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Contemporary Outcomes of Endovascular Interventions for Arterial Acute Limb Ischemia (ALI).
Raphael Byrne, B.A., Luke Marone, MD, Robert Rhee, MD, Jae Cho, MD, Dan Winger, MS, Li Wang, Clareann Bunker, MPH, PhD, Michel Makaroun, MD, Rabih A. Chaer, MD.
University of Pittsburgh, Pittsburgh, PA, USA.
OBJECTIVES:Thrombolysis for arterial ALI has become first line therapy based on studies published over two decades ago primarily using urokinase. The purpose of this study was to assess outcomes of patients treated for ALI using contemporary lytic agents and endovascular techniques.
METHODS: Consecutive patients with lower extremity ALI treated with thrombolysis between 2005-2011were studied. All patients were treated with tPA delivered via catheter directed thrombolysis (CDT) and/or pharmacomechanical thrombolysis (PMT), with adjunctive endovascular or surgical interventions. Procedural success and outcomes were obtained for the whole series and were also compared between the CDT and PMT groups. Limb salvage, and survival were assessed using Kaplan-Meier estimation and Cox proportional hazards models.
RESULTS: 154 limbs (83 CDT only, 56 CDT for incomplete PMT, 15 standalone PMT), were treated in 147 patients presenting with ALI (Rutherford class I 9.7%, class IIa 70.1%, class IIb 20.1%). Mean follow-up was 15.20 months(range:0.56-56.84). Patient characteristics and indications for intervention are detailed in Table. Technical success was achieved in 80.5% of cases, with a 30-day mortality rate of 5.2%. Procedural complications included systemic bleeding(5.8%), access site hematoma(4.5%), and acute renal failure(3.9%). The mean runoff score improved from 13.42 pre- to 7.43 post intervention. Adjuvant revascularization procedures were required in 89.0% of patients and were endovascular(68.8%), hybrid(9.1%) or open(11.0%). Only 7.1% of patients required a fasciotomy. Overall rate of major amputation was 14.9% (18.1% for CDT only, 11.3% for PMT, p=NS). Predictors of limb loss by life table analysis included ESRD (HR=12.754, p=0.0479), and poor pedal outflow (p=0.0022), with an incremental protective effect for improved pedal outflow [(HR=0.212, p=0.0078 for 1 pedal outflow vessel);(HR=0.062, p=0.003 for ≥2 pedal outflow vessels)]. Gender, smoking, diabetes, Rutherford score, runoff score, and thrombosed popliteal aneurysm, were not significant predictors of limb loss. In addition, limb salvage appeared equivalent between the CDT and PMT groups.
CONCLUSIONS: Endovascular therapy with thrombolysis using tPA remains an effective treatment option for patients presenting with lower extremity ALI, with equivalent limb salvage with CDT or PMT. Patients with ESRD and poor pedal outflow have increased risk of limb loss and may benefit from alternative revascularization strategies.
Patient Characteristics and indications for intervention
|Sex (Female)||65 (42.2)||34 (41.0)||31 (43.7)||0.746|
|CAD||83 (55.7)||44 (55.0)||39 (56.5)||0.87|
|Afib||33 (22)||21 (25.9)||12 (17.4)||0.239|
|Hypertension||116 (78.4)||62 (77.5)||54 (79.4)||0.843|
|Diabetes||59 (39.9)||34 (42.5)||25 (36.8)||0.504|
|Dialysis||7 (4.7)||3 (3.8)||4 (5.8)||0.704|
In situ thrombosis
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