Amputation due to PAD, particularly in patients with CLI, still a growing major concern

Despite progress in the treatment of peripheral artery disease (PAD) and critical limb ischemia (CLI), the rate of amputations and associated mortality remains high, particularly in CLI patients.

  • Low Quality of life
    associated with CLI amputation
  • Significant
    morbidity and mortality
  • Spiraling Burden
    on the healthcare system
  • CLI Mortality Rates
    exceed those for every other form of occlusive cardiovascular disease, including symptomatic coronary artery disease (CAD), and reflect the systemic atherosclerotic burden associated with CLI.2

CLI is associated with poor quality of life and high treatment costs, especially when amputation is inevitable2

Besides poor survival rates, prognosis with respect to limb preservation in CLI patients is poor, particularly in no-option CLI patients, where 6-month major amputation rates have been reported to be as high as 50%.2

More can be done to help prevent CLI treatment from becoming the precursor to amputation.

Impact of current PAD/CLI disease on amputations

PAD AND CLI affected 215 million people worldwide in 2015, predicted to be 230 million by 20203

Nearly 18 million U.S. citizens suffer from PAD—projected to increase to 24 million by 2030.4


CLI currently afflicts 2.8 to 3.5 million of those diagnosed with PAD. This is projected to rise to 4.5 to 5.6 million by 2030.4

  • An estimated 25% of CLI patients will undergo amputation.
  • Amputations due to CLI could reach one million by 2030.
  • Approximately 65,000 to 70,000 major amputations are currently performed for PAD, and almost all of these patients suffer from CLI.5

Advances in minimally invasive CLI treatment

Rates of amputations in the general population with PAD/CLI

Amputations in the overall PAD population are declining, but despite recent advances, amputations in CLI continue to be a primary procedure1

  • Patients with CLI are
    referred late
    in their course1
  • There is no agreed-upon definition of a
    non-salvageable limb6
  • There are still
    not enough viable device options
    small enough for BTK to make PVI
    (peripheral vascular intervention) a first-line choice

Complication rate of CLI amputation

The 20% to 37% major complication rate associated with amputation is considerably higher than the 16% to 17% average for vascular surgery and the average of 5% to 9% for endovascular surgery.2

  • 20%–37%

  • 16%–17%

  • 5%–9%

Less invasive methods of CLI intervention

There is a strong trend in every single area of cardiovascular and endovascular medicine toward the use of less invasive methods and toward more minimally invasive approaches. Catheters are becoming easier to use, smaller in size, and more sophisticated, facilitating the delivery of therapies and rapid recovery of patients.

Rapid development of less invasive techniques and devices

Endovascular, minimally invasive techniques for the treatment of Peripheral Vascular Disease (PVD), PAD and CLI are being developed very rapidly. At some point in the near future, they could have the potential to overtake the development of surgical techniques.

The next step is already happening, with the development of smaller micro stents, drug-eluting balloons, sub 4Fr delivery systems, new fully integrated micro-intervention systems, and innovative devices providing pedal access for BTK lesions.

References: 1. Varu VN, Hogg ME, Kibbe MR, Review article: Critical limb ischemia. Journal of Vascular Surgery Volume 51, Issue 1, January 2010, 230–241. Accessed at, October 17, 2016. 2. Teraa M, Conte MS, Moll FL, Verhaar MC. Contemporary Reviews: Critical Limb Ischemia: Current Trends and Future Directions. J Am Heart Assoc 2016; 5: e002938. 3. Global Peripheral Artery Disease Market: Trends & Opportunities (2015-2020), February 2016 (Page 19). Daedal Research Group. 4. Critical Limb Ischemia. Volume 1 United States Epidemiology, 2010. Accessed at[orts/cliepiusreprot.php., October 14, 2016. 5. Yost ML. Cost-Benefit Analysis of Critical Limb Ischemia in the Era of the Affordable Care Act. Endovascular Today. May 2014. 6. Thukkani AK, Kinlay S. Endovascular Intervention for Peripheral Artery Disease. US Department of Veteran Affairs. Accessed at Accessed October 10, 2016.

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