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Published on: January 18, 2018
Endovascular management of patients with critical limb ischemia
Mark F Conrad1, Robert S Crawford, Lauren A Hackney
1Massachusetts General Hospital, Vascular and Endovascular Surgery, 15 Parkman Street, WAC 440, Boston, MA 02114, USA. mconrad@partners.org
Insights
Percutaneous intervention (PTA) shows low primary patency but high limb salvage rates for critical limb ischemia (CLI). Close follow-up and interventions support PTA as a first-line therapy for CLI patients.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Endovascular Therapy
Background:
- Percutaneous intervention (PTA) is a common treatment for peripheral vascular disease.
- Its effectiveness in critical limb ischemia (CLI), characterized by extensive disease, requires further definition.
- This study evaluates long-term clinical outcomes and patency rates of PTA in CLI patients.
Purpose of the Study:
- To define the 5-year clinical and patency data for percutaneous intervention (PTA) in patients with critical limb ischemia (CLI).
- To identify predictors of patency, limb salvage, and mortality following PTA in CLI.
- To assess the role of PTA as a first-line therapy for CLI.
Main Methods:
- Infrainguinal PTA ± stent was performed in 409 patients (447 limbs) with CLI (Rutherford IV-VI) between 2002 and 2007.
- Kaplan-Meier analysis assessed primary patency, assisted patency, limb salvage, and survival.
- Multivariate models identified predictors of outcomes.
Main Results:
- Five-year primary patency was 31%, assisted patency 75%, and limb salvage 74%.
- Survival at 5 years was 39%.
- Dialysis dependence, limited runoff, and warfarin use predicted lower primary patency; dialysis dependence, female gender, and limited runoff predicted limb loss; dialysis dependence, diabetes, and poor runoff predicted mortality.
Conclusions:
- Despite low primary patency, percutaneous intervention (PTA) achieves excellent limb salvage in critical limb ischemia (CLI) with diligent follow-up and secondary interventions.
- The 12% annual death rate and achievable limb salvage validate PTA as a first-line therapy for CLI.
Background:
Although percutaneous intervention (PTA) is considered first-line therapy for peripheral vascular disease in many scenarios, its role in critical limb ischemia (CLI), wherein anatomic disease is more extensive, remains unclear. In the present study, late (5-year) clinical and patency data for PTA in CLI are defined.
Methods:
From January 2002 to December 2007, 409 patients underwent infrainguinal PTA ± stent for CLI (Rutherford IV-VI) of 447 limbs. Primary patency, assisted patency, limb salvage, and survival were assessed using Kaplan-Meier. Predictors of patency, limb salvage, and death were determined using multivariate models.
Results:
Demographics included age (70 ± 12 years old), diabetes (65.8%), and dialysis dependence (13%). The superficial femoral artery was treated in 58% of the patients, 16% were limited to the crural vessels, 38% had multilevel treatment, and stents were placed in 26%. Eighty percent of patients received postprocedure clopidogrel. Mean follow-up was 28 months (0-83). Five-year primary and assisted patency were 31% ± 0.04 and 75% ± 0.04, respectively. Limb salvage at 5 years was 74% ± 0.038. Sixty-three patients had major amputations. Survival at 5 years was 39% ± 0.03. Multivariate analysis identified dialysis dependence (P = .0005; 2.7 [1.6-4.8]), ≤1 vessel runoff (P = .02; 1.5 [1.1-2.0]), and warfarin use (P = .001; 1.7 [1.25-2.3]) as negative predictors of primary patency, but none of these were negative predictors of assisted patency. Dialysis dependence (P = .006; 2.5 [1.3-4.8]), female gender (P = .02; 2.0 [1.1-3.7]), and ≤1 vessel run-off (P = .04; 1.8 [1.0-3.2]) predicted limb loss. Dialysis dependence (P = .0003; 2.3 [1.5-3.5]), diabetes (P = .04; 1.5 [0.5-2.1]), and poor run-off (P = .04; 1.6 [1.2-2.1]) were predictors of mortality.
Conclusion:
Although primary patency is low, excellent limb salvage rates can be achieved in patients with CLI through close follow-up and secondary interventions. These data, and the 12% annual death rate, validate PTA as first-line therapy in patients with CLI.
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