Alternative vein bypass in octogenarians with chronic limb-threatening ischaemia.

BACKGROUND: Octogenarians are regarded as one of the frailest patient groups among the chronic limb-threatening ischaemia population with high perioperative morbidity and mortality rates. As a result, alternative vein bypass surgery in the absence of sufficient great saphenous vein is often not considered as a potential treatment option. The aim of this study was to compare the results of octogenarians undergoing alternative vein bypass surgery due to chronic limb-threatening ischaemia to younger patients. METHODS: A single-centre retrospective analysis of patients undergoing bypass surgery for chronic limb-threatening ischaemia with alternative autologous vein grafts between 1997 and 2018 was performed. Patients aged over 80 years were compared with those under 80 years. Graft patency rates were assessed and a risk factor analysis for limb loss was performed. RESULTS: In total, 592 patients underwent bypass surgery during the study interval. Twenty-one per cent (n = 126) of patients were 80 years or older. At 4 years, primary, primary-assisted and secondary patency as well as limb salvage rates were not significantly different between the two groups (46% versus 50%, 60% versus 66%, 69% versus 72%, 72% versus 77%, for octogenarians versus non-octogenarians respectively). Major amputations were performed in 27 (21%) octogenarians and 91 (20%) non-octogenarians (P = 0.190). No higher 30-day and long-term mortality rates nor morbidity rates were detected in the octogenarian group with a median follow-up time of 27 (interquartile range 12-56) months. Minor amputation, the reason for alternative vein grafts, as well as the profunda femoris artery as proximal origin of the bypass were risk factors for limb loss in the postoperative course. CONCLUSION: Alternative vein bypass surgery in octogenarians with chronic limb-threatening ischaemia is safe and effective in terms of patency rates, limb salvage and survival compared with younger patients in the absence of sufficient great saphenous vein. Age alone should not be a deterrent from performing bypass surgery.

Popliteal-to-Distal Extreme Bypass in Endovascular Era.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) is characterized by rest pain and tissue loss, with an annual mortality rate of 20% and amputation rate of 40%, if not treated. Open bypass surgery is recommended in CLTI, depending on the availability of good quality venous material, outflow artery patency, and surgical expertise. The aim of the study is to analyze primary patency, limb salvage, and survival rate in patients undergoing popliteal-to-distal bypass. METHODS: All consecutive patients who underwent popliteal-to-distal bypass surgery between January 2016 and December 2021 were enrolled in the study. Primary outcomes were primary patency, limb salvage, and overall survival. Secondary outcomes included amputation-free survival and secondary patency. RESULTS: Forty-nine patients were included during the study. Technical success was achieved in 100% of cases. Target outflow artery was in 27% (n. 13) of cases the anterior tibial artery, in 27% (n. 13) the dorsalis pedis, in 2% (n. 1) the peroneal artery, in 30% (n. 15) the retromalleolar tibial artery, in 10% (n. 5) the medial plantar artery, and in 4% (n. 2) the tarsal artery. Two-year primary patency was 85% ± 5. Secondary patency rates were 86% ± 3 at 2 years. The overall survival was 81% ± 6 at 2 years, the amputation-free survival was 70% ± 9, and the limb salvage rate was 81% ± 6. CONCLUSIONS: Popliteal-to-distal bypass requires high technical expertise to be performed. When a good autologous vein and adequate outflow artery are present, they can be feasible with good patency rates and overall survival.

Long-Term Outcomes of Anatomical and Extra-Anatomical Bypass for the Treatment of Unilateral Iliac Artery Lesions a Systematic Review Aggregated Data and Individual Participant Data Meta-Analysis.

BACKGROUND: We investigated the long-term safety and efficacy of anatomical and extra-anatomical bypass for the treatment of unilateral iliac artery disease. METHODS: A systematic search on PubMed, Scopus and Web of science for articles published by June 2023 was performed. We implemented a 2-stage individual participant data meta-analysis and pooled survival probabilities using the multivariate methodology of DerSimonian and Laird. The primary endpoint was primary patency at 5 and 10 years of follow-up. RESULTS: Ten studies encompassing 1,907 patients were included. The 5- and 10-year pooled patency rates for anatomical bypass were 83.27% (95% confidence interval (CI): 69.99-99.07) and 77.30% (95% CI: 60.32-99.04), respectively, with a mean primary patency time representing the duration individuals remained event-free for 10.08 years (95% CI: 8.05-10.97). The 5- and 10-year pooled primary patency estimates for extra-anatomical bypass were 77.02% (95% CI: 66.79-88.80) and 68.54% (95% CI: 53.32-88.09), respectively, with a mean primary patency time of 9.25 years, (95% CI: 7.21-9.68). Upon 2-stage individual participant data meta-analysis, anatomical bypass displayed a decreased risk for loss of primary patency compared to extra-anatomical bypass, hazard ratio 0.51 (95% CI: 0.30-0.85). The 5- and 10-year secondary patency estimates for anatomical bypass were 96.83% (95% CI: 90.28-100) and 96.13% (95% CI: 88.72-100), respectively. The 5- and 10-year secondary patency estimates for extra-anatomical bypass were 91.39% (95% CI: 84.32-99.04) and 85.05% (95% CI: 74.43-97.18), respectively, with non-statistically significant difference between the 2 groups. The 5- and 10-year survival for patients undergoing anatomical bypass were 67.99% (95% CI: 53.84-85.85) and 41.09% (95% CI: 25.36-66.57), respectively. The 5- and 10-year survival for extra-anatomical bypass were 70.67% (95% CI: 56.76-87.98) and 34.85% (95% CI: 19.76-61.44), respectively. The mean survival time was 6.92 years (95% CI: 5.56-7.89) for the anatomical and 6.78 years (95% CI: 5.31-7.63) for the extra-anatomical groups. The pooled overall 30-day mortality was 2.32% (95% CI: 1.12-3.87) with metaregression analysis displaying a negative association between the year of publication and mortality (ß =-0.0065, P < 0.01). Further analysis displayed a 30-day mortality of 1.29% (95% CI: 0.56-2.26) versus 4.02% (95% CI: 1.78-7.03), (P = 0.02) for studies published after and before the year 2000. Non-statistically significant differences were identified between the 2 groups concerning long-term and 30-day mortality outcomes. CONCLUSIONS: While we have demonstrated favorable long-term primary and secondary patency outcomes for both surgical techniques, anatomical bypass exhibited a reduced risk of primary patency loss potentially reflecting its inherent capacity to circumvent the anticipated disease progression in the distal aorta and the contralateral donor artery. The reduction in perioperative mortality observed in our review, coupled with the anachronistic demographic characteristics and inclusion criteria presented in the existing literature, underscores the imperative necessity for contemporary research.

Predictors of amputation-free survival and wound healing after infrainguinal bypass with alternative conduits.

OBJECTIVE: Inadequate vein quality or prior harvest precludes use of autologous single segment greater saphenous vein (ssGSV) in many patients with chronic limb-threatening ischemia (CLTI). Predictors of patient outcome after infrainguinal bypass with alternative (non-ssGSV) conduits are not well-understood. We explored whether limb presentation, bypass target, and conduit type were associated with amputation-free survival (AFS) after infrainguinal bypass using alternative conduits. METHODS: A single-center retrospective study (2013-2020) was conducted of 139 infrainguinal bypasses performed for CLTI with cryopreserved ssGSV (cryovein) (n = 71), polytetrafluoroethylene (PTFE) (n = 23), or arm/spliced vein grafts (n = 45). Characteristics, Wound, Ischemia, and foot Infection (WIfI) stage, and outcomes were recorded. Multivariable Cox proportional hazards and classification and regression tree analysis modeled predictors of AFS. RESULTS: Within 139 cases, the mean age was 71 years, 59% of patients were male, and 51% of cases were nonelective. More patients undergoing bypass with cryovein were WIfI stage 4 (41%) compared with PTFE (13%) or arm/spliced vein (27%) (P = .04). Across groups, AFS at 2 years was 78% for spliced/arm, 79% for PTFE, and 53% for cryovein (adjusted hazard ratio for cryovein, 2.5; P = .02). Among cases using cryovein, classification and regression tree analysis showed that WIfI stage 3 or 4, age >70 years, and prior failed bypass were predictive of the lowest AFS at 2 years of 36% vs AFS of 58% to 76% among subgroups with less than two of these factors. Although secondary patency at 2 years was worse in the cryovein group (26% vs 68% and 89% in arm/spliced and PTFE groups; P < .01), in patients with tissue loss there was no statistically significant difference in wound healing in the cryovein group (72%) compared with other bypass types (72% vs 87%, respectively; P = .12). CONCLUSIONS: In patients with CLTI lacking suitable ssGSV, bypass with autogenous arm/spliced vein or PTFE has superior AFS compared with cryovein, although data were limited for PTFE conduits for distal targets. Despite poor patency with cryovein, wound healing is achieved in a majority of cases, although it should be used with caution in older patients with high WIfI stage and prior failed bypass, given the low rates of AFS.

Secondary interventions following open vs endovascular revascularization for chronic limb threatening ischemia in the BEST-CLI trial.

OBJECTIVES: Patients undergoing revascularization for chronic limb-threatening ischemia experience a high burden of target limb reinterventions. We analyzed data from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) randomized trial comparing initial open bypass (OPEN) and endovascular (ENDO) treatment strategies, with a focus on reintervention-related study endpoints. METHODS: In a planned secondary analysis, we examined the rates of major reintervention, any reintervention, and the composite of any reintervention, amputation, or death by intention-to-treat assignment in both trial cohorts (cohort 1 with suitable single-segment great saphenous vein [SSGSV], n = 1434; cohort 2 lacking suitable SSGSV, n = 396). We also compared the cumulative number of major and all index limb reinterventions over time. Comparisons between treatment arms within each cohort were made using univariable and multivariable Cox regression models. RESULTS: In cohort 1, assignment to OPEN was associated with a significantly reduced hazard of a major limb reintervention (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.28-0.49; P < .001), any reintervention (HR, 0.63; 95% CI, 0.53-0.75; P < .001), or any reintervention, amputation, or death (HR, 0.68; 95% CI, 0.60-0.78; P < .001). Findings were similar in cohort 2 for major reintervention (HR, 0.53; 95% CI, 0.33-0.84; P = .007) or any reintervention (HR, 0.71; 95% CI, 0.52-0.98; P = .04). In both cohorts, early (30-day) limb reinterventions were notably higher for patients assigned to ENDO as compared with OPEN (14.7% vs 4.5% of cohort 1 subjects; 16.6% vs 5.6% of cohort 2 subjects). The mean number of major (mean events per subject ratio [MR], 0.45; 95% CI, 0.34-0.58; P < .001) or any target limb reinterventions (MR, 0.67; 95% CI, 0.57-0.80; P < .001) per year was significantly less in the OPEN arm of cohort 1. The mean number of reinterventions per limb salvaged per year was lower in the OPEN arm of cohort 1 (MR, 0.45; 95% CI, 0.35-0.57; P < .001 and MR, 0.66; 95% CI, 0.55-0.79; P < .001 for major and all, respectively). The majority of index limb reinterventions occurred during the first year following randomization, but events continued to accumulate over the duration of follow-up in the trial. CONCLUSIONS: Reintervention is common following revascularization for chronic limb-threatening ischemia. Among patients deemed suitable for either approach, initial treatment with open bypass, particularly in patients with available SSGSV conduit, is associated with a significantly lower number of major and minor target limb reinterventions.

Impact of Perioperative Blood Transfusion in Anemic Patients Undergoing Infra Inguinal Bypass.

OBJECTIVE: Patients who present with lower extremity ischemia are frequently anemic and the optimal transfusion threshold for this cohort remains controversial. We sought to evaluate the impact of blood transfusion on postoperative major adverse cardiac events (MACE), including myocardial infarction, dysrhythmia, stroke, congestive heart failure, and 30-day mortality for these patients. METHODS: All consecutive patients who underwent infra-inguinal bypass at our institution from 2011 to 2020 were included. Perioperative red blood cell transfusion was the primary exposure, and the primary outcome was MACE. Univariate and multivariable analyses were performed to assess the impact of patient and procedural variables, including red blood cell transfusion, stratified by hemoglobin (Hgb) nadir: <7, 7-8, and >8 g/dL. RESULTS: Of the 287 patients reviewed for analysis, 146 (50.9%) had a perioperative transfusion (mean: 1.6 ± 3 units). Patients who received a transfusion had a mean nadir Hgb of 8.3 ± 1.0 g/dL, compared to 10.1 ± 1.7 g/dL without a transfusion. The overall incidence of MACE was 15.7% (45 of 287 patients). Univariate analysis demonstrated that MACE was associated with blood transfusion (P = 0.009), lower Hgb nadir (P = 0.02), and higher blood loss (P = 0.003). On multivariate analysis, transfusion was independently associated with MACE for patients with a Hgb nadir >8 g/dL (OR: 3.09; P = 0.006), but not for patients with Hgb nadir 7-8 g/dL (OR: 0.818; P = 0.77). Additionally, patients with MACE had significantly longer length of hospital stay than for patients without (13 vs. 7.7 days, P = 0.001). CONCLUSIONS: For patients undergoing infra-inguinal bypass, receiving a red blood cell transfusion with a Hgb nadir >8 g/dL was associated with a 3-fold increase in MACE, with nearly twice the length of stay. For patients with a Hgb 7-8 g/dL, transfusion did not increase or reduce the incidence of MACE. These findings suggest no benefit of blood transfusion for patients with Hgb nadir >7 g/dL and harm for Hgb >8 g/dL, however causation cannot be proven due to the retrospective nature of the study and randomized studies are needed to confirm or refute these findings.

Contemporary Use of the Femoropopliteal Vein in Vascular Reconstructions.

INTRODUCTION: Current practice patterns favor endovascular treatment, resulting in fewer open procedures. When needed, greater saphenous vein and/or prosthetic conduits are considered the first choice for open vascular bypass. However, there is a cohort of patients in which these conduits are either not available or not suitable to address the surgical requirements. One alternative is to use femoropopliteal vein (FPV), an often-overlooked conduit. We report on the contemporary use of FPV in a tertiary vascular institution. METHODS: All patients who underwent FPV harvest, as defined by CPT code 35572, between 2005 and 2019 were identified. Patient demographics (sex, age, baseline laboratory values, medical co-morbidities), indication for use of FPV, complications specific to vein harvest, operative details, post-operative course, and outcomes were recorded. RESULTS: Ninety patients had harvest of FPV for creation of 123 conduits. In this study, a conduit was defined as a segment of vein used to perfuse a distinctly separate vascular bed. We identified four cohorts in which FPV was used: aorto-iliac reconstruction in 38 patients for infected graft (19), occlusive disease (8), aortitis (5), mycotic aneurysm (5), and malignancy (1); peripheral artery revascularization in 26 patients for ilio-femoral reconstruction (15), femoropopliteal reconstruction (4), upper extremity/cerebrovascular reconstruction (6), and coronary bypass (1); mesenteric revascularization in 20 patients for acute or acute on chronic ischemia (12), chronic ischemia (7) or aneurysm (1); and dialysis access in 6 patients. There was a high incidence of pre-existing comorbid conditions in all groups, but most notably those patients who underwent aorto-iliac reconstruction. Harvest-related or conduit-related complications included compartment syndrome, graft-associated hemorrhage, surgical site infection, and lymphatic complications. Primary graft patency at 3 years was 83% ± 4% (aorto-iliac), 83% ± 6% (peripheral), 100% (mesenteric), and 23% ± 19% (dialysis access, P < 0.001). CONCLUSIONS: While use of FPV has potential significant harvest-related, conduit-related, or systemic complications, FPV is useful for a variety of needs, almost universally available, and durable. In the current era where endovascular approach is the focus, FPV should not be forgotten as a potential conduit that can be used for a variety of vascular reconstruction indications.

Contemporary outcomes of concomitant suprainguinal bypass with infrainguinal revascularization procedures in patients with chronic limb-threatening ischemia.

OBJECTIVE: Combined suprainguinal and infrainguinal revascularization is sometimes necessary in the treatment of patients with chronic limb-threatening ischemia (CLTI). However, data on outcomes of concomitant revascularization procedures are lacking. We studied the outcomes of patients with CLTI who underwent suprainguinal bypass (SIB) alone, SIB with concomitant infrainguinal bypass (IIB), and SIB with concomitant infrainguinal peripheral endovascular intervention (IIPVI). METHODS: We reviewed all patients in the Vascular Quality Initiative with CLTI who underwent SIB from January 2010 to June 2020. Logistic regression, Kaplan-Meier survival estimates, log-rank tests, and Cox regression were used to analyze outcomes. Outcomes were 30-day mortality, perioperative myocardial infarction, perioperative major amputation, 1-year amputation-free survival, and 5-year survival. RESULTS: Of 8037 patients included, 81.3% (n = 6537) underwent SIB alone, 9.7% (n = 783) underwent SIB+IIB, and 8.9% (n = 717) underwent SIB+IIPVI. The indication for surgery was rest pain in 5040 (62.5%) and tissue loss in 3031 (37.6%). There were no significant differences in 30-day mortality and perioperative myocardial infarction rates. However, there was 2.8-fold increased odds of perioperative major amputation in both SIB+IIPVI (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.30-5.88; P = .008) and SIB+IIB (OR, 2.79; 95% CI, 1.38-5.54; P = .004) among patients with rest pain as compared with SIB alone. Comparing SIB+IIPVI with SIB alone, there were no significant differences in 1-year freedom from amputation and amputation-free survival. SIB+IIPVI was associated with a 27% increased risk of 5-year mortality (hazard ratio [HR], 1.27; 95% CI, 1.03-1.55; P = .035). Compared with SIB alone, SIB+IIB was associated with 97% increased risk of 1-year major amputation among patients with rest pain (HR, 1.97; 95% CI, 1.06-3.69; P = .033), but a 47% decreased risk of 1-year major amputation or death for patients with tissue loss (HR, 0.53; 95% CI, 0.37-0.78; P = .001). SIB+IIPVI, compared with SIB+IIB, was associated with a two-fold increased risk of 1-year major amputation or death (HR, 2.04; 95% CI, 1.04-2.23), P = .003) and a 52% increased risk of 5-year mortality (HR,1.52; 95% CI, 1.04-2.24; P = .032) among patients with tissue loss. CONCLUSIONS: This study shows that SIB with concomitant infrainguinal revascularization in patients with rest pain is associated with an increased risk of amputation, whereas SIB+IIB in patients with tissue loss is associated with decreased risk of amputation or death. SIB+IIB outperformed SIB+IIPVI in patients with tissue loss. SIB with infrainguinal revascularization should be limited in patients with rest pain in line with current guidelines, but SIB+IIB may be preferred in patients with tissue loss.

Outcomes of bypass and endovascular interventions for advanced femoropopliteal disease in patients with premature peripheral artery disease.

OBJECTIVE: Patients with premature peripheral artery disease (PAD), defined as age ≤50 years at presentation, have had poor outcomes with open and endovascular lower extremity revascularization. It is unclear whether either strategy is associated with better outcomes because comparative studies have been limited to case series in this patient population. The aim of the present study was to compare the outcomes of patients with premature PAD who had undergone bypass or endovascular revascularization for advanced femoropopliteal disease. Our hypothesis was that open bypass would provide superior long-term outcomes compared with endovascular intervention for patients with premature advanced femoropopliteal PAD. METHODS: All the patients with premature PAD who had undergone isolated femoropopliteal lower extremity revascularization and included in the Vascular Quality Initiative infrainguinal bypass and peripheral vascular intervention files were reviewed from 2003 through 2019. Propensity score matching (1:1) was performed between patients who had undergone femoropopliteal bypass and endovascular interventions for isolated femoropopliteal Trans-Atlantic Classification System C or D lesions. The 1-year outcomes, including reintervention, patency, major amputation, and mortality, were analyzed. RESULTS: Of the 2538 included patients, 902 had undergone isolated femoropopliteal endovascular intervention and 1636 had undergone femoropopliteal bypass. The endovascular intervention group were more likely to have diabetes (68.9% vs 54.0%; P < .001), coronary artery disease (31.0% vs 23.0%; P < .001), renal failure requiring dialysis (14.2% vs 7.2%; P < .001), and claudication (45.1% vs 36.6%; P < .001) compared with the bypass group. After propensity score matching, 466 patients were in each group with no significant differences in the baseline characteristics. Perioperative morbidity was higher with femoropopliteal bypass compared with endovascular intervention (12.0% vs 7.9%; P = .038); however, the rates of major amputation and mortality were not different. At 1 year, patients who had undergone femoropopliteal bypass were less likely to require reintervention (17.0% vs 25.2%; P = .012). However, no differences were found in major amputation (7.7% vs 7.9%; P = .928) or mortality (5.2% vs 5.2%; P = 1.00). Propensity score matching was also performed between femoropopliteal bypass with the great saphenous vein and isolated femoropopliteal endovascular interventions, and the outcomes were similar. CONCLUSIONS: For patients with premature PAD and advanced femoropopliteal disease, bypass surgery decreased the reintervention rate at 1 year but was associated with increased perioperative morbidity and hospital length of stay compared with endovascular therapy. No differences were found in major amputation or mortality between the two strategies.

Outcome of Femoral-popliteal Bypass Procedures in Different Ethnic Groups in England: A Retrospective Analysis of Hospital Episode Statistics.

BACKGROUND: Previous studies, mainly from the United States, have reported worse outcomes from lower limb bypass procedures in ethnic minority populations. Limited nationwide data are available from ethnic minority populations from Europe. The aim of this study is to investigate outcomes from lower limb bypass procedures in ethnic minorities from England. METHODS: We enquired the "Hospital Episode Statistics" database, using ICD-10 codes to identify all cases of femoral-popliteal bypass operations from English NHS Hospitals from 01/01/2006 to 31/12/2015. Every case was followed up for 2 years for subsequent events. The primary outcomes were mortality and major leg amputation. Patients were broadly categorised according to Black, Asian and White ethnicity. Chi-square test was used to the ethnic groups and odds ratios (OR) were calculated using White ethnic group with the largest numbers of participants as a reference category. RESULTS: In the examined 10-year period, 20825 femoral-popliteal bypass procedures (250 of Black, 167 of Asian, and 20.408 of White ethnicity) were recorded. Thirty-day and 2-year mortality were 2.8% and 16.8% with no significant ethnic differences. Patients of Black ethnicity had higher risk of limb loss compared to Whites (23.2% vs. 15.6%, OR = 1.63, 95% confidence interval (CI) 1.21-2.19, P < 0.01). There was no significant difference in amputation rates between Asians and Whites (16.2% vs.. 15.6%, P = 0.94). CONCLUSIONS: Patients of Black ethnicity are at higher risk of limb loss after a femoropopliteal bypass procedure. Further research is needed to identify the causes of this discrepancy.

Early evaluation of the infrainguinal revascularization strategy selection tool of the Global Vascular Guidelines for chronic limb-threatening ischemia patients.

OBJECTIVE: The Global Vascular Guidelines (GVG) propose a novel Global Anatomic Staging System (GLASS) with the Wound, Ischemia, and foot Infection (WIfI) classification system as a clinical decision-making tool for interventions in chronic limb-threatening ischemia (CLTI). We assessed the validity of clinical staging and the relationship between the treatments recommended by the GVG and the outcomes of the actual procedures. METHODS: This retrospective, single-center, observational study included 117 patients with CLTI undergoing infrainguinal revascularization in our hospital between 2015 and 2019. Of those patients, 55 underwent open bypass (OB) and 62 underwent endovascular revascularization (EVR). Femoropopliteal, infrapopliteal, and inframalleolar GLASS grades were assigned based on angiographic images. These grades were combined to determine the revascularization strategy recommended by the GVG: "endovascular," "indeterminate," and "open bypass." The indeterminate category includes three subcategories: GLASS stage III, WIfI stage 2; GLASS stage II, WIfI stage 3; and GLASS stage II, WIfI stage 4. For the purposes of this study, we labeled these subcategories A, B, and C, respectively. The primary outcome was the correlation between the revascularization strategies recommended by the GVG and the actual procedures performed. The relationships between the actual procedures and overall survival, limb salvage, and patency were also examined. RESULTS: The femoropopliteal and infrapopliteal GLASS grades were higher in the OB group. EVR was performed more often for GLASS stages I and II and was more often classified as indeterminate B and C, whereas OB was performed more often in GLASS stage III and was more often classified as indeterminate A. There were no statistically significant differences in the inframalleolar/pedal disease descriptor or in the 30-day postoperative complication rates between the two groups. In higher GLASS stages, the technical success rate of EVR was lower, and lesion complexity was more severe. Patients for whom the recommended strategy according to the GVG would have been OB but who underwent EVR were associated with low limb salvage and patency rates. CONCLUSIONS: The GVG provide good guidance for the selection of the revascularization strategy. When the GVG indicate OB, it should be the treatment of choice, rather than EVR, for patients who are fit to undergo the procedure.

A Comparison of Contemporary Clinical Outcomes Following Femoro-Popliteal Plain Balloon Angioplasty and Bypass Surgery for Chronic Limb Threatening Ischemia.

INTRODUCTION: Despite the BASIL-1 trial concluding that bypass surgery (BS) was superior to plain balloon angioplasty (PBA) in terms of longer-term amputation free (AFS) and overall survival (OS), CLTI patients are increasingly offered an endovascular-first revascularization strategy. This study investigates whether the results of BASIL-1 are still relevant to current practice by comparing femoro-popliteal (FP) BS with PBA in a series of CLTI patients treated in our unit 10 years after BASIL-1 (1999-2004). METHODS: We retrospectively analyzed prospectively gathered hospital data pertaining to 279 patients undergoing primary FP BS or PBA for CLTI in the period 2009 to 2014. We report baseline characteristics, 30-day morbidity and mortality, major adverse cardiovascular events (MACE) and long-term AFS, limb salvage (LS), OS, major adverse limb events (MALE), and freedom from re-intervention (FFR). RESULTS: 234 (84%) and 45 (16%) patients underwent PBA and BS respectively. PBA patients were significantly older (77 vs 71 years, P = 0.001) and more likely to be female (45% vs 28%, P = 0.026). Bollinger and GLASS anatomic scores were significantly more severe in the BS group. Technical success was better for BS (100% vs 87%, P = 0.007). Index hospital stay was shorter for PBA (9.1 vs 15.6 days, P = 0.035) but there was no difference in hospital days or admissions over the next 12 months. AFS (HR 1.00), LS (HR 1.44), OS (HR 0.81), MALE (HR 1.25) and FFR (HR = 1.00) were not significantly different between PBA and BS. CONCLUSION: Important clinical outcomes following FP BS and PBA for CLTI have not changed significantly in our unit in the 10 years following the BASIL-1 trial. BASIL-1 therefore remains relevant to our current practice and should inform our approach to the management of CLTI going forward.

Sarcopenia in Patients Undergoing Lower Limb Bypass Surgery is Associated with Higher Mortality and Major Amputation Rates.

BACKGROUND: Sarcopenia is adversely associated with survival in several diseases. Vasculopathy is often associated with multimorbidity and consequent deconditioning with poor long-term outcomes. This study examined the impact of sarcopenia on clinical outcome in patients with and without critical limb-threatening ischaemia who underwent infrainguinal bypass surgery. METHODS: All patients undergoing infra-inguinal surgical revascularisation in 2016-2018 were retrospectively reviewed. Sarcopenia was defined as a skeletal muscle area at the L3 vertebral level (defined as L3 muscle area < 114cm2 for men or <89.8cm2 for women) on CT angiography. The primary outcome was overall survival by analysed by time to event analysis. Secondary outcomes included ipsilateral major lower-limb amputation, length of hospital stay, myocardial infarction and surgical-site infection. RESULTS: A total of 116 patients with a mean age of 66.9 years were included, with a mean follow-up of 21 months. 14 (12%) of patients were sarcopenic; there were more patients with diabetes (40% vs 7%) in the sarcopenic group, p=0.018. Age, gender, Rutherford grade at presentation, other co-morbidities, other laboratory tests, conduit material and Rutherford grade at presentation were similar in those with and without sarcopenia and were statistically insignificant upon testing. Overall survival was worse for sarcopenic patients (Log Rank P=0.001) and Hazard Ratio for death 5.8; 95%CI 1.8-19.1; P=0.001. Major lower-limb amputation occurred more frequently in patients with sarcopenia (7/14 [50%] vs 23/102 [23%]; P=0.046). There was no difference in other secondary outcomes including rates of graft occlusion, myocardial infarction, surgical site infection and length of stay. Adding SMA measurement to a multivariate generalised linear model including age, sex, diabetes, and haemoglobin improved the AUROC from 0.75-0.85. CONCLUSION: In this cohort of patients undergoing vascular surgery, sarcopenia defined using L3 muscle area was significantly associated with overall mortality and major lower-limb amputation.

Contemporary Endovascular 30-Day Outcomes for Critical Limb Threatening Ischemia Relative to Surgical Bypass Grafting.

OBJECTIVES: Data from 2011-2014 showed lower extremity bypass(LEB) outperforming infrainguinal endovascular intervention(IEI) regarding major adverse limb events(MALE) but noted no significant difference in major adverse cardiac events(MACE) in propensity matched cohorts. This study aimed to determine if more recent(2015-2018) endovascular outcomes data have improved relative to surgical bypass. METHODS: Patients who underwent intervention for chronic limb threatening ischemia (CLTI) from 2015-2018 were identified using the American College of Surgeons National Quality Improvement Program(NSQIP) Vascular Surgery module. The cohort was categorized as undergoing lower extremity bypass(LEB) or infrainguinal endovascular intervention(IEI). Primary 30-day outcomes included major adverse cardiac events(MACE), major adverse limb events(MALE), and major amputation. Inverse probability weighting was used for multivariable analysis. RESULTS: A total of 10,783 patients underwent an infrainguinal intervention for CLTI from 2015-2018. Of these, 6,003(55.7%) underwent LEB and 4,780(44.3%) underwent IEI. Forty percent of the cohort was considered "high anatomic risk" by Objective Performance Goals(OPG) standards, and 13.6% were considered "high clinical risk." The IEI cohort vs. the LEB cohort experienced a Myocardial infarction(MI)/Stroke rate of 1.8% vs. 3.6%(p < .001), and had a mortality rate of 2.0% vs. 1.7%(p = .22), which yielded a composite MACE of 3.4% vs. 4.8%(p = .001). The rate of reintervention for IEI vs LEB was 4.4% vs. 5.3%(p = .04), the loss of patency (without re-intervention) rate was 1.8% vs. 1.8%(p = 1.0), and the major amputation rate was 4.1% vs. 3.5%(p = .15), which resulted in a MALE rate of 9.1% vs. 8.8%(p = .50). Following inverse probability weighting, comparing the IEI to the referent LEB, MALE AOR = 1.17, 95% CI[1.01 -1.36], p = .036, MACE AOR = 0.61, 95% CI[0.49-0.74], p < .001, and major amputation AOR = 1.31, 95% CI[1.05 -1.62], p = .016. CONCLUSION: Endovascular outcomes continue to demonstrate inferiority in major amputation and overall MALE. However, endovascular intervention has a significantly reduced incidence of MACE. Overall, these results demonstrate an improvement in endovascular MACE rates in recent years relative to surgical bypass.

Arm Vein versus Small Saphenous Vein for Lower Extremity Bypass in the Absence of Both Great Saphenous Veins.

BACKGROUND: Bypass surgery remains the gold standard for long and complex arterial occlusions in the lower limb. The vein is regarded superior to prosthetic conduits in peripheral arterial bypass surgery. However, this option is often limited because of previous bypass, stripping, or poor quality of the ipsilateral and/or contralateral great saphenous vein (GSV). Under these circumstances, the arm vein (AV) and small saphenous vein (SSV) are the only alternative autologous vein grafts. METHODS: We analyzed all consecutive patients treated at an academic tertiary referral center between January 1998 and July 2018 using either the AV or SSV as the main peripheral bypass graft. Study end points were primary patency, secondary patency, limb salvage, and survival. RESULTS: In total, 416 bypass procedures using exclusively AV (n = 327) or SSV (n = 89) were performed. There was a predominance of male gender. The majority of risk factors were evenly distributed between groups. The mean follow-up period was 2.3 years (0.9 to 13.3 years). Five-year primary and secondary patency rates were 39% (95% CI: 31-47%) and 67% (59-75%) for AV and 53% (41-66%) and 76% (67-86%) for SSV, respectively (P = 0.2 and 0.25). The five-year limb salvage and survival rates were 71% (68-81%) and 84% (77-90%) for AV and 78% (67-88%) and 90% (82-98%) for SSV, respectively (P = 0.52 and 0.11). CONCLUSIONS: Both AV and SSV are equally effective alternatives for peripheral bypass if no GSV is available. Although there was a trend toward better results with the SSV, there was no significant difference between the 2 options.

Comparative Analysis of Outcomes in Patients Undergoing Femoral Endarterectomy plus Endovascular (Hybrid) or Bypass for Femoropopliteal Occlusive Disease.

INTRODUCTION: The gold-standard for management of combined common femoral artery (CFA) and superficial femoral artery (SFA) atherosclerotic occlusive disease has traditionally been open femoral endarterectomy and femoral-popliteal bypass. Hybrid approaches involving an open and endovascular component are increasingly common. The aim of this study was to compare perioperative outcomes in patients who underwent an open versus hybrid revascularization. METHODS: NSQIP data, years 2012-2017, were queried for patients who underwent nonemergent CFA endarterectomy with either SFA transluminal intervention or bypass. The primary outcome of interest was a composite of cardiovascular, pulmonary, and renal complications (systemic) and mortality. Two propensity-weight adjusted analyses were performed: 1) comparing hybrid and prosthetic bypass 2) comparing hybrid and vein bypass. RESULTS: There were 4,478 patients included (1,537 hybrid, 1,408 prosthetic, 1,533 vein); 64.8% were men, and the mean age was 67.8 ± 9.7 years; 29.9% had claudication, 38.8% had tissue loss, and 31.3 were unspecified. In the propensity-weighted analysis comparing hybrid to prosthetic bypass, there was no difference in systemic complications (OR = 1.29 for prosthetic vs. hybrid; 95% CI: 0.95-1.76; P = 0.107) or mortality (OR = 1.54; 95% CI: 0.71-3.33; P = 0.275). Prosthetic bypass was associated with more deep surgical-site infections (OR = 2.02; 95% CI: 1.19-3.45; P = 0.010), postoperative sepsis (OR = 2.07; 95% CI: 1.13-3.76; P = 0.018), unplanned 30-day readmission (OR = 1.28; 95% CI: 1.04-1.58; P = 0.021), and the composite of any complication (OR = 1.38; 95% CI: 1.18-1.61; P < 0.001). In the propensity-weighted analysis comparing hybrid to vein bypass, there was no difference in systemic complications (OR = 1.10 for vein vs. hybrid; 95% CI: 0.81-1.49; P = 0.552) or mortality (OR = 0.91; 95% CI: 0.42-2.00; P = 0.819). Vein bypass was associated with more superficial surgical-site infections (OR = 1.45; 95% CI: 1.04-2.02; P = 0.028), and the composite of any complication (OR = 1.32; 95% CI: 1.13-1.54; P = 0.001). Overall mortality was significantly higher patients with systemic complications (13.9% vs 0.1%; P < 0.001). Systemic complications were less common in patients with claudication undergoing hybrid revascularization than vein or prosthetic bypass. CONCLUSIONS: Claudicants undergoing bypass experienced more systemic complications than those undergoing hybrid procedures, but there appears to be no increased risk of systemic complications or mortality with open reconstruction when compared to hybrid procedures for other indications. Other complications, such as infection, postoperative transfusion, and readmission, were more common in the bypass groups.

Safety and durability of concomitant carotid endarterectomy with carotid-subclavian bypass grafting.

BACKGROUND: Concomitant carotid endarterectomy (CEA; for severe internal carotid artery stenosis) with carotid-subclavian bypass grafting (CSBG; for proximal common carotid artery or subclavian artery occlusion) is rarely used. Only a few studies have been reported. This report analyzed early and late clinical outcomes of the largest study to date of the combined procedures in our institution. METHODS: Electronic medical records of patients who had concomitant CEA with CSBG during three decades were analyzed. Indications for surgery were arm ischemia, neurologic events, and clinical subclavian steal. Early (30 days) perioperative complications (stroke, death, and others) and late complications (stroke, death) were recorded. Kaplan-Meier analysis was used to estimate late graft/CEA primary patency, freedom from stroke, and stroke-free survival rates. Graft patency was determined clinically and confirmed using duplex ultrasound. Outcomes were compared with previously published data on isolated CSBG by the same group. RESULTS: There were 37 combined procedures analyzed. Mean age was 64 years (range, 45-81 years). Indications for surgery were arm ischemia in 12 (32%), hemispheric transient ischemic attack or stroke in 15 (41%), vertebrobasilar insufficiency in 4 (11%), symptomatic subclavian steal in 10 (27%), and asymptomatic common carotid artery occlusion with severe internal carotid artery stenosis in 6 (16%). The 30-day perioperative (stroke and death) rate was 5.4% (one stroke and one death). Immediate symptom relief was noted in 100%, with 2.7% (transient ischemic attack) symptom recurrence. The crude patency rate of both CEA and CSBG was 92%. At 1 year, 2 years, 3 years, 4 years, and 5 years, respectively, primary patency rates were 100%, 96%, 96%, 96%, and 85%; freedom from stroke rates were 97%, 97%, 97%, 97%, and 97%; and stroke-free survival rates were 94%, 94%, 87%, 82%, and 78%. When these outcomes were compared with the isolated CSBG group alone (28 patients), there was no difference in perioperative stroke (2.7% for concomitant CEA/CSBG vs 0% for isolated CSBG), perioperative death (2.7% vs 2.8%), or late patency rates (92% vs 96%). CONCLUSIONS: Concomitant CEA/CSBG is safe and durable. There was no significant difference in perioperative stroke/death or late patency rates compared with isolated CSBG.

Literature review and meta-analysis of the efficacy of cilostazol on limb salvage rates after infrainguinal endovascular and open revascularization.

BACKGROUND: Current clinical guidelines recommend the use of cilostazol in the treatment of patients with infrainguinal peripheral artery disease (PAD) who experience intermittent claudication. However, the role of cilostazol therapy in patients with advanced PAD and critical limb ischemia (CLI) remains unclear. To conduct a meta-analysis of randomized controlled trials and cohort studies that evaluated the effect of cilostazol vs standard antiplatelet therapy on limb-related and arterial patency-related outcomes. We also reviewed literature pertinent to the effect of cilostazol on wound healing in patients with advanced PAD. METHODS: We performed a MEDLINE, EMBASE, COCHRANE (CENTRAL), SCOPUS, and US Clinical Trials database search for all trials and studies since 1999 that compared cilostazol with standard antiplatelet therapy in the setting of infrainguinal PAD revascularization procedures (endovascular or open). Aggregate data was collected from four randomized control trials and six retrospective cohort studies. The end point incidence ratios and treatment effects were generated from each study and reported as hazard ratios (HR) using a random-effect model. We also reviewed 10 studies that evaluated the effect of cilostazol on wound healing in patients with advanced PAD. RESULTS: From more than 25,000 total patients, 3136 patients met our inclusion criteria. All patients had at least lifestyle-impacting intermittent claudication, and more than 50% met the definition of CLI (Rutherford class ≥4). Patient age range was 53 to 83 years, and the majority were male (66%). The mean follow-up time averaged 2 years across all studies. Meta-analysis revealed that cilostazol treatment favored amputation-free survival (hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.69-0.91), limb salvage rate (HR, 0.42; 95% CI, 0.27-0.66), decreased repeat revascularization (risk ratio [RR], 0.44; 95% CI, 0.37-0.52), and decreased restenosis (RR, 0.68; 95% CI, 0.61-0.76). Cilostazol treatment also increased freedom from target lesion revascularization (RR, 1.35; 95% CI, 1.21-1.53) with no difference in all-cause mortality. Effective wound healing was found to be an inconsistent outcome measure in patients receiving cilostazol therapy. CONCLUSIONS: We observed that cilostazol therapy has a beneficial impact on all limb-related and arterial patency-related outcomes, but no effect on all-cause mortality in patients with advanced PAD and CLI undergoing revascularization procedures. Additional studies are needed to evaluate the effect of cilostazol therapy on wound healing in patients with advanced PAD.

Outcomes of open and endovascular interventions in patients with chronic limb threatening ischemia.

OBJECTIVES: Widespread adoption of endovascular therapy for the treatment of chronic limb-threatening ischemia has transformed the field of vascular surgery. In this modern era, we aimed to define where open surgical interventions are of greatest benefit for limb salvage. METHODS: Patients who underwent interventions for chronic limb-threatening ischemia were identified in the vascular-targeted lower extremity National Surgical Quality Improvement Program database for open surgical interventions (OPEN) and endovascular surgical interventions (ENDO) from 2011 to 2017. Patients were further stratified based on the criteria of chronic limb-threatening ischemia (rest pain or tissue loss), and the location of the diseased arteries (femoropopliteal or tibioperoneal). The main outcomes measured included 30-day mortality, amputation, and major adverse cardiovascular events. RESULTS: A total of 17,193 patients were revascularized for chronic limb-threatening ischemia: 10,532 were OPEN and 6661 were ENDO. OPEN had higher 30-day mortality, major adverse cardiovascular events, pulmonary, renal dysfunction, and wound complications. However, OPEN resulted in significantly lower 30-day major amputation (3.8% vs. 5.0%, odds ratio (OR): 0.83 [0.72-0.97], P = .018). Subgroup analysis revealed a higher mortality rate in OPEN was observed only in tibioperoneal intervention for tissue loss. Major adverse cardiovascular event was higher in OPEN for most subgroups. OPEN for patients with tissue loss had significantly lower amputation rate than ENDO in both femoropopliteal and tibioperoneal subgroups (3.7% vs. 5.1%, OR: 0.76 [0.59-0.98], P = .036, and 4.7% vs. 6.6%, OR: 0.74 [0.57-0.96], P = .024, respectively). The benefit of open surgery in reducing the amputation rate was not seen in patients with rest pain. CONCLUSIONS: Open surgical intervention is associated with significantly better limb salvage than endovascular intervention in patients with tissue loss. Surgical options should be given more emphasis as the first-line option in this cohort of patients unless the cardiopulmonary risk is prohibitive.

An Endovascular-First Approach for Aortoiliac Occlusive Disease is Safe: Prior Endovascular Intervention is Not Associated with Inferior Outcomes after Aortofemoral Bypass.

BACKGROUND: Although prior endovascular intervention is a risk factor for inferior outcomes after infrainguinal bypass, there are few studies evaluating the effect of prior aortoiliac endovascular intervention (AIEI) on outcomes after aortofemoral bypass (AFB). We sought to determine if prior AIEI was predictive of adverse events after AFB. METHODS: The Vascular Quality Initiative was queried for all patients who underwent AFB form 2009 to 2019. Urgent/emergent cases and repeat procedures were excluded. Primary outcomes were major perioperative complications, major adverse limb event (MALE)-free survival, and long-term survival. Multivariable logistic regression identified predictors of major complications. Predictors of MALE-free survival were identified with Cox proportional hazards modeling. RESULTS: There were 3,056 patients who underwent AFB; 618 had a prior AIEI. Mean age was 60.3 ± 8.7 years, and 58.7% of patients were men. There was no difference in major complications between the 2 groups (AIEI: 23.8%, no AIEI: 24.5%; P-value = 0.70). Factors associated with major complications were chronic obstructive pulmonary disease (odds ratio [OR]: 1.28, 95% confidence interval [CI]: 1.07-1.54; P = 0.008), simultaneous lower extremity intervention (endarterectomy, bypass, or transluminal intervention, OR 1.41, 95% CI: 1.18-1.69; P < 0.001), congestive heart failure (CHF) (OR 1.58, 95% CI: 1.15-2.16; P = 0.004), increased age (OR 1.03 per year, 95% CI: 1.02-1.04; P < 0.001), increasing operative blood loss (OR 1.35 per liter, 95% CI: 1.21-1.50; P < 0.001), increasing operative time (OR 1.07 per hour, 95% CI: 1.02-1.13; P = 0.008), and end-to-side proximal anastomosis (OR 1.23, 95% CI: 1.03-1.46; P = 0.022). One-year MALE-Free survival was 88.2% (95% CI: 85.2-90.7%) for the prior AIEI group and 89.7% (95% CI: 88.3-90.7%) for the group without prior AIEI (logrank P-value = 0.201). Predictors of MALEs/death were history of a bypass (hazard ratio [HR] 1.51, 95% CI: 1.16-1.96; P = 0.002), increasing degree of ischemia on presentation (HR 1.28 per increasing level of ischemia, 95% CI: 1.16-1.41; P < 0.001), diabetes (HR 1.29, 95% CI: 1.05-1.59; P = 0.014), simultaneous peripheral vascular intervention (HR 2.06, 95% CI: 1.02-4.15; P = 0.044), CHF (HR 1.60, 95% CI: 1.18-2.18; P = 0.002), end-stage renal disease on hemodialysis (HR 5.07, 95% CI: 2.45-10.48; P < 0.001), and presenting hemoglobin<9 g/dl (HR 1.76, 95% CI: 1.02-3.02; P = 0.041). One-year survival for the prior AIEI group was 94.5% (95% CI: 92.2-96.1%) and 94.0% (95% CI: 92.9-94.9%) for the group with no prior AIEI (logrank P = 0.486). Prior AIEI did not predict any of the primary outcomes in multivariable analysis. CONCLUSIONS: An endovascular-first approach for aortoiliac occlusive disease appears to be safe and does not portend to inferior results after AFB.