When trying to prevent lower extremity amputation, it is critical that wound clinicians restore blood flow in a quick and aggressive fashion. This author offers a historic perspective of advances in endovascular technologies and how they can save limbs.
The title of this article, “The Impact of Restoring Flow in Order to Preserve Limbs,” cannot be emphasized enough as restoring blood flow to preserve limbs is the essential step when attempting to save an ischemic lower extremity.
The emergence of endovascular technologies over the past 15 years has had the single most important impact for the patients I have treated in that time, and therefore, I would like to present a historical perspective to fully appreciate how important these breakthroughs have been.
On a personal note, I have dedicated my medical career and clinical practice of nearly 25 years to wound management and lower extremity preservation. I could have turned this into a purely academic presentation, complete with extensive citations and references to lend credibility to the message. But as the saying goes, “been there, done that.” This time, I would like to share some stories and, in the process, further motivate you in your efforts and help you better understand the importance of your contributions to the medical specialty of wound management.
Turf Jobs and Turf Wars
Wound care found me around 1995 during my first year of training at the Department of Veteran Affairs Medical Center in Philadelphia. The impact that the VA experience had on my career continues today. The need to do better for our veterans became apparent and unfortunately, amputees were easy to find throughout the facility, and especially at the front entrance to the facility. Seeing amputees sitting in wheelchairs while smoking, portable oxygen in tow, was not something I could initially comprehend. My travels over the years to other VA facilities across the country confirmed that what I had at the Philly VA was not unique.
Advanced wound care was in its early stages and lower extremity bypass was the only option to restore blood flow to lower extremities in 1995–96. Additionally, there was no negative pressure wound therapy (NPWT) or cellular- and tissue-based products (CTPs), and wound care centers were in their infancy.
So, how did we manage ischemic wounds and lower extremities? One day, I was invited to scrub in on a lower extremity bypass with a vascular surgeon. After gowning, the scrub nurse whispered to me, “Dr. Bell, what do we call a VA patient with two legs?” I just shrugged my shoulders and replied, “I don’t know.” To which she replied, “Pre-op.”
I share that bit of my early history because it seems like a different lifetime when considering the options and resources that we now have, and that began to emerge not long after I was stumped by the punchline of gallows humor in the Philly VA OR.
In Wound Care, Time Is Tissue
Within 5 years of hearing that memorable riddle from the vascular surgeon, I found myself quickly becoming established as a wound specialist in my private practice, located in Jacksonville, Florida. As word began to reach providers in the community that I had a free-standing wound center that included home visits, my referrals increased. This also meant the acuity level of patients I was seeing became more apparent, and the number of patients with severe peripheral arterial disease (PAD) also increased.
With the increase in such patients came the challenge of managing non-emergent ischemic wounds and a model that typically required a two-week wait for a vascular specialist outpatient consultation, followed by at least another week before vascular testing would be performed. As one of the mantras in the wound care community states, “time is tissue,” and the time lost while waiting for evaluation, testing and intervention for my patients became increasingly frustrating.
What became especially frustrating was a trend I noticed, and that was the lack of recognition of the underlying cause of many of the ischemic wounds and patients with PAD I had referred to my practice. In some instances, I felt as if an abandoned baby had been left on my doorstep, or that I had been given the proverbial “hot potato.” Some refer to the practice of referring a patient out of one’s comfort zone to another provider as a “turf job.” That being stated, the frustration that came with referring to vascular surgeons who did not communicate back with me became a recurring source of aggravation, especially when a patient would return with either a missing leg, or I would learn the patient had been subsequently referred to either home health or another wound center for care for continuing care.
In many instances, palliative care was all we could offer for patients who were assessed and determined not to be bypass candidates. Keeping someone free from infection, keeping a limb attached, and keeping a patient at home were all worthwhile goals, but healing and a return to some measure of quality of life was always our reason for providing our services. Not being able to treat a wound aggressively and watching the undignified downward spiral occur in such patients was a reminder that so much of what we do as providers is often beyond our control.
A Closer Look at Advances in Limb Salvage Technology
Around 2006, I began performing non-invasive segmental lower extremity vascular studies in my office/wound center with the PADnet system (Biomedix). My thought process was expediting care in my high-risk PAD patients. Instead of waiting 2 weeks for an initial appointment with a vascular specialist and then another week or two before testing could be performed, why not have arterial studies completed beforehand and then send the results along to the consultant before the patient was evaluated? Bringing the PADnet system into my office connected me with the local interventionist, a cardiologist, who was interpreting my study results. I had no idea at this point that a cardiologist was not only reading my studies, but had the capabilities and skill set to use technology that provided a minimally invasive method of opening arterial blockages in the lower extremity.
Before long, I found myself collaborating with my interventional cardiologist colleague and what happened soon after is worth describing. Patients who had previously been recommended for lower extremity amputation, as they were not bypass candidates, represented a significant number in my patient population. My newly found cardiologist colleague asked me to send one patient to him to see if he could help. When you are offered a zero percent chance at something, any possibility of hope is worth the effort. With nothing to lose, I made my first referral to an “interventionist” (also a term that was new to me) and shortly thereafter, saw firsthand the technological breakthrough and all its possibilities. My life as a provider had changed for the better, as did the lives of countless patients. Seeing what happened after opening a blocked artery associated with an open wound, let alone the symptoms of severe PAD, was nothing short of miraculous.
I began learning more about the world of endovascular medicine, and how the skill set of a cardiologist or radiologist could be used to open calcified and otherwise occluded arteries, using devices such as balloon angioplasty, stents and atherectomy devices including the SilverHawk (FoxHollow). This is not to endorse the product specifically, but it was the team at FoxHollow that first recognized the value of bringing podiatrists together with interventionists (cardiologists, radiologists, vascular surgeons who utilized endovascular technologies) to begin addressing what some refer to as “toe and flow”—simply stated, to work together in healing ischemic lower extremity wounds and reducing preventable amputations.
I also began living the “team approach” to lower extremity preservation, now in almost daily communication with my interventional cardiologist colleague. I essentially stopped referring to local vascular surgeons as I had found the specialist who offered my patients the care and hope they deserved. His efforts also made my efforts not only worth it, but also gave me a glimpse into what lower extremity preservation could be for the masses, fully anticipating the wave of complications from an ever-increasing diabetic and aging population.
What happened within a year of my first referral to my interventional cardiologist is an equally important part of this story. I was at an end of year school party for my daughter’s grade school class when I ran into a fellow parent who happened to be a vascular surgeon. We got into a discussion about endovascular technologies. He began reciting the patency statistics of vessels that had undergone revascularization using endovascular methods and why bypass or amputation were the only viable options.
I politely stated my case, which was my previously mentioned stance, “If you are offered a zero percent chance at something, but someone offers you even a 20 percent chance at success, isn’t it worth the effort?” Another one of my replies was, “Give me some blood flow and give my patient and me a chance.” I also reminded him that the pain I witnessed associated with ischemic wounds was beyond description and that my experiences had been that pain levels in post-endovascular patients usually improved significantly, often resulting in a decreased need or no need for further pain medications. The other point I explained to him was that just having blood flow to a wound not only improved the ability to heal wounds but that my patients were beyond grateful for the effort. Statistics are fine and important, but not one patient of mine cared about patency rates, and at this point and from my perspective, neither did I.
Another interesting event that occurred was when vascular surgeons began contacting me, about a year after my discussion with the vascular surgeon at the school party. Several came by my office to introduce themselves. Another sent me a note stating that he was doing endovascular procedures and asked if I would send patients his way. This was a guy who never told me that he had amputated the leg of a patient I had referred to him a few years previously. Funny how the situation and approach changed so quickly from pushback and patency rates, to the competition between interventionists, namely between the vascular surgeons and the cardiologists. New turf wars had begun.
The Present and the Future of Limb Salvage
Much has happened in the world of wound care and lower extremity preservation since my first exposure to chronic wounds during my first year of residency. We have seen the validation of the team approach to both wound management and limb preservation. Both areas of medicine continue to evolve as unique medical specialties. The impact on population health and our health care system because of advanced wound care and the emergence of endovascular medicine are indisputable. The impact of “restoring blood flow to preserve limbs” is a statement that resonates on multiple levels.
Without question, we have helped many individual patients with the emerging technologies that have enabled interventionists to restore blood flow to a limb in which blood flow had ceased. Technology has also changed how we practice for the better, and also changed the mindset of many who were initially reluctant to adopt endovascular technology. A new generation of specialists is being trained and endovascular techniques have gone from a last resort and hope to the first line of treatment when stenotic and occluded limbs are encountered.
The latest statistics on diabetes are as worrisome as they were expected to be, with diabetes now affecting 10.5 percent of the American population, or 34.2 million people and 88 million with pre-diabetes, according to the Centers for Disease Control’s 2020 National Diabetes Statistics Report.1 The future does not bode well for patients and providers when considering these numbers. PAD and critical limb ischemia are expected to continue to increase in conjunction with the rise in diabetes. Access to the care that will be needed is a serious concern. The numbers of people requiring treatment are overwhelming and the number of providers available to manage them has created a disaster waiting to happen.
While the technology has made incredible improvements in wound care and lower extremity preservation possible, another concern is whether newer technologies will emerge that will enable us to meet the demand of what is likely to come. Endovascular devices and techniques that are used today are something I wish I had been able to offer to many patients under my care during the early stages of my career. The management of heart disease and the emergence of medications such as statins, as well as improved surgical techniques, and an improved understanding of the roles of diet and lifestyle, among other advances, have greatly improved survival rates and quality of life for those with coronary artery disease (CAD). The important goal for PAD patients will be like those of the CAD patients. We must work to educate the public about PAD and prevent those with PAD from deteriorating into critical limb ischemia patients, while developing strategies, regimens, and treatments beyond salvage procedures.
Bottom line: it is always easier to prevent than it is to treat. The impact of ischemic limbs on our health care system and population in general must be addressed quickly and aggressively.
Dr. Desmond Bell is the Founder and President of the “Save A Leg, Save A Life” Foundation, a multidisciplinary non-profit organization dedicated to the reduction in lower extremity amputations and improving wound healing outcomes through education, evidence-based methodology and community outreach. He also serves as Chief Medical Officer of Omeza. In 2020, he joined MD Coaches as an Executive Physician Coach, serving as a peer to peer mentor. Dr. Bell is a board certified wound specialist (CWS), having served on the Board of Directors of the American Board of Wound Management for 6 years and presently serves on the Board of the American Board of Wound Management Foundation. He has also been elected as a Fellow of the Royal College of Physicians and Surgeons of Glasgow and is a member of the CLI Global Society.
1. Centers for Disease Control and Prevention. National Diabetes Statistics Report 2020. https://www.cdc.gov/diabetes/data/statistics/statistics-report.html.