DESPITE CURRENT LEVEL 1 EVIDENCE THE OUTLOOK FOR AN UPSURGE IN CAROTID STENTING (CAS) IS BRIGHT FRANK J. VEITH LINC LEIPZIG JANUARY 27, 2015
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1 DESPITE CURRENT LEVEL 1 EVIDENCE THE OUTLOOK FOR AN UPSURGE IN CAROTID STENTING (CAS) IS BRIGHT FRANK J. VEITH LINC LEIPZIG JANUARY 27, 2015
2 Disclosure Speaker name: FRANK J. VEITH
3 DESPITE SOME OF TODAY S OPTIMISTIC TALKS CAROTID STENTING OR CAS IS CURRENTLY IN DECLINE GENERALLY FOR TREATMENT OF SYMP & ASYMPTOMATIC CAR STENOSIS THIS IS BECAUSE
4 WITH SYMPTOMATIC CAROTID STENOSIS PATIENTS RECENT RANDOMIZED TRIALS* SHOW HIGHER STROKE RATES WITH CAS THAN CEA, AND *(CREST, ICSS, ETC)
5 WITH MOST ASYMPTOMATIC CAROTID STENOSIS PATIENTS BEST MEDICAL TREATMENT HAS SUCH LOW STROKE RATES THAT IT MAKES CAS (& CEA) UNNECESSARY
6 3-6% PER YR IN 1985 < 1% / YR IN 2014 ANNUAL STROKE RATE WITH ASX CS DECREASED DUE TO BETTER BMRx & STATINS FROM 3-6% TO <1% / YR FROM A ABBOTT & R NAYLOR
7 HOWEVER, I BELIEVE OUTLOOK FOR CAS IS BRIGHT BECAUSE 3 ADVANCES MAY DECR STROKES, IMPROVE CAS RESULTS & MAKE CURR RCTs OBSOLETE 1. BETTER EMBOL PROTECT DEVICES WITH CESS/REVERSAL OF FLOW 2. CERVICAL ACCESS (SILK ROAD SYSTEM) TO AVOID THE AORTIC ARCH & REV FL 3. MEMBRANE OR MESH COVERED STENTS TO STOP DELAYED STROKES
8 OUR 1995 EX VIVO MODEL OF CAS
9
10
11 DEBRIS THOUGH STENT CAUSING DELAYED EMBOLI
12 A MESH COVERED STENT TO PREVENT DELAYED EMBOLIZATION
13 SILK ROAD CERVICAL ACCESS SYSTEM WITH REVERSAL OF FLOW Following Slides Courtesy Of Chris Kwolak & Sumaira Macdonald
14 A NEW, SURGICALLY-INSPIRED ENDOVASCULAR SOLUTION ENROUTE Transcarotid Stent and Neuroprotection System Shorter delivery system and wires for simplified setup and delivery Blood flow is returned to femoral vein Blood flow is reversed from the common carotid artery Dynamic Flow Controller Hi / Low / Off Embolic filter (200µ) CAUTION: Investigational device. Limited by federal (USA) law to investigational use. The ENROUTE Transcarotid Stent and Neuroprotection Systems bear the CE mark of conformity and are available for sale in EU and EFTA countries.
15 SURGICAL OUTCOMES IN STROKE REDUCTION Silk Road Clinical Studies PROOF TESLA ROADSTER Study type First In Man Multicenter EU Post- Market Registry US Pivotal IDE Number of Patients Profile All-comers All-comers High Surgical Risk Status Complete Complete Enrollment Complete
16 FOR SYMPTOMATIC & ASX PTS IF THESE 3 ADVANCES DECREASE CAS STROKE RATES CAS WOULD BE MORE COMPETITIVE TO CEA & WOULD REPLACE CEA MORE WIDELY THAN IT DOES NOW
17 FOR ASYMPTOMATIC PATIENTS THERE ARE PROMISING WAYS ON THE HORIZON TO SELECT THOSE AT HIGH RISK OF STROKE 1. TCD DETECTED MICROEMBOLI 2. DUPLEX PLAQUE EVALUATION 3. MRI & CT PLAQUE EVALUATION 4. SILENT MRI & CT INFARCTS SOME ASX PT GROUPS HAVE >12% PER YEAR STROKE RISK vs <1%
18 THESE HIGH RISK ASYMPTOMATIC PTS SELECTED BY THESE METHODS CLEARLY WOULD BENEFIT FROM CAS OR CEA - IN ADDITION TO BEST MEDICAL TREATMENT THUS INCREASING THE NUMBER OF PATIENT NEEDING CAS
19 HOWEVER THERE IS 1 RESERVATION: THAT IS THE EFFICACY OF THESE 3 METHODS FOR DECREASING CAS STROKE RATES & IMPROVING ASX PATIENT SELECTION MUST BE PROVEN BY APPROPRIATE CLINICAL TRIALS
20 MY CONCLUSIONS 1. DESPITE THIS RESERVATION I BELIEVE THE OUTLOOK FOR CAROTID STENTING OR CAS IS BRIGHT IN THE FUTURE 2. ALL VASCULAR SPECIALISTS SHOULD PREPARE FOR IMPROVING CAS RESULTS
21 THANKS FOR YOUR ATTENTION MORE DISCUSSION
22
23 THE SILK ROAD PROCEDURE Surgically Inspired - It s All about stroke Direct carotid access with CCA clamp & vessel control Robust flow reversal akin to backbleeding No discrimination macro and micro emboli Transcarotid Endovascular Advantage Procedural speed and interventional device control Shorter delivery system and wires for simplified setup and delivery Broad population of patients eligible for this procedure Patient Friendly, Less Invasive Procedure Reduced rate and severity of cranial nerve injury Local anesthesia can improve recovery time Cosmetic result of a less invasive procedure ROADSTER Study to be presented at VIVA and VEITH, 2014
24 DESPITE CURRENT LEVEL 1 EVIDENCE THE OUTLOOK FOR AN UPSURGE IN CAROTID STENTING (CAS) IS BRIGHT FRANK J. VEITH LINC LEIPZIG JANUARY 27, 2015
FRANK J. VEITH MAC TH MUNICH VASCULAR CONF
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