Prophylactic muscle flaps in high-risk-for-poor-healing patients with prosthetic bypasses increases deep wound complications.

BACKGROUND: Incisional complications of groin after inflow or infrainguinal bypasses with prosthetic conduits can result in major morbidities that require reoperation, infected graft removal, and limb loss. Muscle flaps are typically performed to treat groin wound complications, but they are also done prophylactically at the time of index procedures in certain high-risk-for-poor-healing patients to mitigate anticipated groin wound complications. We used a nationwide multi-institutional database to investigate outcomes of prophylactic muscle flaps in high-risk patients who underwent prosthetic bypasses involving femoral anastomosis. METHODS: We utilized ACS-NSQIP database 2005-2021 to identify all elective inflow and infrainguinal bypasses that involve femoral anastomoses. Only high-risk patients for poor incisional healing who underwent prosthetic conduit bypasses were selected. A 1:3 propensity-matching was performed to obtain two comparable studied groups between those with (FLAP) and without prophylactic muscle flaps (NOFLAP) based on demographics and comorbidities. 30-day postoperative outcomes were compared. RESULTS: Among 35,011 NOFLAP, 990 of them were propensity-matched to 330 FLAP. There was no significant difference in 30-day mortality, MACE, pulmonary, or renal complications. FLAP was associated with higher bleeding requiring transfusion, longer operative time, and longer hospital stay. FLAP also had higher overall wound complications (15.2% vs. 10.6%; p = 0.03), especially deep incisional infection (4.9% vs. 2.4%; p = 0.04). CONCLUSION: Prophylactic muscle flap for prosthetic bypasses involving femoral anastomosis in high-risk-for-poor-healing patients does not appear to mitigate 30-day wound complications. Caution should be exercised with this practice and more long-term data should be obtained to determine whether prophylactic flaps decrease the incidence of graft infection.

The association of chronic obstructive pulmonary disease and 30-day outcomes of infrainguinal bypass surgery: A propensity-score matching study.

BACKGROUND: Infrainguinal bypass surgery is an effective treatment for peripheral artery disease (PAD). While chronic obstructive pulmonary disease (COPD) has been linked to heightened risks of mortality and morbidity in major surgery, a thorough investigation into COPD's impact on infrainguinal bypass outcomes remained underexplored. Thus, this study aimed to assess the 30-day outcomes for COPD patients undergoing infrainguinal bypass surgery. METHODS: COPD and non-COPD patients who underwent infrainguinal bypass were identified in American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database from 2011 to 2022. Patients of age<18 were excluded. A 1:1 propensity-score matching was used to match demographics, baseline characteristics, symptomatology, procedure, conduit, and anesthesia. Thirty postoperative outcomes were compared. RESULTS: There were 3,183 (12.64%) and 22,004 (87.36%) patients with and without COPD, respectively, who underwent infrainguinal bypass. COPD patients had a higher comorbid burden. After propensity-score matching, COPD patients had higher sepsis (3.55% vs 2.42%, p = 0.01), wound complications (18.94% vs 16.40%, p = 0.01), and 30-day readmission (18.00% vs 14.92%, p < 0.01). However, COPD and non-COPD patients had comparable 30-day mortality (2.54% vs 2.67%, p = 0.81), and organ system complications including cardiac (3.58% vs 3.99%, p = 0.43), pulmonary (3.96% vs 3.20%, p = 0.12), and renal complications (1.70% vs 1.82%, p = 0.78). Limb-specific outcomes including major amputation (2.95% vs 2.50%, p = 0.30), untreated loss of patency (1.85% vs 1.38%, p = 0.16), and patent graft (98.24% vs 98.65%, p = 0.27) were also comparable between the cohorts. CONCLUSION: While COPD might be associated with the development of PAD due to potentially shared pathophysiology, it may not be an independent risk factor for the major 30-day outcomes in infrainguinal bypass surgery.

Long-term outcomes of below-the-knee bypass surgery using heparin-bonded expanded polytetrafluoroethylene grafts.

PURPOSE: To report the outcomes of below-the-knee (BK) bypass surgery using heparin-bonded expanded polytetrafluoroethylene (ePTFE) grafts, performed in two centers since its launch in Japan. METHODS: We conducted a retrospective analysis of databases from two medical centers, evaluating 51 limbs in 42 consecutive patients with peripheral arterial disease (PAD), who underwent BK bypass surgery using heparin-bonded ePTFE grafts between October, 2013 and April, 2023. RESULTS: Thirty-three limbs (64.7%) were classified as Rutherford category 4-6 and 33 limbs (64.7%) had a history of ipsilateral revascularization. Technical success was achieved in 98% of the patients. The 30 day mortality rate was 2.4% (n = 1) and the overall 30 day complication rate was 9.5% (n = 4). The median follow-up period was 38 (interquartile range 13-67) months. Three patients required major amputation and 14 died during follow-up. Primary patency rates at 1, 3, and 5 years were 67.8%, 57.5%, and 46.5%, respectively, while secondary patency rates for these periods were 84.6%, 70.0%, and 66.0%, respectively. Overall survival rates at 1, 3, and 5 years were 90.1%, 74.5%, and 70.9%, respectively. CONCLUSIONS: BK bypass surgery using heparin-bonded ePTFE graft is a viable and durable option for patients with PAD, who are deemed unsuitable for autologous vein bypass surgery.

Outcomes of lower extremity revascularization in octogenarians and nonagenarians for intermittent claudication.

OBJECTIVE: Revascularization for intermittent claudication (IC) due to infrainguinal peripheral arterial disease (PAD) is dependent on durability and expected benefit. We aimed to assess outcomes for IC interventions in octogenarians and nonagenarians (age ≥80 years) and those younger than 80 years (age <80 years). METHODS: The Vascular Quality Initiative was queried (2010-2020) for peripheral vascular interventions (PVIs) and infrainguinal bypasses (IIBs) performed to treat IC. Baseline characteristics, procedural details, and outcomes were analyzed (comparing age ≥80 years and age <80 years). RESULTS: There were 84,210 PVIs (12.1% age ≥80 years and 87.9% age <80 years) and 10,980 IIBs (7.4% age ≥80 years and 92.6% age <80 years) for IC. For PVI, patients aged ≥80 years more often underwent femoropopliteal (70.7% vs 58.1%) and infrapopliteal (19% vs 9.3%) interventions, and less often iliac interventions (32.1% vs 48%) (P < .001 for all). Patients aged ≥80 years had more perioperative hematomas (3.5% vs 2.4%) and 30-day mortality (0.9% vs 0.4%) (P < .001). At 1-year post-intervention, the age ≥80 years cohort had fewer independently ambulatory patients (80% vs 91.5%; P < .001). Kaplan-Meier analysis showed patients aged ≥80 years had lower reintervention/amputation-free survival (81.4% vs 86.8%), amputation-free survival (87.1% vs 94.1%), and survival (92.3% vs 96.8%) (P < .001) at 1-year after PVI. Risk adjusted analysis showed that age ≥80 years was associated with higher reintervention/amputation/death (hazard ratio [HR], 1.22; 95% confidence interval [CI], 1.1-1.35), amputation/death (HR, 1.85; 95% CI, 1.61-2.13), and mortality (HR, 1.92; 95% CI, 1.66-2.23) (P < .001 for all) for PVI. For IIB, patients aged ≥80 years more often had an infrapopliteal target (28.4% vs 19.4%) and had higher 30-day mortality (1.3% vs 0.5%), renal failure (4.1% vs 2.2%), and cardiac complications (5.4% vs 3.1%) (P < .001). At 1 year, the age ≥80 years group had fewer independently ambulatory patients (81.7% vs 88.8%; P = .02). Kaplan-Meier analysis showed that the age ≥80 years cohort had lower reintervention/amputation-free survival (75.7% vs 81.5%), amputation-free survival (86.9% vs 93.9%), and survival (90.4% vs 96.5%) (P < .001 for all). Risk-adjusted analysis showed age ≥80 years was associated with higher amputation/death (HR, 1.68; 95% CI, 1.1-2.54; P = .015) and mortality (HR, 1.85; 95% CI, 1.16-2.93; P = .009), but not reintervention/amputation/death (HR, 1.1; 95% CI, 0.85-1.44; P = .47) after IIB. CONCLUSIONS: Octogenarians and nonagenarians have greater perioperative morbidity and long-term ambulatory impairment, limb loss, and mortality after PVI and IIB for claudication. Risks of intervention on elderly patients with claudication should be carefully weighed against the perceived benefits of revascularization. Medical and exercise therapy efforts should be maximized in this population.

A systematic review and meta-analysis of primary bypass surgery compared with bypass surgery after endovascular treatment in peripheral artery disease patients.

OBJECTIVE: Both bypass surgery and endovascular treatment are well-recognized interventions for the treatment of peripheral artery disease; however, the effect of failed endovascular treatment on subsequent surgeries remains controversial. A systematic review was conducted to compare the outcomes of primary bypass and bypass surgery after endovascular treatment. METHODS: Three academic databases (Embase, PubMed, and Scopus) were searched from their inception to August 2022. Two independent investigators searched for studies that reported the outcomes of primary bypass surgery and bypass surgery after endovascular treatment in patients with peripheral artery disease. Abstracts and full-text studies were screened independently using duplicate data abstraction. Dichotomous outcome measures were reported using a random-effects model to generate a summary odds ratio (OR) and 95% confidence interval (CI). The risk of bias was assessed using the Newcastle-Ottawa Scale. RESULTS: Seventeen retrospective observational studies were selected from 3911 articles and included 8064 patients, 6252 of whom underwent primary bypass surgery and 1812 underwent bypass surgery after endovascular treatment. The mean age was 69.0 years and 61.2% (n = 4938) were male. For perioperative outcomes, the 30-day results showed no difference in mortality (OR, 0.76; 95% CI, 0.53-1.10), or amputation (OR, 0.89; 95% CI, 0.67-1.20). For short- to mid-term outcomes, primary patency did not differ at 6 months (OR, 0.98; 95% CI, 0.81-1.19), 1 year (OR, 1.12; 95% CI, 0.97-1.30), or 2 years (OR, 1.17; 95% CI, 0.85-1.61) follow-up. Amputation-free survival did not differ at 6 months (OR, 1.03; 95% CI, 0.82-1.30), 1 year (OR, 1.09; 95% CI, 0.89-1.32), 2 years (OR, 1.18; 95% CI, 0.93-1.50), or 3 years (OR, 1.09; 95% CI, 0.84-1.40) of follow-up. No significant difference was found in overall survival or second patency. CONCLUSIONS: This meta-analysis of retrospective, nonrandomized, observational studies suggests that prior endovascular treatment of lower extremity arterial disease does not result in worse perioperative, short-term, or mid-term clinical outcomes of subsequent infrainguinal bypass surgery compared with patients without prior endovascular treatment.

A framework for perioperative care for lower extremity vascular bypasses: A Consensus Statement by the Enhanced Recovery after Surgery (ERAS®) Society and Society for Vascular Surgery.

The Society for Vascular Surgery and the Enhanced Recovery After Surgery (ERAS) Society formally collaborated and elected an international, multi-disciplinary panel of experts to review the literature and provide evidence-based suggestions for coordinated perioperative care for patients undergoing infrainguinal bypass surgery for peripheral artery disease. Structured around the ERAS core elements, 26 suggestions were made and organized into preadmission, preoperative, intraoperative, and postoperative sections.

Long-term outcome and cancer incidence after lower extremity bypass surgery in patients with critical limb threatening ischemia.

PURPOSE: The influence of cancer development on long-term outcome after lower extremity bypass surgery in patients with critical limb threatening ischemia was investigated. METHODS: Patient survival and cancer incidence were recorded for 21,082 patients with peripheral artery disease (PAD) stage III (n = 5631; 26.7%) and stage IV (n = 15,451; 73.3%) registered with the AOK health insurance company in Germany who underwent infrainguinal bypass surgery. All patients were preoperative and in their history cancer-free. RESULTS: After a median follow-up of 44 months, 25.6% of all patients developed cancer (Kaplan-Meier estimated), with no significant differences between patients with PAD stage III and IV (cancer incidence stage III 25.7%, stage IV 25.5%; p = 0.421). In the Cox regression analysis, male gender (HR 1.885; 95% CI 1.714-2.073, p < 0.001) and age over 70 years (HR 1.399; 95% CI 1.285-1.522, p < 0.001) were significant risk factors for the development of cancer. Survival was significantly lower in stage IV (23.4%) compared to stage III (44.5%) (HR 1.720; 95% CI 1.645-1.799, p < 0.001). Cancer was a significant risk factor for overall survival in PAD stage III patients (HR: 1.326; 95% CI 1.195-1.471, p < 0.001) but not in PAD stage IV (HR 0.976; 95% CI 0.919-1.037, p = 0.434). CONCLUSION: Patients with PAD stage III have significantly better survival after infrainguinal bypass surgery compared to patients with stage IV. While cancer incidence was essential for survival in stage III, it was of no importance in stage IV.

Valvulotomy of the great saphenous vein in ex situ non-reversed and in situ setting: a multicenter post-market study to assess the safety and efficacy of the AndraValvulotome™".

PURPOSE: To evaluate the safety and technical success of the AndraValvulotome™ device (Andramed GmbH, Reutlingen, Germany) in patients with peripheral arterial disease (PAD) requiring bypass surgery using the great saphenous vein (GSV) as graft. METHODS: This was a multicenter, post-market observational study conducted in 2021 in 11 German centers. Safety and efficacy data were prospectively collected and analyzed. Primary endpoints were the absence of device-related serious adverse events until 30 ± 7 days follow-up, the clinical efficacy of valvulotomy, which was defined as pulsatile blood flow in the bypass and the number of insufficiently destroyed vein valves. Secondary endpoints were the number of valvulotomy passages, the primary patency rate of the venous bypass (determined by a color-duplex sonography showing a normal blood flow through the bypass and absence of stenosis or occlusion), and the primary technical success defined as the absence of product-specific (serious) adverse events and clinical efficacy. RESULTS: Fifty-nine patients were enrolled. The mean age of the patients was 71 years (46-91), and 74.6% were males. The vein material used for bypass grafting had a median length of 47.5 cm (range 20-70 cm) with a median diameter of 5.0 mm (range 3-6 mm) and 4.0 mm (range 2-6 mm) in the proximal and distal segments, respectively. The technical success rate was 96.6%. The primary patency rate was 89.9% at 30 days follow-up. The clinical efficacy was rated as very good in 81% of patients, fair in 17%, and poor in 2%. Between 1 and 5 (average 2.9) valvulotome passages were performed. One product-related serious adverse event was recorded (bypass vein dissection). CONCLUSION: The AndraValvulotome™ can be considered a safe and effective device to disrupt venous valves during in situ non-reversed bypass surgeries using GSV grafts in patients with PAD.

Comparative analysis of patients undergoing lower extremity bypass using in-situ and reversed great saphenous vein graft techniques.

OBJECTIVE: Autologous great saphenous vein (GSV) is considered the conduit of choice for lower extremity bypass (LEB). However, the optimal configuration remains the source of debate. We compared outcomes of patients undergoing LEB using in-situ and reversed techniques. METHODS: The Vascular Quality Initiative database was queried for patients undergoing LEB with a single-segment GSV in in-situ (ISGSV) and reversed (RGSV) configurations for symptomatic occlusive disease from 2003 to 2021. Patient demographics, procedural detail, and in-hospital and follow-up outcomes were collected. The primary outcome measures included primary patency at discharge or 30 days and one year. Secondary outcomes were secondary patency, and reinterventions at discharge or 30 days and one year. Cox proportional hazards models were created to determine the association between bypass techniques and outcomes of interest. RESULTS: Of 8234 patients undergoing LEBs, in-situ and reversed techniques were used in 3546 and 4688 patients, respectively. The indication for LEBs was similar between the two cohorts. ISGSV was performed more frequently from the common femoral artery and to more distal targets. RGSV bypass was associated with higher intraoperative blood loss and longer operative time. Perioperatively, ISGSV cohort had higher rates of reinterventions (13.2 vs 11.1%; p = 0.004), surgical site infection (4.2 vs 3%; p = 0.003), and lower primary patency (93.5 vs 95%; p = 0.004) but a comparable rate of secondary patency (99 vs 99.1%; p = 0.675). At 1 year, in-situ bypasses had a lower rate of reinterventions (19.4% vs 21.6%; p=0.02), with similar rates of primary (82.6 vs 81.8%; p = 0.237) and secondary patency (88.7 vs 88.9%; p = 0.625). After adjusting for significant baseline differences and potential confounders, in-situ bypass was independently associated with decreased risks of primary patency loss (HR 0.9; 95% CI, 0.82-0.98; p = 0.016) and reinterventions (HR 0.88; 95% CI, 0.8-0.97; p = 0.014) but a similar risk of secondary patency loss (HR 0.99; 95% CI, 0.86-1.16; p = 0.985) at follow-up, compared to reversed bypass. A subgroup analysis of bypasses to crural targets showed that in-situ and reversed bypasses had similar rates of primary patency loss and reinterventions at 1 year. Among patients with chronic limb-threatening ischemia, in-situ bypass was associated with a decreased risk of reinterventions but similar rates of primary and secondary patency and major amputations at 1 year. CONCLUSIONS: In patients undergoing LEBs using the GSV, in-situ configuration was associated with more perioperative reinterventions and lower primary patency rate. However, this was offset by decreased risks of loss of primary patency and reinterventions at 1 year. A thorough intraoperative graft assessment with adjunctive imaging may be performed to detect abnormalities in patients undergoing in-situ bypasses to prevent early failures. Furthermore, closer surveillance of reversed bypass grafts is warranted given the higher rates of reinterventions.

Non-reversed and Reversed Great Saphenous Vein Graft Configurations Offer Comparable Early Outcomes in Patients Undergoing Infrainguinal Bypass.

OBJECTIVE: Data on the efficacy of non-reversed and reversed great saphenous vein bypass (NRGSV and RGSV) techniques are lacking. The aim of the study was to compare the outcomes of patients undergoing open infrainguinal revascularisation using NRGSV and RGSV from a multi-institutional database. METHODS: The Vascular Quality Initiative database was queried for patients undergoing infrainguinal bypasses using NRGSV and RGSV for symptomatic occlusive disease from January 2003 to February 2021. The primary outcome measures included primary and secondary patency at discharge and one year. Secondary outcomes were re-interventions at discharge and one year. Cox proportional hazards models were used to evaluate the impact of graft configuration on outcomes of interest. RESULTS: Of 7 123 patients, 4 662 and 2 461 patients underwent RGSV and NRGSV, respectively. At one year, the rates of primary patency (78% vs. 78%; p = .83), secondary patency (90% vs. 89%; p = .26), and re-intervention (16% vs. 16%; p = .95) were similar between the RGSV and NRGSV cohorts, respectively. Subgroup analysis based on outflow bypass target and indication for revascularisation did not show differences in primary and secondary outcomes between the two groups. Multivariable analysis confirmed that RGSV (NRGSV as the reference) configuration was not independently associated with increased risk of primary patency loss (hazard ratio [HR] 1.01; 95% confidence interval [CI] 0.91 - 1.13; p = .80), secondary patency loss (HR 0.94; 95% CI 0.81 - 1.10; p = .44), and re-intervention (HR 1.03; 95% CI 0.91 - 1.16; p = .67) at follow up. CONCLUSION: The study shows that RGSV and NRGSV grafting techniques have comparable peri-operative and one year primary and secondary patency and re-intervention rates. This effect persisted when stratified by outflow targets and indication for revascularisation. Therefore, optimal selection of vein grafting technique should be guided by the patient's anatomy, vein conduit availability, and surgeon's experience.

Autologous saphenous vein and heparin-bonded expanded polytetrafluoroethylene as graft materials for below-the-knee femoro-popliteal bypass in patients with critical limb ischemia: A propensity score-matched analysis.

OBJECTIVE: To compare the outcomes of heparin bonded expanded polytetrafluoroethylene (HePTFE) and autologous saphenous vein (ASV) in patients undergoing below-knee (BK) femoro-popliteal bypass for critical limb ischemia (CLI). DESIGN: Retrospective single-centre matched case-control study. METHODS: From 2003 to 2019, 275 consecutive BK bypasses for CLI were performed, 109 with the ASV and 166 with a HePTFE graft. All the baseline characteristics that were reliably measured and were potentially relevant in the decision-making process were included as confounders in a logistic regression model and the factors that were significantly different between the two groups then used to perform a propensity matching analysis. Propensity score-based matching was performed in a 1:1 ratio to compare outcomes. Arterial hypertension, hyperlipemia, the need for tibial anastomosis at the distal level and the run-off status were the covariates included in the matching. Follow-up outcomes were estimated by Kaplan-Meier methods and compared with log rank test. RESULTS: After propensity matching, 101 HePTFE bypasses were matched with 101 ASV bypasses. The median duration of follow-up was 37 months (range 1-192). The 5-year survival rate was 67.5% (standard error (SE) 0.05) in the HePTFe group and 64.5% (SE 0.06) in the ASV group (p = 0.8, log rank 0.04). Primary patency rates were 38% (SE 0.06) in the HePTFE group and 41% (SE 0.06) in the ASV group (p = 0.7, log rank 0.3). Also assisted primary patency and secondary patency rates did not differ in the two groups. Amputation-free survival was 53% (SE 0.05) in the HePTFE group and 58% (SE 0.06) in the ASF group (p = 0.6, log rank 0.2). CONCLUSIONS: HePTFE provided 5-year similar results to those obtained with use of the ASV in equivalent patients with CLI undergoing below-knee or tibial bypass.

Prosthetic versus native artery inflow for infrainguinal bypass.

BACKGROUND: Infrainguinal bypass performed after previous prosthetic inflow reconstruction offers a choice of where to perform the proximal anastomosis. The hood of a previous inflow bypass might be technically easier to isolate during reoperative surgery. However, the more distal native artery might offer better patency to the outflow revascularization. The purpose of the present study was to compare the outcomes of infrainguinal bypass using the hood of a previous inflow bypass vs the native artery as the inflow source. METHODS: A single vascular group's database was queried for all cases of infrainguinal bypass performed after previous prosthetic inflow bypass to a femoral artery from January 2006 to December 2016. The demographics, indications, operative details, and long-term results were recorded and analyzed. Two groups were compared stratified by the location of the proximal anastomosis for the distal bypass. In one group, the inflow source for the distal bypass was from the hood of a previous inflow graft (prosthetic). In the second group, the distal native arterial tree was used as the inflow source. A subset analysis of the patency of the distal bypass was also performed between the two groups for those in which the previous inflow reconstruction had become occluded. Patency was calculated using the Kaplan-Meier method. RESULTS: A total of 197 patients had undergone infrainguinal bypass after previous inflow bypass from 2006 to 2016. Of the 197 procedures, 59 (30%) had used the hood of the previous bypass as the inflow source (prosthetic group) and 138 (70%) had used the native artery distal to the hood of the inflow bypass as the inflow source (native group). The indications were similar between the two groups. The two groups had a similar proportion of men and a similar incidence of hypertension, hyperlipidemia, coronary artery disease, tobacco use, and renal disease. The previous inflow procedures were also similar between the two groups. The native artery used for the inflow source in the native group was the profunda femoris in 80 (58%), common femoral artery in 51 (37%), and superficial femoral artery in 7 (5.1%). Patency was significantly greater for the native group at 1 year (91% vs 75%; P = .0221). Also, the patency after inflow bypass occlusion significantly favored the native group at 1 year (87% vs 40%; P = .0035). CONCLUSIONS: Infrainguinal bypass performed after previous ipsilateral inflow bypass offers the option of using the hood of the bypass or a native artery as the inflow source. The present study demonstrated greater patency rates when using the distal native artery as the inflow source. The native artery option also offered continued patency when the inflow bypass occluded.

The association of estimated glomerular filtration rate with outcomes following infrainguinal bypass for peripheral arterial disease.

OBJECTIVE: Chronic kidney disease (CKD) is a recognized predictor of long-term survival, frequently coexisting with peripheral arterial disease (PAD). Estimated glomerular filtration rate (eGFR) is a more accurate marker of renal function than creatinine. This study sought to determine the graded impact of CKD, defined by eGFR, on infrainguinal lower extremity bypass (LEB) outcomes. METHODS: This retrospective study examined 44,332 patients from the Vascular Quality Initiative database who underwent LEB between January 2003 and November 2019. The GFR was estimated using the Modification of Diet in Renal Disease equation. Multivariable logistic regression was used to study perioperative mortality and Kaplan-Meier survival estimation and multivariable Cox regression were used to evaluate 5-year mortality, 1-year major amputation, and major amputation/death. RESULTS: The 30-day mortality odds was increased for CKD 3 (odds ratio [OR], 1.58; 95% confidence interval [CI], 1.32-1.91; P < .001) and CKD 5 (OR, 3.08; 95% CI, 2.45-3.87; P < .001) relative to CKD 1 to 2. Comparing CKD stages 3, 4, and 5 with CKD 1 and 2, there was a stepwise increase in the adjusted hazard of 5-year mortality (hazard ratio [HR], 1.18; 95% CI, 1.09-1.27; P < .001), (HR, 1.73; 95% CI; 1.47-2.03; P < .001) and (HR, 2.58; 95% CI, 2.33-3.84; P < .001), respectively. Although the risk of 1-year death or major amputation did not differ for CKD 3 compared with CKD 1, this was 50% higher for CKD 4 (HR, 1.50; 95% CI, 1.26-1.78; P < .001) and doubled for CKD 5 (HR, 2.07; 95% CI, 1.87-2.29; P < .001) compared with CKD 1 and 2. The adjusted HR for major amputation in 1 year was 0.81 (95% CI, 0.71-0.92; P = .002), 1.14 (95% CI, 0.84-1.54; P = .396) and 1.56 (95% CI,1.31-1.84; P < .001) for CKD 3, 4, and 5, respectively, compared with CKD 1 and 2. CONCLUSIONS: The estimated GFR is a useful predictor of postoperative mortality, overall survival, and/or amputation after LEB in patients with PAD. It should be considered in the preoperative risk-benefit analysis process to guide patient selection in the population with concomitant PAD and CKD being considered for LEB.

The association between preoperative length of stay and surgical site infection after lower extremity bypass for chronic limb-threatening ischemia.

OBJECTIVE: Surgical site infection (SSI) is an important complication of lower extremity bypass (LEB) and the rate of SSI after LEB varies widely in the existing literature, ranging from 4% to 31%. Prolonged length of stay (LOS) has been implicated in the occurrence of SSI across multiple surgical disciplines. The impact of preoperative LOS in patients with chronic limb-threatening ischemia (CLTI) undergoing LEB is unknown. We examined the association of preoperative LOS on SSI after LEB. METHODS: A retrospective analysis of the Society for Vascular Surgery Vascular Quality Initiative Infrainguinal Bypass Registry identified patients undergoing elective LEB for chronic limb-threatening ischemia from 2003 to 2019. Patients undergoing LEB for acute limb ischemia, urgent/emergent procedures, aneurysm, or who had concomitant suprainguinal bypass were excluded. The primary outcome measure was postoperative SSI. Multivariable forward stepwise logistic regression was then performed including all variables with a P value of less than .10 in both matched and unmatched cohorts to evaluate for demographic and perioperative predictors of SSI. Propensity score matching was used to create matched cohorts of patients for each LOS group. RESULTS: A total of 17,883 LEB procedures were selected for inclusion: 0 days (12,362 LEB), 1 to 2 days (1737 LEB), and 3 to 14 days (3784 LEB). Patients with the greatest preoperative LOS were more likely to have vein mapping (0 days preoperative LOS, 66.3%; 1-2 days, 65.2%; 3-14 days, 73.2%; P < .01) or computed tomography angiography/magnetic resonance angiography (0 days, 32.1%; 1-2 days, 34.4%; 3-14 days, 38.4%; P < .01). Patients with 3 or more days of preoperative LOS had longer procedure lengths (0 days, 244 minutes; 1-2 days, 243 minutes; 3-14 days, 255 minutes; P < .01) and were more likely to have completion angiogram (0 days, 27.1%; 1-2 days, 29.5%; 3-14 days, 31.6%; P = .02). Multivariable logistic regression demonstrated that preoperative LOS of 3 to 14 days was associated with increased rate of SSI (odds ratio [OR], 1.92; 95% confidence interval [CI], 1.20-3.07; P = .01). Transfusion of 3 or more units (OR, 2.87; 95% CI, 1.89-4.36; P < .01) and prolonged procedure length (>220 minutes; OR, 1.86; 95% CI, 1.26-2.73; P < .01) were also significantly associated with postoperative SSIs. CONCLUSIONS: Many factors including preoperative comorbidities and operative complexity covary with preoperative LOS as risk factors for SSI. However, when patients are matched based on comorbidities and factors that would predict overall clinical complexity, preoperative LOS remains important in predicting SSI.

Effect of infrainguinal bypass tunneling technique on patency and amputation in patients with limb ischemia.

OBJECTIVE: We investigated the association of tunneling technique on patency and amputation in patients undergoing lower extremity bypass for limb ischemia. METHODS: The National Vascular Quality Initiative database infrainguinal bypass module from 2008 to 2017 was queried for analysis. We excluded cases with non-great saphenous vein grafts, grafts using multiple segments, aneurysmal disease indications, bypass locations outside the femoral to below the knee popliteal artery or tibial arteries, and missing data on tunneling type and limb ischemia. The main exposure variable was the tunneling type, subcutaneously vs subfascially. Our primary outcomes were primary patency and amputation. The secondary outcomes included primary-assisted patency and secondary patency. Univariate and multivariate logistic regression models were used. RESULTS: A total of 5497 bypass patients (2835 subcutaneous and 2662 subfascial) were included. Age, race, graft orientation (reversed vs not reversed), bypass donor and recipient vessels, harvest type, end-stage renal disease, smoking, coronary artery bypass graft, congestive heart failure, P2Y12 inhibitor at discharge, surgical site infection at discharge, and indication (rest pain vs tissue loss vs acute ischemia) were analyzed for an association with the tunneling technique (P < .05). Multivariate analyses demonstrated that the tunneling type was not associated with primary patency, primary-assisted patency, secondary patency, or major amputation (P > .05). CONCLUSIONS: Compared with subfascial tunneling, the superficial tunneling technique was not associated with primary patency or major amputation in limb ischemia patients undergoing infrainguinal bypass with a single-segment great saphenous vein.

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.

Inframalleolar bypass for chronic limb-threatening ischemia.

The aims of this study were to analyze the results of inframalleolar bypass for chronic limb-threatening ischemia (CLTI) and to identify outcome-predicting factors. All consecutive patients undergoing inframalleolar bypass for CLTI between 2015 and 2018 were included in this retrospective, single-center study. Outflow artery was the most proximal patent vessel segment in continuity with inframalleolar arteries. Bypasses originating from the popliteal artery were defined as 'short bypasses'. Sixty patients underwent inframalleolar bypass, with four patients undergoing bilateral procedures, making a total of 64 limbs included. The mean age was 73 ± 14 and 52 (81%) were male. The great saphenous vein was the preferred conduit (n = 58, 91%), in a devalvulated fashion (n = 56, 88%). Superficial femoral artery was the most common inflow artery for 'long' grafts (n = 22, 34%), while popliteal artery was the inflow artery for all 'short' grafts (n = 25, 39%). Dorsalis pedis artery was chosen as an outflow artery in 41 patients (63%). Median follow-up was 21 months. Two-year primary and secondary patency, limb salvage, amputation-free survival, and overall survival rates were 67 ± 6%, 88 ± 4%, 84 ± 4%, 72 ± 6%, and 85 ± 4%, respectively. At multivariate analysis, dialysis was an independent predictor for poor primary patency (HR, 4.6; 95% CI, 1.62-13.05; p = 0.004), whereas a short bypass was independently associated with an increased primary patency (HR, 0.3; 95% CI, 0.10-0.89; p = 0.03). In conclusion, bypass grafting to the inframalleolar arteries resulted in good patency rates, limb salvage and overall survival. Dialysis patients had lower primary patency but still had good limb salvage and survival. Short bypass was a predictor of improved primary patency.

Limb-Based Patency After Surgical vs Endovascular Revascularization in Patients with Chronic Limb-Threatening Ischemia.

PURPOSE: To determine whether limb-based patency (LBP) after infrainguinal revascularization for chronic limb-threatening ischemia (CLTI) is similar between bypass surgery and endovascular therapy (EVT). MATERIALS AND METHODS: The database for the Surgical Reconstruction vs Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) study was interrogated to identify 130 patients (mean age 73±8 years; 94 men) who underwent bypass surgery and 271 patients (mean age 74±10 years; 178 men) who underwent EVT alone. Skin perfusion pressure (SPP) and the ankle-brachial index (ABI) were measured before the procedure and at 0, 1, and 3 months after revascularization. The outcome measure was hemodynamically evaluated LBP (SPP ≥10 mm Hg or ABI ≥0.1) maintained over the first 3 months after treatment. Any reintervention or major amputation was regarded as loss of LBP. The associations between the revascularization strategy (bypass vs EVT) and between the preoperative characteristics and the study outcome (ie, SPP- or ABI-based LBP), were determined using generalized linear mixed models with a logit link function. Patency rates are presented with the 95% confidence interval (CI). RESULTS: The bypass surgery group had a higher stage of limb severity (WIfI) and anatomic complexity (GLASS) than the EVT group, whereas the EVT group had a higher prevalence of heart failure. Both SPP- and ABI-based LBP rates were higher in the bypass group than in the EVT group. SPP-based LBP rates at 3 months were 73.8% (95% CI 63.4% to 84.2%) in the bypass group and 46.2% (95% CI 38.5% to 53.8%) in the EVT group; the corresponding ABI-based LBP rates were 71.5% (95% CI 61.8% to 81.2%) and 44.0% (95% CI 37.3% to 50.7%). CONCLUSION: LBP is an important concept in the new global vascular guidelines for assessing the anatomic and hemodynamic status of CLTI patients. The present study found that LBP was significantly lower in the EVT group vs the bypass surgery group.

Examination of race and infrainguinal bypass conduit use in the Society for Vascular Surgery Vascular Quality Initiative.

BACKGROUND: Vein conduit is known to have better patency than prosthetic for infrainguinal bypass. Here we explore if racial disparities exist in infrainguinal bypass vein conduit use amid preoperative patient and systemic factors. METHODS: Retrospective Society for Vascular Surgery Vascular Quality Initiative data for 23,959 infrainguinal bypasses between 2003 and 2017 for occlusive disease were analyzed. For homogeneity, only infrainguinal bypasses originating from the common femoral artery were included. Demographics of patients receiving vein vs prosthetic were compared and logistic regression analyses were performed with race and preoperative factors to evaluate for predictors of vein conduit use. RESULTS: Adjusted regression models demonstrated black patients were 76% as likely (p < .001) and Hispanic patients 79% as likely (p = .003) to have vein conduit compared to white patients. Factors positively correlating with vein use included vein mapping, more distal bypass target, tissue loss or acute ischemia bypass indications, commercial insurance, and weight. Factors against vein use included advanced age, female gender, ASA class 4, urgent procedure, preoperative mobility limitation, prior CABG or leg bypass, prior smoking, preoperative anticoagulation, and a bypass performed in the Southern US or before 2012. While black and Hispanic patients were less likely to receive vein, they were vein mapped at similar or higher rates than other groups. CONCLUSION: Racial disparities exist in conduit use for infrainguinal bypass, with black and Hispanic patients less likely to receive vein bypasses. However, the contribution of race to conduit selection is small in adjusted and unadjusted models. Overall, pre-operative variables in the Vascular Quality Initiative poorly predicted vein conduit use for infrainguinal bypass.

Socioeconomic Distressed Communities Index associated with worse limb-related outcomes after infrainguinal bypass.

OBJECTIVE: Several studies have demonstrated that socioeconomic factors may affect surgical outcomes. Analyses in vascular surgery have been limited by the availability of individual or community-level socioeconomic data. We sought to determine whether the Distressed Communities Index (DCI), a composite socioeconomic ranking by ZIP code, could predict short- and long-term outcomes for patients with peripheral artery disease. METHODS: All Virginia Quality Initiative patients (n = 2578) undergoing infrainguinal bypass (2011-2017) within a region of 17 centers were assigned a composite DCI score. The score was developed by the Economic Innovation Group and is normally distributed from 0 (no distress) to 100 (severe distress) based on measures of community unemployment, education level, poverty rate, median income, business growth, and housing vacancies. Severely distressed communities were defined as the top quartile DCI (>75). Hierarchical regression assessed short-term outcomes, and time-to-event analyses assessed long-term results. RESULTS: Infrainguinal bypass patients in this study came from disproportionately distressed communities, with 29% of patients living within the highest distress DCI quartile (P < .0001), with high variability by hospital (DCI range, 12-67). These patients from severely distressed areas were younger, more likely to smoke, and disproportionately African American and had higher rates of medical comorbidities (all P < .05). Whereas patients from severely distressed communities had an equivalent rate of 30-day major adverse cardiac and cerebrovascular events (5% vs 4%; P = .86), they had increased rates of major adverse limb events (MALEs) at 13% vs 10% (P = .03). This trend persisted in the long term, with higher 1-year estimates of MALEs (21% vs 17%; P = .01) as well as the components of amputation (17% vs 12%; P = .006) and thrombectomy (11% vs 6%; P = .002). Patients with high socioeconomic distress also had higher rates of occlusion (17% vs 11%; P = .003). CONCLUSIONS: In this study, patients from severely distressed communities were found to have increased rates of MALEs, an association that persisted long term. Mitigating risk associated with socioeconomic determinants of health has the potential to improve outcomes for patients with peripheral artery disease.