Subintimal angioplasty of long superficial femoral artery occlusions

PURPOSE: To investigate the value of subintimal angioplasty (SA) and selective stent placement in the treatment of long (> or =15 cm) superficial femoral artery (SFA) occlusions. MATERIALS AND METHODS: During a period of 4.5 years, 67 long SFA occlusions in 61 patients (52 male, 9 female) were intended to be treated with SA, either retrogradely (n = 55) or antegradely (n = 12). Postprocedural medical treatment included aspirin + ticlopidine/clopidogrel (AT/C) combination. In 25 patients warfarin was also given for 3-6 months. Patients were followed up for 1-30 months (mean 12.5 +/- 9.0 months). Hemodynamic patencies were determined with the Kaplan-Meier method, risk factors affecting patency were evaluated with the Cox model, and the patencies of the subgroups were compared with log-rank test. RESULTS: Subintimal recanalization was technically successful in 59 of 67 occlusions. Technical success was 83% in the first 30 procedures, 92% in the last 37, and 100% in the last 29. Forty-six occlusions were treated with SA alone and 13 with SA and stent placement. On an intention-to-treat basis, primary patency at 6 and 12 months was 49% and 22%, respectively, and assisted primary patency at 6 and 12 months was 69% and 57%, respectively. Patency rates were not significantly different in patients with claudication versus critical limb ischemia, or in those treated with SA alone versus SA and stent placement. With the multivariate Cox model, medical treatment with AT/C combination was identified as the only significant risk factor for both primary patency and assisted primary patency. With the Kaplan-Meier analysis, primary and assisted primary patencies were significantly higher in the warfarin group than the AT/C group (P =.0002 and.0001, respectively). CONCLUSION: SA is a simple and safe method with a high technical success rate in the endovascular treatment of long SFA occlusions. Long-term patency rates, however, seem unsatisfactory, despite early reports. Subintimal stent placement provides cumulative patency at least as good as SA alone. Warfarin may significantly improve both primary patency and assisted primary patency after subintimal recanalization, but even with this treatment patency rates are still lower than those reported for bypass surgery. Therefore, in long SFA occlusions, SA is not recommended for claudicants but may be valuable in patients with critical limb ischemia.     

Combined stent placement and high dose PGE1 drip infusion for chronic occlusion of the superficial femoral artery as a modality to salvage chronic critical limb ischemia

PURPOSE: To assess the initial effect, short-term patency, and limb salvage rates of combined stent placement and high-dose prostaglandin E-1 (PGE1) drip infusion for chronic occlusion of the superficial femoral artery (SFA). MATERIALS AND METHODS: A total of 15 arteriosclerotic occlusive lesions of the SFA were treated in 11 consecutive patients (mean age: 78.4 years old). All cases were of category 4 or 5, based on the criteria of the Society of Vascular Surgery and Intermittent Society for Cardiovascular Surgery (SVC/ISCVS). In all cases a self-expandable stainless steel stent was implanted. PGE1 treatment was started 3-5 days before stent placement and continued for 7-10 days after the intervention. The technical success, limb salvage outcomes, patency rates, and complications were examined. RESULTS: In all cases, the technical success rate of the procedure was 100%. After stent implantation, the clinical status of all cases was improved by at least +2, and major amputation was not required in any cases. The 12-month primary, secondary patency rates, and limb salvage rate were 57%, 100%, and 100%, respectively. CONCLUSION: Combined stent placement and high-dose PGE1 drip infusion is a treatment of choice for salvaging the lower limb of a patient with chronic critical ischemia.     

Twelve-month Results of the EverFlex Stent in the Superficial Femoral Artery

PurposeTo evaluate the clinical efficacy of EverFlex stents (length, 6–20 cm) for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA).Material and MethodsOver a period of 18 months, 56 SFA lesions in 53 patients were treated with an EverFlex stent. The following parameters were documented before the intervention, immediately afterward, and 12 months later: clinical stage, ankle-brachial index, and peak systolic velocity ratio (PSVR). The primary study endpoint was the primary patency rate after 12 months (defined as a PSVR < 2.5).ResultsIn 18% of the 56 lesions, complete occlusions were present. Mean lesion length was 9.4 cm ± 5.3, and mean stent length was 12.6 cm ± 5.6. Of the 53 patients enrolled in the study, a 12-month follow-up was performed in 46. The primary patency rate after 12 months was 71.7%. In-stent restenosis or occlusion occurred in 13 patients. Compared with the total study group, the mean stent length in these 13 patients was greater (14.0 cm ± 7.3) and the incidence of de novo lesions was lower. In the patient group with stents less than 10 cm in length (n = 24), six patients (25%) required a repeat intervention, compared with seven patients (32%) in the group with stents longer than 12 cm.ConclusionsAlthough the primary patency rate associated with the EverFlex stent is comparable to those in published data, the present results demonstrate a higher percentage of in-stent stenoses in patients in whom longer SFA stents were implanted.     

Percutaneous treatment of complete chronic occlusions of the superficial femoral artery

PURPOSE: This study was done to evaluate the mid-and long-term patency rates of complete (from the origin to Hunter's duct) chronic occlusions of the superficial femoral artery (SFA) treated by angioplasty and/or stenting. MATERIALS AND METHODS: From February 2002 to March 2005, 21 patients with complete occlusion of the SFA and good distal runoff (two or three patent vessels) were treated with endovascular recanalisation. All patients had severe claudication or critical limb ischaemia. In all cases, recanalisation was performed with a contralateral approach by percutaneous transluminal angioplasty (PTA), with stenting only when PTA provided unsatisfactory results (due to elastic recoil and complications such as dissection). In the case of calcified occlusions and when the true lumen of the SFA could not be crossed, subintimal angioplasty was performed. Follow-up was done at 6 and 12 months and annually thereafter (range 6-55 months, mean 23 months) with clinical evaluation and colour-Doppler ultrasound. RESULTS: Immediate technical success was achieved in all cases (100%), with postprocedural angiography demonstrating complete recanalisation of the SFA. Two distal embolisations (9.5%) occurred, both treated successfully by local thrombolysis. Primary patency rates at 6, 12, 24, 32 and 44 months were 93.3%, 69.2%, 72.7%, 62.5% and 40%, respectively; secondary patency rates at 6, 12 and 24 months were 100%, 84.6% and 81.8%, respectively. CONCLUSIONS: Percutaneous treatment of complete chronic occlusions of the SFA showed good mid-and long-term primary patency rates, with few periprocedural complications. Reocclusions can be treated by a percutaneous technique, which ensures a good secondary patency rate.     

Long-Term Results after Placement of Aortic Bifurcation Self-Expanding Stents: 10 Year Mortality,Stent Restenosis,and Distal Disease Progression

Purpose To retrospectively evaluate the 10 year follow-up results in patients who had “kissing” self-expanding stent aortic bifurcation reconstruction. Methods Forty-three patients were treated with “kissing” self-expanding stents for aortoiliac occlusive disease. Early follow-up with clinical and ankle brachial pressure indices (ABPI) was performed at 3, 6, 12, and 24 months and with intra-arterial digital subtraction angiography at 12–24 months; clinical and angiographic follow-up was performed for symptom recurrence up to 10 years after treatment. Retrospective record review was performed to assess mortality, clinical patency, angiographic patency, and secondary assisted patency of both stents and downstream peripheral vessels at 5 and 10 years follow-up. Results The 2 year primary angiographic and secondary assisted stent patencies were 89% and 93%, respectively. At 10 years follow-up in 40 patients the mortality was 38% (due to myocardial infarction, stroke, chronic renal failure, malignancy, and liver failure). At 5 and 10 years follow-up the primary clinical stent patency was 82% and 68%, and the secondary assisted stent patency 93% and 86%, respectively. At 5 and 10 years, the distal vessel patency was 86% and 72%, and the secondary assisted distal vessel patency treated by surgical or endovascular techniques was 94% and 88%, respectively. At 10 years there was no limb loss. Conclusion The long-term (10 year) results of aortic bifurcation arterial self-expanding stent placement in patients with arterial occlusive disease show a 10 year primary stent patency rate of 68% but a secondary assisted patency rate of 86%. In addition there is a high overall mortality due to other cardiovascular causes and the rate of distal disease progression and loss of patency is similar to the loss of stent patency rate.     

Evaluating Patency Rates of an Ultralow-Porosity Expanded Polytetrafluoroethylene Covered Stent in the Treatment of Venous Stenosis in Arteriovenous Dialysis Circuits

PurposeTo evaluate the efficacy of an ultralow-porosity expanded polytetrafluoroethylene (ePTFE) covered stent in the treatment of autogenous arteriovenous fistula (AVF) and prosthetic arteriovenous graft (AVG) venous outflow stenoses.Materials and MethodsClinical and angiographic outcomes of 20 consecutive patients with arteriovenous dialysis circuits treated with the endoprosthesis were reviewed following institutional review board approval. Patients were followed routinely at 2 months and 6 months after stent placement, or earlier if clinically warranted. The primary endpoint was 2- and 6-month primary treatment area patency. Secondary endpoints included primary circuit patency, primary assisted patency, and secondary patency.ResultsEleven patients with AVFs and nine patients with AVGs were treated successfully with the covered stent. Primary treatment area patency rates were 85% ± 16 at both 2 months and 6 months. Primary circuit patency rates were was 65% ± 21 and 45% ± 22, respectively; primary assisted patency rates were 90% ± 13 and 85% ± 16, respectively; and secondary patency rates were 100% and 90% ± 13, respectively. Of the three cases of lost primary treatment area patency, two developed thrombosis and one developed recurrent stenosis. No significant differences were found between patients with AVFs and AVGs.ConclusionsData from this preliminary study suggests that the ultralow-porosity ePTFE covered stent may be a clinically viable option for treatment of venous outflow stenoses in arteriovenous vascular access circuits.     

Results of iliac artery stent placement in patients younger than 50 years of age

PURPOSE: To determine long-term outcome in patients 50 years of age or younger treated with iliac artery stent placement. MATERIALS AND METHODS: The records of 412 patients who underwent iliac artery stent placement during a 62-month study period were reviewed retrospectively. Forty-two patients younger than age 50 (mean age = 45 y) at the time of stent placement were included in the study population. Presenting symptoms included claudication (47%), rest pain (17%), ulceration/tissue loss (31%), and blue toe syndrome (5%). Anatomic, hemodynamic, and clinical success rates of the stent placement procedure were assessed. Stent patency rates were calculated by life-table methods. RESULTS: Fifty-nine iliac lesions were treated with stents; 62% of patients underwent treatment of a single lesion whereas 38% had multiple lesions treated. Thirty-one percent were treated after a failed angioplasty procedure and 69% were treated with stent placement primarily. After stent placement, 34 patients (82%) experienced symptomatic relief, although eight of these patients (19%) underwent a planned ipsilateral infrainguinal bypass procedure during the same hospitalization. During follow-up, five patients (12%) required a bypass procedure as a result of stent failure and two patients (5%) required below-knee amputation. Seven patients (17%) required endovascular stent revision, with none requiring additional surgery. At 1, 2, and 3 years, the primary patency rates were 86%, 72%, and 65%, and the secondary patency rates were 90%, 88%, and 88%, respectively. CONCLUSIONS: Iliac stent placement successfully addresses the presenting symptoms of young patients with peripheral vascular disease and results in patency rates that are similar to those reported in a more general population. With appropriate postprocedural surveillance, restenosis can be addressed in many patients with use of endovascular techniques, limiting the need for surgical revision.     

PTA Versus Carbofilm-Coated Stents in Infrapopliteal Arteries: Pilot Study

Purpose: To determine the primary success and short-term patency of stent application as a primary treatment modality for high-grade lesions of the infrapopliteal arteries compared with treatment with percutaneous transluminal angioplasty (PTA) in critical limb ischemia in a randomized prospective study. Methods: Endovascular therapy was performed on 95 lesions in 51 patients (mean age 72.0 years, range 47–80 years) who presented clinically with Fontaine stages III and IV. One patient underwent treatment in both limbs. After angiographic lesion identification, patients were randomized for treatment by PTA (53 lesions in 27 patients) or stent application (42 lesions in 24 patients). Follow-up by clinical investigation and conventional angiography or spiral CT angiography was performed in 37 patients (57 lesions) 6 to 12 months after the procedure, or when clinically indicated. Evaluation was performed by two observers, double-blinded, with thresholds for lesion restenosis of 50% and 70%. Statistical evaluation was performed on a lesion basis by Kaplan–Meier estimated probability rates, and log-rank and Wilcoxon tests. The primary endpoint was the angiographic patency rate of treated lesions. Results: The inter-reader agreement was high (κ = 0.82). For the stent group the cumulative primary patency at 6 months was 83.7% at the 70% restenosis threshold, and 79.7% at the 50% restenosis threshold. For PTA, the primary patency at 6 months was 61.1% at the 70% restenosis threshold and 45.6% at the 50% restenosis threshold. Both results were statistically significant (p < 0.05). Conclusion: Infrapopliteal stent application is an effective treatment modality for high-grade lesions in chronic critical limb ischemia. Compared with PTA, higher patency rates can be expected after 6 months.     

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.     

Treatment of hemodialysis-related central venous stenosis or occlusion: results of primary Wallstent placement and follow-up in 50 patients.

PURPOSE: To analyze the effectiveness of stent placement as the primary treatment for central venous obstruction in patients undergoing hemodialysis. MATERIAL AND METHODS: Fifty-seven Wallstents were placed in 50 patients with symptomatic shunt dysfunction and arm swelling due to central venous obstruction. Technical success, complication, and patency rates were evaluated. RESULTS: Stent deployment was successful in all patients, and early rethrombosis (within 1 week) was noted in one patient (2%). Seventy-three episodes of reobstruction occurred and were treated percutaneously with angioplasty alone in 54 cases (74%). Nineteen cases (26%) necessitated additional stent placement. The 3-, 6-, 12-, and 24-month primary patency rates were 92%, 84%, 56%, and 28%, respectively. Cumulative overall stent patency was 97% after 6 and 12 months, 89% after 24 months, and 81% after 36 and 48 months. CONCLUSION: In the treatment of brachiocephalic and subclavian venous obstruction, stent placement shows excellent technical results and helps preserve vascular access for a substantial period. Multiple repeat interventions are, however, frequently required to maintain patency.     

Comparison of SMART stent placement for arteriovenous graft salvage versus successful graft PTA

PURPOSE: To compare the SMART (shape memory alloy recoverable technology) stent with percutaneous transluminal angioplasty (PTA) alone in hemodialysis access venous stenoses. MATERIALS AND METHODS: A prospective, nonrandomized study was undertaken in 60 patients with dysfunctional polytetrafluoroethylene dialysis grafts. Indications for stent placement were acute PTA failure, rapid restenosis, and vessel perforation. The primary endpoint was improved graft patency in patients treated with stents compared with that in patients whose disease responded to PTA alone. The secondary endpoints were lower postprocedural midgraft pressures and similar complication rates compared with PTA alone. RESULTS: The key venous stenosis was at the graft-to-vein anastomosis in all but two patients. Thirty-five patients showed a response to PTA alone. Sixteen patients received stents for stenoses greater than 30% after angioplasty, six for rapidly recurrent stenosis, and three for venous rupture. Nine patients received stents across the level of the elbow joint. Stenosis after intervention was significantly less frequent in the stent group (7% vs 16%; P = .001), but the midgraft systolic pressure ratios did not significantly differ. The clinical success rates were 100% after stent implantation and 97% after PTA alone. Except for venous rupture, there were no procedure-related complications, and, excluding early graft thrombosis, there were no complications at 30 days. A single stent fracture was found on follow-up. The mean primary graft patency times were 5.6 months after PTA and 8.2 months after stent treatment (P = .050). When stents were placed across the level of the elbow joint, the mean primary graft patency time was 8.9 months. CONCLUSION: Implantation of the SMART stent is safe and effective for the treatment of residual or rapidly recurrent dialysis access venous stenoses and is associated with better patency than PTA alone.     

Prospective,Multicenter Clinical Study of the Covera Vascular Covered Stent in the Treatment of Stenosis at the Graft-Vein Anastomosis of Dysfunctional Hemodialysis Access Grafts

PurposeTo study the use of the self-expanding Covera covered stent for the treatment of stenotic lesions at the venous anastomosis of hemodialysis arteriovenous grafts (AVGs).Materials and MethodsA total of 110 patients with AVG venous anastomotic stenosis of ≥50% and access dysfunction were treated at 14 centers in the United States using percutaneous transluminal angioplasty followed by covered stent placement. The primary end points were 30-day safety and 6-month target lesion primary patency (TLPP). The secondary measures included access circuit primary patency, circuit cumulative patency, and the number of reinterventions through 24 months.ResultsFreedom from a primary safety event at 30 days was 96.4% while the 6-month TLPP rate was 70.3%. Seventy-five patients completed 24-month follow-up (68.2%). The TLPP rates were 54.2% at 365 days and 36.9% at 730 days while the access circuit primary patency rates were 16.7% at 365 days and 7.8% at 730 days (Kaplan-Meier analysis). The access circuit cumulative patency rates were 85.4% at 12 months and 73.6% at 24 months. The number of reinterventions to maintain the patency of the access circuit was 3.6 ± 3.1 at 24 months (1.6 ± 1.9 at the target lesion).ConclusionsUse of the Covera covered stent for hemodialysis graft-vein anastomotic stenosis provided a safe treatment option with a TLPP rate of 70.3% at 6 months and TLPP and cumulative access circuit patency rates of 36.9% and 73.6% at 2 years.     

Iliac Artery Stent Placement Relieves Claudication in Patients with Iliac and Superficial Femoral Artery Lesions

Purpose

To evaluate the efficacy of iliac artery stent placement for relief of claudication in patients with both iliac and superficial femoral artery (SFA) lesions.

Methods

Stent placement for only iliac artery occlusive disease was performed in 94 limbs (74 patients) with both iliac and SFA occlusive disease on the same limb. All procedures were performed because intermittent claudication did not improve after continuation of antiplatelet medication therapy and home-based exercise for 3 months. Rutherford classification was 2 in 20 limbs and 3 in 74 limbs. Patients with critical limb ischemia were excluded. Median duration of follow-up was 40 months. Primary patency rates of the iliac stent, clinical improvement rates, and risk factors for requiring additional SFA procedures were evaluated.

Results

Primary patency rates of the iliac stent at 1, 3, 5, and 7 years were 97, 93, 79, and 79 %, respectively. The initial clinical improvement rate was 87 %. Continued clinical improvement rates at 1, 3, 5, and 7 years were 87, 81, 69, and 66 %, respectively. SFA Trans-Atlantic Inter-Society Consensus (TASC) II C/D lesion was a significant risk factor for requiring additional SFA procedures.

Conclusion

Intermittent claudication was relieved by iliac stent placement in most patients with both iliac and SFA lesions. Thus, the indications for treatment of the SFA intended for claudicants should be evaluated after treatment of the iliac lesion.     

Early rethrombosis of clotted hemodialysis grafts: graft salvage achieved with an aggressive approach

OBJECTIVE: The purpose of this study was to assess the efficacy of repeated pulsed spray pharmacomechanical thrombolysis for salvage of early rethrombosis of hemodialysis grafts and to identify factors that predict successful outcome. MATERIALS AND METHODS: Thirty-four patients with initial successful thrombolysis were referred for repeated thrombolysis because of early rethrombosis. Repeated thrombolysis occurred within 1 month of initial thrombolysis. Technical success and patency rates were calculated. Causes of graft thrombosis and procedural modifications were analyzed. RESULTS: The 39 rethrombosed grafts were successfully treated using pharmacomechanical thrombolysis, and patients underwent subsequent hemodialysis. The underlying flow-limiting stenoses were treated with balloon angioplasty using a larger balloon (41%), a same-size angioplasty balloon (18%), stent placement (15%), or increased anticoagulation (5%). A new stenosis location was discovered in 18%. Mean primary patency was 80.9 days (2.6 months) and secondary patency was 235.4 days (7.8 months). With life table analysis, 1-, 3-, 6-, and 12-month primary patency rates were 72%, 31%, 23%, and 15%, and secondary patency rates were 77%, 62%, 51%, and 31%, respectively. Graft patency rates in our study were compared with our institutional historic graft patency rates, with no significant difference noted (p = 0.76). No major procedural complications occurred. CONCLUSION: Adequate technical success and patency rates for pharmacomechanical thrombolysis occur even for hemodialysis grafts that rethrombose within 1 month. After thrombolysis, aggressive search for and treatment of additional stenoses are warranted.     

Randomized, multicenter study comparing expanded polytetrafluoroethylene-covered endoprosthesis placement with percutaneous transluminal angioplasty in the treatment of superficial femoral artery occlusive disease

PURPOSE: To compare the safety and effectiveness of the Viabahn endoprosthesis with that of percutaneous transluminal angioplasty (PTA) alone in the treatment of symptomatic peripheral arterial disease (PAD) affecting the superficial femoral artery (SFA). MATERIALS AND METHODS: From 1998 to 1999, patients with symptomatic SFA PAD were enrolled in a prospective, multicenter randomized study and underwent either PTA alone (n = 100) or PTA followed by stent-graft placement (expanded polytetrafluoroethylene/nitinol self-expanding stent-graft) (n = 97) for stenoses or occlusions of the SFA that were 13 cm long or shorter. At baseline, there were no significant differences between the PTA and stent-graft treatment groups, including chronic limb ischemia status and treated lesion length. RESULTS: The stent-graft group had a significantly higher technical success rate (95% vs 66%, P < .0001) and 1-year primary vessel patency rate at duplex ultrasonography (65% vs 40%, P = .0003). A patency benefit was seen for lesions at least 3 cm long. At 12 months, chronic limb ischemia status was 15% further improved for the stent-graft group (P = .003). There were no significant differences between treatment groups with regard to the occurrence of early or late major adverse events. CONCLUSIONS: In this multicenter study, the patency, technical success, and clinical status results obtained with stent-grafts were superior to those obtained with PTA alone.     

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.     

Endovascular treatment of atherosclerotic arterial stenoses and occlusions of the supraaortic arteries: mid-term results from a single center analysis

OBJECTIVE: To determine mid-term patency rates after endovascular treatment of supraaortic atherosclerotic arterial stenoses and occlusions using percutaneous transluminal angioplasty (PTA) and stent placement. PATIENTS AND METHODS: During a period of 83 months, 48 patients (18 female, 30 male; mean age 61 years, range 31-82 years) were included into this prospective single-center study. Fifty-five lesions of the brachial and cephalic arteries (subclavian/axillary artery n = 42, innominate artery n = 7, origin common carotid artery n = 6) were treated using PTA (n = 38), PTA plus stent (n = 11) or primary stent placement (n = 6). For anticoagulation, patients received a bolus of heparin (5000 IU) intraarterially during the intervention followed by intravenous application for 24h. At discharge, life-time application of ASA (100mg/day) was initiated. Follow-up protocol included clinical examination, colour-coded duplex ultrasound and intraarterial angiography in case of re-stenosis. RESULTS: PTA and stent placement were technically successful in all patients (100%). No major complications occurred. Of seven patients presenting with total occlusions, six were treated with stent placement. Stent implantation was also performed in all lesions located at the origin of the supraaortic arteries (n = 6). In 38 lesions, the result of PTA was satisfactory. Mean follow-up time is 22 months (range 1-83 months). During follow-up examinations, re-stenoses occurred in 10 cases (at 1 month n = 2, at 6 months n = 2, at 12 months n = 3, at 24 months n = 3). In 9 lesions, re-interventions were performed (PTA n = 7; PTA plus stent n = 2). According to Kaplan-Meier life-table analysis, cumulative primary and primary assisted patency rates are 69.5% (patients at risk n = 15; standard error 9%) and 90.6% (patients at risk n = 16; standard error 6.3%) at 20 months, respectively. CONCLUSIONS: Endovascular treatment of atherosclerotic obstructive disease in brachial and cephalic arteries is a safe procedure showing promising mid-term patency rates.     

“Full metal jacket” with direct stenting of complete chronic occlusions of the superficial femoral artery

Purpose

This study evaluated the short- and midterm patency of complete total occlusions of the superficial femoral artery (SFA) treated with direct stenting.

Materials and methods

Fifty-two consecutive patients (36 men and 16 women; mean age 73.6 years; range 58–85) with chronic complete SFA occlusion and good distal run-off (two or three patent vessels) underwent endovascular recanalisation by direct stenting. All patients were symptomatic (severe claudication or critical ischaemia). Recanalisation was achieved by using a contralateral approach in 44 patients and an ipsilateral antegrade access in eight patients. A total of 152 nitinol stents were used: three stents in 32 cases, four stents in eight cases and two stents in 12 cases. Follow-up consisted of clinical evaluation and colour Doppler ultrasound at 6, 12, 18 and 24 months.

Results

The immediate technical success rate was 100%, with complete SFA recanalisation documented on postprocedural angiography. Four cases of distal embolism occurred, which were treated successfully with intra-arterial thrombolysis. During the follow-up, 12 reocclusions were observed: eight were treated with mechanical thrombectomy and in-stent angioplasty, and four were converted into femoropopliteal bypasses. The primary patency rates at 6, 12, 18 and 24 months were 92.3%, 76.9%, 69.2% and 69.2%, respectively. The secondary patency rates at 6, 12, 18 and 24 months were 100%, 100%, 92.3% and 92.3%.

Conclusions

The percutaneous treatment of chronic complete SFA occlusions yielded good primary and secondary patency rates in the short and medium term, with few periprocedural complications. Reocclusions were treated using the percutaneous technique, which guarantees a good secondary patency rate.

     

Treatment of malignant biliary obstruction with a PTFE-covered self-expandable nitinol stent.

OBJECTIVE: We wanted to determine the technical and clinical efficacy of using a PTFE-covered self-expandable nitinol stent for the palliative treatment of malignant biliary obstruction. MATERIALS AND METHODS: Thirty-seven patients with common bile duct strictures caused by malignant disease were treated by placing a total of 37 nitinol PTFE stents. These stents were covered with PTFE with the exception of the last 5 mm at each end; the stent had an unconstrained diameter of 10 mm and a total length of 50-80 mm. The patient survival rate and stent patency rate were calculated by performing Kaplan-Meier survival analysis. The bilirubin, serum amylase and lipase levels before and after stent placement were measured and then compared using a Wilcoxon signed-rank test. The average follow-up duration was 27.9 weeks (range: 2-81 weeks). RESULTS: Placement was successful in all cases. Seventy-six percent of the patients (28/37) experienced adequate palliative drainage for the remainder of their lives. There were no immediate complications. Three patients demonstrated stent sludge occlusion that required PTBD (percutaneous transhepatic biliary drainage) irrigation. Two patients experienced delayed stent migration with stone formation at 7 and 27 weeks of follow-up, respectively. Stent insertion resulted in acute elevations of the amylase and lipase levels one day after stent insertion in 11 patients in spite of performing endoscopic sphincterotomy (4/6). The bilirubin levels were significantly reduced one week after stent insertion (p < 0.01). The 30-day mortality rate was 8% (3/37), and the survival rates were 49% and 27% at 20 and 50 weeks, respectively. The primary stent patency rates were 85%, and 78% at 20 and 50 weeks, respectively. CONCLUSION: The PTFE-covered self-expandable nitinol stent is safe to use with acceptable complication rates. This study is similar to the previous studies with regard to comparing the patency rates and survival rates.     

Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial

PURPOSE: To investigate further the safety and efficacy of the sirolimus-eluting S. M.A.R.T. Nitinol Self-expanding Stent by comparison with a bare stent in superficial femoral artery (SFA) obstructions. MATERIALS AND METHODS: This randomized, double-blind study involved 57 patients (29 in the sirolimus-eluting stent group and 28 in the bare stent group) with chronic limb ischemia and SFA occlusions (66.7%) or stenoses (average lesion length, 81.5 mm +/- 41.2). Stent implantation followed standard interventional techniques and a maximum of two stents could be implanted. The primary endpoint was the in-stent mean lumen diameter at 6 months as determined by quantitative angiography. RESULTS: Both stent types were effective in revascularizing the diseased SFA and allowing sustained patency for at least 6 months. There was no statistically significant difference between treatment groups in the in-stent mean lumen diameter at 6 months (4.94 mm +/- 0.69 and 4.76 mm +/- 0.54 mm for sirolimus-eluting and bare stent groups, respectively; P = .31). Although the diameter of the target lesion tended to be larger and percent stenosis tended to be lower with the sirolimus-eluting stent, there were no statistically significant differences between treatments in terms of any of the variables. The mean late loss values were 0.38 mm +/- 0.64 and 0.68 mm +/- 0.97 for the sirolimus-eluting stent group and the bare stent group, respectively (P = .20). The binary restenosis rates, with a cutoff of 50% at 6 months, were zero in the sirolimus-eluting stent group and 7.7% in the bare stent group (P = .49). Clinical outcomes matched angiographic outcomes with improvements in ankle-brachial index and symptoms of claudication. There was no significant difference between treatments in terms of adverse events. CONCLUSION: Although there is a trend for greater efficacy in the sirolimus-eluting stent group, there were no statistically significant differences in any of the variables.