Success in BTK/BTA Intervention:Disease Characteristics, Anatomy &

Advanced Techniques

Timothy E. Yates, MD

Mount Sinai Medical Center

Miami Beach, FL USA

Disclosure

Speaker name:

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I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

X I do not have any potential conflict of interest

Questions for the Real World

• How to increase technical/clinical success?

• CLI -> wound-healing and no major amputation

• Do certain patient characteristics and anatomy drive success below the knee and ankle?

• Who should I intervene upon (or NOT)?

Questions for the Real World

• Data?

• Dr. Biamino asked ~ 976x @ LINC 2018 re: BTA intvn

• Dr. Manzi noted >5000 BTK patients, but BTA <500

• Why does it matter?

• Pedal plantar loop UNFORGIVING final flow pathway

• Restenosis rates below the ankle?

• No one really knows

• Does it matter in CLI???

Factors – The pedal inflow

• Fernandez et al 2009 J Vasc Surg

• Retrospective, n= 111 patients (83% tissue loss)

• Majority - DM and/or CKI

• Tibial angioplasty (14% laser atherectomy)

• Popliteal runoff and ABI improved (p < 0.01)

• 1 yr limb salvage -> 75%

• 1 yr re-intvn -> 50%

Factors – The pedal inflow

• Factors associated with wound healing

• Multilevel intervention (HR = 2.1; P = 0.009)

• Tibial laser atherectomy (HR = 3.1; P = 0.01)

• Factors associated with impaired limb salvage

• Renal insufficiency (HR = 5.7; P = .03)

• Need for pedal intervention (HR = 13.75; P = .04)

• Isolated peroneal intervention (OR = 7.80; P = .01)

• DM, smoking, statin therapy and revascularization of >1 tibial vessel - no impact on limb salvage or wound healing

Factors – What about the pedal outflow and angiosome?

• Rashid et al 2013 J Vasc Surg

• N= 154 patients (141 RC5/6) w/ distal bypass• DM 76%, CKI 28%

• Direct vs indirect angiosomal revascularization

• Pedal arch quality

• Complete (CPA), Incomplete (IPA) or no arch (NPA)

• Primary end points

• Patency rates, amputation-free survival (AFS) & rate of healing and time to healing

Factors – What about the pedal outflow and angiosome?

• 1°/2° patency, AFS not different despite angiosomalvs nonangiosomal revasc

• Quoted by Azuma also 2012

• Better overall healing and rate of healing between the CPA vs IPA vs NPA groups (P = .0264)

Factors – What about the pedal outflow and angiosome?

• Rashid also corroborated - Azuma et al (2012) and Pomposelli et al (1995)

• Degree of renal disease -> direct effect on outcome

• ESRD pts had significantly lower healing and limb salvage

• 2°/2 poor quality of pedal arch in these patients? Medial calcification? Small vessel caliber? Long segment occlusion?

Courtesy Andres Garcia

Factors – Outcomes in patients after technically success revascularization• Kawarada et al 2012 Catheter Cardiovasc Interv

• N=85 patients, 106 limbs

• Evaluate wound healing and adverse outcomes despite successful infrapopliteal intervention

• Reintervention, AFS, salvage and healing rates on par with prior studies

Factors – Outcomes in patients after technically success revascularization• Infectious wound -> predictor of major

amputation despite successful intervention

• DM and pedal arch quality-> predictors of wound healing

• ESRD on hemodialysis -> predictor of death

Courtesy Amputation Prevention Center and

Amputation Prevention Centers of America Courtesy Arthur C. Lee, MD Courtesy NIH

Factors – Who should be fixed?

• Santema et al 2017 Eur J Vasc Endovasc Surg

• Retrospective analysis of 144 CLI patients

• Compared intervention to conservative care in terms of AFS and overall survival

• Conservative tx: Analgesia & “optimal wound care”

Factors – Who should be fixed?

• No statistical difference in AFS or OS

• CV mortality biggest driver of AFS -> lethal nature of CLI

• Majority > 1 endovascular procedure

Summary of Reviewed Studies

• Tibiopedal intvn effective and salvage high

• Re-intervention rates are high -> cost, risk

• Pedal arch quality & patency (completeness, calcification) does matter to expeditious wound healing; may not matter to patency, OS or AFS

Summary of Reviewed Studies

• Poor prognostic indicators

• Renal failure is a bad player, extensive calcium & long-segment occlusion

• ESRD = early death -> leave alone?

• Pedal-predominant disease and DM

• Peroneal-only runoff -> poorer outcomes

• Infected wounds

Summary of Reviewed Studies

• Not all patients may need interventions for CLI

• We still have not affected AFS or OS

• Medical management also improved over time

• Prospective study (like CREST II) needed

Subjective -> Objective Algorithm for BTA (alla Biamino)

• Objective criteria yet to be written –#CLIfighters time to #stopthechop

• In my practice

• Non-healing surgical wounds after intervention

• Successful intervention depends on a successful plan and excellent imaging

Algorithm for BTA Intervention

• 68 y/o M with left 5th

ray amputation and site osteomyelitis 1 month-post op

Algorithm for BTA

Anatomy• Manzi (Radiographics 2011)

• Lateral -> arch/plantar bifurcation

• AP -> 1st IM space

• “Desert leg/foot” -> “dancing (or crossing) in the dark”

• Confidence in course by fluoro/EVUS ↑ success

Variant Anatomy is Common

• Recent 82 y/o F DM lateral heel wound (suspect peroneal distribution)

• Pedal-plantar loop recan -> AT/PT

Variant Anatomy is Common

• Recanalization demonstrates common tibioperoneal artery

• Two vessel runoff and intact loop

• Lateral heel blush

Technique – Crossing and Recanalization Strategies

• Be flexible

• Alternative points of entry; consider staging

• US-guided recanalization of occluded vessel

• Pedal-plantar loop

• Manzi et al 2009 J Cardiovasc Surg (Torino)

• TAMI

• Mustapha/Saab 2014 Catheter & Cardiov Interv

• SAFARI, CART, re-entry, tibiopedal access, trans-collateral, PIERCE

• Final therapy limited to angioplasty +/- atherectomy

Technique – Perfusion Goals

• Taylor and Attinger et al

• Angiosomal reperfusion

• Manzi, Ferraresi, Palena, Mauri

• Complete vs. wound-related artery revasc

• Rundback et al

• Angiosomal vs. Angiographosomal

• True angiographic wound-directed revascUtsunomiya et al 2012 J Vasc Surg

Conclusions - A Strategy For Success

• Know your patient, their disease and the bad players

• ESRD, peroneal runoff, DM with pedal-only disease and infected wounds

• Pedal arch integrity matters - unforgiving endplate

• Understanding of anatomy is key

• Post-procedural perfusion is crucial; study needed

• Technical success -> not always clinical success; sometimes saying “no” is the right option

Thank you

• timothyeyatesmd@gmail.com

• Get in touch anytime you are in Miami

References

1. Luis Mariano Palena, MD. An Extreme Approach to CLI Revascularization A useful technique for treating challenging cases of obstructive arterial disease below the knee and ankle.

2. Arthur C. Lee, MD, and Matheen A. Khuddus, MD. Pedal Arch Revascularization The rationale behind this procedure and tips from preprocedure planning to intervention

3. Nathan Fernandez, MD, Ryan McEnaney, MD,Luke K. Marone, MD, Robert Y. Rhee, MD, Steven Leers, MD, Michel Makaroun, MD, and Rabih A. Chaer, MD J Vasc Surg. Predictors of failure and success of tibial interventions for critical limb ischemia. J Vasc Surg. 2010 Oct; 52(4): 834–842. doi: 10.1016/j.jvs.2010.04.070. PMCID: PMC4076901. NIHMSID: NIHMS561038.

4. J Cardiovasc Surg (Torino). 2009 Jun;50(3):331-7. Clinical results of below-the knee intervention using pedal-plantar loop technique for the revascularization of foot arteries. Manzi M1, Fusaro M, Ceccacci T,Erente G, Dalla Paola L, Brocco E

5. Xiao-Li Song, MD, Yue-Qi Zhu, MD, [...], and Jun-Gong Zhao, MD. Predictors for Better Blood-Flow Restoration of Long-Segmental Below-the-Knee Chronic Total Occlusions after Endovascular Therapy in Diabetic Patients.

6. Ferraresi R, Palena LM, Mauri G, et al. Interventional treatment of the below the ankle peripheral artery disease. In: Lanzer P, editor. PanVascular Medicine. 2nd ed. New York: Springer-Verlag; 2015:3205-3226.

7. Annals of Vascular Surgery Volume 24, Issue 3, April 2010, Pages 349-359. The Impact of Isolated Tibial Disease on Outcomes in the Critical Limb Ischemic Population. Presented at the Southern Association for Vascular Surgery Annual Meeting, Scottsdale, Arizona, January 20, 2009. Author links open overlay panelBruce H.GrayApril A.GrantCorey A.KalbaughDawnW.BlackhurstEugene M.LanganIIISpence A.TaylorDavid L.Cull

8. Joyal,D et al. The Retrograde Technique for Recanalization of Chronic Total Occlusions. JACC Intervention 2012;5:1-11

9. Manzi, M et al. Vascular Imaging of the Foot. RSNA 31(6), 2011

10. Mustapha et al. Tibial-pedal arterial access & retrograde interventions for advanced peripheral arterial disease & critical limb ischemia Special Report - Interventional Cardiology ( 2015) Volume 7, Issue 5. http://www.openaccessjournals.com/articles/tibialpedal-arterial-access--retrograde-interventions-for-advanced-peripheral-arterial-disease--critical-limb-ischemia.html

References

11. Society for Vascular Surgery/International Society for Cardiovascular Surgery scoring system proposed by Sacks et al

12. Santema et al (Eur J Vasc Endovasc Surg (2017) 53, 371e379. https://vascular12octubre.com/Articulos/Eur-J-Vasc-Endovasc-Surg-371-379.pdf

13. R. J. Hinchliffe1*, J. R. W. Brownrigg1 , G. Andros2 , J. Apelqvist3 , E. J. Boyko4 , R. Fitridge5 , J. L. Mills6 , J. Reekers7 , C. P. Shearman8 , R. E. Zierler9 , N. C. Schaper10, on behalf of the International Working Group on the Diabetic Foot (IWGDF). Effectiveness ofrevascularization of the ulcerated foot in patients with diabetes and peripheral artery disease: a systematic review. http://www.iwgdf.org/files/2015/PADTherapy.pdf

14. Sumpio, B. Contemporary Evaluation and Management of the Diabetic Foot Scientifica (Cairo). 2012; 2012: 435487. Published online 2012 Oct 9. doi: 10.6064/2012/435487 PMCID: PMC3820495. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3820495/

15. Manzi, M & Luis Palena. Treating Calf and Pedal Vessel Disease: The Extremes of Intervention. Semin Intervent Radiol. 2014 Dec; 31(4): 313–319. doi: 10.1055/s-0034-1393967. PMCID: PMC4232433. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4232433/

16. Okamoto et al. Current Perspective on Hemodialysis Patients with Peripheral Artery Disease. Ann Vasc Dis. 2017 Jun 25; 10(2): 88–91. doi: 10.3400/avd.ra.17-00034 PMCID: PMC5579783. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5579783/

17. Kawarada et al. Catheter Cardiovasc Interv. 2012 Nov 1;80(5):861-71. doi: 10.1002/ccd.24370. Epub 2012 May 4. Predictors of adverse clinical outcomes after successful infrapopliteal intervention.

18. Azuma, N., Uchida, H., Kokubo, T., Koya, A., Akasaka, N., and Sasajima, T. Factors influencing wound healing of critical ischaemic foot after bypass surgery: is the angiosome important in selecting bypass target artery?. Eur J Vasc Endovasc Surg. 2012; 43: 322–328

19. Panayiotopoulos, Y.P., Edmondson, R.A., Reidy, J.F., and Taylor, P.R. A scoring system to predict the outcome of long femorodistalarterial bypass grafts to single calf or pedal vessels. Eur J Vasc Endovasc Surg. 1998; 15: 380–386

20. Panayiotopoulos, Y.P., Tyrrell, M.R., Owen, S.E., Reidy, J.F., and Taylor, P.R. Outcome and cost analysis after femorocrural and femoropedal grafting for critical limb ischaemia. Br J Surg. 1997; 84: 207–212

21. Pomposelli, F.B. Jr., Marcaccio, E.J., Gibbons, G.W., Campbell, D.R., Freeman, D.V., Burgess, A.M. et al.Dorsalis pedis arterial bypass: durable limb salvage for foot ischemia in patients with diabetes mellitus. J Vasc Surg. 1995; 21: 375–384

22. Utsunomiya et al. Impact of wound blush as an angiographic end point of endovascular therapy for patients with critical limb ischemia. J Vasc Surg, 2012;55:113-21.

Success in BTK/BTA Intervention:Disease Characteristics, Anatomy &

Advanced Techniques

Timothy E. Yates, MD

Mount Sinai Medical Center

Miami Beach, FL USA