endovascular first vs. a personalized approach to

Endovascular First vs. A Personalized Approach to Revascularization in CLIMitchell D. Weinberg MDSystem Director of Peripheral Intervention Department of Cardiology Northwell Health

1

Conflicts of Interest

Consulted for a variety of interventional companies 1. Medtronic 2. Boston Scientific 3. CSI

Month Day, Year 2

CASE79 female with • NIDDM • HTN • Chol • CAD prior LAD stent • ICM LVEF 45%, NYHA II • CRI: Cr 1.6. GFR 38 • Non-palpable but

faintly dopplerable pulses.

3

TPT Stenosis

PT Occlusion

s

AT distal occlusion

PT

AT Stenosis

Peroneal Occ

Peda

l arc

h dz

Lessons of BASIL

Month Day, Year 4

1. Saphenous vein offers greatest patency in those with >2 yr longevity and usable vein

2. More frail patients or those without conduit should get PTA 3. Prosthetic bypass is worse than the other two options

One Very Balanced Algorithm: See SVM PAD TOOLKIT

Month Day, Year 5https://www.vascularmed.org

https://www.vascularmed.org/

So much has happened since Basil

But we are witnessing the endo revolution • Devices and techniques ↑ • Interventional volume is ↑ • Surgical volume and skill ↓ • Amputation appears ↓ . Causality?

Endovascular RevolutionNon-US National Trends

Month Day, Year 7ANZ J Surg 89 (2019) 309–313

Endovascular Interventions

Minor Amp

Major Amp Open Surg

• Endo Increasing • Bypass Decreasing • Amputations Down

Endovascular Revolution US Trends

Month Day, Year 8

• Endo Increasing • Bypass Decreasing • Amputations Down

Current State in US: NSQIP 2012-2015 Short-term MACE and Mortality Key Issue

Month Day, Year 9

• Surgery First Strategy • ↑ MACE • ↑ Mortality • ↑ Wound complication • ↓ Major Amp (not present

after ESRD excluded)

J Vasc Surg 2019;69:156-63Ann Surg 2017;265:424–430

Cardiovascular Outcomes are

Consistently Worse With Bypass at 30

days in distal bypass and bypass in general

Identifying Patients at Excessive Risk for Bypass: NSQIP

Month Day, Year 10

J Vasc Surg 2013;57:1186-95

Risk Factors Outcomes by Risk Score

Low, Medium and High Risk Categories

Performance against others

What Degree of Increased Risk is

Acceptable?

The Perceived Challenge?

Month Day, Year 11

PATENCY Risk

Patency: Infrapopliteal Revasc!The Best StillMeta-Analysis: Autologous Vein Best at 3 years

Month Day, Year 12J Vasc Surg 2018;68:624-33

• Saphenous Vein Likely Still Better

• DES better than BMS • All are better than PTFE

The “Endo Revolution” is Challenging Tenets of Care

Month Day, Year 13

Patency:Femoropliteal Stenting

(unlike BASIL) Modern Tech Threatens Bypass

Month Day, Year 14

Bosiers. LINC 2019

ZilverPass

SUPER B

Bypass vs Modern PVI Modern Tech Long SFA Lesion May Be

Equivalent with New Tech

Evolving Surgical Outcomes In the Current Era Worse than During BASIL

Modern Day Bypass Surgery

Outcomes: May Be Worse

Than Past

J Vasc Surg 2018;-:1-8

Worse AFS

Worse Limb Salvage

Worse Mortality

Current Assessment of Surgical Volumes VQI Data:

Month Day, Year 16 Vasc Surg 2017;66:1457-63

Median Surgical Bypass Volume:

5.7 bypass/year

But Could Be Defined Soon (Required Ongoing Trials Slide…..)

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The Answers May Be Coming……

The Current State: Endo VS BypassENDO BYPASS

Materials needed Wires/Stents/Balloons Venous Condiut

Approach CFA, Pedal, UE etc Standard

Eligibility Most Eligible Limited by Comorbidities

Risk Relatively Low Considerable

Skill Requirements Interventional Skill Set Considerable Surgical Skill

Goals Direct flow/Mult Vessels 1 V straight line flow

Repeat/Revision Options Repeatable/May Affect BG Difficult Revision/Affects PVI

Variation skills and outcomes

Considerable Considerable

Month Day, Year 18

Case Continued

Month Day, Year 19

CASE79 female with • NIDDM • HTN • Chol • CAD prior LAD

stent • ICM LVEF 45% • CRI: Cr 1.6. GFR 42

20

TPT Stenosis

PT Occlusion

s

AT distal occlusion

Peda

l arc

h dz

21

POSTERIO

R TIBIAL

Anterior Tibial

Peda

l arc

h dz

Conclusions

1. Interventional and surgical skill are evolving rapidly. But in different directions.

2. Femoropopliteal device performance could soon rival femoropopliteal bypass.

3. Infrapopliteal bypass with a venous conduit likely still offers the best patency in skilled hands.

4. Skilled and experienced hands may be hard to find. 5. The best approach still remains a tailored approach incorporating

• Interventional and surgical capabilities • Patient specific risk • Anatomic features (nature of dz, runoff, etc)

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Variation in Bypass AND PVI: VQI and MEDICARE Analyses

Month Day, Year 26

VQI Peri-op

Outcomes after Bypass and PVI:

Significant Variation

Vasc Surg 2017;66:810-8 Surgery 2018.

MEDICARE Over 20% risk adjusted

variability between various hospitals across all major

vascular procedures

The Answer to Endo First vs Surgery Differs with the Patient, Operator Skill, and Hospital

Direct Revascularization Works

Month Day, Year 27

Direct Better Wound Healing

No Difference in Amp or Limb Salvage

2017 European Society for Vascular Surgery. Available online 17 January 2018

Direct Revascularization May Offer Benefit

Direct Revascularization: Meta-analysisUnnecessary If Collaterals Present


No difference between Direct and

Indirect with collaterals

Direct better wound healing and

amputation rates without collaterals

Direct Revascularization May Not Matter if Collaterals

Present

Revascularization of 2 Vessels Improves Healing


Two vessels -Wound healing rate higher

-Wound healing times shorter -Less repeat procedures

The More Vessels the Better

PEDAL VESSELS CAN

BE VERY DIFFERENT

Month Day, Year 30

BAD Really Bad

The Worst

The Impact of Pedal Vessel and Loop Intervention

Month Day, Year 31J Cardiovasc Surg 2018;59:655-64

Caliber of Pedal Vessels May Impact Outcomes

Pedal Artery Patency Impacts Outcomes

Month Day, Year 32J Am Coll Cardiol Intv 2017;10:79–90

Pedal Artery Intervention May Improve Wound Healing In Low and Intermediate Risk

Patients

Pedal Artery Intervention

Month Day, Year 33

Currently: What Should the Approach be? European Algoritm? Guidelines?

Month Day, Year 34

Awaited Research: What Will it Bring

Month Day, Year 35

Vascular Health and Risk Management 2017:13 161–168

endovascular first vs. a personalized approach to

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