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CRT 24: Clinical Outcomes in Outpatients with CLTI: The CLIPPER Cohort

Published: 21 Mar 2024

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CRT 24 - Dr Alexander Fanaroff (Penn Medicine, US) joins us in this short interview to discuss the findings of a national cohort of patients with chronic limb-threatening ischemia, CLIPPER.

The CLIPPER cohort includes the baseline data and outcomes of 1.13 million patients with chronic limb-threatening ischemia.

Findings from the study showed that for individuals with a diagnosis to limb revascularization time of less than 30 days, there was no association between time from diagnosis to revascularization, and clinical outcomes including major amputation. However, in patients with a diagnosis to limb revascularization time of greater than 30 days, for each additional 10 days increase, there was a 2.5% increased risk of major amputation.

Interview Questions:

  1. What are the current unmet needs of patients with CLTI
  2. What is the methodology behind this study?
  3. What are your key findings?
  4. How should these findings impact practice?
  5. What are your take home messages?
  6. What are the next steps?

Recorded remotely from Philadelphia, 2024.

Transcript

"My name is Alex Fanaroff. I'm an assistant professor of medicine at the University of Pennsylvania.

What are the current unmet needs of patients with CLTI

So, we know that patients with CLTI have bad outcomes. They have a high likelihood of dying, a high likelihood of amputation, and we're aware of large disparities in care for historically marginalized racial and ethnic groups, individuals of low socioeconomic status, and those from rural areas. Despite advancements in CLTI care, it hasn't progressed as much as other areas of cardiology. This might be due to the lack of a robust quality improvement apparatus around CLTI compared to other cardiovascular diseases.

What is the methodology behind this study?

To address this, we developed a database comprising over a million CLTI patients using Medicare claims data. We identified CLTI patients within this dataset who underwent outpatient endovascular vascularization. Using standard statistical methods, we analyzed the association between the time from CLTI diagnosis to revascularization and clinical outcomes.

What are your key findings?

Our key finding suggests that for individuals with a diagnosis to liver vascularization time of less than 30 days, there was no significant association between the time taken and clinical outcomes, including major amputation.

However, for those with a diagnosis or vascularization time exceeding 30 days, each additional ten-day delay in diagnosis to liver vascularization time corresponded to a 2.5% greater risk of major amputation. Moreover, for every 30 days beyond the initial 30, there was an additional 7.5% increased risk of major lower extremity amputation.

How should these findings impact practice?

These findings underscore the importance of prompt vascularization in CLTI patients to prevent complications such as wounds, ischemia, or gangrene.

While our research may not be sufficient to prompt immediate guideline changes, it emphasizes the significance of reducing diagnosis to limb revascularization time. We hope this encourages further research and development of quality improvement strategies, similar to the approach taken with door-to-balloon time in STEMI care.

What are your take home messages, and what are the next steps?

Moving forward, it's essential to investigate the reasons behind delays in CLTI diagnosis and revascularization. This involves examining barriers at the health system, physician, and patient levels.

Additionally, we need to identify healthcare systems with low diagnosis to limb revascularization times and understand the strategies contributing to their success. This research parallels the foundational work done with door-to-balloon time and could serve as a quality measure to improve CLTI patient care.

In conclusion, CLTI and PAD are critical disease states with profound impacts on patients' quality of life. While progress has been made, more research and initiatives are needed to advance the field and improve outcomes for these patients.”

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