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

Transcription

1 Success in BTK/BTA Intervention: Disease Characteristics, Anatomy & Advanced Techniques Timothy E. Yates, MD Mount Sinai Medical Center Miami Beach, FL USA

2 Disclosure Speaker name:... 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

3 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)?

4 Questions for the Real World Data? Dr. Biamino asked ~ 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???

5 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%

6 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

7 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

8 Factors What about the pedal outflow and angiosome? 1 /2 patency, AFS not different despite angiosomal vs nonangiosomal revasc Quoted by Azuma also 2012 Better overall healing and rate of healing between the CPA vs IPA vs NPA groups (P =.0264)

9 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

10 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

11 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

12 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

13 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

14 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

15 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

16 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

17 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

18 Algorithm for BTA Intervention 68 y/o M with left 5 th ray amputation and site osteomyelitis 1 month-post op

19 Algorithm for BTA

20 Manzi (Radiographics 2011) Lateral -> arch/plantar bifurcation AP -> 1 st IM space Desert leg/foot -> dancing (or crossing) in the dark Confidence in course by fluoro/evus success Anatomy

21 Variant Anatomy is Common Recent 82 y/o F DM lateral heel wound (suspect peroneal distribution) Pedal-plantar loop recan -> AT/PT

22 Variant Anatomy is Common Recanalization demonstrates common tibioperoneal artery Two vessel runoff and intact loop Lateral heel blush

23 Be flexible Technique Crossing and Recanalization Strategies 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

24 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 revasc Utsunomiya et al 2012 J Vasc Surg

25 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

26 Thank you Get in touch anytime you are in Miami

27 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 Oct; 52(4): doi: /j.jvs PMCID: PMC NIHMSID: NIHMS J Cardiovasc Surg (Torino) Jun;50(3): 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: Annals of Vascular Surgery Volume 24, Issue 3, April 2010, Pages 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, Author links open overlay panelbruce H.GrayApril A.GrantCorey A.KalbaughDawn W.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: Manzi, M et al. Vascular Imaging of the Foot. RSNA 31(6), 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.

28 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, 371e 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 of revascularization of the ulcerated foot in patients with diabetes and peripheral artery disease: a systematic review Sumpio, B. Contemporary Evaluation and Management of the Diabetic Foot Scientifica (Cairo). 2012; 2012: Published online 2012 Oct 9. doi: /2012/ PMCID: PMC Manzi, M & Luis Palena. Treating Calf and Pedal Vessel Disease: The Extremes of Intervention. Semin Intervent Radiol Dec; 31(4): doi: /s PMCID: PMC Okamoto et al. Current Perspective on Hemodialysis Patients with Peripheral Artery Disease. Ann Vasc Dis Jun 25; 10(2): doi: /avd.ra PMCID: PMC Kawarada et al. Catheter Cardiovasc Interv Nov 1;80(5): doi: /ccd 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: Panayiotopoulos, Y.P., Edmondson, R.A., Reidy, J.F., and Taylor, P.R. A scoring system to predict the outcome of long femorodistal arterial bypass grafts to single calf or pedal vessels. Eur J Vasc Endovasc Surg. 1998; 15: 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: 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: 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:

29 Success in BTK/BTA Intervention: Disease Characteristics, Anatomy & Advanced Techniques Timothy E. Yates, MD Mount Sinai Medical Center Miami Beach, FL USA