Barry T. Uchida

Silicone-covered self-expanding metallic stents for the palliation of malignant esophageal obstruction and esophagorespiratory fistulas: Experience in 32 patients and a review of the literature ☆ ☆☆ ★ ★★ ♢

Abstract Esophagogastric malignancies often are manifested with progressive dysphagia or esophagorespiratory fistulas. Palliative modalities currently available have significant limitations. A modified Gianturco-Rosch silicone-covered self-expanding metallic Z stent was used in 32 consecutive patients with malignant esophageal obstruction (n =24) or esophagorespiratory fistulas (n = 8). The stent was placed successfully in all patients. Dysphagia improved by at least two grades in 21 of the 24 patients (87.5%); the mean dysphagia grade fell from 3.21 to 1.08. Six of the 8 patients with fistulas were able to resume a normal diet, and the other 2 were able to eat solids without symptoms of aspiration. Complications occurred in 10/32 patients (31%) and included stent migration (4 patients), food impaction (2 patients), membrane disruption with tumor ingrowth (1 patient), tumor overgrowth (1 patient), early pressure necrosis with hemorrhage (1 patient), and late pressure necrosis with sepsis (1 patient). The latter 2 patients died, giving a mortality rate of 6.3%. Many complications were managed with endoscopic or interventional radiologic techniques. Although randomized prospective clinical trials are needed, the silicone-covered Gianturco-Rosch Z stent offers promise for the effective palliation of malignant esophageal obstruction and esophagorespiratory fistulas. (Gastrontest Endosc 1994;40:22-33.)

Gianturco expandable wire stents in the treatment of superior vena cava syndrome recurring after maximum‐tolerance radiation

Two patients with superior vena cava syndrome (SVCS) recurring after maximum‐tolerance radiation were treated by placing a Gianturco expandable wire stent (GEWS) into the obstructed superior vena cava. The SVCS symptoms rapidly disappeared and good short‐term (6 months) palliation was achieved. GEWS placement is a promising therapeutic alternative for palliation of SVCS symptoms when other therapeutic modes cannot be used or are not effective.

Treatment of malignant esophageal obstruction with silicone-coated metallic self-expanding stents

Six patients with high-grade malignant esophageal obstruction were treated with silicone-coated metallic self-expanding esophageal stents (Z stents). Endoscopic placement of stents was well tolerated. All patients achieved excellent palliation, defined by a decrease of at least two dysphagia grades, which was sustained. Complications occurred during follow-up in four patients and included stent migration, silicone disruption with tumor ingrowth, food impaction, and perforation (discovered at autopsy) at the distal stent site. Three of the four complications were promptly treated by endoscopic or radiologic intervention. Recent modification in stent design and placement technique will hopefully reduce complications. The self-expanding stent has several theoretical advantages over the rigid plastic stent and Nd:YAG laser for palliation of obstructing esophageal malignancy.

Gianturco-Rösch expandable Z-stents in the treatment of superior vena cava syndrome.

Gianturco-Rösch expandable Z-stents were used in 22 patients with superior vena cava syndrome (SVCS). Stents were placed in all patients in the SVC and in 17 patients, also into the innominate veins. Stent placement resulted in complete relief of symptoms in all patients. Twenty-one patients had no SVCS recurrence from 1 to 16 months, to their death, or to the present time. SVCS recurred only in 1 patient 9 months after stent placement due to tumor ingrowth and secondary thrombosis. Based on ours and on other reported experiences, expandable metallic stents are effective devices for treatment of the SVCS which is difficult to manage by other means.

Bile Duct Injury as a Major Cause of Stenosis and Occlusion in Transjugular Intrahepatic Portosystemic Shunts: Comparative Histopathologic Analysis in Humans and Swine

PURPOSE A comparative histologic analysis of human and swine transjugular intrahepatic portosystemic shunts (TIPS) was performed to investigate factors limiting TIPS patency and to further develop an animal model for TIPS. MATERIALS AND METHODS Twenty-one human and 13 porcine shunts were evaluated by means of gross inspection, histologic evaluation, and electron microscopy. RESULTS Severe stenosis (> 75% narrowing) or occlusion was detected with portal venography in nine of the 21 human shunts (48%) and in 10 of 13 porcine shunts (77%). Gross or histologic evidence of a substantial biliary fistula was observed in seven of nine porcine shunts and in seven of eight human shunts with severe parenchymal tract stenosis or occlusion. No evidence of substantial bile duct injury was identified in the 13 human shunts or two swine shunts with patent, nonstenotic parenchymal tracts (P < .01, Fisher exact). Histologic findings in porcine shunts mimicked human tissue responses, including a metaplastic proliferation of bile duct epithelium at sites of bile duct transection. CONCLUSION Bile duct transection and bile leak are significantly associated with TIPS parenchymal tract abnormalities in patients and swine. TIPS in swine created with the Wallstent faithfully reproduce gross morphologic and histologic changes observed in patients.

Stent-Grafts for Revision of TIPS Stenoses and Occlusions: A Clinical Pilot Study

PURPOSE To assess the clinical and technical results of stent-graft placement for revision of transjugular intrahepatic portosystemic shunt (TIPS) stenoses and occlusions. MATERIALS AND METHODS Six patients who developed recurrent TIPS stenosis or occlusion of the parenchymal tract underwent shunt revision with use of polytetrafluoroethylene (PTFE) stent-grafts anchored at both ends by Z stents and centrally supported by Wallstents. RESULTS Before graft placement, mean primary patency was 50 days (range, 9-100 days). Patients underwent one to eight revisions with angioplasty or stent placement (mean, 3.2). Three patients had biliary-TIPS fistulas documented with use of a prototype double occlusion balloon catheter. Stent-grafts were successfully placed within the obstructed shunt, creating an excellent lumen in all cases. The portosystemic gradient was decreased from a mean of 24.3 mm Hg (range, 12-35 mm Hg) to a mean of 10.3 mm Hg (range, 7-16 mm Hg). Five of six patients were asymptomatic and no complications occurred (median clinical follow-up, 331 days). One patient died of pre-existing multi-organ system failure. The duration of primary patency after stent-grafting was improved (mean, 229 days; range, 27-324 days) and the difference approached statistical significance despite the small sample size (P = .056, paired t test). Three patients remained primarily patent at a mean venographic follow-up of 315 days. One shunt occluded at 1 month from residual thrombus in the portal vein, and one stenosis occurred that was secondary to misplacement of the original stent-graft. Patency was re-established in each of these patients. CONCLUSION PTFE covered stent-grafts are effective for shunt revision in patients with tract stenosis or occlusion and appear to improve TIPS patency.

Aortic and venous valve for percutaneous insertion

Summary The purpose of this paper is to present in vitro and in vivo experimental evaluation of a new, artificial, bicuspid, aortic and venous valve. Valves were constructed from square stents with barbs covered by porcine small intestine submucosa (SIS). A valve 15 mm in diameter was tested in a flow model (2.5 l/min) with pressure measurement. A 100-ml rubber bag attached to a side arm of the flow model simulated heart ejection fraction. In acute (n=6) and short-term (n=3) experiments conducted in four swine and four dogs, valves ranging from 16 - 28mm in diameter were placed into the ascending aorta through 10 F sheaths; three were placed subcoronary and six in a supracoronary position. Function and stability of the valves were studied with pressure measurements and aortograms. Three short-term animals were sacrificed for gross and histologic evaluation at one, two and four weeks respectively. In an acute experiment, venous valves with four barbs were placed into the IVC through an 8 F guiding catheter in three dogs. For longer-term testing, valves were placed into the IVCs and iliac veins of three young swine. The animals were followed up after two weeks with venograms, then were sacrificed for gross and histologic evaluation.

Treatment of Malignant Esophageal Obstructions with Covered Metallic Z Stents: Long-term Results in 52 Patients☆

PURPOSE To prospectively evaluate the clinical efficacy of silicone-covered Gianturco-Rösch self-expandable Z (GRZ) stents in the treatment of malignant esophageal obstruction. PATIENTS AND METHODS GRZ stents were placed in 52 patients (39 men, 13 women) with severe dysphagia due to high-grade malignant esophageal obstruction. RESULTS Stent placement was technically successful, and immediate relief of dysphagia was achieved in 50 of 52 patients (96%), with long-term relief in 47 patients (90%). Fifty-one patients (98%) died during follow-up (range, 1 week to 33 months; mean, 4.3 months). Late complications were most prevalent and included stent migration (n = 5), food impaction (n = 2), chest pain (n = 2), membrane disruption with tumor ingrowth (n = 1), granulomatous reaction above the stent (n = 1), esophageal perforation with mediastinitis (n = 1), and upper gastrointestinal hemorrhage (n = 4). Twelve complications were easily managed with medical, endoscopic, or radiologic intervention. Four deaths may have been related to stent placement (early mortality rate, 7.7%). CONCLUSION GRZ stents provide relatively safe and effective long-term palliation in patients with severe, malignant esophageal obstruction.

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 Malignant Esophagorespiratory Fistulas with Silicone-covered Metallic Z Stents

PURPOSE To prospectively evaluate the clinical efficacy of covered metallic Z stents in the treatment of esophagorespiratory fistulas (ERFs). PATIENTS AND METHODS Twelve patients with severe aspiration symptoms from malignant ERFs were treated with silicone-covered, metallic, self-expanding Gianturco-Rösch Z (GRZ) stents. RESULTS Fluoroscopically guided stent placement was successful and well tolerated in all patients. Immediate postprocedural endoscopy and esophagography showed excellent coverage of the fistulas in all cases. Aspiration symptoms were completely relieved in eight of 12 patients (67%). Four of 12 patients (33%) were improved and able to eat a soft diet. There were no stent-related deaths. Nine patients have died and three patients are alive. Mean follow-up for the entire group was 3.9 months (range, 1 week to 10.5 months). Nonfatal complications occurred in three of 12 patients (25%). Complications included one membrane disruption and one granulomatous reaction with a slight upward stent migration. CONCLUSION GRZ stents are an effective and safe means of palliation in patients with malignant esophagorespiratory fistulas.