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

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

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme Migliaia di lavori in letteratura ma pochissimi trials multicentrici,randomizzati, prospettici, controllati XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

Carotid Endarterectomy Randomized Trials of Symptomatic Patients North American Symptomatic Carotid Endarterectomy Trial European Carotid Surgery 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 XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

Carotid 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%. XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

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

Misurazione della % di stenosi XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

The inappropriate use of carotid endarterectomy CMAJ • August 31, 2004; 171 The inappropriate use of carotid endarterectomy Henry J.M. Barnett XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

Chambers BR, You RX, Donnan GA 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 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. 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%). XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

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

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

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme Barnett, H. J.M. CMAJ 2004;171:473-474 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. Stenosi asintomatica XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

Appropriate procedures 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 CMAJ • August 31, 2004; 171 (5). doi:10.1503/cmaj.1040170 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 XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme SICVEREG 2003 Frequenza Percentuale Percentuale cumulata ASINTOMATICO 2225 53,5 SINTOMATICO 1718 41,3 94,9 NON CLASSIFICATO 212 5,1 100,0 Totale 4155 SINTOMATICITÀ XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

Evoluzione dell’ateroma carotideo 5% degli strokes XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme Lesioni TAC TAC negativa XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme Circolo di Willis XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme SICVEREG 2003 SHUNT Frequenza Percentuale Percentuale cumulata NO 3382 81,4 SI 773 18,6 100,0 Totale 4155 XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme Paziente asintomatico TAC negativa no shunt Placca stabile – Buon circolo di Willis Intervento inutile XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme Paziente asintomatico TAC negativa shunt Placca stabile – Scarso circolo di Willis Intervento utile se stenosi emodinamica XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme Paziente asintomatico lesioni TAC no shunt Placca instabile – Buon circolo di Willis Intervento utile XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme Paziente asintomatico lesioni TAC shunt Placca instabile – scarso circolo di Willis Intervento utile XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme Paziente sintomatico (?) tac negativa no shunt Placca stabile – Buon circolo di Willis Intervento inutile XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme Paziente sintomatico tac negativa shunt Placca stabile – Scarso circolo di Willis Intervento utile XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme Paziente sintomatico lesioni TAC no shunt Placca instabile – Buon circolo di Willis Intervento utile XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme Paziente sintomatico lesioni TAC shunt Placca instabile – Scarso circolo di Willis Intervento utile XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

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

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

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

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme J Vasc Surg 2004; 40:254-61 What is “High Risk” “Hostile Neck” XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme CMS Guidelines for Carotid Stenting 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. XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme

27th Charing Cross International Symposium Aprile 2005 There is no satisfactory high level evidence that carotid stenting is effective XXIV CONGRESSO NAZIONALE ACOI 25/28 Maggio 2005 - Montecatini Terme