New concepts for filter protection during CAS: double filtration Alberto Cremonesi MD, FESC
First Experience with the PALADIN Carotid Post-Dilation Balloon with Integrated Embolic Protection Alberto Cremonesi MD, FESC
Disclosure Alberto Cremonesi I have the following potential conflicts of interest to report: Consulting Boston Scientific Abbott Medtronic Terumo Contego Medical
While CAS Results are steadily Improving 30d MANE rate vs enrollment start and duration 1992 2015
Stroke Remains the Achilles Heal for Filter Protected Carotid Artery Stenting 10 % 8 6 4 2 0 Contralateral Ipsilateral CAPTURE 3500: Stroke by Symptoms, Age, and Location
When Do Strokes Occur During Filter Protected Carotid Artery Stenting? 60 % 50 40 30 20 10 The Vast Majority of the Risk of Stroke related to the Stenting Procedure Occurs During Post-Dilation 25% 70% 0 Access Stenting 5% Post-Procedure
Hypothesis
Double Filtration Symptomatic LICA Primary EPD Secondary EPD Post-Dilation Balloon
Double Filtration Primary EPD 221 Non-consecutive Patients 2 Centers, Prospective, Non-Randomized Secondary EPD Double Filtration using a variety of primary filters and stents FilterWire used for all secondary filter 30 Day Neurological Death, Stroke, MI Post-Dilation Balloon
Procedural Events 30-Day Events Double Filtration: Procedural and 30 day Results N=221 Number % Myocardial Infarction 0 0% Stroke 1 0.48% Neurological Death 0 0% Myocardial Infarction 1 0.48% Neurological Death 0 0% Stroke 0 0% Total Neurological Death/Stroke/MI 2 0.96%
Limitations of Double Filtration using Two Separate Filters 1. Cost of an extra filter 2. Extra time require to deploy a second filter 3. 36% of patients with insufficient landing zone for a second filter
PALADIN Carotid Post-Dilation Balloon with Integrated Embolic Protection (IEP) Technology Filter Chassis Minimal Landing Zone Sheathless Design Filter Membrane with 40-Micron Pore Size Angioplasty Balloon First filter with ability to adjust size to suit patient anatomy
PALADIN
PALADIN Balloon Post-Dilation
Registry Clinical Experience Baseline Characteristics Registry (n=50) Age (mean) 69 Gender (male) 66.7% Asymptomatic 91.7% Symptomatic 8.3% Hypertension 85.4% Hyperlipidemia 81.3% Diabetic (Type II) 35.4% Smoker: Current/Former 35.4/39.6% Prior MI 10.4% Prior TIA/Stroke 8.3/0%
Registry Clinical Experience Procedure Results Registry (n=50) Femoral Access 100% Target Vessel: Lesion Length (mm) RVD (mm) Left ICA Right ICA 47.9 52.1 14.3±5.35 5.3±0.65 Diameter Stenosis (%DS) 83.5±8.9 Primary EPD: Distal Filter Proximal 95.8% 4.2% Stent Deployed 100%
Full Clinical Experience Procedure Results Registry* (n=50) Other ** (n=33) Paladin Technical Success 100% 100% Procedure Success 100% 100% MACE (through D/C) 0% 0% MACE (through 30 days) 2%* 0% * 1 Stroke at day 12 due to stent thrombosis in a patient with a mesh covered stent who did not take ASA or clopidogrel. Treated with thrombolytic therapy ** Non-registry commercial patients in which Paladin used according to IFU
DW-MRI Evaluation: Preliminary Results DW-MRI Results Paladin (n=15) Incidence of New Lesions 13% # Lesions per patient 0.13 Mean Lesion Volume (cm 3 ) 0.01 Comparative DW-MRI Results Across Studies Incidence of New Lesions Mean Lesion Volume (cm 3 ) Paladin (n=15) CARENET 1 CGuard (n=26) PROFI 2 Proximal group (n=31) PROFI 2 Filter group (n=31) ICSS 3 Filter group (n=37) 13% 48% 45% 87% 73% 0.01 0.06 0.16 0.59 NA 1. Schofer. TCT 2014 2. JACC. April 2012 3. Lancet, March 2010
Diameter, μm Particle size distribution in Paladin Filter >200 200 190 180 170 160 150 140 130 120 101-110 91-100 81-90 71-80 61-70 51-60 41-50 31-40 0 50 100 150 200 250 300 350 Particle Frequency
Conclusions Double filtration using the Paladin balloon demonstrated excellent safety and technical success Majority of the particles captured are less than 100 microns Double filtration appears to reduce the incidence of new ischemic DW MRI lesions as compared to distal EPDs as well as proximal protection Double filtration may help to reduce the problem of minor stroke during CAS This hypothesis needs to be studied in larger studies
New concepts for filter protection during CAS: double filtration Alberto Cremonesi MD, FESC