Executive Summary

Executive Summary 2019

PROPENSITY SCORE–ADJUSTED COMPARISON OF LONG-TERM OUTCOMES AMONG REVASCULARIZATION STRATEGIES FOR CRITICAL LIMB ISCHEMIA

Circulation: Cardiovascular Interventions
September 2019

WHAT IS KNOWN:

  • A diagnosis of critical limb ischemia portends a grave prognosis that is more fatal than most cancers.
  • Few studies have reported long-term comparative outcomes among specific revascularization techniques for critical limb ischemia patients.

WHAT THE STUDY ADDS:

  • Among Medicare beneficiaries with critical limb ischemia who received percutaneous transluminal angioplasty, stent placement, atherectomy, or surgical bypass, minor differences in mortality (ranging from 49.3% to 54.7%) and major amputation (ranging from 6.8% to 10.8%) rates were observed among treatment groups over 4 years.

The Critical Limb Ischemia (CLI) Global Society was established in 2016 by passionate leaders to address the unmet need of CLI. The intent of the Society is to work toward a coalition of global organizations that share an interest in CLI to facilitate implementation of goals that will lead to ideal management of this impactful problem to improve quality of life by preventing amputations and death due to CLI.

BACKGROUND: Few studies have compared long-term outcomes among specific treatment modalities for critical limb ischemia. The aim of this study was to compare long-term outcomes with percutaneous transluminal angioplasty (PTA), stent placement, atherectomy, or surgical bypass in patients diagnosed with critical limb ischemia.

METHODS: In this observational study using Medicare claims data, we identified incident cases with a primary critical limb ischemia diagnosis who received PTA, stent placement, atherectomy, or surgical bypass. We used propensity score weighting to determine the association of treatment type with all-cause mortality and major (above ankle) amputation over 4 years follow-up.

RESULTS: Among 36 860 patients (10 904 PTA; 11 295 stent placement; 4422 atherectomy; 10 239 surgical bypass), all-cause mortality over 4 years was 49.3% with atherectomy, 51.4% with surgical bypass, 53.7% with stent placement, and 54.7% with PTA (P<0.05 for all pairwise comparisons). Major amputation rates over 4 years were 6.8% with atherectomy, 7.8% with stent placement, 8.1% with PTA, and 10.8% with surgical bypass (P<0.05 for all pairwise comparison except PTA versus stent).

CONCLUSIONS: Among Medicare beneficiaries who received PTA, stent placement, atherectomy, or surgical bypass for critical limb ischemia, high mortality and major amputation rates were observed with minor differences among treatment groups. Statistically significant group differences of uncertain clinical importance were observed for several comparisons. Results from observational research may be susceptible to bias because of unmeasured confounders and, therefore, these comparative results should be interpreted with caution.

CLI GLOBAL SOCIETY COALITION SUBMITS ICD-10 PROPOSAL FOR 2021 UPDATE

As part of its mission to raise awareness and better define CLI disease, the CLI Global Society is leading a multi-specialty medical society task force to differentiate CLI disease from Peripheral Arterial Diseases in the medical coding and billing nomenclature, beginning with ICD-10 CM Diagnosis codes.

The goal is to support the myriad of coding professionals, educators, compliance staff and physicians to identify and define CLI in order to track and monitor patient treatments and outcomes in the future.

The CLI Global Society’s proposal was presented to the CDC ICD-10 CM Coordination & Management Committee for addition to the 2021 update on October 1, 2019. This effort is a first step in building awareness, of the complexity associated with caring for patients who experience critical limb ischemia, among public and commercial payers.

Public comments were due by November 8, 2019 and is now under consideration by the CDC. The Society anticipate notification by June 2020 regarding the decision on the final codes in the “Official Addendum” to the FY 2021 Inpatient Payment Rule.

CURRENT SOCIETY ACTIVITIES

Membership continues to grow and goal to exceed 500 members in 2019 has been met. Global presence continues to excel with member representation in 40 countries.

The Society has been actively involved in supporting educational content focused on CLI in support of our mission. This includes partnerships and collaborations to provide member discounts and networking opportunities. Visit www.cliglobalsociety.org/events for a full list of upcoming events.

The Membership and Social Media Committee has worked hard to develop a video education series with a step-by-step  guide of recognizing, diagnosing, treatment, and therapies for CLI. The series will launch in late November 2019 with previews available to the public and full videos available to members only at www.cliglobalsociety.org/education.

CRITICAL LIMB ISCHEMIA IS A THREAT TO LIFE AND LIMB

A recent publication on behalf of the CLI Global Society confirmed that CLI is an under-diagnosed and under-treated deadly disease that requires proper diagnostic imaging and increased awareness. Worldwide, 202 million adults have peripheral arterial disease (PAD) which has a higher prevalence than ischemic heart disease, heart failure, Alzheimer’s disease/ dementia, cancer, HIV/AIDS and opioid addiction. Among 9 to 20 million adults with PAD in the United States, 11% suffer from CLI. This is likely considered an underestimation.

We must address the unmet need of critical limb ischemia. In the United States lower extremity PAD manifests as CLI in nearly 1 million Medicare patients per year with an estimated annual cost of over 3 billion dollars.1 One in 190 Americans (1.6 million) are living with loss of a limb. Unchecked, this number may more than double by 2050 to 3.6 million.2
Barry T. Katzen, MD
President, CLI Global Society

REFERENCES

1. Jihad A. Mustapha MD, Barry T. Katzen MD, Richard F. Neville MD, Robert A. Lookstein MD, Thomas Zeller MD, Larry E. Miller PhD, Michael R. Jaff DO. Determinants of Long-Term Outcomes and Costs in the Management of Critical Limb Ischemia: A Population-Based Cohort Study. J Am Heart Assoc. 2018;7:e009724. DOI: 10.1161/JAHA.118.009724.
2. J Vasc Surg. 2013 June ; 57(6): 1471–1480.e3. doi:10.1016/j.jvs.2012.11.068. The incidence and health economic burden of critical limb ischemia and ischemic amputation in Minnesota: 2005–2007. Circulation. 2009; 120:S1148.