Revolutionary Advance? Yes, It Is a Game Changer for Both Outcomes - - PowerPoint PPT Presentation

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Revolutionary Advance? Yes, It Is a Game Changer for Both Outcomes - - PowerPoint PPT Presentation

Nov 02, 2023 435 likes •634 views

Is Transcarotid Artery Revascularization (TCAR) a Revolutionary Advance? Yes, It Is a Game Changer for Both Outcomes and Adoption of Carotid Stenting! Christopher Kwolek, MD Massachusetts General Hospital Disclosure Statement of Financial

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Is Transcarotid Artery Revascularization (TCAR) a Revolutionary Advance? Yes, It Is a Game Changer for Both Outcomes and Adoption of Carotid Stenting!

Christopher Kwolek, MD Massachusetts General Hospital

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Disclosure Statement of Financial Interest

  • Grant/Research Support
  • Consulting Fees/Honoraria
  • Major Stock Shareholder/Equity
  • Royalty Income
  • Ownership/Founder
  • Intellectual Property Rights
  • Other Financial Benefit
  • Abbott, Silk Road, WL Gore
  • Silk Road
  • Company Names
  • Company Names
  • Company Names
  • Company Names
  • Company Names

Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.

Affiliation/Financial Relationship Company

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There is a single, fundamental premise to treating carotid disease

The intent of carotid revascularization is to prevent stroke.

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Is TCAR a game changer for

  • utcomes?

YES!

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ROADSTER Study Outcomes in High Surgical Risk Patients

Intention to Treat & Per Protocol Groups

Per Protocol excludes major protocol deviations All FDA-approved carotid stent systems were used per site preference (Acculink, Xact, Precise, Protégé, Wallstent)

High Surgical Risk Pivotal Group, ITT (N=141) Pivotal Group, PP (N=136) S/D/MI 5 3.5% 4 2.9% Major Stroke 0% 0% Minor Stroke 2 1.4% 1 0.7% Death 2 1.4% 2 1.5% MI 1 0.7% 1 0.7% Stroke & Death 4 2.8% 3 2.2%

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ROADSTER Study Outcomes

Key Subgroups

High Surgical Risk Pivotal ITT Age ≥ 75 Symptomatic Female N N=66 (47%) N=36 (26%) N=49 (35%) S/D/MI 3 (4.5%) 1 (2.8%) 1 (2.0%) Major Stroke 0% 0% 0% Minor Stroke 0% 0% 0% Death 3.0% 2.8% 2.0% MI 1.5% 0% 0% Stroke & Death 3.0% 2.8% 2.0%

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4.1% 2.3% [VALUE]

0.0% 0.5% 1.0% 1.5% 2.0% 2.5% 3.0% 3.5% 4.0% 4.5%

30-Day All Stroke (1) TF-CAS CEA TCAR

CREST 30-Day Results vs. ROADSTER

CREST – 30-Day All Stroke Rates

Stroke Rate

  • 1. N Engl J Med 2010;363:11-23.

Standard Surgical Risk vs. High Surgical Risk

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Is TCAR a game changer for adoption?

ABSOLUTELY!

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US Procedure Volume

After 20 years of evolution, CAS is stagnant

*Health Advances, HCUP **Stroke. 2015;46:120-125.

86%

CEA

14%

CAS

96K 16K

~112,500 carotid interventions (2013)*

59% of patients are HSR AND 81% of HSR patients are treated with CEA**

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An alternative to CEA remains an unmet need

More S/D is not the answer (TF-CAS)

J Vasc Surg. 2013 May ; 57(5): 1318–1324.

6.4% 3.7% 7.9% 4.8% Symptomatic Asymptomatic High Surgical Risk CEA High Surgical Risk CAS n=5,736

30 Day Stroke and Death in the SVS Vascular Registry

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4.1% 2.3% [VALUE]

0.0% 0.5% 1.0% 1.5% 2.0% 2.5% 3.0% 3.5% 4.0% 4.5%

30-Day All Stroke (1)

If you Solve the Stroke Problem

CREST – 30-Day All Stroke Rates

  • 1. N Engl J Med 2010;363:11-23.

You Solve the Adoption Problem

CREST CAS CREST CEA ROADSTER TCAR

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Is TCAR too complex?

NO!

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TCAR is a short and simple procedure

  • Mini-incision (like

EVAR, TEVAR and TAVR)

  • Local Anesthesia
  • Direct carotid access

avoids arch navigation

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TCAR is a short and simple procedure

  • Dedicated TCAR tool

set for direct CCA access

  • No crossing lesion
  • No filter - no balloons
  • Short, direct path to

lesion for accurate stent deployment

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Procedure Times for TCAR in ROADSTER

CREST – 30-Day All Stroke Rates

Minutes

*Stroke 2012;2408-2416.

Compared with TF-CAS and CEA procedure times in CREST*

69 171 74

20 40 60 80 100 120 140 160 180

Procedure Time in Minutes

TF-CAS CEA TCAR

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Outcomes as a function of the number of patients per physician in CAPTURE 2

Gray WA et al. JACC Cardiovasc Interv 2011;4:235-246

CREST-2

Credentialing threshold

TCAR SD Rate = 2.8%

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How was 1.4% stroke rate (0.7% PP) achieved in ROADSTER?

 Gen 1 Device  29 operators

  • 4 operators with >5 TCAR procedures
  • 1 operator with 1-5 TCAR procedures
  • 24 operators with NO PRIOR TCAR

experience

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Summary: TCAR is a game changer

 TCAR 30-day stroke rate of 1.4% (0.7% PP)  TCAR delivers a minimally invasive alternative to

CEA , benefits of proximal occlusion

 TCAR is simple and efficient, the benefits of CAS

with a short learning curve