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4/8/19 BTK Intervention: Approach, Technique and Outcomes Venita Chandra, MD Clinical Associate Professor of Surgery Division of Vascular Surgery Stanford Medical School, Stanford, CA UCSF Vascular Symposium San Francisco April 5 th , 2019

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4/8/19 1 STANFORD

Vascular Surgery

BTK Intervention: Approach, Technique and Outcomes

Venita Chandra, MD Clinical Associate Professor of Surgery Division of Vascular Surgery Stanford Medical School, Stanford, CA UCSF Vascular Symposium San Francisco April 5th, 2019

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Vascular Surgery

Disclosures

  • Abbott Medical Advisory Board Member
  • Medtronic- consultant
  • Cook Medical - consultant
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4/8/19 2 STANFORD

Vascular Surgery

BTK Intervention: Approach, Technique and Outcomes

Venita Chandra, MD Clinical Associate Professor of Surgery Division of Vascular Surgery Stanford Medical School, Stanford, CA UCSF Vascular Symposium San Francisco April 5th, 2019

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Vascular Surgery

Patterns of CLI

Rueda et.

  • al. JVS

2008:47(5) All Segments 5% AI + Fem 1% AI 3% Fem + Pop/Tib 30% Pop/Tib 54% Fem 4%

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The Doctors Dilemma with CLI patients

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“I marvel that society would pay a surgeon a fortune to remove a person’s leg, but nothing to save it!”

  • Ge

Georg rge Bern rnard rd Sha haw- Th The Do Doctor’s Dil Dilemma STANFORD

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BTK Revascularization Challenges

  • Long, complex, often calcified nature of lesions1
  • Often associated with multilevel disease, thus success is inflow- and outflow-

dependent2

  • High restenosis rate3
  • Limb salvage poorly correlated to primary patency3
  • Not a lot of validated treatment algorithms
  • Requires application of multiple tools and techniques
  • Outcomes related to multiple anatomic and physiologic parameter
  • 1. Liistro F, et al. Circ 128:615-21 (2013).
  • 2. Norgren L, et al. J Vasc Surg 45:S5-67 (2007).
  • 3. Kudo T, et al. J Vasc Surg 41:423-35 (2005).
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My BTK/CLI Goals of Therapy

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1) Relieving pain 2) Healing ulcerations 3) Preventing major amputation 4) Improving patient’s QOL 5) Prolonging survival

Goals of therapy for CLI (Rutherford 4–6) with infra- popliteal arterial disease include:

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Angiosome based approach

8

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What Do We Know?- Angiosomes

Neville RF, Attinger CE, Bulan EJ, et al. Revascularization of a specific angiosome for limb salvage: does the target artery matter? Ann Vasc Surg 2009;23:367—73.

Higher healing AND limb salvage rates after DIRECT distal bypass STANFORD

Vascular Surgery

Angiosomes: Endovascular Approach

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  • 250 patients
  • 12 month ulcer

healing:

  • Direct: 69%
  • Indirect: 47%
  • p=0.021
  • Faster ulcer healing in

Direct group

Söderström, J Vasc Surg 2013

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What About Pedal Flow?

Palena LM, Manzi M. Endovasc Ther. 2014. Dec;21 (6) 775-8

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  • Intact pedal arch and pedal

arch angioplasty associated with improved AFS and limb salvage

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Endovascular Strategy

  • Treat all lesions to obtain in-line flow to the foot/affected areas
  • Choice of BTK revascularization depends on patients anatomy/symptoms
  • Angiosome concept
  • Pedal arch anatomy
  • Treatment involves:

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TOOLS

  • Access
  • Support catheters
  • Wires
  • Balloons
  • Other adjunctive

devices/technologies

  • Crossing technologies
  • Atherectomy
  • Reentry devices
  • Stenting
  • Drug eluting technologies
  • Etc.
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Access

  • Various Approaches
  • Up and Over
  • Antegrade
  • Retrograde

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My BTK Approach

HEAD FEET

  • Longest sheath

possible

  • Liberal use of

vasodilators

  • Heparinization
  • Ultrasound and fluoro-

guided retro access

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Tools

My Workhorse Products

Wires Catheters Balloons

Abbott Command .014”/.018” Cook CXI .018” + .035” Combo Abbott Armada 14 Terumo Glidewire Advantage .014” Corsair Catheter Abbott Armada 14 XT “Crossing Balloon” V18 Wire Cook Hydro ST .014” Cook LP 14 and 18 CTO wires

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  • Remember goal : pulsatile flow to

foot/affected area

  • Look for the BLUSH
  • Avoid subintimal
  • Sometimes collaterals are just as big as

some native tibials

  • If I can’t get inline antegrade, try via

collateral or pedal loop

  • Increasing interest in optimizing pedal loop
  • Ok to come back another day
  • Remember open bypass works GREAT

Technique/Tips

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BTK Case

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BTK Case

AT wire TPT wire

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BTK Outcomes

  • Heterogeneous nature of existing

data challenges interpretation

  • Patient populations
  • Lesion types
  • Definitions
  • Follow-up (e.g. wound care)
  • Numerous treatment modalities
  • POBA
  • Atherectomy
  • DCB
  • BMS
  • DES

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  • Retrospective study of 106

CLTI pts who undergo endo revasc

  • 50% BTK
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  • Wound healing 45% at

12 months

  • Sustained limb salvage
  • f 87%
  • Severity of tissue loss (ie

R6) associated with reduced primary patency, limb salvage and AFS STANFORD

Vascular Surgery

  • 30 day outcomes looking at problem
  • f “early technical failure” of EVT in

BTK

  • Low dissection (6.4%)
  • Provisional Stenting: 9.9%
  • Amputation rates between 1.5% for

DES and 4.4% with PTA

  • Procedural success rates of 91.2%

(PTA) and 98.6% (BMS)

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Limb Salvage 1° Patency 2° Patency

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What Do We Know?- CLI Treatment

Results 1 month 6 months 1 year 2 years 3 years

Primary Patency PTA 77.4 ± 4.1 65.0 ± 7.0 58.1 ± 4.6 51.3 ± 6.6 48.6 ± 8.0 Bypass 93.3 ± 1.1 85.8 ± 2.1 81.5 ± 2.0 76.8 ± 2.3 72.3 ± 2.7 P <0.5 <0.5 <0.5 <0.5 <0.5 Secondary Patency PTA 83.3 ± 1.4 73.8 ± 7.1 68.2 ± 5.9 63.5 ± 8.1 62.9 ± 11.0 Bypass 94.9 ± 1.0 89.3 ± 1.6 85.9 ± 1.9 81.6 ± 2.3 76.7 ± 2.9 P <0.5 <0.5 <0.5 Limb Salvage PTA 93.4 ± 2.3 88.2 ± 4.4 86.0 ± 2.7 83.8 ± 3.3 82.4 ± 3.4 Bypass 95.1 ± 1.2 90.9 ± 1.9 88.5 ± 2.2 85.2 ± 2.5 82.3 ± 3.1 Romiti M, et. Al. Meta-Analysis of Infrapopliteal Angioplasty for Chronic Critical Limb Ischemia. JVS Vol 47, Issue 5, May 2008.

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What Do We Know?- CLI Treatment

Results 1 month 6 months 1 year 2 years 3 years

Primary Patency PTA 77.4 ± 4.1 65.0 ± 7.0 58.1 ± 4.6 51.3 ± 6.6 48.6 ± 8.0 Bypass 93.3 ± 1.1 85.8 ± 2.1 81.5 ± 2.0 76.8 ± 2.3 72.3 ± 2.7 P <0.5 <0.5 <0.5 <0.5 <0.5 Secondary Patency PTA 83.3 ± 1.4 73.8 ± 7.1 68.2 ± 5.9 63.5 ± 8.1 62.9 ± 11.0 Bypass 94.9 ± 1.0 89.3 ± 1.6 85.9 ± 1.9 81.6 ± 2.3 76.7 ± 2.9 P <0.5 <0.5 <0.5 Limb Salvage PTA 93.4 ± 2.3 88.2 ± 4.4 86.0 ± 2.7 83.8 ± 3.3 82.4 ± 3.4 Bypass 95.1 ± 1.2 90.9 ± 1.9 88.5 ± 2.2 85.2 ± 2.5 82.3 ± 3.1 Romiti M, et. Al. Meta-Analysis of Infrapopliteal Angioplasty for Chronic Critical Limb Ischemia. JVS Vol 47, Issue 5, May 2008.

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PTA Outcomes in BTK

Lejay1 Romiti2 BASIL3 ACHILLES4 IN.PACT DEEP5 BIOLUX P-II6

PTA Meta- analysis PTA Meta- analysis Surgery v PTA DES v PTA DCB v PTA DCB v PTA

Subjects

3164 2557 224 (PTA) 101 (PTA) 119 (PTA) 36 (PTA)

1° Patency (12-mo)

60.0% 58.1% 57.1%†

Restenosis (12-mo)

41.9%† 45.6%

TLR (12-mo)

16.5% 13.1% 30.6%

FF-TLR (12-mo) Amputation (12-mo)

20.0% 3.6% 25.7%

Limb Salvage (12-mo)

85.0% 86.0% 71.0%3

  • 1. Lejay A, et al. Acta Chir Belg 110:684-93 (2010).
  • 2. Romiti M, et al. J Vasc Surg 47:975-81 (2008).
  • 3. Adam D, et al. Lancet 366:1925-34 (2005); Amputation-free

survival presented in 12-mo Limb Salvage as 71.0%.

  • 4. Scheinert D, et al. JACC 60:2290-5 (2012).
  • 5. Zeller T, et al. JACC 64:1568-76 (2014).
  • 6. Zeller T, et al. JACC Cardiovasc Interv 8:1614-22 (2015).
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PTA Outcomes in BTK

Lejay1 Romiti2 BASIL3 ACHILLES4 IN.PACT DEEP5 BIOLUX P-II6

PTA Meta- analysis PTA Meta- analysis Surgery v PTA DES v PTA DCB v PTA DCB v PTA

Subjects

3164 2557 224 (PTA) 101 (PTA) 119 (PTA) 36 (PTA)

1° Patency (12-mo)

60.0% 58.1% 57.1%†

Restenosis (12-mo)

41.9%† 45.6%

TLR (12-mo)

16.5% 13.1% 30.6%

FF-TLR (12-mo) Amputation (12-mo)

20.0% 3.6% 25.7%

Limb Salvage (12-mo)

85.0% 86.0% 71.0%3

  • 1. Lejay A, et al. Acta Chir Belg 110:684-93 (2010).
  • 2. Romiti M, et al. J Vasc Surg 47:975-81 (2008).
  • 3. Adam D, et al. Lancet 366:1925-34 (2005); Amputation-free

survival presented in 12-mo Limb Salvage as 71.0%.

  • 4. Scheinert D, et al. JACC 60:2290-5 (2012).
  • 5. Zeller T, et al. JACC 64:1568-76 (2014).
  • 6. Zeller T, et al. JACC Cardiovasc Interv 8:1614-22 (2015).
  • Variability in endpoints
  • Low patency
  • High restenosis
  • Variable amputation/limb salvage rates

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BTK-Atherectomy Outcomes

CALCIUM 3601 DEFINITIVE LE (Infrapop)2

OA+PTA v PTA DA Subjects

25 (OA+PTA) 145

Bail-out Stent

6.9% (2/29) 1.6% (3/189)

MAE (12-mo)

6.7% (1/15)†

FF MAE (12-mo)

79.6%

1° Efficacy (12-mo)

93.1% 84.0%

1° Efficacy Definition

Acute residual stenosis ≤ 30% w/o bail-out stenting or dissection (C through F) Patency = PSVR < 2.4

TLR (12-mo)

6.7% (1/15)

FF-TLR (12-mo)

91.2%

Amputation (12-mo)

0%

Limb Salvage (12-mo)

97.1% (141/145)

  • 1. Shammas NW, et al. J Endovasc Terh 19:480-8 (2012).
  • 2. Rastan A, et al. J Endovasc Ther 22:839-46 (2015).
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4/8/19 16 STANFORD

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BTK-Atherectomy Outcomes

CALCIUM 3601 DEFINITIVE LE (Infrapop)2

OA+PTA v PTA DA Subjects

25 (OA+PTA) 145

Bail-out Stent

6.9% (2/29) 1.6% (3/189)

MAE (12-mo)

6.7% (1/15)†

FF MAE (12-mo)

79.6%

1° Efficacy (12-mo)

93.1% 84.0%

1° Efficacy Definition

Acute residual stenosis ≤ 30% w/o bail-out stenting or dissection (C through F) Patency = PSVR < 2.4

TLR (12-mo)

6.7% (1/15)

FF-TLR (12-mo)

91.2%

Amputation (12-mo)

0%

Limb Salvage (12-mo)

97.1% (141/145)

  • 1. Shammas NW, et al. J Endovasc Terh 19:480-8 (2012).
  • 2. Rastan A, et al. J Endovasc Ther 22:839-46 (2015).

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BMS BTK Outcomes

Falkowski1 DESTINY2 YUKON-BTK3 XCELL4

DES v BMS DES v BMS DES v BMS BMS

Subjects

25 (BMS) 66 (BMS) 79 (BMS) 120

1° Patency (12-mo)

54.4%† 55.6%†

Restenosis (12-mo)

76%† 36.0% 44.4%

TLR (12-mo)

56%† 17.5%

FF-TLR (12-mo)

65%† 54.3% [70.1%]4

Amputation (12-mo)

3.0% 6.4%

Limb Salvage (12-mo)

78.3%4

  • 1. Lejay A, et al. Acta Chir Belg 110:684-93 (2010).
  • 2. Bosiers M, et al. J Vasc Surg 55:390-9 (2012).
  • 3. Adam D, et al. Lancet 366:1925-34 (2005); Amputation-free

survival presented in 12-mo Limb Salvage as 71.0%.

  • 4. Rocha-Singh KJ, et al. Catheter Cardiovasc Interv 80:1042-51

(2012); freedom from clinically-driven TLR is shown in brackets [70.4%] in comparison to freedom from all TLR of 54.3%; Amputation-free survival presented in 12-mo Limb Salvage as 71.0%.

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Falkowski1 DESTINY2 YUKON-BTK3 XCELL4

DES v BMS DES v BMS DES v BMS BMS

Subjects

25 (BMS) 66 (BMS) 79 (BMS) 120

1° Patency (12-mo)

54.4%† 55.6%†

Restenosis (12-mo)

76%† 36.0% 44.4%

TLR (12-mo)

56%† 17.5%

FF-TLR (12-mo)

65%† 54.3% [70.1%]4

Amputation (12-mo)

3.0% 6.4%

Limb Salvage (12-mo)

78.3%4

BMS BTK Outcomes

  • 1. Lejay A, et al. Acta Chir Belg 110:684-93 (2010).
  • 2. Bosiers M, et al. J Vasc Surg 55:390-9 (2012).
  • 3. Adam D, et al. Lancet 366:1925-34 (2005); Amputation-free

survival presented in 12-mo Limb Salvage as 71.0%.

  • 4. Rocha-Singh KJ, et al. Catheter Cardiovasc Interv 80:1042-51

(2012); freedom from clinically-driven TLR is shown in brackets [70.4%] in comparison to freedom from all TLR of 54.3%; Amputation-free survival presented in 12-mo Limb Salvage as 71.0%.

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DES BTK Outcomes

Falkowski1 DESTINY2 YUKON-BTK3 ACHILLES4 IDEAS5 PaRADISE6 DES v BMS DES v BMS DES v BMS DES v PTA DES v DCB DES Subjects

25 (DES) 74 (DES) 82 (DES) 99 (DES) 25 (DES) 106

1° Patency (12-mo)

85%† 80.6%† 75.0%†

Restenosis (12-mo)

16%† 19.4% 22.4%† 28.0%† (6mo) 12.0% (256 ± 244 days)

TLR (12-mo)

12%† 9.7% 10.0% 7.7% (6mo) 15.0%

FF-TLR (12-mo)

91%†

Amputation (12-mo)

1.4% 3.2% 13.8% 7.4% (6mo)

Limb Salvage (12-mo)

94.0% (3yr)

  • 1. Falkowski A, et al. Eur Radiol 19:966-74 (2009).
  • 2. Bosiers M, et al. JVS 55:390-8 (2012).
  • 3. Rastan A, et al. Eur Heart J 32:2274-81 (2011).
  • 4. Scheinert D, et al. JACC 60:2290-5 (2012).
  • 5. Siablis D, et al. J Am Coll Cardiol Cardiovasc Interv 7:1048-56 (2014).
  • 6. Feiring AJ, et al. J Am Coll Cardiol Cardiovasc Interv 55:1580-9 (2010);

follow-up interval for TLR rate not provided.

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DES BTK At-a-Glance

Falkowski1 DESTINY2 YUKON-BTK3 ACHILLES4 IDEAS5 PaRADISE6 DES v BMS DES v BMS DES v BMS DES v PTA DES v DCB DES Subjects

25 (DES) 74 (DES) 82 (DES) 99 (DES) 25 (DES) 106

1° Patency (12-mo)

85%† 80.6%† 75.0%†

Restenosis (12-mo)

16%† 19.4% 22.4%† 28.0%† (6mo) 12.0% (256 ± 244 days)

TLR (12-mo)

12%† 9.7% 10.0% 7.7% (6mo) 15.0%

FF-TLR (12-mo)

91%†

Amputation (12-mo)

1.4% 3.2% 13.8% 7.4% (6mo)

Limb Salvage (12-mo)

94.0% (3yr)

  • 1. Falkowski A, et al. Eur Radiol 19:966-74 (2009).
  • 2. Bosiers M, et al. JVS 55:390-8 (2012).
  • 3. Rastan A, et al. Eur Heart J 32:2274-81 (2011).
  • 4. Scheinert D, et al. JACC 60:2290-5 (2012).
  • 5. Siablis D, et al. J Am Coll Cardiol Cardiovasc Interv 7:1048-56 (2014).
  • 6. Feiring AJ, et al. J Am Coll Cardiol Cardiovasc Interv 55:1580-9 (2010);

follow-up interval for TLR rate not provided.

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DCB BTK Outcomes

Leipzig Registry1 DEBATE- BTK2 IDEAS3 IN.PACT DEEP4 BIOLUX P-II5 Lutonix BTK Registry6 (Interim)

DCB DCB v PTA DCB v DES DES v PTA DCB v PTA DCB Subjects 104 65 (DCB) 25 (DCB) 239 (DCB) 36 (DCB) 371 1° Patency (12-mo) Restenosis (12-mo) 27.4% (3-mo) 27%† 57.9%‡ 41.0% 50.8% TLR (12-mo) 17.3% 18%† 13.6% 9.2% 30.1% FF-TLR (12-mo) 76.0% (n=117) Amputation (12-mo) 4% 8.8% 23.7% 5.2% Limb Salvage (12-mo)

  • 1. Schmidt A, et al. J Am Coll Cardiol 2011;58:1105-1109.
  • 2. Liistro F, et al. Circ 2013;128:615-621.
  • 3. Siablis D, et al. J Am Coll Cardiol Cardiovasc Interv

2014;7:1048-1056.

  • 4. Zeller T, et al. J Am Coll Cardiol 2014;64:1568-1576.
  • 5. Zeller T, et al. J Am Coll Cardiol 2015;8:1614-1622.
  • 6. Presented by Lichtenberg MKW, LINC Leipzig, Germany

2018.

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DCB BTK Outcomes

Leipzig Registry1 DEBATE- BTK2 IDEAS3 IN.PACT DEEP4 BIOLUX P-II5 Lutonix BTK Registry6 (Interim)

DCB DCB v PTA DCB v DES DES v PTA DCB v PTA DCB Subjects 104 65 (DCB) 25 (DCB) 239 (DCB) 36 (DCB) 371 1° Patency (12-mo) Restenosis (12-mo) 27.4% (3-mo) 27%† 57.9%‡ 41.0% 50.8% TLR (12-mo) 17.3% 18%† 13.6% 9.2% 30.1% FF-TLR (12-mo) 76.0% (n=117) Amputation (12-mo) 4% 8.8% 23.7% 5.2% Limb Salvage (12-mo)

  • 1. Schmidt A, et al. J Am Coll Cardiol 2011;58:1105-1109.
  • 2. Liistro F, et al. Circ 2013;128:615-621.
  • 3. Siablis D, et al. J Am Coll Cardiol Cardiovasc Interv

2014;7:1048-1056.

  • 4. Zeller T, et al. J Am Coll Cardiol 2014;64:1568-1576.
  • 5. Zeller T, et al. J Am Coll Cardiol 2015;8:1614-1622.
  • 6. Presented by Lichtenberg MKW, LINC Leipzig, Germany

2018.

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Summary

  • Available data are highly fragmented with variability in patients, lesions,

endpoints and trial design

  • Small RCTs have demonstrated that DES exhibits superior patency and binary restenosis

compared controls of PTA, DCB, and BMS in short lesions

  • Atherectomy may reduce reliance on bail-out stent, but limited data available on

conventional study endpoints

  • In regard to limb salvage, however, all treatments appear to be associated

with low amputation rates

  • Multi-speciality approach with intervention, surveillance, and wound care

necessary in providing optimal outcomes

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Thank You!