Stephanie Voss1,2, Johanna Schechtl1,2, Christian Nöbauer1,2, Sabine Bleiziffer3, Rüdiger Lange1,2,4. 1. Department of Cardiovascular Surgery, German Heart Centre Munich, Technische Universität München, Munich, Germany. 2. Department of Cardiovascular Surgery, German Heart Centre Munich, Insure (Institute of Translational Cardiac Surgery), Technische Universität München, Munich, Germany. 3. Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Centre North Rhine Westphalia, Bad Oeynhausen, Germany. 4. DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.
Abstract
OBJECTIVES: This study sought to determine the percentage of patients potentially eligible for implantation of the Sentinel™ Cerebral Protection System (Sentinel-CPS) during transcatheter aortic valve implantation (TAVI) and to identify the reasons for treatment exclusion. METHODS: We retrospectively performed an analysis of pre-TAVI multislice computed tomography (MSCT) aortograms and data review of all patients undergoing a TAVI procedure in 2017 (n = 317). MSCT evaluation included the assessment of aortic arch anatomy and the vascular dimensions of the brachiocephalic and left common carotid artery. Data analysis focused on comorbid conditions, precluding 6-Fr sheath radial access and filter deployment due to history of previous artery interventions. RESULTS: MSCT and data analysis showed Sentinel-CPS compatibility in 61.5% of patients (n = 195). Sentinel-CPS would have been contraindicated in 38.5% (n = 122) due to one or more of the following: (i) measured diameters of the filter-landing zones <9 or >15 mm in the brachiocephalic artery and <6.5 or >10 mm in the left common carotid artery (n = 116; 88 with carotid dimensions too small); (ii) significant subclavian artery stenosis (n = 4) or an aberrant subclavian artery (n = 3) precluding Sentinel-CPS implantation and (iii) clinical characteristics including hypersensitivity to nickel-titanium (n = 1), radial artery occlusion (n = 1) or previous left common carotid artery interventions (n = 5). CONCLUSIONS: MSCT and clinical data supported Sentinel-CPS compatibility in 61.5% of patients. The most common reason for treatment exclusion was inappropriate diameter within the target landing zone of the left carotid artery. Future device development should address this limitation.
OBJECTIVES: This study sought to determine the percentage of patients potentially eligible for implantation of the Sentinel™ Cerebral Protection System (Sentinel-CPS) during transcatheter aortic valve implantation (TAVI) and to identify the reasons for treatment exclusion. METHODS: We retrospectively performed an analysis of pre-TAVI multislice computed tomography (MSCT) aortograms and data review of all patients undergoing a TAVI procedure in 2017 (n = 317). MSCT evaluation included the assessment of aortic arch anatomy and the vascular dimensions of the brachiocephalic and left common carotid artery. Data analysis focused on comorbid conditions, precluding 6-Fr sheath radial access and filter deployment due to history of previous artery interventions. RESULTS: MSCT and data analysis showed Sentinel-CPS compatibility in 61.5% of patients (n = 195). Sentinel-CPS would have been contraindicated in 38.5% (n = 122) due to one or more of the following: (i) measured diameters of the filter-landing zones <9 or >15 mm in the brachiocephalic artery and <6.5 or >10 mm in the left common carotid artery (n = 116; 88 with carotid dimensions too small); (ii) significant subclavian artery stenosis (n = 4) or an aberrant subclavian artery (n = 3) precluding Sentinel-CPS implantation and (iii) clinical characteristics including hypersensitivity to nickel-titanium (n = 1), radial artery occlusion (n = 1) or previous left common carotid artery interventions (n = 5). CONCLUSIONS: MSCT and clinical data supported Sentinel-CPS compatibility in 61.5% of patients. The most common reason for treatment exclusion was inappropriate diameter within the target landing zone of the left carotid artery. Future device development should address this limitation.
Authors: Ana Paula Tagliari; Enrico Ferrari; Philipp K Haager; Martin Oliver Schmiady; Luca Vicentini; Mara Gavazzoni; Marco Gennari; Lucas Jörg; Ahmed Aziz Khattab; Stefan Blöchlinger; Francesco Maisano; Maurizio Taramasso Journal: J Clin Med Date: 2020-12-20 Impact factor: 4.241