High plateletcrit is associated with early loss of patency after open and endovascular interventions for chronic limb ischemia (original) (raw)
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Endovascular management of patients with critical limb ischemia: Long-term results
Journal of Vascular …, 2011
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 runoff (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 runoff (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.
Outcomes after endovascular intervention for chronic critical limb ischemia
Journal of Vascular Surgery, 2011
This study evaluated outcomes after endovascular intervention (EVI) for chronic critical limb ischemia (CLI) by Rutherford category (RC) 4, rest pain; and 5, tissue loss. Methods: The medical records of all EVI performed for RC-4 to RC-5 by vascular surgeons at a single institution during a 3-year period were reviewed for sustained clinical success (SCS), defined as Rutherford improvement score (RIS) 2 ؉ , without target extremity revascularization (TER). The RC-5 group was evaluated for patency until healing and healing <4 months without recurrence or new ulceration. Secondary sustained clinical success (SSCS) was a RIS of 2 ؉ with TER. The RC-5 group was evaluated for patency until healing and healing at any time during follow-up, without recurrent or new ulceration. Significance was established at the 0.05 level. Results: Of 106 EVI performed for CLI, 78 (74%) were RC-5. There were 39 (37%) men. Mean age was 73 ؎ 12 years. Mean follow-up was 19 months (range, 1-44 months). RC-5 patients were significantly more likely than RC-4 to be diabetic (58% vs 32%; P ؍ .020), dialysis dependent (14% vs 0%; P ؍ .036), and to require distal EVI (53% vs 29%; P ؍ .029). RC-4 patients were more likely to be current smokers (57% vs 32%; P ؍ .023). At 24 months, survival was comparable, with RC-4 at 84% ؎ 8% vs RC-5 at 62% ؎ 7% (P ؍ .09), but limb salvage was significantly better for RC-4 (100%) vs RC-5 (83% ؎ 4%; P ؍ .026), as was SCS (48% vs 21%; P ؍ .006) and SSCS (85% vs 39%; P < .001). Independent predictors of failed SSCS were diabetes (odds ratio [OR], 2.83; 95% confidence interval [CI], 1.07-7.46; P ؍ .036), congestive heart failure (CHF; OR, 3.62; 95% CI, 1.19-10.99; P ؍ .023), and RC-5 (OR, 5.5; 95% CI, 2.4-30.3; P ؍ .001). SSCS was 94% in RC-4 patients without diabetes mellitus (DM) or CHF and 10% in RC-5 with DM or CHF (P < .001) but improved to 67% in RC-5 when neither CHF nor DM were present (P ؍ .004). Conclusions: RC-4 have fewer comorbidities, less advanced ischemia, and better outcome than RC-5. These groups should be evaluated individually. Limb salvage was acceptable, yet early wound healing without TER (SCS) occurred in only 21%. RC-5, DM, and CHF were predictors of poor SSCS. Careful selection of patients should improve outcome.
Endovascular management of patients with critical limb ischemia
Journal of Vascular Surgery, 2011
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 runoff (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 runoff (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.
The Platelet-Lymphocyte Ratio Predict the Risk of Amputation in Critical Limb Ischemia
Journal of Vascular Medicine & Surgery
Primary end point was determined as amputation (limb survival) and all-cause death were performed. The effect of PLR on outcome was studied by constructing a receiver operating characteristic curve. Using a PLR cutoff of ≥ 160, the area under the receiver operating characteristic curve was 0.65 (95% confidence interval [CI] 0.55-0.75) (Figure 1).
Baseline Platelet Activation and Reactivity in Patients with Critical Limb Ischemia
PLOS ONE, 2015
Background Patients with critical limb ischemia (CLI) have a high risk to develop cardiovascular events (CVE). We hypothesized that in CLI patients platelets would display increased baseline activation and reactivity. Objectives We investigated baseline platelet activation and platelet reactivity in patients with CLI. Patients/Methods In this study baseline platelet activation and platelet reactivity in response to stimulation of all major platelet activation pathways were determined in 20 CLI patients (11 using aspirin and 9 using vitamin K-antagonists) included in the Juventas-trial (clinicaltrials.gov NCT00371371) and in 17 healthy controls. Platelet activation was quantified with flow cytometric measurement of platelet P-selectin expression and fibrinogen binding. Results CLI patients not using aspirin showed higher baseline platelet activation compared to healthy controls. Maximal reactivity to stimulation of the collagen and thrombin activation pathway was decreased in CLI patients compared to healthy controls. In line, attenuated platelet reactivity to stimulation of multiple activation pathways was associated with several traditional risk factors for cardiovascular disease.
Determinants of Outcome after Endovascular Therapy for Critical Limb Ischemia with Tissue Loss
Annals of Vascular Surgery, 2014
Background: In this study we examine outcomes of endovascular therapy for critical limb ischemia with tissue loss and identify risk factors for failure of endovascular therapy across a panel of outcome metrics. Methods: A retrospective review (2006e2010) of patients undergoing endovascular therapy for critical limb ischemia with tissue loss provided data for multivariate models of overall survival, amputation-free survival, limb salvage (LS), and wound healing. Results: One hundred six patients underwent endovascular therapy for Rutherford class 5 (88%) or class 6 (12%) ischemia with ulceration and/or gangrene of the heel (15%), forefoot (16%), toe(s) (43%), calf/ankle (11%), or multiple locations (15%). Sustained limb salvage at 1 year was 87%.
Endovascular therapy for acute limb ischemia
Background: Acute limb ischemia (ALI) of the lower extremities remains a challenging clinical dilemma. Treatment of ALI has shifted toward endovascular therapies. The purpose of this study was to assess outcomes in patients treated for ALI with intra-arterial thrombolysis and/or adjuvant endovascular techniques. Methods: Consecutive patients with ALI of the lower extremities treated via endovascular intra-arterial methods between January 1, 2005 and September 30, 2007 were identified and reviewed. Comparisons of success, thrombolysis days, and all 30-day outcomes except mortality were performed using generalized estimating equations with logistic and proportional odds regression. Thirty-day mortality was assessed using logistic regression. Long-term patency, limb salvage, and survival were assessed using time-to-event methods, including Kaplan-Meier estimation and Cox proportional hazards models. Results: The analyzed dataset included 129 limbs treated in 119 patients presenting with ALI (class I 68%, class IIa 23%, class IIb 9%). The mean follow-up was 16.8 months (range: 0-43 months). Technical success was achieved in 82% cases. The 30-day mortality rate was 6.0% with all 30-day deaths occurring in females (P ؍ .002). One (0.76%) central nervous system hemorrhage (CNS) was noted in this cohort. Primary patency for the entire cohort at 12 and 24 months was 50.1% (95% confidence interval [CI], 39.5-60.7) and 37.7% (95% CI, 26.2-49.1), respectively, while secondary patency was 74.0% (95% CI, 64.9-83.1) and 65.3% (95% CI, 54.5-76.2). Multivariable analyses identified patients presenting with femoropopliteal (hazard ratio [HR] 2.63) or tibial thrombosis (HR 2.80); graft thrombosis (vs native artery thrombosis, HR 2.57) and long-term dialysis (HR 3.66, 95% CI, 2.35-5.71, P < .001) were associated with poorer primary patency rates. Cumulative limb salvage at 24 months was 68.8% (95% CI: 59.5-78.1) with female gender (HR 3.34, P ؍ .002) and thrombolysis >3 days (HR 2.35, P ؍ .019) associated with an increased risk of limb loss. Overall 36-month survival was 84.5% (95% CI: 77.5-91.6). Women had decreased survival rates both in the short-and midterm (HR 6.29; 95% CI, 1.78-22.28; P ؍ .004). Conclusions: Endovascular therapy with thrombolysis remains an effective treatment option for patients presenting with lower extremity ALI. Thrombolysis should be limited to <3 days. Female gender negatively affects the rates of limb salvage and survival. ( J Vasc Surg 2011;53:340-6.)
Journal of Vascular Surgery, 2004
The invasive treatment of chronic lower extremity peripheral arterial disease (PAD) has become inconsistent. To standardize treatment at our institution, the Lower Extremity Grading System (LEGS) score was devised, based on arteriographic findings, symptoms, functional status, comorbid conditions, and technical factors. The scoring system was used to direct the invasive treatment approach in patients with lower extremity PAD. The purpose of this study was to prospectively assess outcomes of invasive treatment of lower extremity ischemia as directed by LEGS.
Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.
Global vascular guidelines on the management of chronic limb-threatening ischemia
Journal of Vascular Surgery
Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.