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One Year Evolution of Carotid Angioplasty

Oscar A. Mendiz, Jorge N. Wisner, Juan M. Telayna, Hugo F. Londero.

Departamento de Hemodinamia e Intervenciones por Cateterismo
Fundación Favaloro
Buenos Aires, Argentina.

Abstract
Introduction
Objectives
Material and Methods
Definitions
Discussion
References

Abstract
The aim of this report is to communicate one year evolution of a series of patients treated by carotid stent assisted angioplasty.
There were included 71 patients (81 procedures) with severe symptomatic or asymptomatic carotid obstructions which were treated by angioplasty and were not included in other clinical investigation trial.
Clinical success [residual obstruction less than 30% without major in-hospital complication (death, major stroke, emergent surgery)] was achieved in 96.3% of cases. Major stroke incidence was 1.2%, minor stroke 2.5%, Transient Ischaemic Attack 1.2% and any stroke or death within 30 days was 3.7%.
More than 3 months follow-up was obtained in 100% of eligible cases, (66 patients with 76 procedures) with a mean time of 14.8±7 months. Sixty one patients reached one year follow-up. Restenosis incidence was 4.5% (3.9% by procedure); one was dilated again and the other two were operated on. There were not any ipsilateral ischaemic event during follow-up time.
There was high incidence of non related vascular events probably due to a severe vascular disease of the treated population.
As a conclusion we can say that in this group of patients, carotid angioplasty had good short and long term results, allowing us to consider this kind of treatment as an alternative to surgical approach of extracraneal carotid obstructions.

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Introduction:

Stroke is a high prevalent disease due to extracraneal carotid artery obstruction in one third of the cases in which surgical treatment has proved to be better than medical treatment in symptomatic or asymptomatic patients with severe carotid obstructions. At this time, carotid angioplasty is considered as an alternative treatment in this kind of lesions, but some controversies remain about their indications  The aim of this communication is to report the one year follow-up of a series of consecutive patients treated by carotid Stent assisted angioplasty.

Material and Methods:

Patients with symptomatic, ((60%) or asymptomatic ((80%) carotid obstructions (angiographically evaluated by NASCET method) who were treated by carotid angioplasty between October 1995 and January 1999 were included in the analysis.
There were excluded patients who had had recently repeated transitory ischaemic attacks (TIA) within previous week, haemorragic stroke, intraluminal thrombus, arterio-venous malformations, intracraneal tumors, dye allergy or patients who rejected to sign the inform consent.
Trying to homogenize the population 12 patients who were included in other safety and feasibility new devices protocols were excluded of the analysis.

Definitions:

Procedural Success: residual obstruction less than 30% without in-hospital major complications (death, major stroke, emergent surgery).
Procedural Related Complications.
Major stroke: periprocedural sudden neurological deficit which increases NIH Stroke Scale more than 4 points and remains more than 7 days.
Transient Ischaemic Attack (TIA): Sudden neurological deficit which retrogrades within 24 hours.
Minor Stroke: any other sudden neurological deficit which retrogrades within 7 days.
Restenosis: obstruction greater than 50% evaluated by NASCET method.
Population: Population characteristics and clinical presentation are summarized at Table N°1 & N°2.

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There were treated 92 lesions which were atherosclerotic in 96.3% of the cases and post surgical endartherectomy in 3.7%. They were localized at: right carotid bifurcation and /or internal carotid artery in 49.4%, left carotid bifurcation and/or internal carotid artery in 39.5%, left common carotid artery in 6.2% and right common carotid artery in 4.9%.
The Stents used were balloon-expansible (Palmaz / Palmaz-Schatz) in 73.4%, self-expanding in 12.7%, Nitinol termo-expansibles in 10.1%, and combinations between them in a minor frequency (3.8%). Figure Nº 1

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Procedural success was achieved in 78 of the cases (96.3%) and failure in 3 cases (3.7%). Angiographic success was obtained in one patient who developed a periprocedural major stroke, in other case it was impossible to cross the lesion with the guide wire, in a third patient it was not possible to obtain a stable position with the guiding catheter therefore, the angioplasty was not attempted.
Periprocedural and thirty days complications are shown at the Figure N° 2. Mean hospitalization time was 3.5±3 days.

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Analysis of follow-up evolution was done in patients with more than three months from the procedural date.
This follow-up was completed in all eligible cases (66 patients with 76 procedures) during a mean time of 14.8±7 months. Fifty two patients had reached one year follow-up.
During follow-up 3 (4.5%) patients with restenosis were diagnosed (by echo-Doppler and confirmed by angiography) which correspond to 3.9% of the procedures.
One patient with restenosis at 6 months received a new balloon angioplasty, dying 15 months after procedure due to a myocardial infarction without evidence of new restenosis. Two other restenosis cases (6° & 12° months) were surgically treated because of referring physician preference.
Four patients died during follow-up because of non procedural related causes. Two were during an Acute Myocardial Infarction, and other two were sudden death; one of them in a context of a recent onset unstable angina.
One of two patients who had "Blue Toe Syndrome", due to atheroembolic complication, received aorto-bifemoral By-pass; the other one received only medical treatment, because he was the patient who suffered a major stroke which let him important intellectual deficits.
One patient received a primary PTCA at the Left Anterior Descending artery during an Acute Myocardial Infarction, in other patient a Stent PTCA was performed by restenosis at circumflex artery and a renal PTA was done to the other one.
One patient had a neutropenia with fever , attributed to a Ticlopidine side effect requiring hospitalization for medical treatment.
At 5° months follow-up, one patient with bilateral carotid angioplasty, suffered a minor stroke (minimal deficit completely recovered) due to a small intracraneal haemorrhage (<1cm. at the MRI scan). At that moment he received only Aspirin as antithrombotic treatment.

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Discussion:

Population analyzed was non selected and some patients had high surgical risk. Furthermore this sample include first patients done by the team during their learning curve. Instead of these limitations, the obtained results are promisories, and would be compared to reported surgical series.
A patient who had a major stroke as a complication, had previous stroke history and several ischemic defects at the CT scan previous to the procedure, moreover he had an ulcerated lesion. Therefore it was a case which, actually we would only accept to perform under "cerebral protection". He was completely recovered of his motor deficit but remains with severe intellectual impairment.
Minor strokes were a hemiparesia completely recovered and a minimal hand paresia completely recovered too.
Periprocedural events incidence (any stroke or death) was greater in symptomatic patients, (8.1% vs. 2.9%) which did not reach statistical significance, but showing that asymptomatic patients, even those immediately operated on by other vascular disease, had better evolution.
Restenosis incidence was low at long time follow-up (one year mean time) and possible to treat by re-PTA or by surgery with good results.
Torpid evolution of some patients can be attributed to a diffuse vascular disease affecting multiple territories, demonstrating that after in-hospital results, restenosis was the only related event presented, which was always asymptomatic and easy to treat.
Based in the randomized trails, which were very strict in patients and surgeons selection; surgical endarterectomy remains as the first choice treatment for carotid obstructions. But its known that surgery has some limitations as: usually requires general anesthesia (it has been demonstrated to be possible to perform under local anesthesia), mortality rate is about 1~7% depending on previous symptoms and increasing up to 18% in some series in patients with associated coronary disease. Cranial nerve palsies is about 7~27%, local hematoma about 5.5% and restenosis happens in 5~9% of cases. Also we know that this experience is not possible to translate to all centers.
In the opposite way to previous surgical development, carotid angioplasty had demonstrated, at big international registries done during the last years, to be possible, feasible under local anesthesia; with similar results obtained by surgery even in non selected patients and with a very heterogeneous work team as the included by Dr. Michel Wholey in his international multicenter registry. In these 2048 patients series, technical success was 98.6%, death incidence 1.4%, major stroke 1.3%, minor stroke 1.3% and an incidence of any stroke or death of 5.8% (Michel Wholey).
In discrepancy with surgery, in small series, angioplasty had demonstrated in patients with associated coronary artery disease non significative increasing of morbi-mortality .
Carotid angioplasty technique continues evolving with new techniques and devices development (Stents, protection systems, etc.). Protection systems (we are using in a controlled study) which avoid micro and macro embolization are included within this technological development and will allow decrease related complications.
As a conclusion it is possible to say that in this group of patients, carotid angioplasty had short and long term good results, allowing us to consider it as an alternative technique to the surgery in extracraneal carotid obstructions treatment.

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References

1. Timsit SG, Sacco RL, Mohr JP, et al. Stroke 1992;23:486-491.
2. Gerald Dorros, M.D. J Interven Cardiol 1996;Vol.9,N° 3.193-196.
3. North American Symptomatic Carotid Endarterectomy Trial collaborators. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med 1991;325:445-453.
4. Executive Committee for the Asymptomatic Carotid Atherosclerotis Study. Endarterctomy for asymptomatic carotid stenosis. JAMA 1995;273:142-148.
5. Yadav YS, Roubin GS, Iyer S, et al. Elective Stenting of the extracranial carotid arteries. Circulation 1997;5(4):293-304.
6. Wholey MH, Wholey M, Bergerson P, et al. Cathet Cardiovasc Diagn 1998;44(1):1-6.
7. Moore WS, Vescera CL, Robertson JT, et al.Selection proccess for surgeons in the asymptomatic carotid atherosclerosis study. Stroke 1991;22(1):1353-1357.
8. Archie JP. The endarterectomy-produced common carotid artery step: A harbinger of early emboli and late restenosis. J Vasc Surg 1996;23:932-939.
9. AHA Ad hoc Committee. Guidelines for Carotid Endarterectomy. Circulation. 1995;91:566-579.
10. Lusby RJ; Wylie EJ. Complications of carotid endarterectomy. Surg Clin of North America 1983;63:1293-1301
11. Zierler RE, Brandyk DF, Thiele BL. Strandness ED. Carotid artery stenosis following endarterectomy. Arch Surg 1982;117:1408-1415
12. Edwards WH Jr, Edward WH Sr, et al. Recurrent carotid artery stenosis. Ann Surg 1989;209:662-669.
13 . Shawl FA, Efstratiou A, Lapetina F, et al. (Abstract). J Am Coll Cardiol 1997,29:2(Suppl A),363A.

 

Questions, contributions and commentaries to the Authors: send an e-mail message (up to 15 lines, without attachments) to interven-pcvc@pcvc.sminter.com.ar , written either in English, Spanish, or Portuguese.

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Bioengineering
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Update
Dic/19/1999