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Predicting Amputation using Local Circulating Mononuclear Progenitor Cells in Angioplasty-treated Patients with Critical Limb Ischemia
Published on: September 22, 2020
Prior failed ipsilateral percutaneous endovascular intervention in patients with critical limb ischemia predicts poor
Brian W Nolan1, Randall R De Martino, David H Stone
1Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH 03766, USA. brian.w.nolan@hitchcock.org
Insights
Prior ipsilateral peripheral endovascular intervention (iPVI) significantly increases major amputation and graft occlusion rates in patients undergoing lower extremity bypass for critical limb ischemia. These findings impact revascularization decisions for CLI patients.
Area of Science:
- Vascular Surgery
- Endovascular Interventions
- Critical Limb Ischemia Management
Background:
- Open surgical bypass is standard for critical limb ischemia (CLI).
- Peripheral endovascular intervention (PVI) is increasingly used as a first-line treatment.
- The impact of prior ipsilateral PVI (iPVI) on subsequent lower extremity bypass (LEB) outcomes is unclear.
Purpose of the Study:
- To evaluate the effect of prior iPVI on outcomes of LEB in CLI patients.
- To compare outcomes between patients with and without prior iPVI.
- To identify predictors of adverse outcomes after LEB in CLI.
Main Methods:
- Retrospective cohort analysis of 1880 infrainguinal LEBs (2003-2009) from the Vascular Study Group of New England (VSGNE).
- Primary endpoints: 1-year major amputation and graft occlusion.
- Secondary outcomes: in-hospital major adverse events (MAE), 1-year mortality, and 1-year major adverse limb events (MALE).
- Statistical analysis included life table analysis, log-rank test, and Cox proportional hazards modeling.
Main Results:
- Patients with prior iPVI were more likely to be women and require arm vein conduit.
- Prior iPVI did not affect 30-day MAE or 1-year mortality.
- 1-year major amputation (31% vs. 20%) and graft occlusion (28% vs. 18%) rates were significantly higher in patients with prior iPVI compared to those without.
- Prior iPVI outcomes were similar to prior ipsilateral bypass outcomes.
- Independent predictors of adverse outcomes included prior iPVI, prior ipsilateral bypass, dialysis dependence, prosthetic conduit, and distal bypass target.
Conclusions:
- Prior iPVI is a strong predictor of poor outcomes in LEB for CLI.
- Patients with prior iPVI face higher rates of amputation and graft occlusion.
- Findings aid complex revascularization decision-making for CLI patients.
Background:
Although open surgical bypass remains the standard revascularization strategy for patients with critical limb ischemia (CLI), many centers now perform peripheral endovascular intervention (PVI) as the first-line treatment for these patients. We sought to determine the effect of a prior ipsilateral PVI (iPVI) on the outcome of subsequent lower extremity bypass (LEB) in patients with CLI.
Methods:
A retrospective cohort analysis of all patients undergoing infrainguinal LEB between 2003 and 2009 within hospitals comprising the Vascular Study Group of New England (VSGNE) was performed. Primary study endpoints were major amputation and graft occlusion at 1 year postoperatively. Secondary outcomes included in-hospital major adverse events (MAE), 1-year mortality, and composite 1-year major adverse limb events (MALE). Event rates were determined using life table analyses and comparisons were performed using the log-rank test. Multivariate predictors were determined using a Cox proportional hazards model with multilevel hierarchical adjustment.
Results:
Of 1880 LEBs performed, 32% (n = 603) had a prior infrainguinal revascularization procedure (iPVI, 7%; ipsilateral bypass, 15%; contralateral PVI, 3%; contralateral bypass, 17%). Patients with prior iPVI, compared with those without a prior iPVI, were more likely to be women (32 vs 41%; P = .04), less likely to have tissue loss (52% vs 63%; P = .02), more likely to require arm vein conduit (16% vs 5%; P = .001), and more likely to be on statin (71% vs 54%; P = .01) and beta blocker therapy (92% vs 81%; P = .01) at the time of their bypass procedure. Other demographic factors were similar between these groups. Prior PVI or bypass did not alter 30-day MAE and 1-year mortality after the index bypass. In contrast, 1-year major amputation and 1-year graft occlusion rates were significantly higher in patients who had prior iPVI than those without (31% vs 20%; P = .046 and 28% vs 18%; P = .009), similar to patients who had a prior ipsilateral bypass (1 year major amputation, 29% vs 20%; P = .022; 1 year graft occlusion, 33% vs 18%; P = .001). Independent multivariate predictors of higher 1-year amputation and graft occlusion rates were prior iPVI, prior ipsilateral bypass, dialysis dependence, prosthetic conduit and distal (tibial and pedal) bypass target.
Conclusions:
Prior iPVI is highly predictive for poor outcome in patients undergoing LEB for CLI with higher 1-year amputation and graft occlusion rates than those without prior revascularization, similar to prior ipsilateral bypass These findings provide information, which may help with the complex decisions surrounding revascularization options in patients with CLI.
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