Peripheral Matters | Fadi Saab, MD; Larry J. Diaz-Sandoval, MD; Jihad A. Mustapha, MD

Critical limb ischemia (CLI) represents the final stage in peripheral vascular disease (PVD). It is estimated that 1% of Americans above the age of 50 years will eventually face CLI.¹ The current ever-growing epidemic of obesity and diabetes (thanks to calorie-rich diets) and the aging population are expected to exponentially increase this prevalence to an estimated 2.8 million patients by the year 2020.

The presentation of patients with CLI has traditionally, albeit mistakenly, been stratified by the Rutherford (RF) classification, which, upon its inception, excluded all patients with diabetes. Patients classified as RF IV-VI are considered to have CLI, and, in recent years, their treatment has shifted towards a more aggressive approach, based on performance of early endovascular revascularization.^2-5 Overall, the treatment of CLI is complex and multifaceted, which mirrors its pathophysiologic nature.

This article intends to outline a road map towards the establishment of an efficient and cutting-edge CLI program. The main goal of such a program is to prevent unnecessary amputations, while improving quality of life. At the authors’ institution, this idea has been put into motion with the creation of the StAMP (Stop AMPutations) program. It is a hospital-based, physician-led, comprehensive program in which health care providers coordinate the patient’s care amongst the multiple specialties involved, such as primary care physicians, infectious disease specialists, podiatric specialists, orthopedic specialists, vascular medicine specialists (interventional cardiologists, radiologists, and vascular surgeons), as well as wound care and orthotics specialists (FIGURE 1). The program focuses on the clinical outpatient evaluation and its integration with noninvasive and invasive testing, revascularization procedures, and appropriate follow up, including rehabilitation services.

Revascularization constitutes the main pillar in the treatment of patients with CLI. Historically, this used to be achieved by surgical means. However, the number of infrapopliteal bypasses currently performed is comparatively small and continues to decline. Recent studies on the performance of femorotibial bypasses in the Medicare CLI population have determined that this procedure is only performed between 700 and 800 times per year,⁶ reflecting the significant comorbidities and limitations that surround the performance of this type of surgery. This phenomenon coupled with CLI’s mortality rate (40-50% at 2 years⁷), has lead to an ever-significant increase in the number of endovascular procedures that are being performed across multiple disciplines, including vascular surgery, interventional radiology, and interventional cardiology.

Currently, investigators involved in the Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial are attempting to resolve the clinical conundrum of whether open surgical bypass or endovascular revascularization will lead to better outcomes in the treatment of CLI patients. Moreover, this dilemma will likely be funneled into an equally challenging determination: are all physicians and centers equally qualified to deliver state-of-the-art CLI therapy? The quality and adequacy of the treatment provided to CLI patients cannot be solely assessed based on an individual physician’s technical skills and his/her ability to perform revascularization procedures. The nationwide establishment of comprehensive CLI programs (such as StAMP) is a necessity and should come to the forefront of the health care system in order to guarantee that these complex patients are treated and followed using uniform protocols guided by quality initiatives geared towards improving outcomes, instead of by isolated health care providers and anecdotal experiences.

CLI Programs: Practical Challenges

Endovascular procedures continue to become mainstream in the management of this complex entity, and technological advances and innovations continue to flood the market. A question rapidly arises when one thinks of the multiple layers and aspects that need be considered in order to provide the highest quality care for these patients: should every hospital have a CLI program?

To answer this question, one must consider some of the challenges:

1. CLI patients tend to present with multiple and complex comorbidities, such as heart failure, cardiomyopathy, diabetes, and renal failure.
2. CLI patients typically have multilevel and multivessel disease, which requires the performance of multiple procedures in both lower extremities to establish direct in-line blood flow to the feet in patients with ulcers.⁷
3. Revascularization procedures to treat complex, severely calcified, and long chronic total occlusions (CTOs) tend to be time-consuming and require experienced operators to lead a highly qualified team. Operators and the team must be proficient and master a highly refined set of skills (retrograde tibial pedal access, ultrasound-guided access and interventions, antegrade CFA access, use of the different available devices to cross and treat these long occlusions, etc.) in order to achieve successful clinical outcomes.
4. The creation of a CLI program requires the identification of all the team members (who share the same passion) across the different specialties that need to be involved.
5. The interventional team must be conformed by highly motivated nurses, cath lab techs, physician assistants, nurse assistants, and ultrasound technicians, who will develop the expertise after a long training process. Needless to say, these individuals are rare and, therefore, difficult to recruit.

CLI Centers: Leadership and Champions

To create a successful CLI program, the first step is to identify the physician leader or champion who will be at the heart of this initiative and performing these procedures. Clinicians who work within large institutions will have the added responsibility to help their administration and colleagues understand the impact of the disease in their community in order for them to be willing to provide the resources needed to build such a program. It is important for all the stakeholders to understand that the appropriate management of CLI represents an unmet need in the community where up to 50% of patients continue to undergo amputations without a previous and proper vascular evaluation.⁶ FIGURE 2 shows the main blocks recommended as the first step in initiating a CLI program. The CLI physician champion must be almost exclusively dedicated to treating these patients. This individual must be able to plan the multiple procedures that these patients will require and what should occur with them in between procedures, as well as coordinate the patient’s follow up with the different members of the team and manage the input of data generated by each team member to elaborate new recommendations. To be able to efficiently perform all of these tasks, this physician must develop the needed expertise, which is unlikely to occur while performing only one to two procedures per month. The future CLI therapist must constantly be driven to learn new technologies and techniques, stay abreast of the wealth of data that continues to emerge, and continue to improve the talents that he or she has already acquired.

Attending and networking at advanced courses should be part of the job description, as this will foster operators to continue to learn about the constant development of new devices, techniques, and approaches. Finally, a metric of success of such a program should rely on the establishment of an institution-based program, in which this physician leader trains other physicians to master the previously mentioned skills in order for the program to operate independently.

Visit ACC.org/CLIProgram to read more including protocols, currently proposed criteria to establish a CLI program, the conclusion, and to see remaining figures.

References

1. Weitz JI, Byrne J, Clagett GP, et al. Circulation. 1996;94:3026-49.
2. Al-Omran M, Tu JV, Johnston KW, et al. J Vasc Surg. 2003;38:289-95.
3. Anderson PL, Gelijns A, Moskowitz A, et al. J Vasc Surg. 2004;39:1200-8.
4. Egorova NN, Guillerme S, Gelijns A, et al. J Vasc Surg. 2010;51:878-85, 885 e1.
5. Goodney PP, Beck AW, Nagle J, et al. J Vasc Surg. 2009;50:54-60.
6. Goodney PP, Travis LL, Nallamothu BK, et al. Circ Cardiovasc Qual Outcomes. 2012;5:94-102.
7. Shiraki T, Iida O, Takahara M, et al. J Vasc Surg. 2014;60:383-9.

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Drs. Saab, Diaz-Sandoval, and Mustapha, are practicing cardiologists at the Heart & Vascular at Metro Health Hospital, in Wyoming, MI.

Keywords: CardioSource WorldNews Interventions, Diabetes Mellitus, Epidemics, Obesity, Peripheral Vascular Diseases, Prevalence

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