Vascular Assessment Enters the 21st Century

New, non-invasive technologies are the key to better outcomes and efficient management of wound care patients

Worldwide, diabetes and peripheral arterial disease continue to rise, with more than 30 million Americans now carrying the diagnosis of Type 2 diabetes mellitus1, and more than 8 million Americans diagnosed with PAD.

I recently had the opportunity to lecture on the topic of “New Technologies in Non-Invasive Vascular Evaluation” at the Undersea and Hyperbaric Medical Society conference in Dallas, Texas on September 7, 2019, and it was evident from the audience response that there is keen interest in the subject.

It’s easy to understand why, because never has there been a more pressing need to quickly and reliably assess the vascular status of our patients. Seasoned wound clinicians know that without a clear and early assessment of vascular status, it is impossible to make appropriate and timely wound care decisions and assure optimal outcomes.

However, as Caroline Fife, M.D. and other thought leaders have pointed out, too often, clinicians evaluate vascular status in a hit or miss fashion, to the detriment of patients. While there are wound care centers with pro-active vascular evaluation policies, where at minimum, ABI testing is performed on new patients presenting with a lower extremity wound and any PAD risk factors, just as many wound care programs do not have consistent policies for such testing.

One of the reasons for this is that commonly available vascular screening methodologies, such as Ankle Brachial Index, and the related Toe Brachial Index suffer from significant limitations in the diabetic populations common in our wound centers. Factors such as vascular calcification which are common in these patients render ABI data difficult to interpret. TBI addresses some of these limitations, but it can be very difficult to reliably administer the test in a significant percentage of patients.

More importantly, ABI and TBI do not tell us anything about microvascular flow in the wound bed, and certainly nothing about tissue oxygenation – an essential factor for wound healing.

Transcutaneous Oxygen Mapping, or TCOM, long accepted as the “Gold Standard” for assessing tissue oxygenation (and collaterally, microvascular blood flow) and thereby assessing potential for wound healing, also suffers from very significant limitations in clinical practice.

One key limitation of TCOM is that it cannot be used to directly assess perfusion of plantar skin; the site of some of our most challenging wounds. In addition, the TCOM electrodes in common use are not suitable for assessing perfusion in the toe, due to their size.

In addition to these technical limitations, TCOM is an expensive technology to purchase and maintain, with typical devices costing more than $50,000 to purchase. My group recently received a $76,000 quote for maintenance costs for six devices. They also require a significant training investment to use effectively, and testing can be time consuming, consuming valuable technician time and bed minutes in the clinic.

In an era of decreasing margins, and increasingly stringent demands for efficient, optimal utilization, the limitations and expenses associated with ABI and TCOM are forcing clinical leaders, and clinic owners to look to new technologies offering a better cost-benefit ratio.

As I pointed out in my recent lecture, two technologies are generating enthusiasm for new paradigms in non-invasive vascular evaluation in the wound clinic and bringing hope that wound care programs can grow beyond the current technical limitations and cost burdens imposed by existing technologies. The two technologies I focused on are Combined Skin Perfusion Pressure and ABI with PVR (Vasomed PAD-IQ), and Hyperspectral Imaging (Kent Imaging “Snapsho2t,” and Hypermed “Hyperview”).

While Hyperspectral Imaging and Skin Perfusion Pressure are very different from a technological perspective, each of these new devices address the imperative to quickly, repeatedly, and cost-effectively assess the vascular status of our patients, so that treatment decisions can be optimized from the point of care, on the first visit.

Hyperspectral imaging technology is not fundamentally new, but the use of hyperspectral imaging to assess skin blood flow is a recent development. Many wound care clinicians have seen one or more of these devices demonstrated at industry trade shows, such as SAWC, and those who have seen them are typically intrigued by what they see.

These units are just a bit bigger than an iPAD, and are capable of capturing an image that provides direct, quantitative visualization of oxygenated hemoglobin, deoxygenated hemoglobin, and oxygen saturation, superimposed on a visual image of the wound and surrounding skin.

Hyperspectral images can be obtained in seconds, without expendable costs, by a technician or provider with as little as five minutes of training, and they are compelling to look at, but are they useful clinically? The literature is meager right now, but several groups are publishing clinically oriented papers assessing the utility of the technology for wound care and vascular medicine.

These studies have looked at the predictive value of hyperspectral imaging in patients with vascular ulcers and diabetic foot ulcers, and what has been consistently evident is that deoxy-hemoglobin imaging data correlates reasonably well with TcPO2:

TcPO2 and DeOxyHgb (r2 = 0.63, P < 0.0001)2

Hyperspectral imaging also correlates with angiosomal anatomy:

“Deoxyhemoglobin values for the plantar metatarsal, arch, and heel angiosomes were significantly different between patients with and without PAD (P <.005)”3

Finally, and perhaps most meaningfully, in a study of 73 diabetic foot ulcers in 66 patients, over a 24 week period, hyperspectral imaging correctly predicted healing with 80% sensitivity, and non-healing with 74% Specificity.4 Thus as a predictor of healing, hyperspectral imaging compares quite favorably with TCOM, whose generally accepted sensitivity for prediction of healing is 72%.

Having evaluated one of these units in a wound clinic setting, I find the information helpful, but difficult to integrate into the practice patterns necessitated by LCD strictures, and commonly accepted treatment pathways. I intend to watch these devices evolve, and champion their promise. They likely represent a future evolutionary step in wound care and vascular medicine, but I don’t think they are a compelling replacement for TCOM at this time.

If Hyperspectral Imaging is not ready for prime time, Skin Perfusion Pressure may be ready to step into the breach and meet the need for timely and cost-effective evaluation of tissue perfusion in the critical DFU and vascular ulcer population. While not a new technology, SPP is now available in the form of an integrated, elegant device called PAD-IQ, capable of providing rapid, repeatable, predictive test results in the challenging lower extremity wound population.

By combining ABI testing with Pulse Volume Recording (PVR), PAD-IQ can deliver 100 sensitivity for identification of PAD, and 100% negative predictive value for absence of the disease. Integrative SPP allows clinicians to perform accurate and repeatable “perfusion maps,” much like those obtained using multi-channel TCOM testing, but unlike TCOM, users can assess perfusion at the toe, as well as plantar skin.

Having used one of these devices in the wound clinic for 6 weeks, I can say unequivocally that I am ready to give up my TCOM device and embrace a new way of assessing skin perfusion. The PAD-IQ is a well-designed device that meets multiple needs in one unit. Nurses and technicians were quickly trained and performing studies. The perfusion sensor is easy to apply, and the interface is about as elegant as any I have seen on a medical device. Printouts are easy to read, and information rich; the kind of reports one is proud to send to a referral source, or consultant. Results are unambiguous, and graphically clean.

Compared to TCOM, a PAD-IQ test can be completed in less than half the time. Like TCOM, interpretation of SPP is straightforward. Using a cutoff of 30mmHg (capillary opening pressure, not TcPO2), one can readily predict non-healing status, and determine the need for intervention.

How does SPP compare to TCOM in clinical trials? Lo, et. al. found that SPP alone successfully predicted wound outcome in 87% of the cohort compared to TcPO2 at a rate of 64% (P < 0.0002). In addition, SPP was more sensitive in predicting wound healing than TcPO2 (90% versus 66%; P <0.0001).5

These are impressive results, and I feel just what we need to move the management of lower extremity ulcers, and particularly diabetic foot ulcers forward. Too many programs are confounded by unsystematic, subjective vascular evaluation heuristics.

It is as though we have been evaluating vascular status in these technically complex, challenging cases using a “magic 8 ball.” I believe that, until we are assessing every lower extremity wound patient with PAD risk factors early, and definitively, we will be “running in place” as a specialty, generating inconsistent, suboptimal outcomes.

It is time, I feel, to make vascular testing simple, reliable, and something that happens at the bedside at the point of consultation in the wound clinic. I for one am ready to embrace change. Please let me know your thoughts and insights. I’ll be presenting on this topic next year at ACHM, where I look forward to sharing much more data.

Marcus Gitterle, M.D., FACCWS
Chief Medical Officer
WoundCentrics, LLC




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1Centers for Disease Control, 2019
2Jafari-Saraf L, Wilson SE, Gordon IL. Hyperspectral image measurements of skin hemoglobin compared with transcutaneous PO2 measurements. Annals of Vascular Surgery. 2012;26(4):537–548
3Chin JA, Wang EC, Kibbe MR. Evaluation of hyperspectral technology for assessing the presence and severity of peripheral artery disease. Journal of Vascular Surgery. 2011;54(6):1679–1688
4Bolton, L., Hyperspectral Imaging: Early Warning of Low Tissue Perfusion Wounds, 2012;24(10):A8-A105 Lo, T, et al, Prediction of wound healing outcome using skin perfusion pressure and transcutaneous oximetry: a single center experience in 100 patients, Wounds, 2009 Nov: 21(11) 310-6
5Lo, T, et al, Prediction of wound healing outcome using skin perfusion pressure and transcutaneous oximetry: a single center experience in 100 patients, Wounds, 2009 Nov: 21(11) 310-6

A Message from WoundCentrics, NALTH Visionary Partner: The Evolving Role of Wound Care in Long Term Acute Care

The Evolving Role of Wound Care in Long Term Acute Care

With the FY 2020 phase out of blended payments beginning October 1, 2019, most LTACHs have begun severely limiting, or eliminating altogether, non-qualifying LTACH admissions. As expected, this has greatly reduced the number of wound related DRGs admitted and discharged from long term acute care hospitals. As these patients are more and more often cared for in other settings one might reasonably expect that the importance of wound care in the LTACH would be decreased. While some facilities diversify their scope of service to include co-located skilled nursing facilities or inpatient rehab beds, others have developed outpatient wound centers to meet patient needs.

As a company devoted exclusively to wound care, across the continuum of care, it is obvious to us that the severe wounds we formerly cared for are no longer commonly seen as the primary reason for admission in the LTACH. We do care for them in many other levels of care that we previously did not. However, rather than the loss of primary wound care admissions resulting in a decrease in the incidence of wounds in the LTACH setting, the new LTACH admission criteria appears to have resulted in an equal and often increased incidence of wounds in the nearly two dozen LTACHs WoundCentrics serves. In addition, in the dozens of acute care hospitals we provide care in, we see qualifying patients with wounds go unreferred or unaccepted by our LTACH partners.

Even in those LTACHs where the incidence of wounds has decreased, the DRG case weight changes almost always result in equivalent or greater financial returns in response to wound care than were previously seen with DRG changes related to patients with primary wound care related DRGs. Consider the two examples below;

A 592 DRG (SKIN ULCERS WITH MCC) HAS A CASE WEIGHT OF 0.9629 AND IF DEBRIDED WOULD BECOME A DRG 570 (SKIN DEBRIDEMENT WITH MCC) WITH A CASE WEIGHT OF 1.2916. WITH THE LTACH-PPS STANDARD RATE OF $42,677.64 THAT WOULD INCREASE THE DRG PAYMENT BY $14,028.34

A DRG 207 (RESPIRATORY DIAGNOSES WITH >96 HOURS VENTILATOR SUPPORT) AND A CASE WEIGHT OF 1.8628 WOULD BECOME A DRG 166 (OTHER RESPIRATORY SYSTEM OR PROCEDURE WITH MCC) IN MOST CASES AND CARRY A CASE WEIGHT OF 2.3392. THE RESULTING DRG PAYMENT WOULD INCREASE BY $20,331.27. PATIENTS WHO DID NOT MEET THE 96 HOURS OF VENTILATOR SUPPORT SUCH AS DRG 208 ($47,966.25 INCREASE) OR DRG 189 ($58,792.72 INCREASE) RESULT IN AN EVEN GREATER IMPACT

As you can see, wound care still has an important role to play in the LTACH.

We invite you to stop by the WoundCentrics booth while at the Fall NALTH Conference or grab one of our team members any time during the conference and let us give you some examples of the real life experiences our LTACH partners have seen in their facilities this year.

Company Contact
Ken Rideout, Development
kenrideout@woundcentrics.com
Cell / Text: 281-989-5398

Stuart Oertli, COO, Asks: “Are you Planning for the New LTACH Rules this Year?” What are your plans to combat a decrease in admissions and lost revenue?

The WoundCentrics Specialized Wound Services program, designed for Long Term Acute Care Hospitals, is proving to be an option to help hospitals flourish under the new LTACH rules.  Our focus on wound care services will improve quality wound care, improve clinical alignment for both patients and providers all while continuing to demonstrate a substantial return on investment for hospitals who contract with WoundCentrics.  

I would like to offer a couple of observations from our newest LTAC Hospital partner.  Prior to engaging WoundCentrics,  there was significant concern from both local administration and corporate leadership that the need for wound care would be greatly diminished as blended payments phase out starting this fall.  Additionally, there was no plan to admit primary wound DRG patients once true site neutral reimbursement began.

The argument against incurring a new expense for a specialized wound care program was that the LTAC Hospital currently had a very well respected, albeit a very busy, local wound care Medical Director in place.   He was affiliated with multiple Acute Care Hospitals and usually, rounded at the LTACH once or twice a week, typically at the end of the day or after 6pm.  Due to his busy day schedule, it was impossible for him to fully integrate with the hospital’s bi-weekly IDT team meetings, nor did he have the time to support the facility wound care nurse on a daily basis.

Additionally, the LTACH facility was already staffed with a well educated, employed wound care team already in place.  The facility had a strong corporate commitment to quality and decision support to assist the staff on the ground.  The local CEO was recently recruited from a major LTAC Hospital ownership group, with a great deal of LTACH experience and pushed to implement our Specialized Wound Services program and worked hard to receive the support from his corporate leadership and full buy-in from his clinical team.

Here is the ROI example I wanted to share: 

The WoundCentrics employed Nurse Practioner wound specialist started seeing patients under the management of the WoundCentrics program at this 38 Bed LTACH in early May.  During the first 2 weeks,  the clinical team identified and completed 7 unique wound debridements,4 of them on LTACH compliant admissions despite the fact that their current payer mix was about 50% site neutral, 50% LTACH compliant). 1 of the debridements was on a patient with a commercial payer who extended authorization due to the active wound care being provided and the final 2 were site neutral Medicare payers.

Four (4) of the wound debridements have been coded thus far and are shown below. I provide this information in hopes that ROI will be immediately evident: 

Patient 1: Admission DRG 207 (1.8542), Post-Debridement DRG 166 (2.4628). Revenue Increase $27,223.83 

Patient 2: Admission DRG 592 (0.9330), Post-Debridement DRG 570 (1.3477). Revenue Increase $18,550.32 

Patient 3: Admission DRG 207 (1.8542), Post-Debridement DRG 166 (2.4628). Revenue Increase $27,223.83 

Patient 4: Admission DRG 208 (1.1033), Post-Debridement DRG 166 (2.4628). Revenue Increase $60,813.02 

Total Revenue Increase from first two weeks of program = $133,811.00.

Assuming net of 50% after expenses (incremental costs are likely much less), the net revenue would be $66,805.50. We proposed a $7,500 monthly fee for single locations, and a corporate rate is available for multiple facilities.  Thus, the entire first year program cost was covered within 2 weeks of program implementation and before considering the additional benefits from commercial and site neutral revenue changes. 

During the third week, 2 additional unique debridements were completed bringing the total revenue increase from the first three weeks of the program to $195,975.29:

Patient 5: Admission DRG 699 (0.6746), Post-Debridement DRG 856 (1.5413). Revenue Increase $34,940.46

Patient 6: Admission DRG 207 (1.8542), Post-Debridement DRG 166 (2.4628). Revenue Increase $27,223.83

This early success with our Wound Services program has our new LTACH client off to a great start.  Continued focus on quality wound care and constant revenue cycle review with administration will provide the revenue to keep the facility financially viable and in position to offer their valuable services to patients in their healthcare community.

What is Your Plan to Survive the new LTACH Rules?

The WoundCentrics Specialized Wound Services program has provided quality wound care for all our facilities and the revenue example provided above repeatable and reliable. It is consistent with every LTACH facility where we have been able to implement our full program with the support of and in coordination with the locate wound care team.  We have historical performance data that shows we have achieved similar results (many times far better) in every single location where we've created an LTACH partnership.

If you are considering plans to attack lost revenue related to decreased volumes and full implementation of site neutral payments for LTAC Hospitals in the coming months, please contact us for more information on how the WoundCentrics Specialized Wound Services program might work with the Wound Care team in your facility. 

For more details about WoundCentrics visit our web site:    www.woundcentrics.com                                                              Contact:  Ken Rideout, VP Development(281) 989-5398

Wound research collaboration

Though woundcare is now a well established specialty, fundamental questions remain unanswered with respect to the pathologies which result in non-healing wounds. WoundCentrics is helping to champion the cause of basic wound research by promoting provider involvement in active research.

Case in point is an exciting partnership between the US Army Institute for Surgical Research (ISR), and one of our clinicians, CEO Marcus Gitterle, MD. The ISR was founded to focus on the scientific aspects of wound healing, an issue that impacts countless warfighters and civilians annually. The capabilities of their primary lab in San Antonio, Texas, are without peer in this field.

To help advance the clinical science of wound healing, Dr. Gitterle began a long-term collaboration with the US Army, designed to harness the synergy between our large clinical footprint and provider expertise, and their best-of-breed laboratory expertise.

The first study under this collaborative agreement was launched in February, 2016. This study is expected to be the first complete study of the human wound microbiome, including all bacterial, fungal and viral components.

In addition, the study represents the first use of “transcriptomics,” in non-healing wounds, allowing researchers to analyze signaling between microbiome organisms, thought to be a potential source for healing interventions.

Our goal in this research collaboration is to help advance understanding of the complex role of the human microbiome in contributing to non-healing wounds, and ultimately to help identify solutions to wound healing challenges through this understanding.

We are aware that many organizations in woundcare pursue research affiliations, but these are predominantly relationships that create revenue, and the focus is predominantly on products, rather than fundamental scientific insight.

WoundCentrics is proud to facilitate important research that is not funded by industry, and which has the potential to significantly advance the science of wound healing.  It’s our way of “giving back.”

Antibiotic Stewardship Enters the Information Age

Antibiotic stewardship programs have now become commonplace but these programs are implemented in widely varying manners and show wide variations in impact, both clinically and financially.

WoundCentrics, LLC aims to improve the impact of antibiotic stewardship for all stakeholders, through a new product called ABX Steward (ABXSteward.com).

Embodying best practices in information design, HIPAA compliance and clinical antibiotic stewardship policy, ABX Steward enables a pharmacy-based, clinical review of antibiotic prescribing down to the individual case level.

ABX Steward enables your pharmacy staff to conveniently submit clinical data electronically to our cloud-based infrastructure, where it is transmitted to our team of board-certified ID experts for timely review.

Within 24 hours of initiation of the review process, a formal recommendation is sent to the pharmacy where it can be placed on the patient’s chart for action by the prescribing physician.

Reviews are objective, timely and conform to best practices. Moreover, unlike traditional, on-site review programs, there are no cumbersome physician contracts, or monthly minimum charges, and information technology is leveraged appropriately to improve the efficiency of the review process.

We believe ABX Steward to be the future of antibiotic stewardship and it is available today!

The future of wound care in the long-term acute care hospital setting

A Note From Our CEO

The future of wound care in the long-term acute care hospital setting is a troubling concern. Without a clear vision and plan for dealing with impending changes to admission requirements for wounds and acceptance of IPPS patients, some fear that LTACHS will no longer be able to provide the critical capabilities they offer to patients with limb and life-threatening wounds.

The National Association of Long Term Hospitals (NALTH) is conducting a wound care symposium in San Antonio, TX on September 28-29, 2015. At this conference I will be giving a presentation specifically devoted to addressing these concerns. In this presentation I will show how viable and profitable wound care remains in the LTAC setting.  To attend this event, please go to the NALTH website:http://www.nalth.com

My company, WoundCentrics, LLC has spent more than a year systematically preparing for these changes, so that our clients can continue to prosper, grow, and deliver impeccable care within their markets Let us show you how to plan for your facility’s future.

I look forward to seeing you in San Antonio.

Marcus Gitterle, M.D.
CEO, WoundCentrics

How aligned is your woundcare program?

In an insightful article in Becker Hospital Review, authors Lovrien, Peterson, and Salmon distinguish three types of provider alignment; namely Clinical Activity Alignment, Economic Alignment, and Alignment of Purpose, proposing that enduring success in a future healthcare market requires balanced emphasis on all three parameters of provider-hospital alignment.[1]

Woundcare is a critically important service line in the LTAC, with wounds representing a disproportionate share of discharge diagnoses, and a disproportionate share of CC and MCC diagnoses.

Forward thinking organizations have made development of Woundcare Departments a strategic focus. It’s no secret that the most successful LTAC organizations reap the rewards of high-functioning woundcare programs, in season and out, largely on the basis of provider alignment.

But how do we measure the parameters of alignment that predict successful, profitable woundcare programs? The answer is critical if a hospital, or health system intends to optimize, and maximize its woundcare opportunity.

Kurt Salmon, the strategic advisory firm whose analysts wrote the aforementioned article, offers a tool to help facilities and systems perform this sort of analysis, but it is not specific to woundcare. Let’s see if we can create some focused benchmarks using the framework, to help shed some light on alignment as it pertains to woundcare programs.[1]

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