Carlo Setacci Chief Department of Surgery Vascular and Endovascular Unit University of Siena

Transcription

1 Which carotid procedures are required to grade the stroke risk? Carlo Setacci Chief Department of Surgery Vascular and Endovascular Unit University of Siena

2 Faculty disclosure Carlo Setacci I have no financial relationships to disclose.

3 Can we elaborate a risk-score for CAS? CAS patients are HIGH risk patients for CEA (local and sistemic conditions ) Which conditions are really predictive of stroke during CAS? 2/38

4 to avoid each of the following complications Major complications Major embolic stroke Cerebral hemorrhage (including hyper-perfusion syndrome) Acute stent thrombosis Minor complications Carotid artery spasm Sustained hypotension / bradycardia Minor embolic neurological events (TIAs) Carotid artery dissection Carotid perforation Contrast encephalopathy Vascular access site complications 3/38

5 CEA risk-score Prediction of benefit from carotid endarterectomy in individual patients: a risk-modelling study P M Rothwell, C P Warlow, on behalf of the European Carotid Surgery Trialists Collaborative Group Vol 353 June 19, /38

6 Stroke. 2008;37: Risk score for adverse events within 30days CAS Age >80 years, DM with HbA1c >7%, Plaque Ulceration, Contralateral stenosis > 50% 5/38

7 Stroke. 2008;37: /38

8 J Vasc Surg 2008;47:88-95 Increased prevalences of severe aortic arch calcifications and target lesion ulceration are associated with an increased risk for magnetic resonance DWI detected embolic events during CAS. Because in our study arch calcification and target lesion ulceration were more prevalent in octogenarians, this association may explain the increased risk of CAS in the elderly. 7/38

9 J Endovasc Ther 2006, Jun; 13: Our experience confirms that CAS can be offered to older patients with results comparable to those for younger people. -Anatomic complexity of the aortic arch and supra-aortic vessels is more frequent in elderly patients and this may represent a challenge for technical success. - The various age-related anatomical features can be successfully managed if CAS is performed in high volume centers by highly skilled operators. 8/38

10 Carotid Plaque and Embolic Load Echolucent plaques generated a higher number of embolic particles following CAS Ohki et al, J Vasc Surg1998; 27(3): Low GSM value plaques generated b a higher number of embolic particles following CAS Henry et al, J Endovasc Ther2002; 9(1):1-13 Carotid plaque echolucency, as measured by GSM 25, does increase the risk of stroke in carotid stenting. ICAROS study Biasi et al, Circulation 2004; 119: /38

11 J Vasc Surg 2008;47:81-7 Octogenarians had a higher incidence of 30-day adverse events at 10.0% vs 3.8% (p.029). Two variables are independently associated with 30-day stroke rate: Lesion length >15 mm (OR 6.38) Ostial involvement (OR 3.12) 10/38

12 Learning Curve What should we do? 11/38

13 CREST trial: learning curve operators <15 CAS:stroke/death rate 7.1% operators >15 CAS:stroke/death rate 3.7% 12/38

14 EVA-3S: learning curve stroke/death rate:9.6% 12 CAS or 35 stenting procedures in the supra aortic trunks, 5 of which had to be CAS 13/38

15 SPACE: learning curve stroke/death rate:6.84% 25 successful percutaneous transluminal angioplasties or stent procedures 2008: at least 30 14/38

16 Stroke. 2006;37: /38

17 Stroke and death rate at 30 days, from 2000 to 2006 for CAS and CEA 30 day Stroke and death rate Patients (%) SETACCI C. Carotid Artery Stenting in a Single Center: Are Six Years of Experience Enough to achieve the Standard of Care? EJVES. 2007;34: Years Siena experience CAS CEA As the experience increases (learning curve), the complications decrease. 16/38

18 Invited Commentary SPACE and EVA 3S trials : the need of standards for Carotid Stenting Carlo Setacci, MD; Alberto Cremonesi, MD. EJVES 2007; 33: /38

19 Invited Commentary As difficult as it is to say, we must admit that both EVA 3S and SPACE didn t match an acceptable level of physician training and credentialing. The consequences of this technical bias on the reported CAS results are left to the scientific community s evaluation. Setacci C, Cremonesi A. SPACE and EVA 3S trials : the need of standards for Carotid Stenting. EJVES 2007; 33: /38

20

21 Carotid Artery Stenting: First Consensus Document of the ICCS-SPREAD Joint Committee Alberto Cremonesi, MD; Carlo Setacci, MD; Angelo Bignamini, MD; Leonardo Bolognese, MD; Francesco Briganti, MD; Germano Di Sciascio, MD; Domenico Inzitari, MD; Gaetano Lanza, MD; Luciano Lupattelli, MD; Salvatore Mangiafico, MD; Carlo Pratesi, MD; Bernard Reimers, MD; Stefano Ricci, MD; Gianmarco de Donato, MD; Ugo Ugolotti, MD; Augusto Zaninelli, MD Gian Franco Gensini, MD Stroke.2006; 37:

22 CAS: First Consensus Document of the ICCS-SPREAD Joint Committee CAS: Training and Expertise Recommendation 10: Grade GPP [C] Once the basic skill for catheter-based intervention has been achieved by the already-active interventionist, the minimum reccomended training to achieve competence is as follows: 1. At least 150 procedures of supra-aortic vessel engagement (during diagnostic as well as interventional procedures) within 2 years, of which at least 100 as the primary operator. 2. At least 75 carotid stenting procedures, of which at least 50 as the primary operator, within a 2-year fellowship. Recommendation 11: Grade GPP [C] The minimum requirement to maintain technical skill (competence) is the number of 50 carotid stenting procedures performed and documented by each primary operator per year. Stroke.2006; 37: /38

23 Vasc Surg 2008;47: The data in this study demonstrate that high-risk patients treated with CAS achieve comparable outcomes to low-risk patients treated with CEA. Procedural risk factors specific to CAS were: age > 80 years old, aortic arch calcification, access vessel tortuosity, and stenosis as well as ICA tortuosity 21/38

24 Can we elaborate a risk-score for CAS? CEA Yes, we can CAS 22/38

25 Clinical conditions CAS risk score Age > 80 years Diabetes Hypercolesterolemia Symptomatic pts (TIA/minor Stroke) (major Stroke +1) Each factor counts 1 23/38

26 Access Score CAS risk score Risk -score Femoral 0 Radial 1 Axillary 1 CCA 2 24/38

27 Difficult Aortic Arch Risk -score Score = 2 Bovine Score = 0 Score = 1 Accessing the CCA Impact aortic anatomy Score +1 25/38

28 Supra-aortic vessel RISK SCORE 0: no tortuosity 1: point for each tortuosity either in CCA and ICA 2: severe tortuosity tortuosity +2 < /38

29 27/38 Plaque characteristics RISK SCORE Restenosis 0 Native stenosis +1 Calcified plaque +1 Ulcerated plaque +1 Long plaque +1 Controlateral +1 stenosis >50%

30 PROCEDURE Pre-dilatation +1 non protected +2 Time of procedure >30 min +2 for each extra 15 min +1 28/38

31 Operator s experience RISK-SCORE CAS < 25 6 CAS CAS CAS >75 1 CAS > /38

32 CAS risk-score SCORE Risk-score <5 low = CAS mild = CAS 2 >10 high = CAS 3 It does not exist a procedure without risk To know when to quit!!! 30/38

33 When we are beginning 31/38

34 Types of Aortic Arches Type I Normal Type II Type III Bovine Arch CAROTID STENTING:WHEN BEGINNING: TYPE III IS NOT WORTH THE RISK BE VERY SELECTIVE WITH YOUR FIRST 100 PATIENTS 32/38

35 Which lesions can we begin with? Type I: when beginning your carotid program and the Plaque? 1.5 cm or less Proximal internal carotid Non-ulcerative 33/38

36 Avoid: excessive catheter manipulation Aortic arch has its own set of embolic potential 34/38

37 Conclusion The Carotid Artery Stenting is a process of tailoring the endovascular procedure to a specific patient and a specific kind of carotid lesion. We need to have a deep knowledge of patient clinical status, vascular anatomy,carotid plaque findings and technical features of the materials (guiding catheters and sheaths, wires, balloon, stents, etc.). Only a correct learning curve could guarantee all those points 35/38

38 We need to be TRAINED!!! 36/38

39 Consideration Remind even if you are not a surgeon CEA is still working very well!!! 37/38

40