CoreValve High Risk Study - Neu
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1 CoreValve High Risk Study - Neu Adams DH et al. NEJM 2014
2 CoreValve US Pivotal Trial Reardon MJ et al. ACC 2015
3 Stroke incidence and mortality after TAVI Meta-analysis of 10,037 published patients Stroke remains a major TAVI complication which increases 30-day mortality >3 fold EuroIntervention 2012;8: publish online ahead of print March 2012 Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients
4 Stroke incidence and mortality after TAVI Meta-analysis of 10,037 published patients Stroke remains a major TAVI complication which increases 30-day mortality >3 fold EuroIntervention 2012;8: publish online ahead of print March 2012 Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients
5 AK St Georg Study Embolic debris captured during TAVI procedures at AK St Georg (Hamburg) 52 cases of TAVI using Claret Medical Cerebral Protection System performed at AK St Georg (Hamburg) Sapien/XT S3 CoreValve Jena Portico Centera 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 27 (52%) 11 (21%) 9 (17%) 2 (4%) 2 (4%) 1 (2%) Filter contents subsequently analyzed by CVPath Institute Debris captured in 96% of patients Any debris Cerebral embolic debris captured in TAVI patients (n=52) Acute Organizing Valve Tissue Arterial Wall Calcification Foreign material Note: percentages reflect percent of patients in each group in which each particular tissue type was captured. Some filters captured several types of debris, so percentages will not add to 100% ORGANIZED ACUTE ARTERIAL WALL VALVE TISSUE WITH CALCIFIED DEBRIS 1. Schmidt T, Schaefer U, Sanchez O, et al DGK CVPath Institute data on file at Claret Medical. CAUTION: Investigational device. Limited to investigational use by United States law.
6 AK St Georg Study Embolic debris captured by valve type during TAVI procedures at AK St Georg (Hamburg) 52 cases of TAVI using Claret Medical Cerebral Protection System performed at AK St Georg (Hamburg) Sapien/XT S3 CoreValve Jena Portico Centera 27 (52%) 11 (21%) 9 (17%) 2 (4%) 2 (4%) 1 (2%) Filter contents subsequently analyzed by CVPath Institute Debris captured in 96% of patients ACUTE 100% 90% 80% 70% Cerebral embolic debris captured in TAVI patients by valve type Sapien/XT (n=27) S3 (n=11) CV (n=9) ORGANIZED ARTERIAL WALL 60% 50% 40% 30% 20% VALVE TISSUE WITH CALCIFIED DEBRIS 10% 0% Any debris Acute Organizing Valve Tissue Arterial Wall Calcification Note: percentages reflect percent of patients in each group in which each particular tissue type was captured. Some filters captured several types of debris, so percentages will not add to 100% 1. Schmidt T, Schaefer U, Sanchez O, et al DGK CVPath Institute data on file at Claret Medical. Foreign material CAUTION: Investigational device. Limited to investigational use by United States law.
7 LAA Closure Embolic debris captured during LAA closure procedures by Claret Medical Cerebral Protection Systems 5 cases of LAA closure (Watchman and Amplatzer) using Claret Cerebral Protection Systems Filter contents subsequently analyzed at CVPath Institute Debris captured in 100% of patients Debris includes acute and organizing, as well as endocardium and intimal tissue Debris differs from TAVR, as expected, in not including calcification or valve tissue 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Cerebral embolic debris captured in LAA occlusion cases (n=5) Any debris Acute Organizing Tissue Calcification Foreign material Note: percentages reflect percent of patients in the series in which each particular tissue type was captured. Some filters captured several types of debris, so percentages will not add to 100% ENDOCARDIUM INTIMA 1. AK St Georg (Hamburg). CVPath Institute data on file at Claret Medical CAUTION: Investigational device. Limited to investigational use by United States law.
8 MitraClip Embolic debris captured during MitraClip procedures by Claret Medical Cerebral Protection Systems 14 cases of MitraClip TMVR using Claret Medical Cerebral Protection System. Performed at AK St Georg (Hamburg) and University Hospital RWTH (Aachen) Filter contents subsequently analyzed at CVPath Institute Debris captured in 93% of patients Debris includes acute, despite short procedures and high ACT, organized, valve or artery tissue, and foreign material. Debris characterization differs from TAVR, as expected, in not including calcification. 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Cerebral embolic debris captured in MitraClip patients (n=14) Any debris Acute Organizing Tissue Calcification Foreign material Note: percentages reflect percent of patients in the series in which each particular tissue type was captured. Some filters captured several types of debris, so percentages will not add to 100% 1. AK St Georg (Hamburg) and University Hospital RWTH (Aachen). CVPath Institute data on file at Claret Medical CAUTION: Investigational device. Limited to investigational use by United States law.
9 CLEAN-TAVI shows positive outcome Claret Montage Cerebral Protection System significantly reduces new cerebral lesion number and volume at 2 & 7 days, as measured by DW-MRI.
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