Table of Contents  
ORIGINAL ARTICLE
Year : 2015  |  Volume : 2  |  Issue : 1  |  Page : 2-6

Long-term Results of Endovascular Interventions for Subclavian and Innominate Arterial Occlusive Disease


Department of Vascular Surgery, Narayana Hrudayalaya Institute of Vascular Sciences, Bengaluru, Karnataka, India

Date of Web Publication5-Mar-2015

Correspondence Address:
Prof. Ramesh K Tripathi
Department of Vascular Surgery, Narayana Hrudayalaya Institute of Vascular Sciences, Bengaluru, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0972-0820.152823

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  Abstract 

Purpose: Endovascular techniques offer a minimally invasive approach to the management of obstructive lesions of Innominate and Subclavian arteries. However, literature on long-term data on the efficacy of this option is sparse. The aim of this study is to report clinical and imaging results of a 17 years experience of the endovascular management of these lesions with evaluation of end-points at 3 years follow-up.
Material and Methods: A retrospective review of prospectively collected data was undertaken on 112 patients (116 limbs) (mean age 58.9 years, range 36-84) who underwent endovascular treatment by the senior author (robotic kidney transplantation) from 1996 to 2013. There were 141 symptomatic innominate or subclavian arterial occlusive lesions. Endpoints of this study were primary patency, secondary patency and blood pressure differential in the affected limb at 1, 2 and 3 years follow-up.
Results: Initial technical success was achieved in 134 (95.03%) lesions. Cumulative primary patency was 97.77% at 6 months, 95.48% at 1-year, 86% at 2 years and 85.3% at 3 years and secondary patency was 98.5% at 6 months, 95.48% at 1-year, 90% at 2 years and 87% at 3 years.
A sustained nonrecurrence of symptoms and a BP differential improvement by >10 mmHg was observed in 82.7% cases at 3 years. Sub-analysis of data revealed that for nonostial stenotic lesions, balloon angioplasty performed as well as stenting, whereas for ostial stenosis and total occlusions, stenting was superior to balloon angioplasty (P = 0.003). There was a complication rate of 7.8% (2.84% major, 4.96% minor) with an associated mortality rate of 0.89%.
Conclusion: Endovascular interventions can be accomplished safely with a high degree of technical success and excellent long-term clinical results. In accordance with current thinking, it should be the first line of treatment for intrathoracic supra-aortic arterial occlusive disease. In addition, primary stenting for all ostial and total occlusions is recommended.

Keywords: Angioplasty, artery, innominate, stenting, subclavian


How to cite this article:
Meda N, Verma H, Tripathi RK. Long-term Results of Endovascular Interventions for Subclavian and Innominate Arterial Occlusive Disease. Indian J Vasc Endovasc Surg 2015;2:2-6

How to cite this URL:
Meda N, Verma H, Tripathi RK. Long-term Results of Endovascular Interventions for Subclavian and Innominate Arterial Occlusive Disease. Indian J Vasc Endovasc Surg [serial online] 2015 [cited 2019 Sep 15];2:2-6. Available from: http://www.indjvascsurg.org/text.asp?2015/2/1/2/152823


  Introduction Top


Brachiocephalic or subclavian occlusive arterial disease is accountable for significant morbidity in a relatively younger population. [1],[2],[3],[4],[5] Majority of lesions are atherosclerotic and as a minimally invasive alternative to the conventional open surgery, [6],[7] endovascular techniques have emerged as frontline treatment. [8],[9],[10] Although short and mid-term results of endovascular treatments have been extensively reported, [4],[5],[8],[9],[11],[12] there is a paucity of durability studies of endovascular interventions for supra-aortic disease. [10],[13] We report our 17 years experience of endovascular management of 141 supra-aortic arterial occlusive lesions in 112 patients.


  Material and Methods Top


Patients

A retrospective analysis was performed of prospectively collected data on endovascular interventions performed by the senior author on innominate and subclavian arterial occlusive lesions treated during a 17 years period of 1996-2013.

Out of 127 patients presenting with one or more symptoms and signs of upper limb ischemia, subclavian-vertebral steal syndrome (other causes of dizziness/black outs/drop attacks ruled out by ENT and neurological consultations), distal embolization and coronary ischemia, 112 patients 116 limbs) fully complied with follow-up during the 3-year period following their intervention were included in this study.

The mean age of the present patient group was 58.9 years (range 36-84 years) with a male: female ratio of 1.87:1 (73 males and 39 females).

Clinical presentations included vertebral basilar insufficiency in 61 (54.46%) patients, isolated arm/forearm fontaine grade III (rest pain) in 25 (22.3%), fontaine grade IV (ischemic ulcer) in 3 (2.7%), upper limb Raynaud's phenomenon in 9 (8.03%), distal embolization in 7 (6.25%), transient ischemic attacks in 5 (4.46%) and postcoronary artery bypass graft (CABG) coronary ischemia/angina in 2 (1.78%) patients [Table 1].
Table 1: Presenting symptoms/signs of supra - aortic occlusive disease

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Arm BP differential of 25-29 mmHg was noted in 23 patients (19.8%), 30-34 mmHg in 82 (70.6%), 35-39 mmHg in 6 (6%), 40-44 in 4 (3.4%) patients.

These patients underwent endovascular interventions for 141 lesions with occlusion or >70% stenosis on preoperative computed tomographic angiography (CTA) or digital subtraction angiography (DSA).

There were 29 innominate lesions (20 stenosis, 9 occlusions), 23 right subclavian (17 stenosis, 6 occlusions) and 89 left subclavian lesions (49 stenosis, 40 occlusions). 101 (71.6%) of the lesions were ostial, and 40 (28.4%) were nonostial. There were 108 (76.6%) lesions in the prevertebral region and 33 (23.4%) in the postvertebral section.

Etiology of the lesions included, 101 (71.63%) due to atherosclerosis, 16 (11.34%) due to Takayasu's Disease, 15 (10.64%) due to nonspecific arteritis and radiation arteritis 9 (6.39%) [Table 2].
Table 2: Lesional characteristics

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Risk factors included tobacco chewing/smoking in 87 (77.7%), hypertension in 102 (91.1%), ischemic heart disease 68 (60.7%), diabetes 63 (56.2%), hyperlipidemia 85 (75.9%), renal failure (serum creatinine >1.5 mg%) 37 (33.0%) and polycythemia 3 (2.7%).

Supra-aortic endovascular interventions were performed under local anesthesia in 101 (90.17%) patients and under general anesthesia in 11 (9.83%). Trans-brachial approach was used in 87 (61.7%) cases, trans-femoral route used in 52 (36.8%) cases and 2 (1.5%) cases required a combined brachio-femoral approach.

In the angiographic suite, results were confirmed with postprocedure angiogram and hemodynamic pressure recordings across the stenotic segments.

Follow-up of patients involved regular assessment of patency of interventions by upper limb BP measurements and duplex ultrasound at 1, 6, 12, 24 and 36 months. In doubtful cases, DSA or CTA was used.

A total of 106 (94.64%) patients received a minimum dosage of aspirin 75 mg daily, 92 (65.24%) were on some form of lipid lowering therapy and 39 (27.6%) were on clopidogrel 75 mg daily as a part of pre and posttreatment during their endovascular intervention.

Statistical analysis

Student's test, Chi-square test, Fisher's exact test or multivariate with a stepwise Cox proportional test were used for analysis of the comparison of percentages. Survival curves were calculated using the Kaplan-Meier product limit method and their differences/comparisons assessed by log-rank test with the standard limit with the standard limit of significance set at P < 0.05


  Results Top


Initial overall procedural success was achieved in 134 out of 141 lesions (95.03%). Technical success was achieved in all 86/86 (100%) cases of innominate and subclavian stenoses and in 48/55 (87.2%) cases of the innominate and the subclavian occlusion.

Percutaneous transluminal angioplasty (PTA) alone was performed in 47/86 (54.65%) of stenotic lesions and in 3/48 (6.25%) of complete occlusions. Stenting was required in 39/86 (45.35%) of stenotic lesions and in 45/48 (93.75%) of total occlusions. Indications of stenting were ostial stenosis 61/84 (72.6%), severe elastic recoil after balloon angioplasty 14/84 (16.7%), heavily calcified lesion (primary stenting) 6/84 (7.1%) or dissection during PTA 3/84 (3.6%).

Seven cases of innominate/subclavian occlusion were converted to open surgery because the lesions could not be crossed with the guidewire. This resulted in 5 carotid - subclavian bypasses, 1 carotid-subclavian transposition and 1 ascending aorta - carotid/subclavian bypass.

Results of endovascular therapy for stenosis and occlusive lesions are shown in [Table 3] and [Table 4].
Table 3: Results of angioplasty alone for stenotic and occlusive lesions

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Table 4: Results of angioplasty and stenting for stenotic and occlusive lesions

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Primary patency of ostial subclavian and innominate arterial lesions at 3 years after PTA was 85.24% versus 91.8% after stenting (P = 0.030). For nonostial lesions, primary patency after PTA (95%) compared to after stenting was (92.5%) (P = 0.55).

Cumulative primary patency of endovascular interventions at 36 months for all subclavian and innominate arterial lesions was 99/116 (85.34%) and their Secondary patency rate was 101/116 (87%).

Improvement of systolic blood pressure differential in the affected arm >10 mmHg. was observed in 107/116 (92.2%), 106/116 (91.3%), 102/114 (89.4%) and 89/108 (82.4%) limbs at 6, 12, 24 and 36 months, respectively.

Freedom from presenting symptoms (vertebral basilar insufficiency, isolated arm/forearm claudication fontaine grade III/IV, upper limb Raynaud's phenomenon, distal embolization, transient ischemic attacks and post-CABG coronary ischemia/angina) was observed in 101/112 (90.17%), 101/112 (90.17%), 98/110 (87.2%) and 83/96 (86.4%) patients at 6, 12, 24 and 36 months respectively.

There was one death in our series, due to a postintervention myocardial infarction (mortality 0.89%). The total procedural morbidity rate was 8.5%. These complications include two transient ischemic attacks (TIA's), three digital artery emboli, one false subclavian aneurysm, two brachial artery puncture site occlusions, three groin hematomas (managed nonoperatively) and one transient deterioration of renal function.

Transient ischemic attacks in two patients occurred from procedures on innominate arteries and in one patient from a heavily atherosclerotic short bovine arch. One false left subclavian aneurysm occurred due to sub-intimal dissection during an attempt to cross an occluded proximal subclavian lesion. This patient had Takayasu's disease with an additional occlusion of the innominate artery and underwent ascending aorta-subclavian and carotid bypass with a 12 mm × 7 mm bifurcated polytetrafluoroethylene graft with ligation of left subclavian artery. Of the three digital artery embolizations, one patient underwent digital tip amputation with subsequent healing, one patient had radial branch embolus with anatomical snuff-box pain at wrist managed conservatively and the remainder patient had a painful hand due to a shower of micro-emboli that responded to a course of intravenous prostaglandin.

Risk factors for adverse outcomes of endovascular intervention are detailed in [Table 5].
Table 5: Risk factors for adverse outcomes of endovascular treatment of supra - aortic arterial occlusive disease

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  Discussion Top


Obstructive lesions of the brachiocephalic trunk and the subclavian arteries are uncommon, and only 1.7-4.3% of extracranial vascular reconstructions performed are on the supra-aortic trunks. [14],[15] The risk factors include smoking in 82% of patients, [1] however in our series the incidence was 68%.

Symptoms include upper limb claudication, digital ulceration and necrosis, [16] embolization resulting in TIAs and strokes with or without ocular symptoms, [17] and subclavian-steal syndrome [18] causing vertebrobasilar insufficiency. In our series, one patient had coronary steal phenomenon, [19] where flow through the internal mammary artery is reversed, causing myocardial ischemia.

Acceptable results using open surgical techniques (endarterectomy and arterial bypass or subclavian transposition) is well established for the management of occlusive lesions of the brachiocephalic and subclavian arteries. [1],[14],[20] This approach provides excellent long-term graft patency, with primary patency rates of 98.4% at 5 years and 96.3% at 10 years. [3],[21] However, these procedures may have a significant operative morbidity and mortality rate. [21] Despite improved perioperative care, results of transthoracic repair still carry a mortality of 5.6-18.7% [22],[23],[24] and an overall complication rate of 16 ± 11% for open procedures inclusive of stroke in 3 ± 4%, and death in 2 ± 2% with increased risk if the procedures were transthoracic. [4] Carotid-subclavian bypass also has excellent durability with 100%, 92% and 83% primary patency at 3,5 and 8 years respectively. [25],[26]

On the other hand, endovascular angioplasty/stenting of the brachiocephalic and subclavian arteries is minimally invasive and can be performed safely with a high degree of initial technical success. [5],[27] PTA on the supra-aortic trunks had similar perioperative success as open procedures, but had fewer complications. [5],[11],[27] Although there remain doubts of long-term patency of PTA treated vessels, two recent studies have recommended PTA as the first line treatment for occlusive lesions of the subclavian and brachiocephalic trunks [5],[27] lesions.

In our study, overall very good technical success rates were achieved (95.03%) These results are similar to other series in world literature for PTA of supra-aortic lesions. Motarjeme [8] and Sullivan [5] found they had a 100% success rate when dealing with subclavian stenosis paralleling our experience of technical success in all 86/86 (100%) cases of innominate and subclavian stenoses. Huttl et al. reported a technical success rate of 96.4% in his series of innominate artery angioplasty. [13] While PTA was good for re-canalizing subclavian stenosis, it was not as effective at reopening completely occluded subclavian arteries. [27] Motarjeme [27] reported that only 6/13 (46.2%) of subclavian occlusions were successfully treated in his series, Amor [8] had a success rate of 53.8% and de Vries et al. a success rate of 65%. [10] In our series, we had a success rate for treatment of occlusive lesions in 48/55 (87.2%) cases of the innominate and the subclavian occlusion, which seems to be better than that of other similar studies.

Our short, mid and long-term clinical results of PTA ± stent are satisfactory and reflect superiority of Stenting over PTA for occlusive lesions (P = 0.03) and equivocal results for stenotic lesions (P = 0.9).

When PTA alone was used, the primary patency of the stenosed lesions at 6, 12, 24 and 36 months were 95.75%, 91.48%, 84.7% and 88% and of occlusive lesions during the same periods were 50% at 6 months and 0% thereafter.

When PTA with Stent placement was used, the primary patency of the stenosed lesions at 6, 12, 24 and 36 months were 100%, 92.3%, 89% and 87% of occlusive lesions during the same periods were 100%, 97.7%, 84% and 80% respectively. Cumulative primary patency of all lesions with PTA alone was 87.11% at 3 years in comparison to 93.9% with PTA + stent (P = 0.18).

Though the number of ostial lesions treated by primary angioplasty is small, the data suggest that these lesions respond better to stenting when compared to PTA alone (P = 0.030). Outcomes for interventions of nonostial lesions did not have a statistically significant difference for PTA versus stenting.

The addition of stents vastly improved secondary patency of occlusive lesions in comparison to stenotic lesions [Table 1].

Other studies of PTA of supra-aortic lesions have also shown good long-term patency. Sullivan [5] reported 84% of all lesions treated in his study were patent at 35 months. Amor reported a 16.8% restenosis rate and a 2.6% re-occlusion rate in his follow-up, which averaged 3.51 years (±1.98). Huttl et al. reported primary patency rates of 98 ± 2% at 6 months and 93 ± 4% at 16-117 months. His secondary patency rates were 100% at 6 months and 98 ± 2% at 12-117 months.

Preoperatively, the mean difference in systolic blood pressure between the upper limbs in our series was 32 mmHg. Mean difference of systolic blood pressure of upper limbs was 2 mmHg, 6 mmHg, and 6 mmHg. at 6,12 and 24 months follow-up that correlated with amelioration of presenting symptoms recorded in 90.97%, 89.47% and 86.82% limbs at 6, 12 and 24 months respectively.

Data from world literature suggests low over all morbidity and mortality from endovascular interventions in the supra-aortic segment and is validated by our study. [4],[5],[8],[9],[10],[11],[12],[13],[16],[17],[18],[19],[20],[21],[27],[28],[29],[30]

In our study, we found an overall complication rate of 9.2%, most of them minor. Our complication rate is similar to other reports found in the literature. [5],[8],[9],[10],[12],[13],[16],[17],[18],[19],[20],[27],[28],[29],[30] TIAs following catheter passage through a heavily diseased thoracic aorta may suggest a possible need for placement of a distal carotid embolic protection device prior to endovascular interventions. Similarly, distal protection devices may reduce embolic events in the upper extremity if there is a high suspicion of an ulcerative plaque in subclavian or innominate artery or shaggy aorta although their incidence is thankfully very low.


  Conclusions Top


In our experience, endovascular interventions of supra-aortic vessels can be performed with a very high degree of technical success rate with good long-term clinical outcomes. Based on these results we recommend primary stenting for all total occlusions and stenotic lesions at the ostium.

 
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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