Carotid Artery Stenting Cervical Approach Wael Tawfick Sherif Sultan UCHG, NUIG, RCSI 1. Western Vascular Institute, University College Hospital, Galway, Ireland (UCHG) 2. School of Medicine, National University of Ireland, Galway, Ireland (NUIG) 3. Galway Clinic, Royal College of Surgeons of Ireland, Galway, Ireland (RCSI)
Disclosure Speaker name: Wael Tawfick... I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest
Tensile Strength of Symptomatic Carotid Atherosclerotic Plaque
Symptomatic Carotid Plaque True Stress Vs True Strain Desired lumen after CAST = 30%lumen-gain True strain to open a Carotid stent = 86% Graph shows complete plaque rupture occurs at 49% Stenting was not an option with any symptomatic Carotid patient tested El Homasany B, Lawlor M, Tawfick W, Hynes N, Sultan S. Systematic overview of Neuro-protection devices during Carotid angioplasty & Stenting. Ir J Med Sci 2007 176(1);S1:51 M Lawlor, B El Homasany, S Sultan. Do Cerebral Protection Devices perform effectively? Meta-analysis and Critique of licensed Cerebral Protection Devices. Ir J Med Sci 2006: 175(1);S2 5
CAST and Embolisation ACCESSING THE SITE PERI-PROCEDURE PROTECTING THE SITE TREATING THE SITE LEAVING THE SITE POST MAINTAINING THE SITE INITIAL ANGIO, SHEATH/GUIDE ACCESS EPD PLACEMENT AND DEPLOYMENT PRE-DIL, STENTING, POST-DIL EPD RECAPTURE OR REMOVAL POST-PROCEDURE PLAQUE STABILITY ACCESS DEVICES EMBOLIC PROTECTION IMPLANTS There are multiple stages in the procedure where emboli release occur CAPTURE 3500: 18% of strokes were non-ipsilateral 1 Could more than 30% of strokes be coming from access alone? 1 Gray, WA, et. Al. TCT 06, CAPTURE 3500, Predictors of Outcomes in Carotid Stenting
Cast with or without CPD Leicester-1998 Pittsburgh-2008 CPD No Filter Accunet Dual Antiplatelet Negative Positive Learning Curve 8 cases-positive 25 cases-negative Clinical stroke 5 out of 7 2 out 18 in CPD New MRI Lesions Abandoned 72% in CPD VS 44% in non CPD Conclusion Need for CPD No Need for CPD
CPD Meta-analysis Thirteen licensed embolic protection devices are currently marketed in Europe A Meta-analysis was conducted of each device focussing on features Pore size Guidewire size Fabric of balloon or filter Ability of device to cross tortuous lesions Flow interruption Trouble-shooting during device retrieval El Homasany B, Lawlor M, Hynes N, Sultan S. Systematic overview of Neuroprotection devices during Carotid angioplasty & Stenting. Ir J Med Sci 2007 176(1);S1:51 M Lawlor, B El Homasany, S Sultan. Do Cerebral Protection Devices perform effectively? Meta-analysis and Critique of licensed Cerebral Protection Devices. Ir J Med Sci 2006: 175(1);S2 5
CPD Meta-analysis Device Type Patient Men% Age Procedure Positio n Acc.% Major Strok e Minor Stroke Death Success % Emboshield Filter 276 75 72 280 99 2 2 0 96.55 Guardwire Bal. Occlus.(D) 408 67 69 412 98 1 5 3 94.79 Angioguard Filter 364 83 73 370 88 1 2 0 93.18 Paes Flow reversal 60 60 75 66 93 0 4 0 93.33 Trap Filter 120 59 69 120 93 1 3 0 96.67 Filterwire Filter 184 75 72 192 95 1 1 0 94.91 Spiderx Filter 30 90 74 34 100 0 2 0 93.33 Accunet Filter 278 78 79 282 96 1 3 0 97.56 MO.MA Total Bal. Occlus. All prot. Devices 158 82 71 158 100 1 4 1 96.20 1878 74.3 72.6 1914 95.78 8 26 4 94.95
CPD Meta-analysis The maximum protection afforded by protection devices is 94% +/- 3% Some devices are favourable when crossing the lesion, but have issues when being retrieved We could not recommend any single device over another Any positive feature eg. small pore size was accompanied with a negative element eg. difficulties with device retrieval All devices increased the brain hits as detected by TCD El Homasany B, Lawlor M, Hynes N, Sultan S. Systematic overview of Neuroprotection devices during Carotid angioplasty & Stenting. Ir J Med Sci 2007 176(1);S1:51 M Lawlor, B El Homasany, S Sultan. Do Cerebral Protection Devices perform effectively? Meta-analysis and Critique of licensed Cerebral Protection Devices. Ir J Med Sci 2006: 175(1);S2 5
Hostile Neck Previous neck surgery Previous radiation Uncalculated risk of stroke Difficult dissection Rough manipulation of Carotid
Trans-Femoral CAST
Trans-Cervical CAST
Aim of Study To compare CEA to Trans-femoral CAST (F-CAST) and Trans-Cervical CAST (C-CAST) in high-risk patients regarding clinical success, efficacy in decreasing morbidity & mortality Composite Primary Endpoints Stroke MI Death Secondary endpoints Patency rates Re-intervention Rates
Materials & Methods From 2003 till 2015, 1847 patients were evaluated with carotid stenosis >60% Multiple Logistic Regression was used to control for co-morbidities & anatomical high-risk factors Propensity Scoring was used to adjust for baseline characteristics & selection bias, by matching covariables, creating a pseudo-randomized control design
Demographics CEA F-CAST C-CAST P Number 51 33 19 Mean Age (years) 68.4+/-8.0 69.1+/-9.0 67.4+/-8.5 0.756 Male % 67% 64% 74% 0.130 Bilateral Intervention 4 (7.8%) 2 (6%) 1 (5.2%) 0.664 Contra-lateral Occlusion 3 (5.9%) 1 (3%) 1 (5.2%) 0.321 Echolucent Plaque 6 (11.8%) 4 (12%) 1 (5.2%) 0.427
Peri-operative Stroke & Death CEA F-CAST C-CAST P Value Number 51 33 19 NA Major Stroke 0 (0%) 4 (12.1%) 0 (0%) 0.037 Minor Stroke 1 (1.9%) 2 (6%) 1 (5.2%) 0.062 Death 0 (0%) 0 (0%) 0 (0%) 0.533 MI 1 (1.9%) 0 (0%) 0 (0%) 0.361 Combined 1 (1.9%) 4 (12.1%) 0 (0%) 0.041
5-Year stroke free Survival 100 90 80 70 60 50 40 CEA C-CAST F-CAST 30 20 10 0 CEA: 93.3% +/- 8.05% C-CAST: 92.9% +/- 11.07% (p=0.818, HR= 2.25, 95%CI [0.68-2.48]) F-CAST: 87.9% +/- 3.53% (p=0.194, HR=0.88, 95%CI [0.31-2.55])
5-Year overall Survival 100 90 80 70 60 50 40 CEA C-CAST F-CAST 30 20 10 0 CEA: 96.1% +/- 2.13% C-CAST: 86.4% +/- 4.45% (p=0.736, HR=0.93, 95%CI [0.48-3.79]) F-CAST: 78.8% +/- 6.92% (p=0.548, HR= 1.96, 95%CI [0.31-6.82])
5-Year patency 100 90 80 70 60 50 40 CEA C-CAST F-CAST 30 20 10 0 CEA: 63% C-CAST: 54% F-CAST: 44%
5-Year re-intervention rates 100 90 80 70 60 50 40 CEA C-CAST F-CAST 30 20 10 0 CEA: 65% C-CAST: 50% F-CAST: 45%
Conclusion RCTs have been unable to prove superiority / non-inferiority of CAST Vs CEA CPDs are being singled out as causes of increased morbidity and elevated risk of stroke C-CAST provides a safer option, with significantly less risk of peri-operative stroke and combined stroke/mi/death
Conclusion CAST technology is still lagging Further understanding of plaque stability and tensile strength is required, in order to achieve the optimum endovascular approach
Thank you
Carotid Artery Stenting Cervical Approach Wael Tawfick Sherif Sultan UCHG, NUIG, RCSI 1. Western Vascular Institute, University College Hospital, Galway, Ireland (UCHG) 2. School of Medicine, National University of Ireland, Galway, Ireland (NUIG) 3. Galway Clinic, Royal College of Surgeons of Ireland, Galway, Ireland (RCSI)