to 12 mm. Parallel stents were not used in any patient. The left gastric vein was not embolized. Sclerotherapy Patients assigned to sclerotherapy were treated with 2-mL intravariceal freehand injections of 5% Na morrhuate, for a total of 12 to 20 mL per session. Patients received sclerotherapy every 2 to 3 weeks until all varices were obliterated. After obliteration, surveillance endoscopy was performed every 3 months for 1 year and every 6 months thereafter. If varices recurred, sclerotherapy was again performed at 2- to 3-week intervals until varices were obliterated. Follow-up and Data Collection All patients were followed in the clinical research center outpatient clinic at the Medical College of Virginia by a team of hepatologists and trained nurses. Data were collected from patients during clinic visits, visits to the endoscopy-angiography suite for sclerotherapy, or hospitalizations for any reason. After TIPS were created, patients were seen every month for the first 6 months and every 3 months thereafter. Patency and function of the stents were assessed by Doppler ultrasonography on day 1, week 1, months 1 and 3, and every 3 months thereafter. In the TIPS group, all surviving patients had angiography every 6 months. Angiography was also done if variceal hemorrhage recurred or if results of one of the noninvasive tests suggested that the stent was not patent. Patients undergoing sclerotherapy were seen in the endoscopy suite until varices were obliterated. They were then seen in clinic every month until 6 months from randomization and every 3 months thereafter. Endoscopy was performed before TIPS were created and on day 7, months 1 and 3, and every 3 months thereafter. Varices were photographed in the retroflexed position, at the gastroesophageal junction, and 2 and 5 cm above the gastroesophageal junction. These photographs were later evaluated in a blinded manner by four investigators. Varices were graded as follows: 0, absent; 1, trace (flattens on insufflation); 2, small (minor impingement on lumen after insufflation); 3, greater than 25% of luminal impingement after insufflation; and 4, lumen-occluding varices. Little variability was seen between repeated observations by the same endoscopists (Spearman correlation coefficient = 0.89; P < 0.001) or different endoscopists (rank correlation coefficients > 0.85; P < 0.001). Secondary Interventions Occlusion of TIPS was identified if angiography showed occlusion of the stent. Stenosis of TIPS was defined by angiographic definition of the contour of the shunt (>25% impingement of lumen). Recurrent portal hypertension was arbitrarily defined as a portosystemic gradient greater than 12 mm Hg in patients whose portosystemic gradient immediately after TIPS creation was less than 12 mm Hg. In patients whose portosystemic gradient after TIPS creation was greater than 12 mm Hg, recurrent portal hypertension was defined as a 25% increase in portal pressure. Patients with TIPS occlusion due to shunt thrombosis were treated with angiographic clot removal [20]. Recurrent portal hypertension caused by stent stenosis was managed by dilatation of the stent and placement of additional stents in a series to bridge the stenosed segment. Management of Recurrent Variceal Hemorrhage Recurrent hemorrhage was defined as hematemesis or melena occurring after randomization. All cases of recurrent hemorrhage were examined by endoscopy within 24 hours of hospitalization. Regardless of study group, all patients who had bleeding esophageal varices, esophageal varices with stigmata of bleeding, and gastric varices that were contiguous with esophageal varices were initially injected with 12 to 20 mL of 5% Na morrhuate. Patients in the sclerotherapy group who rebled from varices were offered TIPS if 1) they continued to bleed actively [that is, had bright red blood in nasogastric aspirate and required transfusion of >3 units of packed red blood cells every 8 hours to maintain a hemoglobin level of approximately 9 g/dL] or 2) after they stopped bleeding. Because, in theory, one would not expect varices to be present or to rebleed in the presence of widely patent TIPS, patients in the TIPS group who rebled from varices were studied by angiography either immediately (if they continued to bleed actively despite sclerotherapy) or within 48 hours of control of active hemorrhage. Any TIPS stenoses were corrected by balloon dilatation and further stenting within the original stent. Active hemorrhage that continues despite adequate portal decompression is an indication for embolization of the left gastric vein; however, embolization was not necessary in any patient. End Points and Data Analysis Data were stored in a spreadsheet that was created using Lotus software (Boston, Massachusetts) and were analyzed by using software from Epistat, Inc. (Richardson, Texas). The principal end points studied were rebleeding and survival, and secondary end points were complications and rates of rehospitalization. Intention-to-treat analyses were done. Between-group differences in survival, rebleeding, and encephalopathy were assessed by the Wilcoxon and log-rank tests. Relative risks were also determined, and CIs [21, 22] were used to confirm equivalence when no significant differences between treatment groups were found. Co


Transplantation | 1999

Defining hepatocellular chimerism in a liver failure patient bridged with hepatocyte infusion

Robert A. Fisher; Dawen Bu; Melissa T. Thompson; Jaime Tisnado; Uma R. Prasad; Richard K. Sterling; Marc P. Posner; Stephen C. Strom

BACKGROUND A practical method of monitoring engraftment by transplanted hepatocytes for the purpose of bridging human liver failure to native regeneration is described. METHODS A previously healthy 37-year-old female with a 2-week history of a febrile illness presented with fulminant liver failure. Findings on admission included the following: illicit drug use, serum hepatitis B surface antigen positive, grade 1 encephalopathy, prothrombin time (pt) >100 sec, F7<1%, NH3 150 micromol/L, alanine aminotransferase 4079 U/L, total bilirubin level 11.4 mg/dl, and glucose 70 mg/dl (on IV D10). With immunosuppression, 8.8x10(8), 96% viable human hepatocytes were intraportally infused. Clinical chemistries, total sHLA class I, and ELISA to measure donor-specific sHLA-A1 and -B8 were recorded. Serial transjugular liver biopsies were performed and pooled for histological examination, DNA extraction, and HLA DNA typing. RESULTS The patient fully recovered. At months 3 and 4 with donor biopsy specimen class I HLA DNA no longer detectable, immunosuppression was tapered off. The patient is clinically normal, serum hepatitis B surface antigen negative at 10 months of follow-up. CONCLUSIONS Bridging liver failure with donor hepatocytes with HLA class I antigen disparate from recipients is clinically feasible, and allows for a marker, combined with serial graft histology, to safely wean immunosuppression when native liver regeneration succeeds.


Journal of Computer Assisted Tomography | 1981

Computed Tomography in the Evaluation of Carcinoma of the Ovary

Marco A. Amendola; James W. Walsh; Beatriz E. Amendola; Jaime Tisnado; Don J. Hall; Dean R. Goplerud

Over a 26 month period, 34 patients with histologically proven ovarian malignancy were studied by computed tomography (CT). In nine patients, CT was obtained for evaluation of a pelvic or abdominal mass. Computed tomography was diagnostic of ovarian malignancy in seven and indeterminate regarding the origin of the tumor in two patients. Ten patients were evaluated by CT in order to rule out recurrent ovarian neoplasm. Disease free intervals prior to CT ranged from 6 to 36 months with an average of 18 months. In eight surgically proven cases, CT was true positive for recurrent tumor in six patients, true negative in one, and false positive in one. In 20 patients, serial CT examinations were valuable in the objective assessment of measurable tumor response following chemotherapy and radiation therapy. A major limitation of CT was its inability to detect peritoneal and liver surface implants smaller than 2 cm in size.


American Journal of Transplantation | 2003

Non‐Resective Ablation and Liver Transplantation in Patients with Cirrhosis and Hepatocellular Carcinoma (HCC): Safety and Efficacy

Daniel G. Maluf; Robert A. Fisher; T. Maroney; Adrian H. Cotterell; Ann S. Fulcher; Jaime Tisnado; Melissa J. Contos; Velimir A. Luketic; Richard T. Stravitz; Mitchell L. Shiffman; Richard K. Sterling; Mitchell C. Posner

We investigated the efficacy of nonresective ablation techniques and the tumor‐free survival of cirrhotic patients undergoing liver transplantation for hepatocellular carcinoma (HCC). In group 1, 11 HCC patients were treated with these techniques and transplanted. On the waiting list, patients were treated to complete ablation, judged by gadolinium‐enhanced MRI and alpha‐fetoprotein (AFP) levels. Group 1 was compared with a concurrent group of 10 liver transplant patients (group 2) with incidental HCC (stages T1  three patients, T2  seven patients). The group 1 patients received 36 procedures (4 alcohol ablations, 14 trans ‐hepatic artery chemo‐embolizations, 15 trans ‐hepatic chemo‐infusions, and 3 radio frequency ablations) for treatment of 13 liver masses. Tumor‐node‐metastasis (TNM) stage was reduced in eight patients (72.7%), unchanged in two patients and increased in one patient before transplantation. The mean waiting time for transplantation was 12.9  7.6 months. Both groups had a tumor‐free survival of 100%, at 30  12 months post transplant. On pathology, 54.5% of explanted livers had residual viable HCC after tumor treatment, and 36.4% (4/11) explants had synchronous lesions. Non‐resective ablation therapy is safe and effective in reducing the HCC progression in cirrhotic patients awaiting liver transplantation. The cancer‐free survival rate in this treatment group is equal to that for incidental T1–T2 HCCs.


British Journal of Radiology | 1986

Persistent sciatic artery. Report of three cases and literature review

Mark P. Freeman; Jaime Tisnado; Shao-Ru Cho

Persistence of the sciatic artery (SA) is a rare vascular anomaly, resulting from lack of regression of an embryonal artery to the lower extremity. Forty-nine cases have been published in the world literature since 1832. The persistent sciatic artery (PSA) is particularly prone to undergo aneurysm formation or atherosclerosis. It originates from the internal iliac artery, courses in close proximity to the sciatic nerve, and provides the main supply to the popliteal artery because a hypoplastic superficial femoral artery (SFA), contributing only collaterals to the knees, is usually associated with a PSA. This anomaly should be kept in mind in the clinical assessment of a pulsatile gluteal mass. It also presents a potential hazard during hip and renal transplant surgery.


Journal of Vascular and Interventional Radiology | 2008

Treatment of Infolding Related to the Gore TAG Thoracic Endoprosthesis

D.A. Leung; Ivan Davis; Gundars Katlaps; Jaime Tisnado; M.K. Sydnor; D.J. Komorowski; Derek R. Brinster

The present report describes three cases of thoracic aortic endograft infolding or collapse involving the Gore TAG system. The cases include a penetrating aortic injury, a blunt aortic injury, and a symptomatic type B dissection. In the first case, infolding occurred in a delayed fashion after a normal-appearing 3-month follow-up computed tomographic angiogram. In the other two cases, infolding occurred during the immediate postoperative phase. One of the patients underwent explantation and surgical repair. The other two underwent endovascular repair of the infolded endograft by placement of a balloon-expandable stent in one case and a self-expanding stent in the other.


Radiology | 1979

Evaluation of Retroperitoneal Hemorrhage by Computed Tomography Before and After Translumbar Aortography

Marco A. Amendola; Jaime Tisnado; William R. Fields; Michael C. Beachley; Frederick S. Vines; Shao-Ru Cho; Mary Ann Turner; Karsten F. Konerding

Twenty patients were prospectively studied by computed tomography (CT) before and after undergoing translumbar aortography (TLA). Changes indicative of retroperitoneal bleeding were depicted by CT in all 20 patients despite the predominantly small size of the hematomas. CT scans obtained within two hours after TLA demonstrated: (a) thickening of the diaphragmatic crura, (b) enlargement of the left psoas muscle, and (c) obscuration of the aortic outline by soft-tissue density. Follow-up scans at 24 hours (10 patients) and one week (3 patients) revealed marked decrease in abnormalities, suggesting rapid resorption of the hematoma.


CardioVascular and Interventional Radiology | 1979

Aneurysm of a persistent sciatic artery

Jaime Tisnado; Michael C. Beachley; Marco A. Amendola; S. Levinson

Angiographic examination in a patient with sciatic-like pain on the right side and a firm, pulsatile, non-tender mass in the right buttock revealed a large sciatic artery aneurysm. The aneurysm was successfully resected at surgery.The primitive sciatic artery is the main arterial supply to the lower extremities in the 9-mm embryo. Its persistence, while very rare, is of clinical significance because of the tendency for aneurysms to develop in the artery. Surgical resection is indicated in sciatic artery aneurysms because of the danger of rupture or embolic occlusion of arteries distal to the aneurysm.


Annals of Vascular Surgery | 1990

Traumatic Superior Mesenteric Artery—Portal Vein Fistula

J. Deitrick; P. McNeill; Marc P. Posner; J. Kellum; S. Cho; Jaime Tisnado; H.M. Lee

An interesting and rare case of traumatic superior mesenteric artery-to-portal vein arteriovenous fistula is presented. Initial operative control of the bleeding superior mesenteric artery injury required ligation of the superior mesenteric artery at its origin to prevent exsanguination in an extremely unstable patient with multiple injuries. Early postoperative visceral arteriography documented ligation of the superior mesenteric artery with a proximal superior mesenteric artery-to-portal vein arteriovenous fistula. Percutaneous catheter embolization of the arteriovenous fistula was undertaken successfully at this time. Superior mesenteric artery ligation was surprisingly well tolerated. Major arterioportal fistulas require treatment to prevent long-term complications of intestinal ischemia, portal hypertension, and cirrhosis. Although traditional treatment involves ligation of the arteriovenous fistula and arterial bypass, percutaneous embolization is becoming a viable alternative. Arteriography remains the cornerstone of diagnosis and treatment planning.


CardioVascular and Interventional Radiology | 1989

Transcatheter embolization of an arteriovenous malformation of the scrotum

Diran R. Bezirdjian; Paul D. Reznikov; Jaime Tisnado

There are several vascular abnormalities that could affect the scrotum. The commonest is a varicocele, and differentiation between this and other lesions is possible using Doppler ultrasound and pelvic angiography. A patient with a scrotal arteriovenous malformation (AVM) is presented in whom transcatheter embolization was possible.

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Marc P. Posner

Virginia Commonwealth University

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Velimir A. Luketic

Virginia Commonwealth University

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