Early Results of Lower Extremity Infrageniculate Revascularization with a New Polytetrafluoroethylene Graft

Vascular ◽  
2004 ◽  
Vol 12 (5) ◽  
pp. 318-324
Author(s):  
Francisco Alcocer ◽  
William D. Jordan ◽  
Douglas J. Wirthlin ◽  
David Whitley

When an autologous vein is not available for lower extremity revascularization, prosthetic grafts are often required. However, prosthetic bypass grafts have limited patency for infrageniculate reconstruction. To potentially improve patency, a new geometric modification of the polytetrafluoroethylene (PTFE) graft, Distaflo (Impra, Tempe, AZ), has been developed for lower extremity bypass. We reviewed our early experience with the Distaflo graft in patients who required infrageniculate bypass for lower extremity ischemia when no suitable autologous saphenous vein was available. All patients were maintained on warfarin anticoagulation postoperatively. All grafts were followed at 6- to 12-week intervals with duplex ultrasound evaluation. Patient characteristics, operative procedures, and graft surveillance information were maintained on a computerized registry. Thirty-two patients with limb-threatening ischemia underwent 35 infrageniculate reconstructions with a Distaflo graft between February 26, 1999, and August 24, 2000. Thirty-two of 35 bypasses were performed on extremities that had previously undergone a surgical procedure. Forty-eight previous revascularization procedures were done on these 25 extremities. Thirty grafts were constructed to the tibial outflow sites, whereas the remaining five grafts were placed to the below-knee popliteal artery. One patient died on the second postoperative day secondary to unrelated causes, and only one graft (3%) failed during the same hospitalization. Fifteen of 35 grafts (43%) remained patent 1 to 30 months later. Four patent grafts (6%) were ligated between 2 and 14 months for infectious indications. When considering the 20 failed grafts, 9 patients underwent major amputation, 5 patients remain with chronically ischemic limbs, and 6 patients underwent additional bypass grafts. Twenty-three patients (72%) maintained limb salvage. The Distaflo PTFE graft achieves promising early patency for complex infrageniculate revascularization and may be used as an alternative conduit in patients with critical limb ischemia who do not have an adequate vein for lower extremity revascularization.

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Judith A Hsia ◽  
Sonia Anand ◽  
Mark R Nehler ◽  
Rupert Bauersachs ◽  
Manesh R Patel ◽  
...  

Introduction: Chronic kidney disease (CKD) is common among patients undergoing lower extremity revascularization (LER) for peripheral artery disease (PAD) and identifies a population at high risk for adverse outcomes. The VOYAGER PAD trial demonstrated the efficacy of rivaroxaban in PAD patients after LER on a composite of cardiovascular (CV) and limb ischemic events (HR 0.85 vs placebo, 95% CI 0.76-0.96; p=0.009); this analysis examines the prespecified subgroup of patients with CKD. Methods: VOYAGER PAD (NCT02504216) was a double-blind, placebo-controlled trial which randomized PAD patients with recent LER to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily. The primary endpoint was a composite of acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke or CV death. The primary safety endpoint was TIMI major bleeding. Analysis of the intention-to-treat population utilized Kaplan Meier estimates and Cox proportional-hazards models. Results: Among 6319 VOYAGER patients with baseline estimated glomerular filtration rate (eGFR), 21% were <60 (mostly CKD stage 3) and 79% were ≥60 ml/min/1.73m 2 . During 28-month (median) follow up, patients with CKD had a higher rate of major CV and limb events: placebo group 10.0 events/100 patient-years (95% CI 8.5, 11.8) for eGFR <60 vs 7.4 (95% CI 6.7, 8.2) for eGFR ≥60. Rivaroxaban reduced primary outcome events with no heterogeneity by eGFR category (Figure, p for interaction 0.62). Acute limb ischemia and major amputation were significantly reduced among patients with eGFR<60 (HR 0.55, 95% CI 0.36, 0.86) as well as ≥60 (HR 0.77, 95% CI 0.63, 0.94). TIMI major bleeding was numerically more frequent among patients with CKD with no heterogeneity by treatment group (Figure, p for interaction 0.37). Conclusions: Rivaroxaban reduced major CV and limb events in patients with PAD undergoing LER, including those with CKD, a particularly high-risk population.


Author(s):  
Connie N. Hess ◽  
E. Sebastian Debus ◽  
Mark R. Nehler ◽  
Sonia S. Anand ◽  
Manesh R. Patel ◽  
...  

Background: Patients with peripheral artery disease (PAD) are at heightened risk of acute limb ischemia (ALI), a thrombotic event associated with amputation, disability, and mortality. Prior lower extremity revascularization (LER) is associated with increased ALI risk in chronic PAD. However, the pattern of risk, clinical correlates, and outcomes after ALI early after LER are not well-studied, and effective therapies to reduce ALI post-LER are lacking. Methods: VOYAGER PAD (NCT02504216) randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily or placebo on a background of low-dose aspirin. The primary outcome was a composite of ALI, major amputation of vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. ALI was prospectively ascertained and adjudicated by a blinded committee. The cumulative incidence of ALI was calculated using Kaplan Meier estimates, and Cox proportional-hazards models were used to generate hazard ratios and associated confidence intervals. Analyses were performed as intention-to-treat. Results: Among 6,564 patients followed for a median of 2.3 years, 382 (5.8%) had a total of 508 ALI events. In placebo patients, the 3-year cumulative incidence of ALI was 7.8%. After multivariable modeling, prior LER, baseline ABI <0.50, surgical LER, and longer target lesion length were associated with increased risk of ALI. Incident ALI was associated with subsequent all-cause mortality (HR 2.59, 95% CI 1.98-3.39) and major amputation (HR 24.87, 95% CI 18.68-33.12). Rivaroxaban reduced ALI relative to placebo by 33% (absolute risk reduction 2.6% at 3 years, HR 0.67, 95% CI 0.55-0.82, P=0.0001), with benefit starting early (HR 0.45, 95% CI 0.24-0.85, P=0.0068 at 30 days). Benefit was present for severe ALI (associated with death, amputation, or prolonged hospitalization and ICU stay, HR 0.58, 95% CI 0.40-0.83, P=0.003) and regardless of LER type (surgical vs endovascular revascularization, p-interaction=0.42) or clopidogrel use (p-interaction=0.59). Conclusions: After LER for symptomatic PAD, ALI is frequent, particularly early after LER, and is associated with poor prognosis. Low-dose rivaroxaban plus aspirin reduces ALI after LER, including ALI events associated with the most severe outcomes. The benefit of rivaroxaban for ALI appears early, continues over time, and is consistent regardless of revascularization approach or clopidogrel use.


2018 ◽  
Vol 52 (4) ◽  
pp. 255-261 ◽  
Author(s):  
Toshio Takayama ◽  
Jon S. Matsumura

Background: Complete revascularization, achieving inline flow to the foot through at least 1 patent tibioperoneal artery, is considered to be desirable for treating critical limb ischemia (CLI). Hybrid procedure, combined femoral endarterectomy and endovascular treatment, is commonly performed on patients with CLI because they often present with complicated lower extremity lesions involving the common femoral artery. This study aimed to investigate the efficacy of complete revascularization (CR) achieved by hybrid procedure on limb salvage in patients with CLI. Methods: Between February 2010 and January 2016, 95 limbs (82 patients) were treated by lower extremity hybrid procedure; of these 95 procedures, 61 were for patients with CLI. We defined CR as achieving inline flow to the foot through at least 1 patent tibioperoneal artery. Complete revascularization was performed on 37 limbs, and incomplete revascularization (IR) was performed on 24 limbs. Specific variables, including patient age, male–female ratio, Rutherford classification, preoperative and postoperative ankle–brachial pressure indices (ABIs), follow-up duration (months), primary patency rate, assisted primary patency rate, secondary patency rate, and major amputation rate, were analyzed. Results: The mean age was similar between the groups 67.2 years in the CR group and 70.7 years in the IR group ( P = .11). Limb ischemia severity was significantly higher in the CR group: 63% of the patients scored Rutherford 5 in the CR group, compared to 30% in the IR group ( P = .027). Mean postoperative ABI was significantly higher in the CR group (CR: 0.87, IR: 0.53; P = .0001). Major amputation rate was higher in the IR group (CR: 2.7%, IR: 13%; P = .29), and major amputation-free survival rate at 3 years after the index procedure was higher in the CR group (CR: 97%, IR: 81%; P = .054). Conclusion: Complete lower extremity revascularization was beneficial for patients with CLI, avoiding major amputation.


2020 ◽  
Vol 51 (7) ◽  
pp. 527-533
Author(s):  
Mahesh Anantha-Narayanan ◽  
Azfar Bilal Sheikh ◽  
Sameer Nagpal ◽  
Kim G. Smolderen ◽  
Jeffrey Turner ◽  
...  

Background: There are limited data on outcomes of patients undergoing peripheral arterial disease (PAD) interventions who have comorbid CKD/ESRD versus those who do not have such comorbid condition. We performed a systematic review and meta-analysis to analyze outcomes in this patient population. Methods: Five databases were searched for studies comparing outcomes of lower extremity PAD interventions for claudication and critical limb ischemia (CLI) in patients with CKD/ESRD versus non-CKD/non-ESRD from January 2000 to June 2019. Results: Our study included 16 observational studies with 44,138 patients. Mean follow-up was 48.9 ± 27.4 months. Major amputation was higher with CKD/ESRD compared with non-CKD/non-ESRD (odds ratio [OR 1.97] [95% confidence interval [CI] 1.39–2.80], p = 0.001). Higher major amputations with CKD/ESRD versus non-CKD/non-ESRD were only observed when indication for procedure was CLI (OR 2.27 [95% CI 1.53–3.36], p < 0.0001) but were similar for claudication (OR 1.15 [95% CI 0.53–2.49], p = 0.72). The risk of early mortality was high with CKD/ESRD patients undergoing PAD interventions compared with non-CKD/non-ESRD (OR 2.55 [95% CI 1.65–3.96], p < 0.0001), which when stratified based on indication, remained higher with CLI (OR 3.14 [95% CI 1.80–5.48], p < 0.0001) but was similar with claudication (OR 1.83 [95% CI 0.90–3.72], p = 0.1). Funnel plot of included studies showed moderate bias. Conclusions: Patients undergoing lower extremity PAD interventions for CLI who also have comorbid CKD/ESRD have an increased risk of experiencing major amputations and early mortality. Randomized trials to understand outcomes of PAD interventions in this at-risk population are essential.


2020 ◽  
Vol 25 (6) ◽  
pp. 527-533
Author(s):  
Tanner I Kim ◽  
Anand Brahmandam ◽  
Timur P Sarac ◽  
Kristine C Orion

The development of highly active antiretroviral therapy (HAART) has significantly improved the life expectancy of patients with human immunodeficiency virus (HIV), but has led to the rise of chronic conditions including peripheral artery disease (PAD). However, trends and outcomes among patients with HIV undergoing lower extremity revascularization are poorly characterized. The aim of this study was to investigate the trends and perioperative outcomes of lower extremity revascularization among patients with HIV and PAD in a national database. The National Inpatient Sample (NIS) was reviewed between 2003 and 2014. All hospital admissions with a diagnosis of PAD undergoing lower extremity revascularization were stratified based on HIV status. Outcomes were assessed using propensity score matching and multivariable regression. Among all patients undergoing lower extremity revascularization for PAD, there was a significant increase in the proportion of patients with HIV from 0.21% in 2003 to 0.52% in 2014 ( p < 0.01). Patients with HIV were more likely to be younger, male, and have fewer comorbidities, including coronary artery disease and diabetes, at the time of intervention compared to patients without HIV. With propensity score matching and multivariable regression, HIV status was associated with increased total hospital costs, but not length of stay, major amputation, or mortality. Patients with HIV with PAD who undergo revascularization are younger with fewer comorbidities, but have increased hospital costs compared to those without HIV. Lower extremity revascularization for PAD is safe for patients with HIV without increased risk of in-hospital major amputation or mortality, and continues to increase each year.


2002 ◽  
Vol 16 (1) ◽  
pp. 108-114 ◽  
Author(s):  
Enrico Ascher ◽  
Anil Hingorani ◽  
Natalia Markevich ◽  
Tatiana Costa ◽  
Shreedhar Kallakuri ◽  
...  

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Hiroshi Takahashi ◽  
Yoshitaka Kumada ◽  
Hideki Ishii ◽  
Norio Umemoto ◽  
Ryuta Ito ◽  
...  

Abstract Background and Aims Although lower extremity revascularization has been commonly performed in chronic haemodialysis (HD) patients with peripheral artery disease (PAD), poorer prognosis still remains major problems in such population. Recently, protein-energy wasting (PEW) or malnutrition have been considered to be strongly associated with chronic inflammation and advanced atherosclerosis in HD patients. We investigated the association of geriatric nutritional risk index (GNRI) as a surrogate marker of the PEW, C-reactive protein (CRP) and these joint role with prediction of amputation and/or mortality after lower extremity revascularization in chronic HD patients. Method We enrolled a total of 862 HD patients (age 67±10 years, diabetes 62.9%, critical limb ischemia 53.5%) who successfully underwent lower extremity revascularization (552 with endovascular therapy and 310 with bypass surgery). Patients were divided into tertiles according to GNRI levels; tertile 1 (T1): &lt;80.0, T2: 80.0-96.6and T3: &gt;96.6, and CRP levels; T1: &lt;2.0mg/l, T2: 2.0-12.6mg/l and T3: &gt;12.6mg/l, respectively. They were followed up for up to 8 years. Results During follow-up period (median: 43 months), 63 (7.3%) patients needed major amputation and 202 (23.4%) patients died. Kaplan-Meier analysis shows that amputation-free survival rates for 8 years were 47.5%, 51.6% and 66.5% in T1, T2 and T3 of GNRI, and were 65.8%, 58.7% and 33.2% in T1, T2 and T3 of CRP, respectively (p&lt;0.0001 in both). After adjustment for age, previous coronary artery disease and critical limb ischemia as covariates with p&lt;0.05 by univariate analysis, declined GNRI [hazard ratio (HR) 2.18, 95% confidence interval (CI) 1.57-3.07, p&lt;0.0001 for T1 vs. T3] and elevated CRP (HR 1.78, 95%CI 1.24-2.59, p=0.0016 for T3 vs. T1) were identified as independent predictors of amputation and/or mortality. In the combined setting of both variables, the risk of amputation and/or mortality was 3.77-fold higher (95%CI 1.97-7.69, p&lt;0.0001) in theT1 of GNRI with T3 of CRP than in the T3 of GNRI with T1 of CRP. Similar results were obtained for amputation and mortality, respectively (Figure). Conclusion Among HD patients undergoing lower extremity revascularization, those with pre-procedural declined GNRI and elevated CRP frequently experienced amputation and/or mortality, furthermore, combination of both variables could stratify the risk of amputation and/or mortality.


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