Measurement of Perfusion: Current Limitations and Novel - PDF document

4/17/2018 Measurement of Perfusion: Current Limitations and Novel Technologies Montero‐Baker, Miguel Associate Professor of Surgery Division of Vascular and Endovascular Surgery Baylor College of Medicine Financial Disclosures Proctor/Education ‐ Abbott ‐ Medtronic ‐ Phillips ‐ COOK Stock Options/Ownership ‐ PROFUSA ‐Thermopeutics 2 1

4/17/2018 The term "perfusion" is derived from the French verb 'perfuse' meaning to 'pour over or through’ Flow (Q) ‐ (volume per unit time, for example, L/min) Perfusion is flow per unit tissue mass (ml/min/g) 2

4/17/2018 Pedal loop classification (Kawarada 2012) 3

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4/17/2018 Utsunomiya et al – JEVT 2014 With the development of robust technical skills and more appropriate technology, operators are able to treat more complex and distal disease patterns. This perfect storm of technical skills and advanced tools makes the question “what’s possible” irrelevant; and the question “what’s appropriate” extremely relevant. 5

4/17/2018 <<< ANTERIOR TIBIAL INTERVENTION POSTERIOR TIBIAL INTERVENTION>>> A patent bypass will fail to heal ca. 16% of ischemic heel wounds when there is an incomplete arch – Bercelli et al. JVS 1999 6

4/17/2018 What’s out to there now? And do they really m perfusion? Off table: ‐ SPP ‐ TCO2 ‐ ICGA ‐ MRI On table: ‐ Angiography ‐ 2D ‘perfusion’ software ‐ Micro oxygen sensors 7

4/17/2018 Yamada et al – JVS 2008 WOUND‐O‐SOME 8

4/17/2018 Utsunomiya et al – JEVT 2014 9

4/17/2018 Utsunomiya et al – JEVT 2014 Utsunomiya et al – JEVT 2014 10

4/17/2018 Mean SPP ABI Okamoto et al – Angiology 2015 Shinozaki – InMed 2012 46 mm Hg 12mm Hg 30 mm Hg 11

4/17/2018 Kawasaki et al – In J Pl Surg 2013 12

4/17/2018 Implantable Oxygen Sensors (IOS) *CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use. 25 OMNIA: Oxygen Monitoring Near Ischemic Area Preliminary Results Global PI`s: Marian Broadmann, MD Miguel Montero, MD Mehdi Shishebor, MD A total of 3 study sites are actively enrolling (CE marked): • Prof. M. Brodmann, Med University of Graz / Austria • Drs. T. Bisdas, A. Schwindt, St. Franziskus Hospital Münster / Germany • Dr. M. Werner, Hanusch Hospital Vienna, Austria 20 subjects have been enrolled • 20/20 were Rutherford Class 5 upon enrollment • 18/20 received endovascular treatment • 2/20 had bypass surgery after endo attempt 26 13

4/17/2018 What information do we extract from Lumee Intra‐Surgically? Reperfusion Modulation Maximum Therapeutic during/after interventions interventions LOI Reperfusion Modulation (Unitless) Baseline (Blue Lumee) confidential Pre‐Op Discharge 1 Month 3 Month 6 Month Wound 2 2 1 1 1 ea cm^2 15 Demogr aphics Ischemia 2 0 0 0 0 10 Infection 2 1 1 1 N/A Sex M Wound Ar Age (yrs) 65 5 TP [mmHG] N/A N/A N/A N/A N/A To be ABI 0.53 1.25 1.06 0.867 1.18 Diabetes confirmed 0 TBI N/A N/A N/A N/A N/A Foot Side Left Pre Dis 1mo 3mo 6mo Rutherford (1) (2) (3) Class 5 Wound Left first toe (lateral) issue oxygen index Therapy 1. Treated popliteal a. artherectomy and 4 sets of balloon inflate/deflate 2. Repeat Hawk Balloon 3. Treated anterior tibialis a. balloon inflate/deflate +Provastin T Angiography Flow to foot re-established 6 month Pre‐Tx 1 month 3 month 28 confidential 14

4/17/2018 Intra‐op Lumee shows predictive value for wound healing (Stratification by Wound Status) • For each subject, average intra‐op LOI change across 3 Lumees was computed • Subjects were stratified by wound healing status as improved, no change, or worsen Average increase in LOI [‐] (analysis only includes 13 subjects with 3‐m+ data) • Distribution of average intra‐op LOI change is shown in box‐whisker plot Results show that larger increases in LOI were associated with wound healing outcomes compared with non‐ responding/worsening Improved, No change, Worsen, N=3 N=8 N=2 29 confidential Intra‐op Lumee shows predictive value for wound healing Preliminary Results LOI Change > 6 LOI Change 0‐6 LOI Change <0 Intra‐op Lumee 3‐month * 6‐month *This patient underwent bypass at about 1 30 confidential month after endo treatment 15

4/17/2018 • We have a desperate need to establish OPG for on‐table decision making that leads to optimal clinical outcomes • SPP has been validated as a solid diagnostic and prognostic tool during the treatment of CLI patients. • Intraoperative data, although somewhat cumbersome, may help decide plan of care • We have a desperate need to establish OPG for on‐table decision making that leads to optimal clinical outcomes • IOS are potential tools that show very promising preliminary data The Division of Division of Vascular Surgery & Endovascular Therapy and iCAMP Accepting National and International Visitors The Division of Vascular Surgery and Endovascular Therapy in the Michael E. DeBakey Department of Surgery at Baylor College of Medicine is inviting national and international visitors to work at with world-renowned physicians and scientists in Vascular Surgery, Podiatry Medicine, Limb Salvage, Neurorehabilitation, and Bioengineering to contribute in innovative interdisciplinary research in the area personalized and precision medicine targeting aging population, people with diabetes and plantar ulcers, and those Visitors must meet the suffering from peripheral arterial disease. following requirements: Visiting scholars who are visiting for longer than 6 months enjoy: • Independent funding (a) Library privileges identical with those of the faculty; • Minimum of 6 month (b) Privilege of auditing seminars without fee or record, as space commitment allows (c) Use of laboratory, Clinical, and other space and facilities to • English Proficiency the extent they are available. • Compliance with USCIS (d) Working in an interdisciplinary environment and be actively engaged in highly innovative clinical and translational Visa Regulations for researches to improve stability, healing and mobility across non-USA residents disciplines and in particular among patients suffering from diabetes as well as aging population undergoing major surgical interventions. A DS-2019 Request form has to (e) Candidates will be highly encouraged and are supported to publish the results of their research in high impact be completed for a J-1 Visa prior peer-reviewed journals and/or presenting in national and to visiting. Applicants should send international conferences. an updated CV and a cover letter (d) Candidates will receive training in using advanced summarizing your motivations technologies/tools designed for the purpose of outcomes research, wound healing, fall prevention, frailty screening, and your qualifications to: vascular assessment, and motor-cognitive screening. i-camp@bcm.edu 16

4/17/2018 @monteromiguel mmontero@bcm.edu 17