Author + information
- Jihad Mustapha1,
- Michael Jaff2,
- George Adams3,
- Larry Diaz4,
- Robert Beasley5,
- Theresa McGoff6,
- Sara Finton7,
- Carmen Heaney8,
- Larry Miller9 and
- Fadi Saab7
- 1Metro Heart & Vascular Institute, Wyoming, Michigan, United States
- 2Massachusetts General Hospital, Boston, Massachusetts, United States
- 3University of North Carolina - Chapel Hill, Wake Forest, North Carolina, United States
- 4Metro Health Hospital, Ada, Michigan, United States
- 5Mount Sinai Medical Center, Miami, Florida, United States
- 6Icahn School of Medicine at Mount Sinai
- 7Creighton University Medical Center
- 8Metro Health Hospital, Wyoming, Michigan, United States
- 9Miller Scientific Consulting, Arden, North Carolina, United States
Critical limb ischemia (CLI), defined as Rutherford 4-6 with multilevel/multivessel involvement, is end-stage peripheral arterial disease (PAD). Ankle and toe-brachial indices (ABI, TBI) and toe pressure (TP) are frequently utilized to diagnose and evaluate PAD and CLI. Limb hemodynamic values of ≤0.5 for ABI, ≤0.5 for TBI, and ≤50 mmHg TP are typically considered thresholds for diagnosing CLI. Historically, ABI, TBI, and TP thresholds have been exclusion criteria for studies of infrapopliteal (IP) CLI therapies. Limited evidence exists regarding the correlation between ABI/TBI values and the clinical presentation and treatment response of a CLI patient. These non-invasive hemodynamic studies (NIHS) were evaluated to determine their reliability to predict disease severity and response to endovascular treatment (EVT).
76 CLI patients enrolled in The Peripheral RegIstry of Endovascular Clinical OutcoMEs (PRIME) were evaluated. PRIME is a prospective multicenter outcomes registry focused on minimally invasive EVT for advanced PAD and CLI. Analyzed patients were Rutherford 4-6 with angiographically proven severe below-the-knee disease. Patients underwent baseline NIHS and EVT with 30 to 90 day follow-up NIHS.
Mean age: 74, 68% male. Most common comorbidities were dyslipidemia, hypertension, and diabetes (95%, 91%, 67%, respectively). 86% had ABI > 0.5, 28% TBI > 0.5, and 50% TP > 50 mmHg. 3 months after successful EVT, limb salvage rates, wound healing and Rutherford class improvement were similar among patients with baseline TP lower or higher than 50 mmHg (p=NS). Despite clinical success rates of >90%, only 43-47% of patients achieved ABI/TBI increases >0.15 after EVT. Approximately 50-70% of patients would have been excluded from contemporary studies of novel IP CLI therapies.
NIHS are unreliable predictors of baseline disease severity and response to EVT among CLI patients. Utilization of these thresholds for inclusion in studies of novel CLI therapies excludes many patients who would benefit from these treatments.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention