Anatomical reasons for failure of dual-filter cerebral embolic protection application in TAVR: A CT-based analysis.
TAVR
cerebral embolic protection
device failure
dual-filter embolic protection
Journal
Journal of cardiac surgery
ISSN: 1540-8191
Titre abrégé: J Card Surg
Pays: United States
ID NLM: 8908809
Informations de publication
Date de publication:
Dec 2021
Dec 2021
Historique:
received:
01
08
2021
accepted:
06
09
2021
pubmed:
29
9
2021
medline:
3
11
2021
entrez:
28
9
2021
Statut:
ppublish
Résumé
The dual-filter Sentinel™ Cerebral Protection System (Sentinel-CPS) is increasingly used during transcatheter aortic valve replacement (TAVR). However, complex vascular anatomy may challenge Sentinel-CPS deployment. We sought to investigate the impact of anatomic features of the aortic arch and the supra-aortic arteries on technical device failure of Sentinel-CPS application. Analysis of the multislice computed tomography pre-TAVR aortograms of all patients undergoing TAVR with Sentinel-CPS between 2016 and 2020 (n = 92) was performed. We investigated the impact of aortic arch anatomy, configuration, and the angles of the supra-aortic arteries, including the determination of vascular tortuosity index on device failure of Sentinel-CPS application. The Sentinel-CPS was applied successfully in 83 patients (90.2%). Device failure in nine patients (9.8%) was due to the infeasibility to perform correct deployment of both filters (n = 7) and to obtain peripheral radial access (n = 2). Patients with a failure of Sentinel-CPS application had a higher right subclavian tortuosity index (217 [92-324] vs. 150 [42-252], p = .046), a higher brachiocephalic tortuosity index (27 [5-51] vs. 10 [0-102], p = 0.033) and a larger angulation of the brachiocephalic artery (59° [22-80] vs. 39° [7-104], p = .014) compared with patients with successful application. A brachiocephalic angle more than 59° was predictive for device failure. No differences in aortic arch anatomy or common carotid artery tortuosity were detected between the groups. Brachiocephalic tortuosity was found to be associated with failure of Sentinel-CPS application. Filter-based usage should be avoided in TAVR patients with a brachiocephalic angle more than 59°.
Sections du résumé
BACKGROUND
BACKGROUND
The dual-filter Sentinel™ Cerebral Protection System (Sentinel-CPS) is increasingly used during transcatheter aortic valve replacement (TAVR). However, complex vascular anatomy may challenge Sentinel-CPS deployment.
AIM OF THE STUDY
OBJECTIVE
We sought to investigate the impact of anatomic features of the aortic arch and the supra-aortic arteries on technical device failure of Sentinel-CPS application.
METHODS
METHODS
Analysis of the multislice computed tomography pre-TAVR aortograms of all patients undergoing TAVR with Sentinel-CPS between 2016 and 2020 (n = 92) was performed. We investigated the impact of aortic arch anatomy, configuration, and the angles of the supra-aortic arteries, including the determination of vascular tortuosity index on device failure of Sentinel-CPS application.
RESULTS
RESULTS
The Sentinel-CPS was applied successfully in 83 patients (90.2%). Device failure in nine patients (9.8%) was due to the infeasibility to perform correct deployment of both filters (n = 7) and to obtain peripheral radial access (n = 2). Patients with a failure of Sentinel-CPS application had a higher right subclavian tortuosity index (217 [92-324] vs. 150 [42-252], p = .046), a higher brachiocephalic tortuosity index (27 [5-51] vs. 10 [0-102], p = 0.033) and a larger angulation of the brachiocephalic artery (59° [22-80] vs. 39° [7-104], p = .014) compared with patients with successful application. A brachiocephalic angle more than 59° was predictive for device failure. No differences in aortic arch anatomy or common carotid artery tortuosity were detected between the groups.
CONCLUSIONS
CONCLUSIONS
Brachiocephalic tortuosity was found to be associated with failure of Sentinel-CPS application. Filter-based usage should be avoided in TAVR patients with a brachiocephalic angle more than 59°.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
4537-4545Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2021 The Authors. Journal of Cardiac Surgery Published by Wiley Periodicals LLC.
Références
Kapadia SR, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol. 2017;69:367-377.
Huded CP, Tuzcu EM, Krishnaswamy A, et al. Association between transcatheter aortic valve replacement and early postprocedural stroke. JAMA. 2019;321:2306-2315.
Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019;380:1706-1715.
Van Mieghem NM, El Faquir N, Rahhab Z, et al. Incidence and predictors of debris embolizing to the brain during transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2015;8:718-724.
Van Mieghem NM, van Gils L, Ahmad H, et al. Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised mistral-c trial. EuroIntervention. 2016;12:499-507.
Schafer U. Safety and efficacy of protected cardiac intervention: clinical evidence for sentinel cerebral embolic protection. Interv Cardiol. 2017;12:128-132.
Haussig S, Mangner N, Dwyer MG, et al. Effect of a cerebral protection device on brain lesions following transcatheter aortic valve implantation in patients with severe aortic stenosis: the clean-TAVI randomized clinical trial. JAMA. 2016;316:592-601.
Naber CK, Ghanem A, Abizaid AA, et al. First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation. EuroIntervention. 2012;8:43-50.
Tagliari AP, Ferrari E, Haager PK, et al. Feasibility and safety of cerebral embolic protection device insertion in bovine aortic arch anatomy. J Clin Med. 2020;9.
Halkin A, Iyer SS, Roubin GS, Vitek J. Carotid Artery Stenting. In: Kipshidze NN, Fareed J, Moses JW, Serruys PW, eds. Textbook of Interventional Cardiovascular Pharmacology. London, UK: Taylor & Francis Ltd.; 2007:555-569.
Patel T, Shah S, Pancholy S, et al. Working through challenges of subclavian, innominate, and aortic arch regions during transradial approach. Catheter Cardiovasc Interv. 2014;84:224-235.
Case BC, Forrestal BJ, Yerasi C, et al. Real-world experience of the sentinel cerebral protection device: Insights from the fda manufacturer and user facility device experience (maude) database. Cardiovasc Revasc Med. 2020;21:235-238.
Voss S, Deutsch MA, Schechtl J, et al. Impact of a two-filter cerebral embolic protection device on the complexity and risk of transcatheter aortic valve replacement. Thorac Cardiovasc Surg. 2019;68:616-622.
Voss S, Nobauer C, Lange R, Bleiziffer S. Cerebral protection during transcatheter aortic valve implantation in an extreme high-risk patient. Eur J Cardiothorac Surg. 2017;52:998-999.
Voss S, Schechtl J, Nobauer C, Bleiziffer S, Lange R. Patient eligibility for application of a two-filter cerebral embolic protection device during transcatheter aortic valve implantation: does one size fit all? Interact Cardiovasc Thorac Surg. 2020;30:605-612.
Muller MD, Ahlhelm FJ, von Hessling A, et al. Vascular anatomy predicts the risk of cerebral ischemia in patients randomized to carotid stenting versus endarterectomy. Stroke. 2017;48:1285-1292.
Morris SA, Orbach DB, Geva T, Singh MN, Gauvreau K, Lacro RV. Increased vertebral artery tortuosity index is associated with adverse outcomes in children and young adults with connective tissue disorders. Circulation. 2011;124:388-396.
Faggioli G, Ferri M, Gargiulo M, et al. Measurement and impact of proximal and distal tortuosity in carotid stenting procedures. J Vasc Surg. 2007;46:1119-1124.
Koo TK, Li MY. A guideline of selecting and reporting intraclass correlation coefficients for reliability research. J Chiropr Med. 2016;15:155-163.
Fluss R, Faraggi D, Reiser B. Estimation of the Youden index and its associated cutoff point. Biom J. 2005;47:458-472.
Naggara O, Touze E, Beyssen B, et al. Anatomical and technical factors associated with stroke or death during carotid angioplasty and stenting: results from the endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis (EVA-3s) trial and systematic review. Stroke. 2011;42:380-388.
Seeger J, Gonska B, Otto M, Rottbauer W, Wohrle J. Cerebral embolic protection during transcatheter aortic valve replacement significantly reduces death and stroke compared with unprotected procedures. JACC Cardiovasc Interv. 2017;10:2297-2303.
Rigatelli G, Dell'avvocata F, Vassiliev D, et al. Strategies to overcome hostile subclavian anatomy during transradial coronary angiography and interventions: impact on fluoroscopy, procedural time, complications, and radial patency. J Interv Cardiol. 2014;27:428-434.
Faggioli GL, Ferri M, Freyrie A, et al. Aortic arch anomalies are associated with increased risk of neurological events in carotid stent procedures. Eur J Vasc Endovasc Surg. 2007;33:436-441.
Ahn SS, Chen SW, Miller TJ, Chen JF. What is the true incidence of anomalous bovine left common carotid artery configuration? Ann Vasc Surg. 2014;28:381-385.
Lam RC, Lin SC, DeRubertis B, Hynecek R, Kent KC, Faries PL. The impact of increasing age on anatomic factors affecting carotid angioplasty and stenting. J Vasc Surg. 2007;45:875-880.
Garg N, Sahoo D, Goel PK. Pigtail assisted tracking of guide catheter for navigating the difficult radial: Overcoming the “razor effect”. Indian Heart J. 2016;68:355-360.