3-year Amputation-free Survival Research Articles

Impact of Revascularization Technique on the Outcomes of Peripheral Graft Revision Procedures

The acute occlusion of a peripheral bypass graft leads to acute limb ischemia (ALI) and threatens the viability of the limb if left untreated. The aim of the present study was to analyze the results of surgical and hybrid revascularization techniques for patients with ALI due to peripheral graft occlusions. A retrospective analysis of 102 patients undergoing treatment for ALI due to peripheral graft occlusion between 2002 and 2021 was carried out at a tertiary vascular center. Procedures were classified as surgical when only surgical techniques were used and as hybrid when surgical procedures were combined with endovascular techniques such as balloon or stent angioplasty or thrombolysis. Endpoints were primary and secondary patency and amputation-free survival after 1 and 3years. Of all patients, 67 met the inclusion criteria, 41 were treated surgically and 26 by hybrid procedures. There were no significant differences in the 30-day patency rate, 30-day amputation rate, and 30-day mortality. The 1- and 3-year primary patency rates were 41.4% and 29.2% overall, respectively; 45% and 32.1% in the surgical group, respectively; and 33.2% and 26.6% in the hybrid group, respectively. The 1- and 3-year secondary patency rates were 54.1% and 35.8% overall, respectively; 52.5% and 34.2% in the surgical group, respectively; and 54.4% and 43.5% in the hybrid group, respectively. The 1- and 3-year amputation-free survival rates were 67.5% and 59.2%, overall, respectively; 67.3% and 67.3% in the surgical group, respectively; and 68.5% and 48.2% in the hybrid group, respectively. There were no significant differences between the surgical and the hybrid groups. The results of surgical and hybrid procedures after bypass thrombectomy for ALI to eliminate the cause of infrainguinal bypass occlusion are comparable with good midterm results in terms of amputation-free survival. New endovascular techniques and devices need to be established in comparison to the results of these proven surgical revascularization methods.

Topical and intravenous administration of human umbilical cord mesenchymal stem cells in patients with diabetic foot ulcer and peripheral arterial disease: a phase I pilot study with a 3-year follow-up

BackgroundDiabetic foot ulcer (DFU) is a serious chronic complication of diabetes mellitus that contributes to 85% of nontraumatic lower extremity amputations in diabetic patients. Preliminary clinical benefits have been shown in treatments based on mesenchymal stem cells for patients with DFU or peripheral arterial disease (PAD). However, the long-term safety and benefits are unclear for patients with both DFU and PAD who are not amenable to surgical revascularization.MethodsIn this phase I pilot study, 14 patients with PAD and incurable DFU were enrolled to assess the safety and efficacy of human umbilical cord mesenchymal stem cell (hUC-MSC) administration based on conservative treatments. All patients received topical and intravenous administrations of hUC-MSCs at a dosage of 2 × 105 cells/kg with an upper limit of 1 × 107 cells for each dose. The adverse events during treatment and follow-up were documented for safety assessments. The therapeutic efficacy was assessed by ulcer healing status, recurrence rate, and 3-year amputation-free rate in the follow-up phase.ResultsThe safety profiles were favorable. Only 2 cases of transient fever were observed within 3 days after transfusion and considered possibly related to hUC-MSC administration intravenously. Ulcer disclosure was achieved for more than 95% of the lesion area for all patients within 1.5 months after treatment. The symptoms of chronic limb ischaemia were alleviated along with a decrease in Wagner scores, Rutherford grades, and visual analogue scale scores. No direct evidence was observed to indicate the alleviation of the obstruction in the main vessels of target limbs based on computed tomography angiography. The duration of rehospitalization for DFU was 2.0 ± 0.6 years. All of the patients survived without amputation due to the recurrence of DFU within 3 years after treatments.ConclusionsBased on the current pilot study, the preliminary clinical benefits of hUC-MSCs on DFU healing were shown, including good tolerance, a shortened healing time to 1.5 months and a favorable 3-year amputation-free survival rate. The clinical evidence in the current study suggested a further phase I/II study with a larger patient population and a more rigorous design to explore the efficacy and mechanism of hUC-MSCs on DFU healing.Trial registration: The current study was registered retrospectively on 22 Jan 2022 with the Chinese Clinical Trial Registry (ChiCTR2200055885), http://www.chictr.org.cn/showproj.aspx?proj=135888Graphical

Hemoglobin A1c monitoring practices before lower extremity bypass in patients with diabetes vary broadly and do not predict outcomes

ObjectiveHemoglobin A1c (HbA1c) is used as a marker of glycemic control, but the role of HbA1c before lower extremity bypass (LEB) in patients with diabetes remains unclear. We sought to characterize patients with diabetes undergoing LEB with and without HbA1c monitoring and to determine if HbA1c monitoring practices correlate with better outcomes. MethodsThe Vascular Quality Initiative was queried for all LEB in patients with diabetes (2010-2020). Patients with diabetes were characterized based on therapy: diet-controlled, noninsulin medication use, or insulin use. Glycemic control was characterized by preoperative HbA1c within 6 months of surgery: unknown control (no HbA1c), well-controlled (HbA1c <7%), poorly-controlled (HbA1c 7%-10%), and uncontrolled (HbA1c >10%). Centers with >5 LEB/y were stratified into terciles according to rate of HbA1c monitoring. The unadjusted associations between glycemic control and in-hospital major adverse limb events, major adverse cardiac events, and mortality were assessed with univariate methods. The independent association of center-level HbA1c monitoring with 5-year survival and 3-year amputation-free survival (AFS) was determined with Kaplan-Meier analyses and Cox regression modeling, adjusted for differences in patient characteristics and center volume. ResultsOf 16,092 patients with diabetes undergoing LEB, 4055 (25%) did not have a documented HbA1c. Insulin use was less common in no A1c (48%) and well-controlled diabetes (39%) compared with poorly controlled (67%) and uncontrolled diabetes (78%) (P < .01). In univariate analyses, glycemic control was not associated with differences for in-hospital major adverse limb events, major adverse cardiac events, or mortality. Of 162 centers, HbA1c monitoring practices varied widely (range: 12.5%-100% of LEB). The 3-year AFS and 5-year survival were worse in the highest monitoring tercile vs the lowest (73.6% vs 77.3%, P < .01, 72.1% vs 77.5%, P < .01, respectively). On multivariable analyses, centers in the highest tercile of monitoring had the greatest hazard of AFS (hazard ratio: 1.21, 95% confidence interval: 1.1-1.3, P < .001) and overall mortality (hazard ratio: 1.19, 95% confidence interval: 1.1-1.3, P < 0.001), compared with the centers in the lowest tercile of monitoring. ConclusionsPatients with diabetes and no preoperative HbA1c monitoring do not have worse LEB outcomes compared with those with HbA1c monitoring. Preoperative HbA1c monitoring varies widely, suggesting broad differences in practice and documentation. Centers with the highest rates of monitoring demonstrated inferior outcomes, likely due to other confounding unmeasured variables. These findings indicate that HbA1c monitoring before LEB, unto itself, should not be used as a measure of surgical quality.

Clinical Effect of Revascularization Strategies and Pharmacologic Treatment on Long-Term Results in Patients with Advanced Peripheral Artery Disease with TASC C and D Femoropopliteal Lesions.

Background This study was to assess the clinical outcome and associated parameters of endovascular therapy (EVT group) and bypass surgery (bypass group) in patients with long femoropopliteal TransAtlantic Inter-Society Consensus II (TASC II) C and D peripheral artery disease (PAD). Methods 187 patients who underwent successful EVT or bypass surgery were assessed. The endpoints included the events of cardiovascular disease (CVD) and lower-extremity amputation (LEA), 3-year primary patency, and 3-year amputation-free survival (AFS). Results The 3-year primary and secondary patency rates were better in the bypass group (P=0.007 and P=0.039, respectively), while the incidences of LEA, new CVD events, and mortality were comparable between groups. Weighted multivariate Cox analyses showed that cilostazol treatment (hazard ratio (HR): 0.46, 95% confidence interval (CI): 0.3–0.72, P=0.001), statin treatment (HR: 0.54, 95% CI: 0.33–0.9, P=0.014), and direct revascularization (DR) (HR: 0.47, 95% CI: 0.29–0.74, P=0.001) were predictive factors of 3-year primary patency. Kaplan–Meier curve analyses of time-to-primary cumulative AFS showed that nondiabetes mellitus, mild PAD, and cilostazol and statin treatment were correlated with a superior 3-year AFS (log rank test, P=0.001, P < 0.001, P=0.009, and P=0.044, respectively). Conclusions Endovascular stenting based on the angiosome concept and bypass surgery provide comparable benefits for the treatment of long, advanced femoropopliteal lesions after a short follow-up period, whereas cilostazol therapy for more than 3 months, aggressive treatment of dyslipidemia, and surgical revascularization were associated with higher primary patency.

Impact of Low Activity of Daily Living on the Prognosis of Patients with Critical Limb Ischemia and Sarcopenia

We aimed to investigate the impact of low activity of daily living (ADL) on the long-term outcomes after infrainguinal bypass surgery in patients with critical limb ischemia (CLI) and sarcopenia. In this multicenter retrospective cohort study, 110 patients with CLI who underwent infrainguinal bypass between April 2011 and September 2016 were divided into 4 groups according to the presence or absence of sarcopenia before surgery and ADL at discharge (Normal group: absence of sarcopenia and normal ADL [Barthel Index ≥60]; Low ADL alone group: absence of sarcopenia and abnormal ADL [Barthel Index <60]; Sarcopenia alone group: presence of sarcopenia and normal ADL; Sarcopenia and low ADL group: presence of sarcopenia and abnormal ADL). Three-year overall survival (OS) and amputation-free survival (AFS) were compared among the 4 groups using the Kaplan-Meier method, and Cox proportional hazards models were used to assess the unadjusted and adjusted associations between patient characteristics and 3-year OS and AFS. The Sarcopenia and low ADL group was significantly inferior to the other 3 groups in 3-year OS (versus Normal group, P<0.001; versus Low ADL alone group, P=0.005; versus Sarcopenia alone group, P=0.022) and was significantly inferior to the Normal group and Sarcopenia alone group in 3-year AFS (P<0.001 and P=0.027, respectively). In the multivariable analysis, after adjustment for age, sex, ischemic heart disease, and hemodialysis, the presence of both sarcopenia and low ADL was a significant predictor of 3-year OS (hazard ratio [HR] 5.99, 95% confidence interval [CI] 1.92-18.69, P=0.002) and AFS (HR 3.63, 95% CI 1.27-10.39, P=0.016). Low ADL at discharge was a significant predictor of 3-year OS and AFS in patients with CLI and sarcopenia, while either sarcopenia alone or low ADL alone did not significantly affect outcomes.

Feasibility and Mid-Term Outcomes of Drug-Coated Balloon Angioplasty Between Intermittent Claudication and Critical Limb Ischemia in Patients with Femoropopliteal Disease.

The efficacy of drug-coated balloons (DCBs) in critical limb ischemia (CLI) is unclear. To investigate the clinical characteristics and outcomes of DCBs in symptomatic femoropopliteal disease between patients with intermittent claudication (IC) and CLI. Data were retrospectively collected from three centers in Taiwan on patients who received DCBs for femoropopliteal lesions between March 2013 and June 2017. We compared the clinical characteristics and outcomes regarding binary restenosis, amputation-free survival (AFS), and major adverse limb events (MALEs) between groups. Cox proportional hazards analysis was used to identify predictors of outcome endpoints. We enrolled a total of 200 affected limbs in 174 patients, including 83 limbs in 71 patients with IC and 117 limbs in 103 patients with CLI. Compared to the patients with claudication, those with CLI were older and had higher proportions of medical comorbidities, tissue inflammation, poor runoff, and vessel calcification. The 3-year rates of freedom from binary restenosis (57% vs. 59%, p = 0.781), and MALEs (77% vs. 67%, p = 0.507) were similar between the two groups. However, the 3-year AFS was significantly higher in the IC group compared to the CLI group (91% vs. 73%, p = 0.001). Lesion length and severe calcification independently predicted binary restenosis, and restenotic lesion predicted MALEs. Age, congestive heart failure, and dialysis were independently associated with AFS. Despite advanced limb ischemia and comorbidities, the mid-term outcomes in surviving CLI patients were similar to those in the IC patients after treatment with DCBs for femoropopliteal disease.

Heel Wounds Predict Mortality but Not Amputation after Infrapopliteal Revascularization

Ischemic heel ulcerations are generally thought to carry a poor prognosis for limb salvage. We hypothesized that patients undergoing infrapopliteal revascularization for heel wounds, either bypass or endovascular intervention, would have lower wound healing rates and amputation-free survival (AFS) than patients with forefoot wounds. A retrospective chart review was performed on patients who presented between 2006 and 2013 to our institution with ischemic foot wounds and infrapopliteal arterial disease and underwent either pedal bypass or endovascular tibial artery intervention. Data were collected on patient demographics, comorbidities, wound characteristics, procedural details, and postoperative outcomes then analyzed by initial wound classification. The primary outcome was major amputation or death. Three hundred ninety-eight limbs underwent treatment for foot wounds; accurate wound data were available in 380 cases. There were 101 bypasses and 279 endovascular interventions, with mean follow-up of 24.6 and 19.9months, respectively (P=0.02). Heel wounds comprised 12.1% of the total with the remainder being forefoot wounds; there was no difference in treatment modality by wound type (P=0.94). Of 46 heel wounds, 5 (10.9%) had clinical or radiographic evidence of calcaneal osteomyelitis. Patients with heel wounds were more likely to have diabetes mellitus (DM) (P=0.03) and renal insufficiency (P=0.004). 43.1% of wounds healed within 1 year, with no difference by wound location (P=0.30). Major amputation rate at 1 year was 17.8%, with no difference by wound location (P=0.81) or treatment type (P=0.33). One- and 3-year AFS was 66.2% and 44.0% for forefoot wounds and 45.7% and 17.6% for heel wounds, respectively (P=0.001). In a multivariate analysis, heel wounds and endovascular intervention were both predictors of death; however, there was significant interaction such that endovascular intervention was associated with higher mortality in patients with forefoot wounds (hazard ratio 2.25, P<0.001) but not those with heel wounds (hazard ratio 0.67, P=0.31). Patients presenting with heel ulceration who undergo infrapopliteal revascularization are prone to higher mortality despite equivalent rates of amputation and wound healing and regardless of treatment modality. These patients may benefit from an endovascular-first strategy.

Three-Year Outcomes of Surgical Versus Endovascular Revascularization for Critical Limb Ischemia

The aim of this study was to compare clinical outcomes between surgical reconstruction and endovascular therapy (EVT) for critical limb ischemia (CLI) in today's real-world settings. This multicenter, prospective, observational study registered and followed 548 Japanese CLI patients. The registration was in advance of revascularization; 197 patients were scheduled to receive surgical reconstruction, and the remaining 351 were scheduled to receive EVT. The primary end point was 3-year amputation-free survival, compared between the 2 treatments in an intention-to-treat manner, using propensity score matching. Interaction analysis was additionally performed to explore which subgroups had better outcomes with surgical reconstruction or EVT. After propensity score matching, the 3-year amputation-free survival was not significantly different between the 2 groups (52% [95% confidence interval, 43%-60%] and 52% [95% confidence interval, 44-60%]; P=0.26). Subsequent interaction analysis identified (1) Wound, Ischemia, and foot Infection (WIfI) classification W-3, (2) fI-2/3, (3) history of ipsilateral minor amputation, (4) history of revascularization after CLI onset, and (5) bilateral CLI as the factors more favorable for surgical reconstruction, whereas (1) diabetes mellitus, (2) renal failure, (3) anemia, (4) history of nonadherence to cardiovascular risk management, and (5) contralateral major amputation were as those less favorable for surgical reconstruction. The 3-year amputation-free survival was not different between surgical reconstruction and EVT in the overall CLI population. The subsequent interaction analysis suggested that there would be a subgroup more suited for surgical reconstruction and another benefiting more from EVT. URL: http://www.umin.ac.jp/ctr/. Unique identifier: UMIN000007050.

Similar Patency and Limb Salvage Rates in Comparing Primary Bypass with Bypass Following Failed Endovascular Intervention for Lower Limb Arterial Occlusive Disease

Patients with infrainguinal peripheral arterial disease often undergo multiple revascularization procedures. Although many centers have adopted an endovascular-first approach, some are reluctant for fear of damaging outflow and compromising the outcomes of any subsequent bypasses. A systematic review was conducted of MEDLINE, Embase, and CENTRAL databases for studies that compared outcomes of primary infrainguinal bypass with bypass after failed endovascular intervention for peripheral arterial disease. Abstracts and full-text studies were screened independently by two reviewers with data abstraction done in duplicate. Dichotomous outcome measures were reported using the odds ratio (OR) and 95% confidence interval (CI) and pooled using random-effects models. Study quality was assessed using the Newcastle Ottawa Scale. There were 2112 abstracts screened, with 43 selected for full-text review. Of these, 13 studies involving 7325 patients met the inclusion criteria. Pooling the results of studies comparing primary bypass with bypass after failed endovascular intervention showed no significant difference in primary patency (OR, 1.37; 95% CI, 0.61-3.08; Fig 1) or ipsilateral limb salvage at 1 year (OR, 1.37; 95% CI, 0.57-3.28). Similarly, 30-day amputation rates (OR, 1.75; 95% CI, 0.55-5.59), 30-day mortality (OR, 1.04; 95% CI, 0.67-1.61), and 1-year secondary patency (OR, 0.94; 95% CI, 0.47-1.88) were similar between groups. There was a trend toward higher rates of early graft occlusion (OR, 4.24; 95% CI, 0.81-22.09) and worse 3-year amputation-free survival (OR, 1.52; 95% CI, 0.94-2.45) for patients who failed to respond to endovascular intervention, but this was nonsignificant (Fig 2). Meta-analysis of the existing literature comparing primary bypass with bypass following endovascular intervention shows no significant difference in patency or limb salvage. The existing published data are limited by observational study design, inconsistent patient selection, and significant heterogeneity yet suggest that bypass following failed endovascular intervention does not conclusively result in inferior outcomes.Fig 2Forrest plot comparing the pooled odds ratio (OR [95% confidence interval (CI)] for (A) early graft occlusion (within 30 days; OR >1 indicates higher rates of graft occlusion in the bypass after failed endovascular intervention group) and (B) amputation-free survival at 3 years (OR >1 indicates higher amputation-free survival in the primary bypass group).View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Impact of infrapopliteal endovascular treatment on the outcome of subsequent ipsilateral distal bypass for critical limb ischemia.

We retrospectively reviewed the outcomes of distal bypass for critical limb ischemia and investigated the impact on outcomes of prior unsuccessful ipsilateral infrapopliteal endovascular treatment (EVT). Between January 2005 and December 2014, we performed 142 infrainguinal bypasses for critical limb ischemia with ischemic gangrene (Rutherford classes V or VI), including 80 distal bypasses in 74 patients (male 54, female 20, median age 68.4 years, range 51-81 years). All distal bypasses used an autologous saphenous vein graft. Surgical outcomes were compared between 37 distal bypasses without prior infrapopliteal EVT (NEVT group) and 43 distal bypasses after unsuccessful infrapopliteal EVT (PEVT group). Infrapopliteal EVT was performed with balloon dilatation without stenting in all cases. There were no significant differences in preoperative conditions or risk factors between the NEVT and PEVT groups, except for the era of bypass surgery and dependence on hemodialysis. The 3-year primary and secondary patencies were 69% and 72% in the NEVT group and 78% and 80% in the PEVT group (P=0.86, P=0.79). The 3-year limb salvage rates were 81% in the NEVT group and 82% in the PEVT group (P=0.52), and the 3-year amputation-free survival rates were 56% and 57% in the respective groups (P=0.32). Standard errors of the mean for all Kaplan-Meier curves were <10% within 3 years follow-up. The clinical outcomes of distal bypass without prior infrapopliteal EVT were not superior to those of distal bypass after unsuccessful ipsilateral infrapopliteal EVT. Therefore, unsuccessful infrapopliteal EVT does not have a negative impact on the outcome of subsequent ipsilateral distal bypass in patients with critical limb ischemia.

3-Year Outcomes of the OLIVE Registry, a Prospective Multicenter Study of Patients With Critical Limb Ischemia: A Prospective, Multi-Center, Three-Year Follow-Up Study on Endovascular Treatment for Infra-Inguinal Vessel in Patients With Critical Limb Ischemia.

This study sought to investigate the 3-year follow-up results of OLIVE registry patients. Although favorable 12-month clinical outcomes after endovascular therapy (EVT) in OLIVE registry patients with critical limb ischemia (CLI) from infrainguinal disease have been reported, long-term results after EVT remain unknown. This was a prospective multicenter registry study that consecutively enrolled patients who received infrainguinal EVT for CLI. The primary outcome was 3-year amputation-free survival (AFS), whereas secondary outcome measures were 3-year freedom from major adverse limb events (MALE), wound-free survival, and wound recurrence rate. Prognostic predictors for each outcome were also elucidated by Cox proportional hazard regression analysis or the log-rank test. The completion rate of 3-year follow-up was 95%. Three-year AFS, freedom from MALE, and wound-free survival rates were 55.2%, 84.0%, and 49.6%, respectively. Wound recurrence out to 3 years was 43.9%. After multivariable analysis, age (hazard ratio [HR]: 1.43, p = 0.001), body mass index ≤18.5 (HR: 2.17, p = 0.001), dialysis (HR: 2.91, p < 0.001), and Rutherford 6 (HR: 1.64, p = 0.047) were identified as predictors of 3-year major amputation or death. Statin use (HR: 0.28, p = 0.02), Rutherford 6 (HR: 2.40, p = 0.02), straight-line flow to the foot (HR: 0.27, p = 0.001), and heart failure (HR: 1.96, p = 0.04) were identified as 3-year MALE predictors. Finally, CLI due to isolated below-the-knee lesion was a wound recurrence predictor (HR: 4.28, p ≤ 0.001). Three-year survival, freedom from major amputation, and reintervention rates were 63.0%, 87.9%, and 43.2%. In CLI patients with infrainguinal lesions, 3-year clinical results of EVT were reasonable despite high reintervention and moderate ulcer recurrence rate. (A Prospective, Multi-Center, Three-Year Follow-Up Study on Endovascular Treatment for Infra-Inguinal Vessel in Patients With Critical Limb Ischemia [OLIVE 3-Year Follow-Up Study]; UMIN000014759).

Post-treatment neutrophil-lymphocyte ratio independently predicts amputation in critical limb ischemia without operation

OBJECTIVES:Limited information is available concerning the post-treatment neutrophil-lymphocyte ratio in critical limb ischemia patients who receive conservative therapy. Accordingly, this study was designed to evaluate the predictive value of the post-treatment neutrophil-lymphocyte ratio in critical limb ischemia patients without surgery.METHOD:From January 2009 to January 2011, critical limb ischemia patients were admitted to a vascular center. The demographic data, patient histories, comorbidities and risk factors were documented, and the differential cell count was determined at admission and seven days later after conservative therapy. The cutoff value of the post-treatment neutrophil-lymphocyte ratio was determined by an ROC curve. Patients were divided into groups A and B according to the cutoff value. Amputation-free survival was compared between groups. Univariate and multivariate analyses were used to identify independent risk factors.RESULT:A total of 172 patients were identified with a mean age 71.98±10.09 years; among them, 122 were male. A value of 3.8 was identified as the cutoff value of the post-treatment neutrophil-lymphocyte ratio. Groups A (post-treatment neutrophil-lymphocyte ratio ≥3.8) and B (post-treatment neutrophil-lymphocyte ratio <3.8) showed a significant difference in amputation-free survival (P<0.001). The 1-year, 2-year and 3-year amputation-free survival rates were 79.6%, 55.6% and 46.3%, respectively, in group A; however, in group B, these values were 89.7%, 79.3% and 75.9%, respectively. The post-treatment neutrophil-lymphocyte ratio was identified as an independent predictive factor for amputation in critical limb ischemia patients (P<0.001).CONCLUSION:The post-treatment neutrophil-lymphocyte ratio is an independent predictive factor for amputation in critical limb ischemia patients. Patients with a post-treatment neutrophil-lymphocyte ratio ≥3.8 are likely to suffer from amputation; amputation-free survival usually occurs in patients with a post-treatment neutrophil-lymphocyte ratio <3.8.

Lower extremity autologous vein bypass for critical limb ischemia is not adversely affected by prior endovascular procedure

It has been reported that a failed endovascular intervention adversely affects results of lower extremity bypass (LEB). We reviewed rates of prior endovascular intervention (PEI) in patients undergoing LEB with autologous vein for critical limb ischemia (CLI) to determine effects on graft patency, limb salvage, and amputation-free survival. Retrospective review was conducted of consecutive autologous vein LEBs performed for CLI between 2005 and 2012 at a tertiary care academic medical center. Overall, 314 autologous vein LEBs were performed for CLI, 71% for tissue loss. TransAtlantic Inter-Society Consensus II type D or type C lesions were present in 62% and 25%, respectively. The great saphenous vein was used as a conduit in 83%, and the distal target was infrapopliteal in 60%. The 30-day mortality rate was 3.5%. Primary patency rates at 1year and 5years were 61% and 45%. Secondary patency rates at 1year and 5years were 88% and 64%, with 23% requiring an intervention to maintain patency. The 5-year limb salvage rate was 89%, and the 5-year amputation-free survival was 49%. There were 61 patients (19%) who had undergone a PEI and 253 (81%) who underwent bypass with no prior endovascular intervention (NPEI). There were 19 iliac stents, 29 femoral interventions, 13 popliteal interventions, 9 crural interventions, 9 infrainguinal thrombectomies, and 13 infrainguinal thrombolyses. PEI and NPEI patients had similar demographics and prevalence ofatherosclerotic risk factors. The 1-year primary patency rate was 62% for NPEI patients vs 59% for PEI patients (P=.759). The 1-year and 2-year secondary patency rates were 87% and 79% for NPEI patients vs 89% and 78% for PEI patients (P= .947). The 3-year limb salvage rate was 89% for NPEI patients vs 92% for PEI patients (P= .445). The 3-year amputation-free survival was 59% for NPEI patients vs 52% for PEI patients (P= .399). Median follow-up time was 323days for NPEI patients (interquartile range, 83-918) vs 463days for PEI patients (interquartile range, 145-946; P= .275). Overall operative mortality, patency rates, and limb salvage for autologous vein LEB in CLI patients continue to be excellent in the endovascular era and are not necessarily affected by a prior ipsilateral endovascular procedure. Long-term survival remains poor in CLI patients requiring LEB.

Outcome of Arterial Reconstruction and Free‐Flap Coverage in Diabetic Foot Ulcers: Long‐Term Results

Major amputation for advanced soft tissue loss with bone and tendon exposure, can be prevented in diabetes patients with a combined arterial reconstruction and free-flap transfer. We reviewed our 15-year outcome and evaluated the feasibility to save diabetic feet by means of this aggressive strategy. A total of 55 type II diabetes patients (42-80 years of age), hospitalized between January 1992 and December 2006 for a combined arterial reconstruction and free-flap transfer, were followed until December 2007. All would have otherwise required at least a below-knee amputation. Arterial reconstructions, preferentially with autologous vein, were performed in combination with free tissue transfer, simultaneously or staged. The rectus abdominis muscle was the most frequently used muscle graft, although in recent years a growing number of alternative muscle and perforator flaps were used. The mean follow-up was 22 months (range: 1-180 months). Major complications occurred in 37% with only one in-hospital death. Major amputations were performed in 15 patients, 5 in the early postoperative period. The 1-year and 3-year limb salvage rates were 75.8 and 64.3%, with a 1-year and 3-year amputation-free survival of 69.5% and 55.8%. The 1-year and 3-year secondary patency for graft and free flap was 78.7% and 60.2%, respectively. Renal insufficiency was a major risk factor for limb loss (Hazard Ratio [HR] 5.581 (95% Confidence Interval [CI] 1.384-22.5)). Independent ambulation was regained in 38 patients. Combined arterial reconstruction and free tissue transfer provides an excellent long-term result with regard to amputation-free survival and limb salvage. It should be considered in every diabetes patient with extensive soft tissue deficits before amputation is performed.