carotid angioplasty and stenting in octogenarians: is it safe?
TRANSCRIPT
Carotid Angioplasty and Stentingin Octogenarians: Is it Safe?
M. Henry,1,2* MD, I. Henry,3 MD, A. Polydorou,4 MD, and M. Hugel,1,2 RN
Purpose: Elderly patients have a higher risk of complications in carotid endarterec-tomy. The aim of the study was to evaluate whether carotid artery stenting (CAS) per-formed in octogenarians also increases the procedure related risk. Methods: 870patients (male 626) mean age 70.9 6 9.3 years underwent 930 CAS for de novo lesions(n 5 851) restenoses (n 5 54) post radiation (n 5 14) inflammatory arteritis (n 5 9) posttrauma aneurysms (n 5 2). Indications for treatment: symptomatic carotid stenosis �70% (n 5 577) or asymptomatic stenosis � 80%. Patients were separated into two agegroups: <80 years (749 patients, 806 CAS) and >80 years (121 patients, 124 CAS). 187CAS performed without protection (N.P2) 6 patients >80 years, 743 with protection(NP1) (occlusion balloon: 334, filters: 404, reversal flow: 6) 118 patients >80 years. Dataanalysis included neurological complications, death and myocardial infarction (MI) rateat 30 days, anatomical particularities. Technical points will be described depending onthe age of the patient. Results: Technical success 804/806 in patients <80 years, 123/124 in patients >80 years (NS). 30 days outcomes: in the patient group <80 years weobserved 9 TIA (1.1%) 3 without NP (1.7%) 6 with NP (0.9%), 5 minor strokes (0.6%) 2without NP (1.1%) 3 with NP (0.5%), 3 major strokes: 2 without NP (1.1%) 1 with NP(0.2%), 5 deaths (0.6%) 2 without NP (1.1%) 3 with NP (0.5%). Death/stroke/MI: 14(1.8%) 6 without NP (3.3%), 8 with NP (1.3%). In the group >80 years, we observed 2TIA (1.7%) 1 without NP 1 with NP (0.92%) 1 minor stroke without NP (17%) no majorstroke, no death. Death/stroke/MI 1 without NP (17%). Conclusion: CAS can be per-formed in elderly patients without higher risk than in younger patients. But good indi-cations, a meticulous technique, protection devices are mandatory and some technicalpoints must be pointed out to avoid neurological complications and failures. ' 2008
Wiley-Liss, Inc.
Key words: peripheral vascular disease; carotid; stent; angioplasty; octogenarians;strokes
INTRODUCTION
Stroke represents the third leading cause of death andthe most common and disabling neurological disorder inthe elderly population. Occlusive disease of the extracra-nial circulation is responsible for about 30% of thecases. Randomized controlled trials [1–6] have shownthat carotid endarterectomy (CEA) is superior to medicaltherapy and have demonstrated the efficiency of CEA inreducing the risk of stroke and death in symptomaticand asymptomatic patients. After these trials, CAS wasconsidered to be the gold standard for the treatment ofcarotid stenoses. However, most of these randomized tri-als excluded octogenarian patients from enrollment, con-sidering that they were at a higher procedural risk.Because of the increase of the mean life expectancy
and the growing number of high risk surgical interven-tions, elderly people and octogenarians are becomingstronger candidates for carotid revascularization proce-
dures. The new guidelines for screening of extracranialCarotid Artery Disease [7] is as follows; the subpopula-tion of patients �65 years with at least three cardiovas-cular risk factors, individuals undergoing CABG(patients � 65 years with a history of stroke or TIA leftmain coronary stenosis, peripheral vascular disease,
1Cabinet de Cardiologie, Nancy, France2Global Research Institute, Apollo Clinic, Hyderabad, India3Polyclinique Bois-Bernard, 63 320 Bois-Bernard, France4Panteleimon General Hospital, Athens, Greece
*Correspondence to: M. Henry, Cabinet de Cardiologie, 80, rue
Raymond Poincare, Nancy 54000, France.
E-mail: [email protected]
Received 31 January 2008; Revision accepted 20 February 2008
DOI 10.1002/ccd.21574
Published online 25 August 2008 in Wiley InterScience (www.
interscience.wiley.com).
' 2008 Wiley-Liss, Inc.
Catheterization and Cardiovascular Interventions 72:309–317 (2008)
history of smoking, carotid bruit, diabetes mellitus)and those patients with symptomatic peripheral vascu-lar disease. The issue continues to be debated as towhat can be done for elderly patients and octogenar-ians with significant carotid stenosis. CEA can beproposed but the complication rate remains high inhigher risk patients and particularly in octogenarianswith a mortality rate of 4.7% and a stroke/death rateof 7–10% [8–15]. In a series of 3,061 procedures,Ouriel et al. [16] observed a stroke, myocardial in-farction, and death rate of 7.4% in high-risk patientsand 2.9% in low risk patients.Carotid angioplasty and stenting (CAS) is a possible
substitute for surgery and may be proposed to the ma-jority of high-risk patients suffering from a carotid ste-nosis. However, in contrast to many endovascular pe-ripheral arterial interventions, CAS represents a morechallenging procedure requiring complex catheters, astrong skill base and an extensive learning curve.Without these crucial elements, poor results of CAShave been reported in published studies [17–21].Many centers with experienced operators have offeredCAS routinely to elderly patients as the preferredtreatment for carotid stenosis with a complication ratesimilar to younger patients. However, recent datafrom the lead-in phase of CREST [22], the CAP-TURE 3500 study, and the CASES PMS Study [23]showed that the periprocedural risk of stroke anddeath increases with age causing an inacceptable riskfor octogenarians.The aim of this study was to evaluate whether CAS
performed in octogenarians at a high volume center byexperienced operators affected the procedurally relatedrisk in comparison to the outcomes of CAS in youngerpatients.
METHODS
Study Design
From April 1995 to December 2007, 870 patients(men: 626, female: 244) with a mean age of 70.9 69.3 years (range 22–93) underwent 930 CAS proce-dures for de novo lesion (n 5 851), restenosis (n 554), post radiation (n 5 14), inflammatory arteritis(n 5 9), or post trauma aneurysm (n 5 2). Of thesepatients, 62 had bilateral procedures and 62 patientshad a contralateral carotid occlusion.
Indications
Our indication for CAS was the presence of a symp-tomatic carotid artery stenosis �70% (62%) or asymp-tomatic stenosis �80% (38%). The mean degree ofstenosis was 81.2% (69.2) with a mean lesion lengthof 14.1 mm (66.2) and a mean arterial diameter of
5 mm (61.2). 64% of the patients were consideredhigh-risk patients, with 36% at low risk.The patients were separated into two age categories:
under 80 (749 patients, 806 procedures) and 80 orolder (121 patients, 124 procedures). Demographicdata, angiographic evaluation, and neurological historyof the two patient groups were analyzed (Table I) Onestatistically significant difference between the twogroups is the mean lesion length, which is longer inthe older patients (P < 0.03). Also, older patients havemore coronary diseases, peripheral vascular diseases,and renal stenoses than younger patients (Table II).Finally, the anatomical characteristics were evaluatedusing angiographic images, duplex ultrasound; and insome patients CT scan or MR angiography was usedto classify the aortic arch (types I, II, III) as well asevaluate the supra aortic vessels calcifications andulcerations and the supra aortic vessel tortuosity(>608). These anatomical characteristics are listed inTable III. Data analysis included all neurological com-plications, myocardial infarction and death at 30-days.Written informed consent for intervention was obtainedfrom all patients.
Neurological Assessment
All neurological examinations were performed by anindependent neurologist within 24 hr before the proce-dure and at 30 days with a NIH stroke scale evalua-tion. An echo/color flow Doppler was performed priorto the procedure, the day after and at 30-days. Cerebralimaging CT scan or MRI was done prior to the proce-dure and after the procedure in patients with docu-mented neurological complications.
TABLE I. Demographic Data, Angiographic Evaluation, andNeurological History of the Two Patient Groups
�80 yr <80 yr
No. of patients 121 749
No. of lesions 124 806
Male 89 (72%) 537 (72%)
Mean age (years) 82 6 1.9 68 6 4.6
De novo lesion 110 (88%) 741 (92%)
Restenosis 12 (10%) 42 (5%)
Postradiation 2 (1.7%) 12 (1.5%)
Inflammatory arteritis 0 9 (1.1%)
Post trauma aneurysm 0 2 (0.2%)
Angiographic evaluation
Right carotid artery 66 (53%) 426 (53%)
Left carotid artery 58 (47%) 380 (47%)
Mean % stenosis 82.3 6 7.9 81.2 6 8.7
Mean lesion length (mm) 14.7 6 5.8 13.8 6 6.4 (P < 0.03)
Bilateral carotid stenosis 3 (2.5%) 57 (7.2%)
Contralateral carotid occlusion 10 (8.1%) 52 (6.4%)
Neurological history
Symptomatic 79 (64%) 462 (62%)
Asymptomatic 45 (36%) 284 (38%)
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Carotid Angioplasty and Stenting Techniques
Patients were placed on antiplatelet therapy with as-pirin (100–300 mg/day) and ticlopidine (500 mg/day)or clopidogrel (75 mg/day) at least 3–4 days beforethe procedure. During the procedure, they were given5,000–10,000 units bolus of I.V. heparin to have anactivated clotting time (ACT) > 250. One milligramof atropin (if no contraindication to the drug) wasgiven to reduce the risk of bradycardia and hypoten-sion potentially associated with carotid dilatation.The angioplasty was performed under local anesthe-
sia and mild conscious sedation. The anesthesiologistconstantly monitored the patient’s heart rate, arterialpressure, and the level of consciousness. The neurolog-ical status was also frequently checked during the pro-cedure. Once the procedure was over, the patientswere given aspirin (100 mg/day) indefinitely and ticlo-pidine (500 mg/day) or clopidogrel (75 mg/day) foronly 1 month.
Procedure
The first step of the procedure was to place a guid-ing catheter or a long sheath into the common carotidartery (CCA). In the majority of the cases we used an8F guiding catheter. The technique is well known andhas been largely described [24]. Careful attention wasgiven for the selection of the diagnostic catheter, guid-ing catheter, guide wires depending on the anatomy ofthe aortic arch, the carotid, and the take off of thegreat vessels. Excessive catheter manipulations wereavoided into the aortic arch to ensure minimal detach-ing of atheromatous plaque. The femoral access wasthe most commonly used access (872 procedures). Incase of contraindications due to severe aorto iliaclesions or occlusion, very tortuous arteries, hostile aor-tic arch, particular anatomy (bovine arch for example)we used brachial or radial access (17 cases) or directcarotid artery puncture (13 cases). The tip of the guid-
ing catheter or of the sheath was placed 2 cm belowthe carotid bifurcation, and angiography of the extrac-ranial and intracranial circulation was performed intwo projections with a minimum of contrast. Thus, wewere able to obtain precise information including:degree of stenosis, length of the stenosis and its extentthrough the carotid bifurcation as well as downstream,the morphological characteristics, presence or absenceof intracranial lesions, vessel tortuosities, and diameterof the vessels. The same angiographic imaging wasperformed at the end of the procedure to detect anymodification in the intracranial circulation.
Protection Devices
At the beginning of our experience, 187 CAS wereperformed without protection devices (six in patientsolder than 80 years, 181 in younger patients) However,after protection devices were available, all of the CASprocedures were done under protection (118 in patientsolder than 80 years and 625 in younger patients)Occlusion balloons were used in 334 procedures, re-
versal flow technique in 6 patients, and filters in 404patients. The Angioguard (Cordis, Warren, NJ) wasused in 70 patients, the FilterWire (EPI-Boston Scien-tific, Natik, MA) in 224, the FiberNet (Lumen Bio-medical, Plymouth, MN) in 68, the Accunet (Guidant,Indianapolis, IN) in 35, and the Emboshield (AbbottPark, IL) in 7. Two filters were used in the samepatient.
Stents
At the beginning of our experience, according to anethic committee approved protocol, we implant 293balloon expandable stents (BES). Then only selfexpandle stents (SES) were used with the choicebetween closed cell design stents (Wallstent BostonScientific) and Nitinol open cell design stents. About296 wallstents and 344 nitinol stents were implanted.The choice of these stents was based on the anatomyof the internal carotid artery and on the lesion charac-teristics. Eighty percent of the SES was placed directlywithout predilation of the stenosis, and all stents werepostdilated with the diameter of the balloon to neverover dilate the artery.
TABLE III. Anatomical Characteristics
�80 yr
(n 5 124)
<80 yr
(n 5 806) P value
Aortic arch type I 30 (24%) 395 (49%) <0.001
Aortic arch type II 31 (25%) 234 (29%) 0.5 (NS)
Aortic arch type III 63 (51%) 177 (22%) <0.001
Supra aortic vessel calcification 76 (61%) 338 (42%) <0.001
Supra aortic vessel tortuosity (>608) 79 (64%) 193 (24%) <0.001
NS, not significant.
TABLE II. Risk Factors and Associated Diseases of the TwoPatient Groups
�80 yr
(n 5 121)
<80 yr
(n 5 749) P value
Coronary diseases 72% 61% P < 0.025
Cardiac insufficiency 13% 8% NS
Peripheral vascular diseases 36% 26% P < 0.05
Renal stenosis 15% 9% P < 0.05
Renal insufficiency 10% 7% NS
Pulmonary insufficiency 10% 8% NS
History of hypertension 76% 72% NS
Diabetic mellitus 24% 22% NS
Dyslipidemia 63% 61% NS
Smoking 63% 61% NS
Obesity 16% 15% NS
NS, not significant.
Carotid Angioplasty and Stenting in Octogenarians 311
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Definitions
A transient ischemic attach (TIA) was defined as anew neurological deficit that resolved completelywithin 24 hr. A minor stroke was defined as a newneurological deficit that persisted for >24 hr, but com-pletely resolved or returned to baseline within 7 days.By definition, minor strokes are nondisabling neurolog-ical events. A major stroke was defined as a new neu-rological deficit that persisted after 7 days. The aorticarch was defined according to the origins of the archvessels and classified in three types I, II, III asreported in most of the studies [25]. Aortic arch andgreat vessel calcifications were considered relevant inthe presence of calcified plaque at fluoroscopy. The or-igin of arch vessels and lesion anatomy were catego-rized as tortuous in the presence of an angle >608.
Statistical Analysis
All data is expressed as the mean value 6 SD, or asnumbers of patients or lesions or percentages for cate-gorical variables. The Fisher exact test was used to com-pare the rates between the two age groups for categori-cal variables, and all probability values were two-tailedwith P < 0.05 considered as statistically significant.
RESULTS
Technical success was obtained in 927 procedures(99.6%). There were three failures, one in a patientolder than 80 years and two in younger patients. Thesethree failed attempts were due to very tortuous calci-fied arteries associated with type III aortic arch. At 30days (Table IV) in the 6 patients �80 treated withoutembolic protection; we had one TIA and one minorstroke in symptomatic patients. In the 118 patients�80 treated with embolic protection, we had only oneTIA in an asymptomatic patient treated with an occlu-
sion balloon. Although CAS under protection appearsmore beneficial during the procedure, the number ofpatients is too small to do statistical analysis and drawconclusions. In the younger group (patients <80), 181were treated without embolic protection and 625 withprotection (Table IV). Death, stroke, and myocardialinfarction rate was 3.3% and 1.3%, respectively (P <0.05). According to these numbers observed embolicprotection devices seem to reduce the 30 day compli-cation rate. With embolic protection, death and strokerate is 1.1% for symptomatic patients and 0.8% forasymptomatic patients (P 5 NS). On comparison ofthe older and younger patient subsets, the 30-day com-plication rate was similar. Therefore, this series dem-onstrates that we can perform CAS under protection inoctogenarians with the same complication rate as inyounger patients. In the anatomical evaluation, (TableIII) octogenarian patients had a higher incidence ofType III aortic arch (51% vs. 22%, P < 0.001) and su-pra aortic vessel calcifications (61% vs. 42%, P <0.001). No relationships were found between these an-atomical features and the 30-day outcomes.
DISCUSSION
Over the past few years, the alternative treatment toCEA (CAS) for carotid stenoses has emerged and isgaining acceptance for symptomatic and asymptomaticpatients. The indications are now well accepted forhigh-risk patients and CAS is increasingly performedin patients with significant comorbidities and elderlypeople, owing to the Sapphire study [26] and severalregistries [23,27,28] recently reported. Yadav et al.[26] conducted the Sapphire Study comparing CEAwith CAS and distal protection. A total of 307 patientswere treated: 156 by CAS, 151 by CEA. At 30-dayfollow-up, major adverse events (MAE) (death, stroke,myocardial infraction) were 5.8% for CAS and 12.6%
TABLE IV. CAS in Octogenarians, 30-Day Outcomes
930 Procedures
�80 yr <80 yr
Total Without EPD With EPD Total Without EPD With EPD
NBR 124 6 118 806 181 625
T.I.A. 2 (1.7%) 1 (17%) 1 (0.9%) 9 (1.1%) 3 (1.7%) 6 (0.9%)
Minor stroke 1 (0.8%) 1 (17%) 0 5 (0.6%) 2 (1.1%) 3 (0.5%)
Major stroke 0 0 0 3 (0.4%) 2 (1.1%) 1 (0.2%)
Retinal embolus 0 0 0 4 (0.5%) 0 4 (0.6%)
Hyperfusion syndrome 0 0 0 3 (0.4%) 0 3 (0.5%)
Death 0 0 0 5 (0.6%) 2 (1.1%) 3 (0.5%)
Fatal stroke 4 (0.5%) 2 (1.1%) 2 (0.3%)
Non-fatal stroke 1 (0.1%) 0 1 (0.2%)
M.I. 0 0 0 1 (0.1%) 0 1 (0.2%)
Death/stroke 1 (0.8%) 1 (17%) 0 13 (1.7%) 6 (3.3%) 7 (1.2%)
Death/stroke/M.I. 1 (0.8%) 1 (17%) 0 14 (1.8%) 6 (3.3%) 8 (1.3%)
312 Henry et al.
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for CEA. At 1-year follow-up, MAE were 11.9% forCAS and 19.9% for CEA (P 5 0.048); at 2 yearsMAE were 20.1% for CAS and 26.7% for CEA,respectively. This trial also enrolled patients > 80years, who have long been excluded from previouslarge-scale randomized trials comparing CEA to thebest medical therapy (NASCET [1] ACAS [4]). TheSapphire Study demonstrated that among patients withsevere carotid artery stenosis and coexisting conditions,including octogenarians, CAS under protection is notinferior to CEA. Several registries were recently pub-lished [23,27,28] and the 30-day stroke/death, myocar-dial infarction rate obtained with different protectiondevices and stents is summarized in Table V. All thesereported series show favorable results at least equal ifnot better than the results of historical surgical con-trols. These favorable results were confirmed by ameta-analysis done by Burton et al. [29] including 26studies (2,992 patients treated by CAS under protec-tion). Within this patient group, the pooled periopera-tive rate of any type of stroke was 2.4% 6 0.3%. The30-day minor stroke rate was 1.1% 6 0.2%, the 30-day major stroke rate 0.6% 6 0.2%, and the 30-daymortality rate 0.9% 6 0.4%. Gray [30] recentlyreported a meta-analysis of seven pivotal trials(>3,100 patients) and at 30-day, the MAE was 6.1%,all strokes 4.7%, and major strokes 2.5%.All these studies have provided considerable evi-
dence that the use of an embolic protection devicehave dramatically lowered the incidence of cerebralembolic events during CAS in both symptomatic andasymptomatic patients and has become an integral partof CAS. Despite these results, the indications for CASin the elderly people have become the subject ofdebate after the publication of the interim results ofthe lead-in phase of the CREST study (a randomizedmulticenter trial comparing CEA to stenting [22]). Inthis study, the 30-day death/stroke rate was 12.1% inpatients >80 years and 3.23% in younger patients. Af-ter these results, inclusion of patients >80 years wasstopped. If we look at the Capture 3500 registry results[23], the 30-day death/stroke/MI rate is 6.3% for allpatients, but in symptomatic patients (n 5 482) 17.1%in patients >80 years and 10.2% in patients <80years, and for asymptomatic patients (n 5 3018),respectively, 8% and 4.6%. All these results exceedthe recommended complication rate for symptomatic
and asymptomatic patients in the guideline for endar-terectomy [31]. The results are better in the CASCASES-PMS study recently reported [23]. The 30-dayMAE rate is 5% for all patients (n 5 1107), 7.3% forpatients >80 years (n 5 107).Several authors have previously analyzed the deter-
minants of stroke complicating CAS. Mathur et al., in1998, [32] reported that advanced age is one of themost important independent predictors of proceduralstroke. Roubin et al. [33] also reported in 2001 thatthe best predictor of stroke and death was age �80years. But we have to point out that the patients inthese two series were treated without protection devi-ces. More recently, Schluter et al. [34] published aninteresting multicenter study on the impact of diabetesand age on the 30-day incidence of stroke and death ina series of 695 patients undergoing CAS with protec-tion devices. They found that age had no discrimina-tory power to predict complications in nondiabeticpatients but that an age of 75 years was identified asthe optimal cut point to predict complications in dia-betic patients and in particular major strokes. For allthese authors, the decision to treat elderly diabeticpatients percutaneously must be weighed carefully.Given the poor results from CAS studies in elderly
patients, one could consider CEA to be the bestoption. However, surgery is still a large risk. Thedeath rate increases with age. 1.1% between 65 and69 years, 2.8% between 70 and 74 years; 3.2%between 75 and 79 years; and 4.7% after 80 years[35]. In a series of 3,061 procedures, Ouriel et al.[16] described a stroke, myocardial infarction anddeath rate of 7.4% in high risk patients and 2.9% inlow risk patients.It can therefore be concluded that, with good techni-
ques and clear indications, CAS under protection couldgive at least similar results than CEA in elderlypatients. The results revealed that CAS under protec-tion in octogenarians is a safe procedure, and the 30-day complication rate is not statistically different fromthe results obtained in younger patients. Without pro-tection devices, the risk seems higher in older patientsbut the number of patients treated is too small to drawany conclusion as has been previously mentioned. Ofthe patients included, 64% of octogenarians and 62%of younger patients were symptomatic. In the twogroups of patients, the 30-day complication rate largely
TABLE V. 30-Day Stroke/Death/MI Rate with Different Protection Devices and Stents
Study Cabernet Beach Maveric Archer Security Capture 3500
Stent Nexstent Wallstent Exponent Acculink X ACT Accunet
Protection device Filterwire Filterwire Percusurge Accunet filter Neuroshield Acculink filter
Stroke/death/MI 3.8% 5.8% 5.2% 8.3% 7.2% 6.3%
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respects the guidelines for endarterectomy. Other serieshave been published showing excellent results of CASin octogenarians. Setacci et al. [25] reported a multi-center study with a series of 1,053 patients (1,222 pro-cedures). About 1,078 procedures were done inpatients <80 years and 144 in patients >80 years. Theoverall 30-day death and stroke rate was 2.12% in theolder group and 1.11% in the younger group (P 50.40). Roubin [36] reported a death stroke of 2.4% inoctogenarians treated with protection (n 5 121) and16.5% in patients treated without protection (n 5 81)(P < 0.05). Ahmadi et al. [37] published a series of111 patients and concluded that CAS can be performedsafely in patients >75 years of age. Patient’s age doesnot seem to be an independent risk factor for poor out-come after CAS. In the series of Wholey (n 5 814),the 30-day stroke/death/MI rate was 1% for allpatients, 1.7% for patients >80 years, and 0.8% foryounger patients [35]. For Myla cited by Wholey, [35]in a series of 724 patients, the complication rate for allpatients was 3.5%, 3.1% in patients <80 years, and3.8% in patients >80 years. Iakovou et al. [38] reportedthe results of a multicenter registry (110 patients > 80years, 722 < 80 years). Major stroke and death was1.8% in older patients, 1.5% in younger (P 5 0.9). Allthis data reveals that CAS under protection can be pro-posed to octogenarians with an acceptable complicationrate, not superior to surgical procedures and almost sim-ilar to younger patients. For carotid stenting to bewidely accepted, octogenarians cannot be excluded asthey constitute in some centers to at least 25% ofpatients enrolled. Also, due to the aging population, el-derly patients will be more and more candidates for ca-rotid revascularization. Furthermore, if we want to pro-pose CAS in elderly patients, some rules and techniquesshould be respected and pointed out to reduce the risks.It is crucial to have:
Good Indications with Careful Patient and LesionSelection Depending on
Pre procedure assessments: clinical, neurological,cardiological, and biological assessments to detecthigh-risk patients.Carotid Echo-Doppler examination to quantify the
stenosis and to assess its morphological characteristicslooking for potential associated lesions of the supraaortic vessels. The characterization of the plaques’echodensity according to Nicolaydes’s criteria is veryuseful to define high risk lesion [39,40], echolucentplaques are at higher risk than hyperechogenic plaquesand could lead to different techniques (choice of theprotection device, choice of the stent, cleaning of thedilated, and stented area).Transcranial Doppler
CT scan/MRI are also mandatory before any CAS.Silent infarcts can be detected in asymptomaticpatients.Complete angiographic examination of the aortic
arch and of all the supra aortic vessels with intracra-nial arterial imaging to determine the type of aorticarch, the degree of tortuosities and calcifications forthe different vessels, the presence of distal loops,bends, kinks, which could increase the risks or contra-indicate the procedure.On the basis of these examinations, we can define
which patients could be a good candidate for CAS andbenefit from carotid revascularization.It is accepted to treat symptomatic patients with a
stenosis >70%, but a common consensus for asymp-tomatic patients is lacking. Several reports [39–43]point out that the degree of stenosis and the presenceor absence of neurological symptoms are not reliableselection criteria for conventional or endoluminalrepair of carotid stenosis in the prevention of brain is-chemia and do not sufficiently and accurately identifythe real risk presented by the patient [42]. Other pa-rameters should be used as recently reported [42,43]:Echographic plaque morphology study. Echolucent
plaques have a higher incidence of brain ischemiclesions.Transcranial Doppler monitoring. Patients with
micro emboli are more likely to have stroke (15% vs.1%) [44]Silent brain infarcts detected on DW-MRI or CT scan
are an independent risk factor for future stroke [45]Cerebrovascular reserve: patients with impaired cere-
brovascular reserve have a significantly higher inci-dence of ipsilateral ischemic events (14% vs. 4%) [46]
Good Technique
The first step of the procedure is to place a longsheath or a guiding catheter into the CCA. We knowthat octogenarians have more frequently a type III aor-tic arch (51% vs. 22% in our series) as well as supraaortic vessel tortuosities (64% vs. 24%), which canlead to difficulties when catheterizing the CCA andplacing the patient at a higher risk of brain embolism.The aortic arch is a substantial source of emboli andhas its own set of embolic potential. It is therefore im-portant to choose catheters carefully, guiding catheters,and to avoid excessive catheter manipulation in theaorta. After 20 min of manipulation in the aorta, it isbetter to quit than to have a stroke. To avoid the prob-lem of aortic arch embolism, the direct puncture of theCCA could be an option.
314 Henry et al.
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Good-Stent Selection
Recently, Bosier et al. [47] reported a higher neuro-logical complication rate after implantation of opencell stents than closed cell stents (11.1% vs. 3%). It isalso now well demonstrated that the majority ofstrokes occur post-procedure and before discharge(54.7% in Capture study 58.6% in Exact 900 study)[23]. Furthermore, it seems that the free cell area influ-ences the outcome in CAS. In Bosier’s report, thepost-procedural rate analyzed for different stents variedfrom 1.2% using a closed cell stent (Wallstent) to5.9% using an open cell stent (Medtronic Exponent).The late events varied from 1.2% to 3.4% for free cellareas <2.5 mm2 and 7.5 mm2, respectively (P <0.05). Post-procedural event rate was 1.3% for closedcells and 3.4% for open cells. All these differenceswere highly pronounced among symptomatic patients(p < 0.001). It is likely that the delayed embolicevents are due to embolization of atheromatous pla-ques which protrude through the stent struts, and thisprotrusion is more important with the open cell stents.For these reasons, using closed cell stents is recom-mended except in tortuous vessels where open cellstents are more appropriate. In that case, we use opencell stents with the smallest free cell area.
Cleaning of Dilated Area and Stent
It is crucial to do a meticulous cleaning of thedilated area and of the inner part of the stent by aspi-rating to eliminate the debris often trapped in theseareas. For this cleaning, either an aspiration cathetercan be used or the guiding catheter advanced insidethe stent. With new protection devices, this techniquecan be done very quickly and simply.
Good Choice of Embolic Protection Devices
Embolic protection devices (EPDs) are indispensablefor any CAS. The three types of EPD can be used inoctogenarians: distal occlusion balloon [48], filters[17,49–51], and flow reversal systems [52,53]. Choos-ing an EPD is crucial and depends on the intervention-ist, the lesion, the anatomy of the different vessels, theintracranial circulation, and the collateral circulation.An occlusion balloon or flow reversal systems are con-traindicated in cases of poor collateral circulation andcontralateral occlusion. Patients presenting with tortu-ous supra aortic vessels or type III aortic arch requirea low profile, flexible EPD. Flow reversal systemsseem inadequate because of their larger profile, how-ever, may be beneficial in cases with very tortuousICA, severely angulated ICA kinks, bends above thecarotid stenosis, or if thrombi are suspected. Someauthors advise proximal occlusion to treat plaques with
very high risk of brain embolization (soft plaques, dys-homogenous plaques, plaques with GSM < 25). How-ever, a very low profile filter with a flexible soft tipcan be used and has been developed in the new gener-ation of protection devices. The Fibernet (Lumen Bio-medical, Plymouth, MN) is one such filter that seemsvery promising for lesions with this type of plaquemorphology. This new filter is made of a meshwork offibers, has a very low profile, and is mounted on astandard coronary guide wire so no delivery sheath isneeded. When activated, this filter expands radially tofill the vessel; providing excellent wall opposition. Theretrieval catheter is an aspiration catheter allowing foraspiration and cleaning of the dilated area, the innerpart of the stent and during filter collapse and removal.The possibility of aspiration with this filter is one ofthe major differentiators, which could potentiallyreduce the risk of brain embolization and particularlythe risk of delayed embolic events which are frequentwith other devices and probably due to plaque protru-sion and debris which remain through the struts of thestent.This filter allows capture of debris less than 40 lm
without compromising flow. We performed the firsthuman study with this EPD and reported excellent 30-day results without any CT scan or MRI change at 30-day post-procedure when compared with the baseline[54]. Also, the FiberNet device captured five timesmore debris than with other filter and 30% of emboliwere aspirated within the stent.
The Learning Curve
One of the most important factors to reduce the riskof complications in high-risk patients and octogenar-ians is attributed to the learning curve of CAS. In highvolume centers, the complication rate is not statisti-cally different in patients >80 years than in youngerpatients. Lin et al. [55] reported clearly that the com-plication rate is dramatically reduced with experience.In their series, the complication rate was 18% for thefirst 50 patients, 8% for the group patients number 51and 100, and 2% after 100 procedures. It is wellknown that the poor results published in the EVA 3Sand SPACE Study [21,56] are for a large part due toinexperienced operators. In the Capture 3500 study, allstroke and death rates were 4.6% in high volume cen-ters, 6.9% in low volume centers [30]. It is thereforeimportant to reserve CAS in octogenarians for veryexperienced interventionists having also the possibilityto choose between different stents and protection devi-ces. The fact that in the Crest study has only one pro-tection device and one stent have been used may havebeen one of the negative factors responsible for thehigh complication rate observed in patients >80 years.
Carotid Angioplasty and Stenting in Octogenarians 315
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
CONCLUSION
CAS in octogenarians is feasible and safe with atleast similar results as with surgery. High volume cen-ters experienced little difference in octogenarians ver-sus younger patients. However, careful patient andlesion selection is mandatory. This technique must bereserved to experienced operators coupled by the cor-rect stent and embolic protection options. It is apparentthat some contraindications to CAS still remain andstenting every patient is not the answer. Finally, thephysician has to accept when to say no and when towalk away.
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