XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme 1 Edoardo Croce.

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XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme 1 Edoardo Croce

Transcript of XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme 1 Edoardo Croce.

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XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme 1

Edoardo Croce

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1980: I procedura endovascolare

Kerber CW, Cromwell LD, Loehden OL. Catheter dilatation of proximal carotid stenosis during distal bifurcation endarterectomy.

AJNR Am J Neuroradiol. 1980; 1: 348–349.

1954: I endarterectomia carotidea per TIA

Eastcott HH, Pickering GW, Rob CG. Reconstruction of internal carotid artery in a patient with intermittent attacks of hemiplegia.

Lancet. 1954; 267: 994–996.

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Migliaia di lavori in letteratura ma pochissimi trials

multicentrici,randomizzati, prospettici, controllati

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Randomized Trials of Symptomatic Patients

European Carotid Surgery Trial

North American Symptomatic Carotid Endarterectomy Trial

Veterans Affairs Cooperative Carotid Trial

Randomized Trials of Asymptomatic Patients

Asymptomatic Carotid Atherosclerosis Study

Veterans Affairs Cooperative Study

European Carotid Surgery Trial

Mayo Asymptomatic Carotid Endarterectomy Study

Carotid EndarterectomyCarotid Endarterectomy

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Carotid EndarterectomyCarotid Endarterectomy

These trials have demonstrated that surgical carotid

endarterectomy confers a significant benefit over best current medical management in patients with

symptomatic carotid stenosis >70% with lesser degrees of

benefit in symptomatic lesions of 50% to 69% and asymptomatic lesions of >60%.

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The Lancet 2003; 361:107-116

Analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis

PM Rothwell,   M Eliasziw ,   SA Gutnikov ,   AJ Fox ,   DW Taylor ,   MR Mayberg ,   CP Warlow    and   HJM Barnett 

Surgery increased the 5-year risk of ipsilateral ischaemic stroke in patients with less than 30% stenosis (n=1746, absolute risk

reduction −2·2%, p=0·05), had no effect in patients with 30–49% stenosis (1429, 3·2%, p=0·6), was of marginal benefit in those with 50–69% stenosis (1549, 4·6%, p=0·04), and was highly beneficial

in those with 70% stenosis or greater without near-occlusion (1095, 16·0%, p<0·001). There was a trend towards benefit from surgery in patients with near-occlusion at 2 years' follow-up (262, 5·6%,

p=0·19), but no benefit at 5 years (−1·7%, p=0·9).

Stenosi sintomatica

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CMAJ • August 31, 2004; 171

The inappropriate use of carotid endarterectomyHenry J.M. Barnett

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Authors' conclusions: There is some evidence favouring CEA for asymptomatic carotid stenosis, but the effect is at best barely significant, and extremely small in terms

of absolute risk reduction.

From The Cochrane Library, Issue 2, 2005. Chichester, UK: John Wiley & Sons, Ltd.

Carotid endarterectomy for asymptomatic carotid stenosis (Cochrane Review)Chambers BR, You RX, Donnan GA

Carotid endarterectomy for symptomatic carotid stenosis (Cochrane Review)Cina CS, Clase CM, Haynes RB.

Authors' conclusions: Carotid endarterectomy reduced the risk of disabling stroke or death for patients with stenosis exceeding ECST-measured 70% or NASCET-measured 50%. This result is generalizable only to surgically-fit patients operated on by surgeons

with low complication rates (less than 6%).

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Systematic Review of the Risks of Carotid Endarterectomy in Relation to the Clinical Indication for and Timing of Surgery

R. Bond, MBBS, FRCS; K. Rerkasem, MD, FRCS; P.M. Rothwell, MD, PhD, FRCP

•Risk in patients with ocular events only tended to be lower than for asymptomatic stenosis

•Operative risk was the same for stroke and cerebral transient ischemic attack but higher for cerebral transient ischemic attack than for ocular events only

•Risk in CEA for restenosis is much higher than in primary surgery

•Urgent CEA for evolving symptoms had a much higher risk than CEA for stable symptoms

•There is no difference between early (<3 to 6 weeks) and late (>3 to 6 weeks) CEA for stroke in stable patients

(Stroke. 2003;34:2290.)

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The Lancet 2004; 363:915-924

Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery

PM Rothwell, M Eliasziw ,   SA Gutnikov ,   CP Warlow   and   HJM Barnett 

5893 patients with 33 000 patient-years of follow-up were analysed. Sex (p=0·003), age (p=0·03), and time from the last symptomatic event to randomisation (p=0·009) modified the effectiveness of surgery. Benefit from surgery was greatest in men, patients aged 75 years or older, and those randomised within 2 weeks after their last ischaemic event, and fell rapidly

with increasing delay. For patients with 50% or higher stenosis, the number of patients needed to undergo surgery (ie, number needed to treat) to prevent one ipsilateral stroke in 5 years was nine for men versus 36 for women, five for age 75 years or older versus 18 for younger than

65 years, and five for those randomised within 2 weeks after their last ischaemic event, versus 125 for patients randomised after more than 12 weeks.

Stenosi sintomatica

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Two large trials involving asymptomatic patients have presented evidence that there is modest benefit

favouring CE in subjects with stenosis but no symptoms, provided that highly skilled surgeons are involved and that complication rates are below 3%. Even with this

low operative complication rate, the number needed to treat to prevent 1 stroke in 2 years is 83. In the 2 large

trials involving a total of nearly 4500 patients, the annual stroke and death rate after CE was 1%, versus

2% among those without CE.

Barnett, H. J.M. CMAJ 2004;171:473-474

Stenosi asintomatica

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Variations in rates of appropriate and inappropriate carotid endarterectomy for stroke prevention in 4 Canadian provinces

James Kennedy, Hude Quan, William A. Ghali and Thomas E. Feasby

Appropriate procedures

78.2% (176/225) in Saskatchewan 58.7% (481/819) in Alberta

49.1% (350/713) in Manitoba 46.0% (649/1410) in British Columbia

CMAJ • August 31, 2004; 171 (5). doi:10.1503/cmaj.1040170

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SINTOMATICITÀ

Frequenza PercentualePercentuale

cumulata

ASINTOMATICO 2225 53,5 53,5

SINTOMATICO 1718 41,3 94,9

NON CLASSIFICATO 212 5,1 100,0

Totale 4155 100,0

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Evoluzione dell’ateroma carotideoEvoluzione dell’ateroma carotideo

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Circolo di WillisCircolo di Willis

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SHUNT

Frequenza PercentualePercentuale

cumulata

NO 3382 81,4 81,4

SI 773 18,6 100,0

Totale 4155 100,0

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Paziente asintomatico TAC negativa no shunt

Placca stabile – Buon circolo di Willis

Intervento inutile

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Paziente asintomatico TAC negativa shunt

Placca stabile – Scarso circolo di Willis

Intervento utile se stenosi emodinamica

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Paziente asintomatico lesioni TAC no shunt

Placca instabile – Buon circolo di Willis

Intervento utile

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Paziente asintomatico lesioni TAC shunt

Placca instabile – scarso circolo di Willis

Intervento utile

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Paziente sintomatico (?) tac negativa no shunt

Placca stabile – Buon circolo di Willis

Intervento inutile

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Paziente sintomatico tac negativa shunt

Placca stabile – Scarso circolo di Willis

Intervento utile

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Paziente sintomatico lesioni TAC no shunt

Placca instabile – Buon circolo di Willis

Intervento utile

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Paziente sintomatico lesioni TAC shunt

Placca instabile – Scarso circolo di Willis

Intervento utile

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The Carotid and Vertebral Transluminal Angioplasty Study (CAVATAS)

No significant difference in the risk of stroke or death related to the procedure between carotid endarterectomy and angioplasty

The Wallstent Trial

This trial was stopped early because of poor results from stenting.

The Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)

Perioperative stroke and death rates: 7.3% for surgery versus 4.4% for stenting. Rates of myocardial infarction were 7.3% for surgery versus 2.6% for stenting.

Carotid Revascularization Endarterectomy versus Stent Trial (CREST)currently in progress

CarotidCarotid StentingStenting

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The Centers for Medicare & Medicaid Services (CMS) proposes the following regarding Carotid Stenting:

The evidence is adequate to conclude that carotid artery stenting (CAS) with embolic protection is reasonable and necessary for patients who are

at high risk for carotid endarterectomy (CEA) and who also have symptomatic carotid artery stenosis > 70%.

Coverage is limited to these procedures using FDA approved carotid artery stenting systems and embolic protection devices.

Patients at high risk for CEA are defined as having significant comorbidities and/or anatomic risk factors (i.e., recurrent stenosis and/or previous radical neck dissection), and would be poor candidates for CEA

in the opinion of a surgeon.

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What is “High Risk”?

Serious Co-Morbid Medical Condition Congestive heart failure

(class III/IV0 and /or known severe left ventricular dysfunction LVEF <30%

Open Heart Surgery needed within six weeks

Recent MI (>24 hrs. and <4 weeks)

Unstable angina (CCS class III/IV)

Severe pulmonary disease

Anatomic Challenges Contralateral carotid

occlusion Contralateral laryngeal nerve

palsy Radiation therapy to neck Previous CEA with recurrent

stenosis High cervical ICA lesions or

CCA lesions below the clavicle

Severe tandem lesions Age >80 years

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What is “High Risk”

“Hostile Neck”

J Vasc Surg 2004; 40:254-61

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•The degree of carotid artery stenosis should be measured by duplex Doppler ultrasound or carotid artery angiography and recorded in the patient medical records.

•If the stenosis is measured by ultrasound prior to the procedure, then the degree of stenosis must be confirmed by angiography at the start of the procedure. If the stenosis is determined to be less than 70% by angiography, then CAS should not proceed.

CMS Guidelines for Carotid Stenting

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27th Charing Cross International Symposium

There is no satisfactory high level evidence that carotid stenting is

effective

Aprile 2005Aprile 2005