The Method of Embolic Protection has Important Implications

The Method of Embolic Protection has Important Implications in CAS Outcomes Gary M. Ansel, MD, FACC, SCAI Riverside Methodist Hospital Columbus, Ohio

Gary M. Ansel, MD §Honoraria: §W. L. Gore and Associates, Inc. /Embolitech §Consulting Fees: §Cardiometrics §Covidien/Ev 3 §Flexible Stenting Solutions §Nellix, Inc.

§Consulting Fees: §Nexeon §Ostial Solutions §Sim. Suite §Vascular Think Tank/Becher VSG §Vatrix Medical §Best Doctors §Vascular Performance Products

§Royalty: §Veryan/Novate §Ownership Interest (stock, stock options, or other ownership interests): §Embolitech

My presentation will include off label discussions: Stents

I’m not going to debate this to win!! No More Absolutes About Carotid Disease It is hurting our patients and Medicine in General

Everyone is talking absolutes and in doing so taking away physician decisions and patient options

The Lure of Carotids is Like “ The Carotid RING”

We Realize CMS wants to CONTROL the Carotid Ring but not just this Ring, all Rings

Others also want to deny patient choice and want the “ring” of power

We know the government does not have a Hippocratic oath but what about US!

Richard Cambria and SVS • Signing on the AHA carotid position statement and at the same time writing a negative position for SVS? Maybe now we know why it took so long to get their own board!

Even The Neurologists Like Tom Brott and Anne Abbott Cannot Resist the Power of the Carotid Ring and Resort to Data Decption

So what about this topic? I respect Horst but I have a strange feeling that the “carotid RING” may effect him too.

There are those of us that take care of patients long term

Embolic Protection Devices (EPD) Bottom LIne • There is no level 1 support documenting superiority of one EPD over another • Both proximal and distal protection have a role and physicians can be educated when which may best serve the patient’s procedure

Distal embolic protection Proximal embolic protection

Distal Protection Upside • Intuitive • Maintain flow (excl. bln) – – Perfusion Visibility • Low Profiles • • Downside Pass lesion unprotected Suitable landing zone Wall apposition (excl bln) Tight lesions Tortuosity System stability Pores allow some embolization (excl bln)

Proximal Flow Protection • • • Upside Near total protection Wire freedom Not effected by ICA anatomy – – No landing zone No need to straighten tortuosity – Severe stenoses • ? Choice for high risk lesion • • Downside Larger profile (9 -fr) Intolerance (3 -8%) New mechanism to learn May be ECA dependent

Old confusing statements Room to Improve • Lower profile • Wall apposition • Pore size • Foot plate • Wire independence • Wire transitions

Typical Distal EPD Anatomic Struggles • Distal tortuosity • Short landing zone • Acute angle

EMPi. RE (WL Gore): MAE by Subgroup (Stroke, Death, MI)

Results 1° Endpoint 30 d Results (ITT & Full Population) 30 d Results by Symptoms and Age (ITT) 75 y

Comparison of TCD counts Wire Stent Balloon Total MES counts (filter) – – 25 +/- 22 73 +/- 49 70 +/- 31 196 +/- 84 MES counts (MO. MA) – – 1. 8 +/- 3. 2 11 +/- 19 12 +/- 21 57 +/- 41 (p < 0. 0001).

Recent DEP devices have excellent results

Outcomes of DEP CAS Trials Over Time • CAS results have improved over time due to: 1) more experience; (2) better patient selection ; (3) technology Year: 2000 (Enrollment: 2000 -2008) CREST – 5. 7% Year: 2008 (Enrollment: 2000 -2008) CREST – 1. 1%

Proximal Intolerance

Effect different neuroprotection systems on microembolization Distal EPD (filter wire) vs Proximal protection (MO. MA) • • N = 42 Transcranial doppler Single center nonrandomized Schmidt et al. J Am Coll Cardiol; 2004 Nov 16; 44(10): 1966 -9

Stroke 2011; 42: 675

Why you can’t compare registries • Besides from the well known reasons… – Not randomized – Different timings • Learning curve effect • More aggressive on pts selection with experience – – – Different patient population (symptoms, age, morphology) Different inclusion and exclusion criteria Different operators experience Difference in end point definition Difference in end point calculation and reporting

Riverside Methodist Hospital: Single Center “Octogenarian” Outcomes in Controlled Trials over a 10 -year period

RMH Octogenarians • • • 1998 - 2008 > 90% combo IC and NIR All patients from formal trials All patients with formal independent Neuro 4 IC operators, 2 NIR Single center, non-peer reviewed at present

RMH Octogenarians • N = 154 • Symptomatic state = 17% • EPD utilized = 83% Single center, non-peer reviewed at present

RMH Octogenarians • Results – Peri-procedural (24 hours) • • Major stroke Minor stroke MI Death =0 = 1 (0. 6%) =0 =0 – 30 - Day new events* • Major stroke = 0 • Minor stroke = 0 • Death =0 *(93% f/u) Single center, non-peer reviewed at

Summary: No one best way Treat the patient

High Volume Center Multicenter Registry • • • Octogenarias (83. 2 ｱ 2. 8 yrs) M Male (63. 2%) Independent Neuro evaluation Asymptomatic in two-thirds (68. 2%) Characteristics – – – coronary artery disease (74. 4%) hypertension (87. 8%) dyslipidemia (71. 1%) Diabetic (30. 1%) Tobacco use (56. 5%) Publication pending

Results – (EPD) utilized in 78. 7%* – The 30 -day incidence of stroke and death was 2. 8% (11/389) * Lack of EPD was secondary to cases done prior to EPD availability