Tips and Tricks for CAS T-CAR

Transcription

1 Tips and Tricks for CAS T-CAR H.-H. Eckstein, M. Kallmayer Department for Vascular and Endovascular Surgery, Klinikum Rechts der Isar, Technical University of Munich,, Germany

2 Disclosures Collaborator in clinical trials with the T-CAR System (Silkroad) Research grants from COOK, MEDTRONIC, DFG (unrelated to this talk) 2

3 (Micro)embolism: the achilles heel of CAS Embolism from the carotid artery catheterization of the target vessel crossing the stenosis placement of cerebral protection device pre-dilatation stent implantation post-dilatation recovery of the protection device After the procedure Embolism from the aortic arch 3

4 2015 Systematic Review: 20 studies, 2104 patients: New DWI cerebral lesions occured more often after CAS than after CEA (40,3% versus 12,2%, OR: 5,17 (95%CI 3,31-8,06) 4

5 Protection systems - CAS outcomes Data from the German Carotid Registry , Knappich et al., JACC: Cardiovascular Interventions, ,033 Total number of procedures registered in the statutory nationwide quality assurance registry between January 2009 and December Other procedures* 163,088 CEA procedures 2,152 Procedures for Crescedo-TIA or stroke-in-evolution 2,827 Procedures under special conditions (n=2,249), unclear conditions (n=490) or symptoms not further specified (n=88) 13,086 Number of procedures available for analysis: 8,360 PTA/CAS procedures performed for asymptomatic carotid artery stenosis 4,726 PTA/CAS procedures performed for symptomatic carotid artery stenosis 5

6 Protection systems - CAS outcomes Data from the German Carotid Registry , Knappich et al., JACC: Cardiovascular Interventions, ,033 Total number of procedures registered in the statutory nationwide quality assurance registry between January 2009 and December Other procedures* 163,088 CEA procedures 2,152 Procedures for Crescedo-TIA or stroke-in-evolution 2,827 Procedures under special conditions (n=2,249), unclear conditions (n=490) or symptoms not further specified (n=88) RISK OF ANY IN-HOSPITAL STROKE OR DEATH 13,086 Number of procedures available for analysis: 8,360 PTA/CAS procedures performed for asymptomatic carotid artery stenosis 4,726 PTA/CAS procedures performed for symptomatic carotid artery stenosis 6

7 New CAS technologies Proximal or distal protection Stent design (open cell / closed cell) Micromesh carotid stents C-Guard (terumo) Roadsaver (Inspire) Gore Hybrid Stent Transcarotid Artery Stenting (T-CAR) 7

8 2017 JVS pts (26% symptomatic) 18 sites in the US Stroke and death rate 2.8% 75 pts (63% asymptomatic, single center series (GER) Procedure completed 95% New DWI lesions 11% Minor stroke rate 2,7% Vocal cord paralysis 2,7% 8

9 2016 mean number of emboli Transfemoral CAS TCAR CEA 9

10 TCAR with flow reversal filtered (micro)embolism 10

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12 2016 Recommendations 1.1 Current evidence on the safety of transcervical extracorporal reverse flow neuroprotection for reducing the risk of stroke during CAS shows well-documented risks. 1.2 Patient selection should be carried out by a MDT team (interventional radiologist or a neuroradiologist, a vascular surgeon and a physician with a specialist interest in stroke) 12

13 Trials and registries on T-CAR Roadster 2 trial on 600 pts, multicenter, US and Europe, 60 sites DWI trial on 150 symptomatic patients, four European sites The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP), approved by the FDA, US, since Sept 2016

14 JVS 2018 The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) 638 pts, enrolled between March 2016 and December 2017 Compared to 10,136 pts with transfemoral CAS between 2005 and 2017 TCAR TF CAS TIA/stroke/death 2,2% 3,8% Asymptomatic stenosis 1,4% 2,7% Symptomatic stenosis 3,7% 5,3% 14

15 Our own results (October 2015-September 2018) Patient characteristics % (N) Male 71.2% Age (mean) 72.2 ± 7.3 Asymptomatic 89.8% ICA stenosis 80-99% NASCET 100% ASA II/III 98% Contralateral ICA-occlusion 5.1% Primary outcome Stroke and death 0% Secondary outcome Technical failure rate (conversion) 1.7% Local complications 0% Nerve lesions 3.4% Systemic complications 0% New DWI-lesions after TCAR 23.7% Follow-up Stroke 0% Death 4.8% Non carotid associated 15

16 Male, 74 y, asymptomatic, 90% stenosis right, hostile neck (vertebral ostheosynthesis), TCAR under LA Pre MRI Stent deployment Final angio after post dilatation No new DWIlesions 16

17 Male, 71 y, asymptomatic, 80% stenosis left, contralat occlusion Pre New bilateral DWI-lesions post TCAR mrs = 0 17

18 T-CAR - conclusions Promising technology, especially for vascular surgeons! Frequency of postprocedural new DWI lesions comparable to CEA? More data are needed (especially on symptomatic patients) 18

19 Thank you very much H.-H. Eckstein Department for Vascular and Endovascular Surgery, Klinikum rechts der Isar (MRI), Munich, Germany