Registry to better guide CLTI care; 1 in 6 patients die within first year of diagnosis
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Key takeaways:
- Approximately one in six patients with chronic limb-threatening ischemia died within the first year of diagnosis.
- Insights from the CLIPPER registry may inform quality of care processes for these patients.
Among 1.13 million patients with chronic limb-threatening ischemia and long-term follow-up, approximately one in six died within their first year of diagnosis, a rate that increased to half by 5 years, a speaker reported.
Insights from the CLIPPER database, designed to inform the quality of care for patients with CLTI, were presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
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“Peripheral artery disease is a partial or complete blockage of a lower-extremity artery and 5% to 10% of these patients progress to chronic limb-threatening ischemia, which carries a strong risk for major lower amputations. Unlike other common and morbid cardiovascular diseases, like heart attack, stroke and heart failure, no quality metrics have been developed to measure processes of care for chronic limb-threatening ischemia. Creating a cohort to understand process measures in CLTI is challenging for a number of reasons,” Alexander Fanaroff, MD, MHS, assistant professor of medicine at the Perelman School of Medicine at the University of Pennsylvania, said during a press conference. “This is a diagnosis that people get in the inpatient and outpatient setting; it requires long-term follow-up and underrepresented [groups] often that are seen in smaller, less wealthy hospitals don’t really have access to resources for participating in registries and things like that. You need a cohort that captures data from routine sources, inpatient and outpatient, and watches patients for a long period of time because this process progresses somewhat slowly. That’s what we attempted to do: to create a cohort where we could look at patients with CTLI over as long-term follow-up.”
Using inpatient and outpatient Medicare fee-for-service claims data from 2010 to 2019, Fanaroff and colleagues identified more than 1.13 million patients with CLTI (mean age, 75 years; 48% women; 15% Black) using the following criteria: one diagnostic code for PAD and one for ulceration, infection or gangrene on the same claim, or one CLTI-specific diagnostic code plus PAD testing within 6 months before or after CLTI diagnosis.
At baseline, 50% of patients had diabetes, 81% had hypertension and 26% had kidney disease.
Fanaroff described this population as highly morbid, with a 1-year mortality rate of 16.7% and a 5-year mortality rate of 50.3%.
Overall, 3.3% of patients underwent major amputation in the 6 months after diagnosis of CLTI, plus another 1% between 6 and 12 months after diagnosis. Over long-term follow-up, the rate of major amputation increased approximately 0.5% to 1% per year, according to the presentation.
Moreover, within 30 days of CLTI diagnosis, 20.4% of patients underwent either surgical or endovascular revascularization, which increased to 28% within 6 months, according to the presentation.
“The CLIPPER database of 1.13 million patients with CLTI was developed through extensive manual review of ICD-9 and ICD-10 codes. The important thing here is what the implications of this database are,” Fanaroff said during the press conference. “Process metrics are a key component of quality improvement efforts for other cardiovascular diseases, myocardial infarction, stroke and heart failure, especially. But there are no process measures for CLTI. Because we have now longitudinal inpatient and outpatient data including revascularization, wound care and things like that, over a 10-year follow-up, it facilitates studies examining the association between process measures and outcomes in chronic limb-threatening ischemia overall as well as in subgroups ... to really measure where quality of care is lacking in heart disease and improve it.”
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Fanaroff A, et al. Late-Breaking Presentation VII. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 18-20, 2023; Phoenix.
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