Measurement of Perfusion: Current Limitations and Novel - - PDF document

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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

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Financial Disclosures Proctor/Education ‐ Abbott ‐ Medtronic ‐ Phillips ‐ COOK Stock Options/Ownership ‐ PROFUSA ‐Thermopeutics

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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)

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Pedal loop classification (Kawarada 2012)

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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.

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<<< 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

4/17/2018 7 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

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Yamada et al – JVS 2008

WOUND‐O‐SOME

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Utsunomiya et al – JEVT 2014

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Utsunomiya et al – JEVT 2014 Utsunomiya et al – JEVT 2014

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Okamoto et al – Angiology 2015 Mean SPP ABI Shinozaki – InMed 2012 12mm Hg 30 mm Hg 46 mm Hg

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Kawasaki et al – In J Pl Surg 2013

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*CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use.

Implantable Oxygen Sensors (IOS)

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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

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confidential

What information do we extract from Lumee Intra‐Surgically? Reperfusion Modulation

Maximum during/after interventions Baseline (Blue Lumee) Therapeutic interventions LOI

Reperfusion Modulation (Unitless)

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Sex M Age (yrs) 65 Diabetes To be confirmed Foot Side Left Rutherford Class 5

Wound Left first toe (lateral) 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 Angiography Flow to foot re-established Demogr aphics Pre‐Tx 1 month 3 month 6 month Pre‐Op Discharge 1 Month 3 Month 6 Month Wound 2 2 1 1 1 Ischemia 2 Infection 2 1 1 1 N/A TP [mmHG] N/A N/A N/A N/A N/A ABI 0.53 1.25 1.06 0.867 1.18 TBI N/A N/A N/A N/A N/A Wound Ar ea cm^2 T issue oxygen index (1) (2) (3)

5 10 15

Pre Dis 1mo 3mo 6mo

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Improved, N=8

Average increase in LOI [‐]

• 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 (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

• utcomes compared with non‐

responding/worsening

No change, N=2 Worsen, N=3

Intra‐op Lumee shows predictive value for wound healing

(Stratification by Wound Status)

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Intra‐op Lumee shows predictive value for wound healing Preliminary Results

Intra‐op Lumee 3‐month 6‐month LOI Change > 6

*

LOI Change 0‐6 LOI Change <0

*This patient underwent bypass at about 1 month after endo treatment

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• 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

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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 suffering from peripheral arterial disease.

Visiting scholars who are visiting for longer than 6 months enjoy: (a) Library privileges identical with those of the faculty; (b) Privilege of auditing seminars without fee or record, as space allows (c) Use of laboratory, Clinical, and other space and facilities to the extent they are available. (d) Working in an interdisciplinary environment and be actively engaged in highly innovative clinical and translational researches to improve stability, healing and mobility across disciplines and in particular among patients suffering from diabetes as well as aging population undergoing major surgical interventions. (e) Candidates will be highly encouraged and are supported to publish the results of their research in high impact peer-reviewed journals and/or presenting in national and international conferences. (d) Candidates will receive training in using advanced technologies/tools designed for the purpose of outcomes research, wound healing, fall prevention, frailty screening, vascular assessment, and motor-cognitive screening.

Visitors must meet the following requirements:

• Independent funding
• Minimum of 6 month

commitment

• English Proficiency
• Compliance with USCIS

Visa Regulations for non-USA residents

A DS-2019 Request form has to be completed for a J-1 Visa prior to visiting. Applicants should send an updated CV and a cover letter summarizing your motivations and your qualifications to:

i-camp@bcm.edu

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@monteromiguel mmontero@bcm.edu