Stenting in the Carotid Artery: Initial Experience in 110 Patients

Purpose: To evaluate the feasibility, safety, and efficacy of intravascular stents in the treatment of extracranial carotid artery occlusive disease. Methods: According to protocol, stent therapy was offered to symptomatic patients with ≥ 70% arteriographically defined carotid stenoses or ulcerative lesions and, after September 1994, to asymptomatic patients with ≥ 75% stenoses. From April 1993 to September 1995, 110 nonconsecutive patients (79 males; mean age 72 years, range 45 to 85) consented to participate in the study. The majority (79 [72%]) were asymptomatic. Lesions meeting the treatment criteria were in the proximal common (n = 3); mid common (n = 12); distal common (n = 8); internal (ICA) (n = 92); and external (n = 2) carotid arteries. Seven patients had bilateral ICA stenoses, and 17 patients were treated for postsurgical recurrent disease. The mean lesion length and diameter stenosis for all lesions were 12.4 ± 9.2 mm and 86.5% ± 10.6%, respectively. The procedures were performed either via direct percutaneous access to the cervical common carotid artery or through a retrograde femoral artery approach. Standard balloon dilation preceded deployment of balloon-expandable stents in most cases. No postprocedural anticoagulation was used (aspirin only). Results: In 110 patients (117 arteries) intended for treatment, 109 (99.0%) (116 arteries [99.1%]) were successfully treated with 129 stents (128 Palmaz, 1 Wallstent). One percutaneous procedure failed (0.9%) for technical reasons (stent could not be deployed) and was converted to carotid endarterectomy. Minor complications included 4 cases of spasm (successfully treated with papaverine); 1 flow-limiting dissection (stented); and 6 access-site problems. There were 7 strokes (2 major, 5 reversible) (6.4%) and 5 minor transient events (4.5%) that resolved within 24 hours. Three patients were converted to endarterectomy (2.7%) prior to discharge; 1 stroke patient expired (0.9%), and another patient died of an unrelated cardiac event in hospital. In the 30-day postprocedural period, 2 ICA stents occluded (patients asymptomatic). Clinical success at 30 days (no technical failure, death, endarterectomy, stroke, or occlusion) was 89.1% (98/110). Over a mean 7.6-month follow-up (range 2 to 31), no new neurological symptoms developed. Another stent occlusion at 2 months and one case of flow-limiting intimal hyperplasia at 7 months were detected on routine duplex scanning in asymptomatic patients. Life-table analysis shows an 89% cumulative primary patency rate. Conclusions: Based on this early experience, carotid stenting appears feasible from a technical standpoint, with good midterm patency. However, the incidence of neurological sequelae is a serious problem. Technical enhancements and a more aggressive antiplatelet regimen may have a positive impact on these events.

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The Casper Stent System for carotid artery stenosis

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2017-013583 ◽

2018 ◽

Vol 10 (9) ◽

pp. 869-873 ◽

Cited By ~ 13

Author(s):

Sebastian J Mutzenbach ◽

Katharina Millesi ◽

Cornelia Roesler ◽

Erasmia Broussalis ◽

Slaven Pikija ◽

...

Keyword(s):

Carotid Artery ◽

Double Layer ◽

Carotid Artery Stenosis ◽

Artery Stenosis ◽

Minor Stroke ◽

Technical Failure ◽

Safety And Efficacy ◽

Asymptomatic Patients ◽

Proximal Internal Carotid Artery ◽

Cerebral Mri

PurposeTo report the results of a retrospective analysis of prospectively collected data evaluating the safety and efficacy of a double layer stent engineered for carotid artery occlusive disease.MethodsBetween January 2014 and February 2017, 138 patients (25.4% women; median age 71 years) underwent Casper stent implantation for carotid artery stenosis. Eligibility criteria included stenosis >70% of vessel diameter (or >50% diameter with ulceration) in symptomatic patients or asymptomatic patients with >80% stenosis at the carotid bifurcation or in the proximal internal carotid artery. For all procedures, a distal embolic protection device was used. The primary endpoint was the rate of 90 day major adverse neurological events, defined as minor stroke, major stroke, or death by independent neurological assessment.ResultsStent deployment was completed successfully in all cases without documented technical failure. There were no adverse neurological events or mortalities within 90 days. One thromboembolic occlusion of a small distal branch of the anterior cerebral artery occurred during the procedure and resolved with systemic recombinant tissue plasminogen activator administration. New ischemic lesions, all clinically silent, were seen in 6.5% of patients on post-procedure cerebral MRI.ConclusionThe Casper carotid stent demonstrated safety and efficacy in the treatment of carotid stenosis, with no technical failures and no adverse neurological events seen throughout the 90 day follow-up period. Its double layer structure seems to combine adequate plaque scaffolding with high vessel adaptability.

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Novel Nitinol Stent for Lesions up to 24 cm in the Superficial Femoral and Proximal Popliteal Arteries: 24-Month Results From the TIGRIS Randomized Trial

Journal of Endovascular Therapy ◽

10.1177/1526602817749242 ◽

2017 ◽

Vol 25 (1) ◽

pp. 68-78 ◽

Cited By ~ 11

Author(s):

John R. Laird ◽

Thomas Zeller ◽

Christian Loewe ◽

Jack Chamberlin ◽

Richard Begg ◽

...

Keyword(s):

Clinical Success ◽

Randomized Study ◽

Ankle Brachial Index ◽

The United States ◽

Target Lesion ◽

Primary Patency ◽

Lesion Length ◽

Stent Fracture ◽

Fracture Rate ◽

High Flexibility

Purpose: To evaluate the safety and effectiveness of the TIGRIS stent for lesions up to 24 cm in the superficial femoral and proximal popliteal arteries (SFA/PPA). Methods: This prospective, multicenter, randomized study enrolled 274 subjects at 36 sites in the United States and Europe. Subjects were randomly assigned in a 3:1 ratio to treatment with the TIGRIS stent (n=197; mean age 66.7±9.28 years; 141 men) or LifeStent (n=70; mean age 67.9±8.87 years; 49 men). The primary safety endpoint was 30-day freedom from major adverse events (MAE). The primary efficacy endpoint was primary patency at 12 months. Secondary endpoints included target lesion revascularization (TLR) and stent fracture. Clinical success and quality of life were also assessed. Results: Mean lesion length (107.6 vs 117.9 mm, p=0.29), procedure success (99.5% vs 97.1%, p=0.17), and freedom from MAE (99.5% vs 100%, p>0.99) were similar for the TIGRIS and control groups, respectively. Likewise, there was no difference in primary patency at 12 months (60.6% vs 63.2%, p=0.73) or 24 months (56.3% vs 50.2%, p=0.60) or in TLR at the same time points (76.6% vs 80.6%, p=0.49; 70.5% vs 67.2%, p=0.85). There were no differences in the changes in Rutherford category or the ankle/brachial index through 24 months. The rate of stent fracture was lower for TIGRIS compared with LifeStent (0% vs 32.7%, p<0.001). Conclusion: The TIGRIS stent and LifeStent were similarly effective for the treatment of lesions in the SFA and PPA. The high flexibility and zero fracture rate associated with the TIGRIS stent make this device favorable for use in high-flexion arteries.

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Vacuum-assisted mechanical thrombectomy in extensively occlusive thrombosis of dialysis arteriovenous grafts with indigo system

The Journal of Vascular Access ◽

10.1177/1129729819899264 ◽

2020 ◽

Vol 21 (5) ◽

pp. 673-679

Author(s):

Filippo Piacentino ◽

Andrea Coppola ◽

Andrea Zaghetto ◽

Edoardo Macchi ◽

Giuseppe De Marchi ◽

...

Keyword(s):

Mechanical Thrombectomy ◽

Clinical Success ◽

Primary Patency ◽

Secondary Patency ◽

Technical Failure ◽

Arteriovenous Graft ◽

Venous Outflow ◽

Percutaneous Mechanical Thrombectomy ◽

Arterial Inflow ◽

Surgical Thrombectomy

Purpose: To present a selected series of extensively occlusive thrombosis of arteriovenous graft treated with the Penumbra’s Indigo System. Materials and Methods: Ten patients with acute (within 72 h) extensively occlusive thrombosis of arteriovenous graft (mean extension = 30.1 (range = 15–45) cm) were treated at our institution with the Indigo System. Of the 10 cases, thrombosis was extended to venous outflow in 7 cases and to both arterial inflow and venous outflow in 3 cases. Results: Both anatomic and clinical success were achieved in 8 of the 10 procedures (80.0%). In the 2 cases of technical failure, the patients underwent surgical thrombectomy with the finding of arteriovenous graft exhaustion, which was then replaced. The 6-month primary patency, primary-assisted patency, and secondary patency rates were 37.5% (3/8), 50.0% (4/8), and 62.5% (5/8). We reported 2 complications (one minor and one major adverse event). Conclusion: Percutaneous mechanical thrombectomy aspiration with Indigo System is a relatively safe and effective procedure and can be used even in extensively thrombosed arteriovenous graft.

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PTA and Stenting of Femoropopliteal Trunk With Cordis Smartflex Stent System: A Single-Center Experience

Vascular and Endovascular Surgery ◽

10.1177/1538574419875551 ◽

2019 ◽

Vol 54 (1) ◽

pp. 17-24 ◽

Cited By ~ 1

Author(s):

Luca Garriboli ◽

Tommaso Miccoli ◽

Gianguido Pruner ◽

Antonio Maria Jannello

Keyword(s):

Limb Ischemia ◽

Primary Patency ◽

Lesion Length ◽

Acute Limb Ischemia ◽

Vascular Stent ◽

Stent Patency ◽

Stent Occlusion ◽

End Points ◽

Stent System ◽

Stent Length

Introduction: The aim of this study is to describe our experience in the treatment of femoropopliteal occlusive disease with percutaneous transluminal angioplasty (PTA) followed by stenting with S.M.A.R.T. Flex vascular stent system. Materials and Methods: From June 2014 to October 2018, 80 patients were treated at our Institution for intermittent claudication, critical, or acute limb ischemia due to total occlusion or long diffused lesions of the femoropopliteal segment. Main study end points are primary patency, target lesion revascularization, and stent fractures; secondary end points are major amputation rate, procedure-related bleeding, incidence of intrastent restenosis, and primary assisted patency after reintervention. Results: Mean follow-up time was 21 months (range 2-48 months). Primary patency rate was 80% (64 patients of 80), with mean covered lesion length of 8.2 cm. The deployment of a single stent was obtained for 57 (89%) patients, with a mean stent length of 9.86 cm. Of 80 patients, 2 (2.5%) had early stent occlusion within first 48 hours after the procedure, while 4 (5%) of 80 patients experienced stent occlusion within first 6 months. Of 80 patients, 6 (7.5%) had an intrastent restenosis detected at duplex ultrasound with a primary-assisted patency after simple re-PTA procedures of 83.3% at 12 months. Discussion: In the literature, primary patency after PTA and stenting of the femoropopliteal trunk seems to be related to several variables, such as number of stents used, specific stent length, diameters, type and length of lesions, type of pathology (if acute or chronic), and number of preoperatory patent below-the-knee vessels. In this study, we try to analyze each single factor in order to understand their role in predisposing specific stent restenosis. Conclusions: S.M.A.R.T. Flex vascular stent system has shown good results in terms of primary patency in the treatment of calcified lesions both at SFA and at popliteal level. However, in our experience, stent patency seems to be significantly poorer in patients presenting with acute limb ischemia associated with chronic atherosclerotic disease as well as for lesions located in the mid-distal part of the popliteal artery and both when number of stents increases or number of runoff vessel decreases.

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Retrospective study on early outcomes of carotid stenting

Romanian Neurosurgery ◽

10.33962/roneuro-2021-015 ◽

2021 ◽

pp. 94-97

Author(s):

Saurabh Sharma ◽

Prashant Raj Singh ◽

Ram Kumar Goyal ◽

Raghavendra Kumar Sharma ◽

Yashuhiro Yamada ◽

...

Keyword(s):

Myocardial Infarction ◽

Carotid Artery ◽

Carotid Artery Stenosis ◽

Doppler Ultrasonography ◽

Carotid Stenting ◽

Artery Stenosis ◽

Minor Stroke ◽

Safe Alternative ◽

Asymptomatic Patients

Objective: This study is conducted to evaluate the early events after Carotid artery stenting (CAS) among our patients in a single institute. Methods: This study was conducted on 40 patients. These patients underwent stenting of extracranial carotid arteries. Stenting was performed on symptomatic patients with carotid artery stenosis of more than 50 per cent of asymptomatic patients with more than 70 per cent carotid artery stenosis on Doppler ultrasonography. Follow up period for this study was of one month. Results: 40 patients who underwent CAS between August 2018 and June 2019 were included in the study. Self-expandable hybrid stents were implanted in all patients and pre or poststent-dilatation was performed if required after implantation. None of the patients suffered from a stroke, myocardial infarction or death due to CAS during their hospital stay. Only one patient had a minor stroke during follow up, which was managed conservatively. No transient ischemic attack (TIA), myocardial infarction or death during the follow-up period. Re-stenosis was not observed in the follow-up carotid Doppler ultrasonography; flow rates were within normal limits. Conclusions: Carotid stenting is a safe alternative to CEA (carotid endarterectomy) in the treatment of carotid stenosis regardless of age. CAS with cerebral protection can be performed safely in patients who are at high surgical risk, with low perioperative morbidity and mortality. The durability of the procedure must be determined with a longer follow-up. Further high-quality RCTs are required to address other shortcomings and controversies.

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Benefits of Cerebral Protection during Carotid Stenting with the PercuSurge GuardWire System: Midterm Results

Journal of Endovascular Therapy ◽

10.1177/152660280200900102 ◽

2002 ◽

Vol 9 (1) ◽

pp. 1-13 ◽

Cited By ~ 83

Author(s):

Michel Henry ◽

Isabelle Henry ◽

Christos Klonaris ◽

Isabelle Masson ◽

Michéle Hugel ◽

...

Keyword(s):

Carotid Artery ◽

Balloon Dilation ◽

Microscopic Analysis ◽

Carotid Stenting ◽

Balloon Occlusion ◽

Cerebral Protection ◽

Distal Internal Carotid Artery ◽

Post Radiation ◽

Protection Devices ◽

N 93

Purpose: To examine the possible beneficial effect of a new cerebral protection device based on balloon occlusion of the distal internal carotid artery (ICA) and debris aspiration for patients undergoing carotid artery stenting (CAS). Methods: One hundred and eighty-four CAS procedures were attempted under cerebral protection using the PercuSurge GuardWire system in 167 patients (129 men; mean age 70.5 ± 9.2 years, range 40–91)). The lesions were mainly atherosclerotic, and half (n = 93) were asymptomatic. Eighteen restenotic and 7 post-radiation stenoses were also treated. Results: Technical success was 99.5%. All lesions were stented except 3 postangioplasty restenoses. Prophylactic occlusion during balloon dilation and stenting was well tolerated in 176 (95.7%) patients. Microscopic analysis of the aspirated blood showed different types of particles numbering between 7 and 145 per procedure with a mean diameter of 250 µm (56–2652 µm). The 30-day stroke and death rate was 2.7%: 3 periprocedural complications at <48 hours (1 major stroke and 2 transient ischemic attacks), 1 intracerebral hemorrhage at 3 days, and 1 death of cardiac failure at 3 weeks. Conclusions: This study yielded a favorably low rate of periprocedural embolic events comparable with standard CAS series. Protection devices may play an important role in future carotid interventions and expand the applicability of the procedure. Randomized studies (surgery versus CAS with and without cerebral protection) are awaited.

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Endoluminal Grafting for Aneurysmal and Occlusive Disease in the Superficial Femoral Artery: Early Experience

Journal of Endovascular Therapy ◽

10.1177/152660289500200301 ◽

1995 ◽

Vol 2 (3) ◽

pp. 225-239 ◽

Cited By ~ 25

Author(s):

Edward B. Diethrich ◽

Konstantine Papazoglou

Keyword(s):

Ankle Brachial Index ◽

Balloon Dilation ◽

Primary Patency ◽

Occlusive Disease ◽

Lesion Length ◽

Interventional Treatment ◽

Secondary Patency ◽

Technical Problems ◽

Low Profile ◽

The Mean

Purpose: To examine whether endoluminal grafts (ELGs) of radially expandable polytetrafluoroethylene (PTFE) can successfully form durable internal conduits to revascularize lengthy occlusive disease and exclude aneurysms in the femoropopliteal (FP) arteries. Methods: Under protocol, implantation of an unpredilated PTFE tube ELG anchored with Palmaz stents using a low-profile percutaneous delivery system was attempted in 50 symptomatic patients for a variety of pathologies: (1) restenosis; (2) complex lesions unlikely to be treated successfully with other endoluminal therapies; (3) acute angioplasty failure; and (4) aneurysms. There were 37 occlusions, 14 stenoses, and 2 long, combined stenoticaneurysmal lesions in 47 native arteries, 5 FP grafts, and 1 femorotibial (FT) vein graft. Thirty-two percent of the patients had ≤ 1 vessel runoff. The average lesion length was 20.4 ± 11.4 cm (range 1.5 to 40), and the mean preoperative ankle-brachial index (ABI) at rest was 0.53 ± 0.14. Results: In a 20-month period through April 1995, 50 patients (34 males, 16 females; mean age 69.5 years, range 45 to 87) underwent 54 procedures in 53 limbs; 55 ELGs were successfully deployed in 51 limbs; 2 patients were converted to FP bypass owing to technical problems (96% procedural success). There were 18 inhospital complications: 1 distal wire dissection repaired with an additional ELG; 2 hematomas requiring surgical repair; 1 graft collapse; 1 pseudoaneurysm at the site of a mid-ELG leak; 7 minor access sequelae; and 6 acute ELG thromboses, 4 treated with lytic therapy and balloon dilation, 1 with open thrombectomy, and 1 with bypass grafting. The mean postoperative ABI was 1.01 ± 0.10. During the 30-day postprocedure period, 2 ELGs rethrombosed and 2 other limbs (3 ELGs) occluded; 1 thrombosis and 1 rethrombosis were lysed successfully, but the other 2 patients had an FP bypass. Over the mean 8.3 ± 5.5 month follow-up, 6 additional ELGs occluded and 1 reoccluded; 4 were successfully treated by endovascular techniques for a primary patency of 72% and secondary patency of 84% by life-table analysis. Conclusions: Endovascular grafting is a conceptually attractive technique that has the potential to expand the current boundaries of interventional treatment. This preliminary experience attests to the feasibility and safety of ELG deployment in the superficial femoral arteries. Whether such a device can match the durability of classical revascularization techniques remains to be determined in clinical trials when device configurations and deployment techniques have been standardized.

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Infrainguinal Atherectomy Using the Transluminal Endarterectomy Catheter: Patency Rates and Clinical Success for 144 Procedures

Journal of Endovascular Therapy ◽

10.1177/152660289500100109 ◽

1994 ◽

Vol 1 (1) ◽

pp. 61-70 ◽

Cited By ~ 4

Author(s):

Kenneth A. Myers ◽

Michael J. Denton ◽

Terence J. Devine

Keyword(s):

Patency Rate ◽

Cox Regression ◽

Clinical Success ◽

Balloon Dilation ◽

Primary Patency ◽

Secondary Patency ◽

Open Approach ◽

Primary Patency Rate ◽

Critical Ischemia ◽

Cox Regression Analysis

Purpose: To determine if atherectomy using the transluminal endarterectomy catheter (TEC) is an effective endoluminal therapy for infrainguinal occlusive disease. Methods: Three surgeons used the TEC for 144 infrainguinal atherectomy procedures in 133 patients. The indications were severe claudication in 83, critical ischemia in 56, and graft stenosis in 5 limbs. The pathology was stenosis in 36 and occlusion in 105 limbs. Balloon dilation was also performed in 109 and stenting in 17 limbs. Results: There was initial technical and anatomic success in 124 (86%) procedures. There were 67 technically successful procedures at mean follow-up of 19 months, although 3 of these limbs with gangrene and extensive distal disease required major amputation. There were 26 failures due to stenosis leading to further intervention and 51 due to occlusion. Twenty of these cases were managed conservatively, 21 were treated with repeat endovascular intervention, 31 with bypass grafting, and 5 with amputation. Repeat intervention in 52 limbs resulted in 36 with patent arteries, 10that are occluded, and 6that required amputation. Thirteen of the 14 amputations were for limbs with critical ischemia, but 1 was in a patient with claudication. Life-table analysis showed that the primary patency rate was 51%, the assisted primary patency rate was 61%, and the secondary patency rate was 75% at 15 months. The clinical success rate was 49%, and the salvage rate for limbs with critical ischemia was 78% at 12 months. Univariate log-rank testing showed no significant differences according to the clinical presentation or pathology, but results were worse for lesions > 5 cm long due to more frequent immediate failures. However, multivariate Cox regression analysis showed that results were significantly worse for critical ischemia than for claudication, stenosis compared to occlusions, for limbs with poor runoff, for operations performed by percutaneous rather than an open approach, and for those performed more recently. Conclusions: TEC atherectomy may have a place in selected patients, but the optimal circumstances for its use and long-term efficacy require further study.

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Impact of Lesion Morphology on Durability After Angioplasty of Failed Arteriovenous Fistulas in Hemodialysis Patients

Journal of Endovascular Therapy ◽

10.1177/1526602817748316 ◽

2017 ◽

Vol 25 (5) ◽

pp. 649-654 ◽

Cited By ~ 1

Author(s):

Kotaro Suemitsu ◽

Tatsuya Shiraki ◽

Osamu Iida ◽

Hiroki Kobayashi ◽

Yuki Matsuoka ◽

...

Keyword(s):

Proportional Hazards Model ◽

Negative Impact ◽

Positive Impact ◽

Balloon Dilation ◽

Primary Patency ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Flow Volume ◽

Venous Valve

Purpose: To investigate if morphological patterns of arteriovenous fistula (AVF) venous lesions affect primary patency after percutaneous transluminal angioplasty (PTA). Methods: From July 2014 to June 2015, 262 patients underwent PTA for failed AVFs. A total of 104 patients were excluded owing to (1) calcification or AVF occlusion precluding ultrasound examination, (2) central venous or arterial lesions, and (3) no follow-up, leaving 158 patients (mean age 71±12; 96 men) for analysis. More than half of the patients had one or more previous PTAs for the failed AVF. Prior to PTA the stenotic lesions were assessed using ultrasonography to determine stenotic patterns at the minimum lumen area site and to evaluate the flow volume in the brachial artery. Three stenotic patterns were identified: intimal hyperplasia (IH) stenosis (n=110), shrinking lumen stenosis (n=32), and venous valve–related stenosis (n=16). The main outcome measure was primary patency after PTA estimated using Kaplan-Meier analysis. Predictors for loss of primary patency were determined using a multivariate Cox proportional hazards model; the results are presented as the adjusted hazard ratio (HR) and 95% confidence interval (CI). Results: Median follow-up after PTA was 6.3 months (interquartile range 3.3, 10.5). The 6-month primary patency estimates were 56%±5% in the IH group, 40±9% in the shrinking lumen group, and 100% in the valve stenosis group (IH vs shrinking, p=0.013; IH vs valve, p=0.003). In multivariate analysis, shrinking lumen morphology had a negative impact on primary patency (HR 2.05, 95% CI 1.25 to 3.36, p=0.005), while venous valve–related stenosis had a positive impact (HR 0.19, 95% CI 0.04 to 0.79, p=0.023). Flow volume (10-mL/min increments; HR 0.97, 95% CI 0.96 to 0.99, p=0.004) and history of PTA (HR 1.66, 95% CI 1.06 to 2.60, p=0.029) were also independently associated with primary patency after PTA. Conclusion: The patterns of AVF stenosis as determined by ultrasound can affect the outcome of treatment with balloon dilation.

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