Primary Stenting of Focal Atherosclerotic Infrarenal Aortic Stenoses: Long-Term Results in 13 Patients and a Literature Review

We conducted this study to investigate the value of primary stent implantation for the endovascular treatment of focal atherosclerotic stenoses of the infrarenal abdominal aorta. The data of 13 patients with a localized complex infrarenal aortic stenosis who underwent primary stenting was retrospectively evaluated. The patients (6 females, 7 males) had a mean age of 57.3 ± 9.1 years (mean ± SD). In all patients, the aortic diameter was measured on CT sections, and a self-expanding endoprosthesis was primarily implanted followed by dilatation with single or double balloons. In 3 patients, additional distal stenoses were also endovascularly treated. The procedure was technically successful in all patients. No complications occurred except for 2 minor groin hematomas. During the 43 ± 23 months (mean ± SD) follow-up (range: 12–96 months), all stented aortic segments remained patent. Clinical patency was lost in 4 patients, which was due to atherosclerosis or restenosis distal to the aorta. In view of the excellent early and long-term results, we believe that primary stenting should be considered the first line treatment in properly selected patients with focal atherosclerotic infrarenal stenoses of the abdominal aorta.     

Primary stenting in the treatment of focal atherosclerotic abdominal aortic stenoses

AIM: To evaluate the results of primary stent placement in focal atherosclerotic aortic stenoses using balloon expandable stents. MATERIALS AND METHODS: Twenty-six primary balloon expandable stent placements in the abdominal aorta were performed and reviewed. All the aortic stenoses were atherosclerotic. Patients were followed up by ankle/brachial pressure indices (ABPI) and Doppler ultrasound (US) at 24h after procedure and at 12 and 24 months. Follow-up angiograms were performed at 12 months. RESULTS: Twenty-six stents in 26 patients were placed in the infrarenal aorta. All procedures were technically successful and immediate clinical success was obtained. The mean ABPI significantly improved from 0.52+/-0.10 to 0.94+/-0.09 within 24h after procedure, and remained at 0.90+/-0.12 between 12 and 24 months follow-up (mean 18 months). There was full haemodynamic success at hospital discharge and at 12 and 24 months after the procedure. Clinical success at 12 and 24 months (mean 18 months) was defined as an improvement in the Fontaine classification by at least one class compared with the pre-procedure class and was shown to be 100%. CONCLUSION: In summary, we report that primary stenting is a safe and effective alternative to surgery in cases of symptomatic stenosis of the infrarenal abdominal aorta. The excellent intermediate term results suggested that we would recommend primary stenting as the treatment of choice for focal atherosclerotic stenoses of the infrarenal aorta in selected patients.     

Iliac artery stent placement: clinical experience and short-term follow-up regarding a self-expanding nitinol stent

PURPOSE: To evaluate the effectiveness, safety, and short-term patency rates of a self-expandable nitinol stent (JostentSelfX; Abbott Laboratories, Chicago, IL) for treatment of iliac artery stenoses. MATERIALS AND METHODS: In a prospective study, 34 chronic iliac artery stenoses were primarily treated in 27 patients (mean age, 61.7 years +/- 9.4) by placement of a JostentSelfX. Handling and visibility of the stent was scored on a 4-point scale. Before stent placement, within 3 days after stent placement and at 6 months follow-up, the clinical history, clinical stage according to the Rutherford classification, and the ankle-brachial index (ABI) were assessed. Intra-arterial digital subtraction angiography including measurement of the mean pressure gradient was performed at the time of stent placement and at 6 months follow-up or in case of recurrence of symptoms. The Wilcoxon signed rank test and Kaplan-Meier method were applied for statistical analysis. RESULTS: The immediate technical success rate was 94%. The clinical success rate immediately after the procedure was 96% and 85% at 6 months follow-up. Stent placement significantly decreased the severity of stenoses as well as the mean pressure gradients and significantly increased the ABI. Handling of the stent was judged good. No misplacement occurred. Foreshortening during deployment was negligible and no stent migration was seen. However, visibility of the stent during fluoroscopy was ranked as moderate to bad. Follow-up at 6 months revealed the cumulative angiographic primary patency rate (<50% restenosis and <10 mm Hg mean pressure gradient) to be 0.96. CONCLUSION: The evaluated self-expandable nitinol stent is an effective tool in treating iliac artery stenoses. Apart from poor visibility, handling was good. The angiographic patency rate is comparable with data reported in other stent trials.     

Primary endovascular stent placement for focal infrarenal aortic stenosis: long-term results

PURPOSE: The objectives of this retrospective study were to determine the technical success, safety, and long-term results of primary stent implantation in infrarenal aortic stenosis. MATERIALS AND METHODS: A total of eight atherosclerotic stenoses and one occlusion of the infrarenal aorta (ie, midaortic syndrome) were treated with endoluminal stent placement after balloon angioplasty. Aortoiliac lesions were excluded. Technical success and patency were assessed. RESULTS: Primary technical success in percutaneous transluminal angioplasty and subsequent stent placement was achieved in all patients. No complications occurred, and no morbidity was encountered. Primary clinical patency rates were 100% on all follow-up examinations. Long-term results with a mean follow-up of 110 months (range, 99-117 months) were recorded in seven patients; one patient had died and one was lost to follow-up. CONCLUSIONS: In view of the excellent initial results and promising long-term follow-up data in a small series, stent placement after predilation in properly selected patients with isolated infrarenal aortic stenosis appears to be a promising, durable treatment. It should be considered as a primary method of treatment.     

Primary stent placement for infrarenal aortic stenosis: immediate and midterm results

PURPOSE: To evaluate the safety and the long-term clinical and hemodynamic results of primary stent placement of atherosclerotic calcified stenosis of the infrarenal aorta. MATERIAL AND METHODS: Between July 1996 and July 1999, 15 patients (nine male, si- female; mean age, 53.9 years) with symptomatic, calcified aortic stenosis were treated with primary stent placement. Patients underwent abdominal aortography and bilateral lower extremity arteriography. Follow-up was performed in all 15 patients. Technical success was defined as residual stenosis of less than 30% or a resting trans-systolic pressure gradient of less than 10 mm Hg after stent placement. Clinical patency was defined as the absence or improvement of symptoms after stent placement. Hemodynamic patency was defined as a normal triphasic Doppler waveform in the common femoral artery, an ankle-brachial index greater than 0.90, or the absence of a thigh-brachial pressure gradient at rest in either limb. RESULTS: Technical success was achieved in 13 of 15 patients. The two patients considered to be technical failures had resting trans-systolic pressure gradients of 12 and 13 mm Hg, respectively, after stent placement. After the mean follow-up of 36 months, primary clinical and hemodynamic patency rates were 85% and the secondary hemodynamic patency rate was 100%. Two of five symptomatic recurrences during the 36-month follow-up period (range, 12-46 months) were a result of aortic restenosis and were treated with repeated percutaneous transluminal angioplasty. None of the patients required aortic surgery. Complications of the primary procedure included one puncture site infection, one pseudoaneurysm, and one distal embolization, which delayed discharge of three patients. There was no morbidity during the secondary interventions. CONCLUSION: Primary stent placement as treatment of calcified infrarenal aortic stenosis proved to be safe and also provided durable long-term clinical improvement.     

Aortic bifurcation reconstruction: Use of the memotherm self-expanding nitinol stent for stenoses and occlusions

PURPOSE: To assess the technical success, initial clinical outcome, and intermediate follow-up of the Memotherm nitinol self-expanding stent in aortic bifurcation reconstruction. METHODS: Thirty-three patients (13 male, 20 female), mean age 64 years, were treated, who had symptoms classified by the Surgical Vascular Society/International Society of Cardiovascular Surgery (SVS/ICVS) classification as grade 2 in 11 (33%), grade 3 in 19 (58%) and grade 4 in 3 (9%) patients. Lesions were classified according to severity and type. Indications for placement of a Memotherm nitinol self-expanding stent were failed angioplasty in 14 (42%), chronic occlusions in 12 (37%), and complex stenoses in seven (21%) patients. RESULTS: Sixty-seven stents were technically successfully placed in 66 aorto-iliac segments in 33 patients, with one major complication. Initial clinical outcome was improvement in 25 (81%), no change in four (13%), and a worsening in two (6%) patients by Rutherford criteria. Mean early ankle/brachial pressure index (ABI) gain was 0. 27 for occlusions and 0.05 for stenoses. Clinical follow-up was obtained in all patients, with retrospective angiographic follow-up in 28 (85%) at a mean of 16 months (range 12-26 months). The decrease in ABI and the decrease in angiographic luminal diameter at follow-up was determined as the "late loss." The mean ABI late losses were -0.06, 0.00, and 0.09, and the mean angiographic late losses were 6.7%, 10% and 14% for occlusions, stenoses, and normal segments respectively. Primary clinical patency was 96%, primary angiographic patency was 89%, and secondary angiographic patency was 93%. CONCLUSION: The high technical success of stent placement, the low complication rates for aortic bifurcation reconstruction using the Memotherm self-expanding stent, and high clinical and angiographic patency maintained at intermediate follow-up support their use in aortic bifurcation reconstruction.     

Initial clinical experience with the 4-F self-expanding XPERT stent system for infrapopliteal treatment of patients with severe claudication and critical limb ischemia

PURPOSE: To evaluate the primary success and short-term patency associated with a new 4-F sheath-compatible self-expanding nitinol stent after failed conventional angioplasty of distal popliteal and infrapopliteal lesions in severe lifestyle-limiting claudication (LLC) and chronic critical limb ischemia (CLI). MATERIALS AND METHODS: Between May 2003 and July 2005, 35 patients with Rutherford category 3-5 disease (16 patients with CLI, 19 patients with LLC) underwent percutaneous transluminal angioplasty (PTA) and stent implantation. Indications for stent placement were residual stenosis, flow-limiting dissections, or elastic recoil after PTA. Before and after the intervention and during the 6-month follow-up, clinical investigation, color-flow and duplex Doppler ultrasonography, and digital subtraction angiography were performed. Technical success, primary patency at 6 months, clinical improvement as defined by Rutherford with clinical and hemodynamic measures, and complications were evaluated. RESULTS: A total of 22 patients underwent distal popliteal artery stent placement and 13 underwent tibioperoneal artery stent placement. Stent implantation was successfully performed in all patients. After stent placement, the primary cumulative patency rate for the study group at 6 months was 82%. The mean resting ankle-brachial index at baseline was 0.50 +/- 0.16 and significantly increased to 0.90 +/- 0.17 at 12-24 hours after intervention and 0.82 +/- 0.24 at latest follow-up (P < .001 for both). The sustained clinical improvement rate was 80% at the 6-month follow-up. The 6-month limb salvage rate regarding major amputation was 100%. The rate of major complications was 17%. CONCLUSIONS: Infrapopliteal application of the new nitinol stent is a safe, feasible, and effective method with good short-term patency rate in the treatment of severe LLC and chronic CLI.     

Aortic Bifurcation Reconstruction: Use of the Memotherm Self-Expanding Nitinol Stent for Stenoses and Occlusions

Purpose: To assess the technical success, initial clinical outcome, and intermediate follow-up of the Memotherm nitinol self-expanding stent in aortic bifurcation reconstruction. Methods: Thirty-three patients (13 male, 20 female), mean age 64 years, were treated, who had symptoms classified by the Surgical Vascular Society/International Society of Cardiovascular Surgery (SVS/ICVS) classification as grade 2 in 11 (33%), grade 3 in 19 (58%) and grade 4 in 3 (9%) patients. Lesions were classified according to severity and type. Indications for placement of a Memotherm nitinol self-expanding stent were failed angioplasty in 14 (42%), chronic occlusions in 12 (37%), and complex stenoses in seven (21%) patients. Results: Sixty-seven stents were technically successfully placed in 66 aorto-iliac segments in 33 patients, with one major complication. Initial clinical outcome was improvement in 25 (81%), no change in four (13%), and a worsening in two (6%) patients by Rutherford criteria. Mean early ankle/brachial pressure index (ABI) gain was 0.27 for occlusions and 0.05 for stenoses. Clinical follow-up was obtained in all patients, with retrospective angiographic follow-up in 28 (85%) at a mean of 16 months (range 12–26 months). The decrease in ABI and the decrease in angiographic luminal diameter at follow-up was determined as the “late loss.” The mean ABI late losses were −0.06, 0.00, and 0.09, and the mean angiographic late losses were 6.7%, 10% and 14% for occlusions, stenoses, and normal segments respectively. Primary clinical patency was 96%, primary angiographic patency was 89%, and secondary angiographic patency was 93%. Conclusion: The high technical success of stent placement, the low complication rates for aortic bifurcation reconstruction using the Memotherm self-expanding stent, and high clinical and angiographic patency maintained at intermediate follow-up support their use in aortic bifurcation reconstruction.     

Angioplasty of the terminal aorta: follow-up of 20 patients treated by PTA or PTA with stents

Twenty patients with distal aortic stenosis were treated by PTA for intermittent claudication and, in 3, 'blue toe' syndrome. Additionally, a self-expandable endoprosthesis (stent) was inserted into the aorta in three of the patients. The overall primary success rate (including those with a stent) was 100% with all patients becoming free of symptoms. Mean arm-ankle pressure difference decreased from 48 mmHg to 9 mmHg (P less than 0.01). During a median follow-up period of 15 months no patient had recurrence of claudication, embolism, or deterioration of the non-invasive parameters. Thus, PTA seems suitable for treating stenoses of the abdominal aorta, even in the presence of distal microembolization. Balloon dilatation, with the addition of stents in resistant cases, offers a valuable alternative to surgery in distal aortic stenosis.     

Endovascular treatment of steno-occlusions of the infrarenal abdominal aorta

PURPOSE: Our aim is to report our experience in the endovascular treatment of steno-occlusions of the infrarenal abdominal aorta. MATERIALS AND METHODS: We selected 19 patients (mean age 66.3 years, range 45-80): five with complete occlusion of the infrarenal aorta and both common iliac arteries (CIAs), four of which were associated with occlusion of the external iliac arteries (EIAs); three with complete occlusion and three with severe stenosis of the distal aorta with occlusion or stenosis of the CIAs and EIAs; and eight with focal severe stenosis of the infrarenal aorta. All patients were treated with direct stenting. RESULTS: Immediate technical success was 94.7% (18/19 cases). We observed two cases of distal embolism treated with thrombolysis, one case of mild renal failure and one case of transient angina abdominis. During the follow-up (mean 19.6 months; range 6-48), 2/18 (11.1%) occlusions of an iliac stent occurred 1 and 3 months after the procedure (treated with local intra-arterial thrombolysis). The primary patency rate was 88.8% and the secondary patency rate was 100%. CONCLUSIONS: Direct stenting is a feasible and safe option for the treatment of infrarenal abdominal aortic steno-occlusions, especially in patients at high surgical risk, with good early and late clinical results.     

Endovascular placement of self-expanding nitinol coil stents for the treatment of femoropopliteal obstructive disease

PURPOSE: To report on a prospective two-center study to evaluate safety and effectiveness of a self-expanding nitinol coil stent in patients with femoropopliteal obstructive disease. MATERIALS AND METHODS: The IntraCoil nitinol stent was used in 37 patients (28 men and nine women; mean age, 62.4 y plus minus 10.7; range, 43-81 y) presenting with high-grade stenoses (n = 23) or short (<3 cm) occlusions (n = 17) of the superficial femoral artery (SFA; n = 33) or popliteal artery (n = 4). Indications for stent placement were significant residual stenosis (>30%) or dissection after angioplasty. Follow-up evaluations with measurement of the Doppler ankle-brachial index (ABI), assessment of Rutherford clinical stage, and color-coded duplex sonography were performed at discharge and 1, 3, 6, 12, and 18 months thereafter. Primary endpoints of the study were immediate technical and clinical success and 1-year patency. RESULTS: Initial technical success was achieved in all patients. In 10 patients (27%), more than one 40-mm-long device had to be implanted for total lesion coverage; in three patients (8.1%), stents were placed in two separate segments of the SFA simultaneously. The total number of stents deployed was 50. Stent placement induced an initial improvement of the ABI from 0.54 plus minus 0.2 to 0.92 plus minus 0.11 (P <.01). Follow-up data for 12 months after treatment are available for 29 of 37 patients (78.4%); mean follow-up is 15.6 months (range, 1-26 mo). Primary patency rates at 6 and 12 months were 97.1% (SE = 2.9) and 86.2% (SE = 6.5). The primary assisted patency rate was 100% at 12 months. CONCLUSION: Endovascular placement of the IntraCoil self-expanding nitinol coil stent for salvage of failed angioplasty in patients with femoropopliteal obstructive disease is an effective and safe procedure with promising mid-term results.     

Endovascular Treatment Strategies in Aortoiliac Occlusion

The aim of this study was to report our experience in endovascular treatment of total aortoiliac occlusion. Five patients who underwent endovascular recanalization procedures including manual aspiration thrombectomy, balloon angioplasty, and stent placement for total aortoiliac occlusion in a 4-year period were reviewed retrospectively. The mean age of patients was 51 years (range, 43 to 58 years). All patients had abdominal aorta and bilateral common iliac artery occlusion with or without external iliac artery occlusion. All patients either had a contraindication to surgery or refused it. Initial technical success was obtained in four of five (80%) patients. Endovascular techniques were successful in four patients who had good distal runoff and short-segment aortoiliac occlusion, but failed in a patient who had the worst distal runoff and long-segment aortoiliac occlusion. We observed two major complications, one of which was bilateral rupture of the common iliac arteries treated with covered stent placement. Another patient had extension of intra-aortic thrombus into the iliac stent after primary stenting. This was successfully treated with manual aspiration thrombectomy. Aortic and iliac stents remained patent during the follow-up period (median, 18 months; range, 3 to 26 months) in four patients. Primary patency rates at 6, 12, and 24 months were all 80%. In conclusion, endovascular treatment can be an alternative for aortoiliac occlusion in selected patients. Short- to midterm follow-up so far is satisfactory. Removal of intra-aortic thrombus with manual aspiration thrombectomy before balloon angioplasty and/or stenting is possible and a good alternative to thrombolysis.     

Chimney stent technique for treatment of severe abdominal aortic atherosclerotic stenosis

Application of the "chimney" stent technique is described in a case of complex multilevel atherosclerotic disease involving the juxtarenal aorta. A patient with significant comorbidities was unsuitable for major open reconstructive surgery. He was treated with a combined procedure consisting of chimney stent placement in the juxtarenal aorta, iliac "kissing" stent placement, and right-sided common femoral artery (CFA) replacement. This case shows that the chimney stent technique can be a feasible alternative to leaving a safety wire in the renal arteries and observation during primary angioplasty in complex atherosclerotic lesions of the abdominal aorta.     

主动脉瘤的血管内支架治疗

作者对１例胸腹主动脉瘤（假性）伴后纵隔和腹膜后血肿患者作了密集网格式镍钛合金内支架治疗。经股动脉入路，用１２Ｆ导管将直径２０ｍｍ、长９０ｍｍ内支架跨靶病灶放置，另一直径２４ｍｍ、长５０ｍｍ内支架则用于加固前者。术后即刻造影示动脉瘤被部分隔离；２周后ＣＴ和造影随访显示：瘤腔被完全隔离，主动脉狭窄和受压移位消失，所有分支血管完全畅通，支架无移位。临床随访至今８周未出现腹痛复发，围手术期亦未发生严重并发     

Percutaneous transluminal aortic angioplasty: Early and late results

Percutaneous transluminal angioplasty of the infrarenal abdominal aorta (13 patients) and its bifurcation (15 patients) was performed in 28 patients with a total of 32 dilatation procedures. The group consisted of 16 female and 12 male patients and initial successful dilatation was achieved in all Recurrence within 1 month requiring bypass surgery occurred in 1 patient. Three patients were lost to follow-up. Long-term follow-up in the remaining 24 patients ranged from 1 to 9 years with a mean of 4.5 years. During the follow-up period, repeat angioplasty of the original stenosis was performed in 3 patients and another patient underwent dilatation of a new lesion which developed in the aorta. According to clinical and noninvasive studies, these 4 patients, as well as the other 20, have maintained patency of the treated lesions and are symptom free. No immediate complications requiring surgery occurred. We conclude that angioplasty is the initial treatment of choice in focal lesions of the distal abdominal aorta and its bifurcation.     

Juxtarenal aortic aneurysm: endoluminal transfemoral repair?

Endoluminal transfermoral repair of an abdominal aortic aneurysm by a stent graft placement requires a segment of the nondilated infrarenal aorta of at least 15 mm long for safe stent graft attachment. The possibility of endoluminal treatment of a juxtarenal abdominal aortic aneurysm with partially covered spiral Z stent was assessed in experiment and in three clinical cases. In the experiment, the noncovered spiral Z stent was placed into the abdominal aorta, across the origins of renal arteries and mesenteric arteries, in six dogs. In the clinical cases, a partially covered stent graft was attached in 3 patients with the juxtarenal abdominal aortic aneurysm (of the group of 12 patients with abdominal aortic aneurysm). The stent grafts were attached with proximal uncovered parts across the origins of the renal arteries. In experiment, the renal artery occlusions or stenoses were not observed 36 months after stent placement, and in clinic 3 patients with the juxtarenal aortic aneurysm were successfully treated by stent graft placement. There were no signs of flow impairment into the renal arteries 14 months after stent graft implantation. This approach can possibly expand the indications for endoluminal grafting in the treatment of juxtarenal aortic aneurysms in patients who are at high risk for surgery.     

Endovascular treatment of acute limb ischemia secondary to fracture of a popliteal artery stent

The authors report the case of a patient with acute lower limb ischemia (category IIa) after occlusion of the popliteal artery due to fracture of a long indwelling stent. The patient refused surgical therapy for religious reasons, and an interventional revascularization was performed as acute rescue therapy. After reentry into the distal popliteal artery was achieved, the artery was dilated, and the fragmented stent was crushed, followed by implantation of two helical nitinol stents with high radial force and a third self-expandable nitinol stent. Sufficient primary technical success was achieved, and stent patency was present at midterm follow-up.     

The Efficacy of the Coaxial Technique Using a 6-Fr Introducer Sheath in Stent Placement for Treating the Obstructions Proximal to the Descending Colon

Objective

We wanted to evaluate the efficacy of stent placement using the coaxial technique with a stiff, long introducer sheath in patients with technical failure using an angiographic catheter for the obstructions proximal to the descending colon.

Materials and Methods

Self-expandable metallic stent placement was attempted under fluoroscopy-guidance in 77 consecutive patients who had malignant colorectal obstruction. Stent placement was performed using an angiographic catheter and a guide wire. If the angiographic catheter could not be advanced over the guide wire into the obstructive lesions proximal to the descending colon, then a 6-Fr introducer sheath was used. The technical success rate, the clinical success rate and the complications were analyzed.

Results

Successful stent placement was achieved in 75 of 77 patients (97%). The angiographic catheter failed to advance into the obstructive lesions of 11 patients (M:F = 7:4; mean age, 65.5 years) whose lesions were at the level of the splenic flexure or transverse colon. Therefore, the coaxial technique was implemented in all these 11 patients using a 6-Fr stiff introducer sheath and then the stent placement was successful. There were no complications related to the use of a stiff introducer sheath. Clinical success, which was defined as relief of clinical obstructive bowel symptoms, was obtained within 24 hours in all of patients.

Conclusion

The coaxial technique using a stiff introducer sheath can increase the technical success of fluoroscopy-guided, self-expandable metallic stent placement in patients with colonic obstruction proximal to the descending colon.     

Percutaneous metallic stents in patients with obstructive jaundice due to hepatocellular carcinoma

PURPOSE: To evaluate the technical success and clinical efficacy of percutaneously placed self-expandable metallic stents in patients with obstructive jaundice due to hepatocellular carcinoma (HCC). MATERIALS AND METHODS: Fifteen men (mean age, 59.3 years) with obstructive jaundice resulting from HCC were treated with self-expandable metallic stents (28 stents in 19 sessions). The authors evaluated the technical success, clinical success (decrease of 30% of total serum bilirubin level or <2 mg/dL [34.2 micromol/L]), treatment efficacy according to lowest total serum bilirubin level, complications, and duration of stent patency. RESULTS: Technical success was achieved in all patients. Clinical success was achieved in 11 of the 15 patients (73%). After stent placement, seven patients (47%) had a low bilirubin level (<2 mg/dL [34.2 micromol/L]), three (20%) had an intermediate bilirubin level (2-10 mg/dL [34.2-171 micromol/L]), and five (33%) had a high bilirubin level (>10 mg/dL [171 micromol/L]). A low bilirubin level was achieved in all patients with Child-Pugh A disease and stage T2 or T3 HCC. Major complications such as hemobilia necessitating transfusion (n=1) or abscess formation (n=1) occurred in two of the 19 sessions (10%). The overall mean stent patency was 149.8 days (range, 12-790 days). The mean stent patency in patients with Child-Pugh class A disease (257.8 days) was significantly longer than that of patients with Child-Pugh class B and C disease (123.2 and 63 days, respectively) (P<.05). CONCLUSIONS: The percutaneous placement of a self-expandable metallic stent is a feasible and effective palliative treatment for patients with obstructive jaundice resulting from HCC, especially for those with Child-Pugh class A disease and stage T2 or T3 HCC.     

Flared polyurethane-covered self-expandable nitinol stent for malignant biliary obstruction

PURPOSE: To determine the technical efficacy and safety of a flared polyurethane-covered self-expandable nitinol stent in the management of malignant biliary obstruction and to evaluate its clinical efficacy by estimating stent patency and patient survival rates. MATERIALS AND METHODS: Thirteen patients with common bile duct strictures (nonhilar) caused by malignant disease were treated by placement of 13 nitinol stents. The stents used include a flared section in the proximal portion (12 mm in diameter and 10 mm in length) and a section in the remnant portion that is fully covered with high-elasticity polyurethane, with an unconstrained diameter of 10 mm and a total length of 50-80 mm. Patient survival and stent patency rates were calculated with use of Kaplan-Meier survival analysis. The follow-up bilirubin and serum amylase and lipase levels were calculated, and the differences in means were evaluated with use of a Wilcoxon signed-rank test. The average follow-up duration was 22.9 weeks (range, 8-56 weeks). RESULTS: Placement was successful in all cases. The 30-day mortality rate was 0%. The survival rates were 38% and 24% at 20 and 50 weeks, respectively. Seventy-seven percent of study patients had adequate palliative drainage during their the remainder of their lives. The stent patency rates were 71% and 48% at 20 and 50 weeks, respectively. Three patients (23%) presented with stent occlusion requiring repeat intervention. There were no procedure-related complications such as proximal or distal migration. No complications occurred other than stent occlusion. One patient's stent was removed under endoscopic guidance 15 weeks after its insertion. Bilirubin levels had significantly decreased 1 week after stent insertion (P <.001). CONCLUSION: Preliminary results suggest that placement of a flared polyurethane-covered self-expandable nitinol stent is feasible and effective in achieving biliary drainage. The stents do not migrate, but there is tumor ingrowth into the flared portion of the stent. Treatment of a larger group of patients will be mandatory to validate these long-term results.