Limb-threatening Ischemia Research Articles

The impact of diabetes mellitus on the outcomes of revascularization for chronic limb-threatening ischemia in the BEST-CLI trial

ObjectiveSeveral observational studies have demonstrated an association between diabetes mellitus (DM) and above-ankle amputation after lower extremity revascularization (LER). However, data from prospective randomized trials is lacking. This analysis compares the outcomes of patients with and without DM enrolled in the Best Endovascular vs Best Surgical Therapy in patients with Chronic Limb-Threatening Ischemia (BEST-CLI) trial. MethodsBaseline characteristics were compared between patients with and without DM in the BEST-CLI trial. Cox regression was used to determine the association between DM and major outcomes of major adverse limb events (MALE), reintervention, above-ankle amputation, and all-cause death. ResultsAmong 1777 patients who underwent LER, 69.2% had DM. Compared with patients without DM, those with DM were significantly younger, less likely to be White, and more likely to be Hispanic. Patients with DM were more likely to have hypertension, hyperlipidemia, coronary artery disease, congestive heart failure, and renal disease and be on optimal medical therapy (antiplatelets and statins), whereas patients without DM were significantly more likely to be smokers and have chronic obstructive pulmonary disease. Patients with DM were significantly more likely to present with late Wound Ischemia foot Infection (WIfI) stages (3-4) (73.7% vs 45.9%; P < .001) that were driven predominantly by differences in wound and infection grade. Conversely, patients without DM had significantly lower ankle pressures and toe pressures and were significantly more likely to have WIfI ischemia grade 3 compared with patients with DM (60% vs 52.5%; P = .016). At 3 years, patients with DM exhibited higher rates of above-ankle amputation and all-cause death compared with patients without DM. Kaplan-Meier analysis demonstrated significantly higher MALE or all-cause death compared with patients without DM (3-year estimate: 53.5% vs 46.4%; P < .001). After adjusting for potential confounders, regression analysis demonstrated that DM was independently associated with increased above-ankle amputation (1.75 [1.22-2.51]), all-cause death (1.63 [1.31-2.03]), and MALE or all-cause death (1.24 [1.04-1.47]). ConclusionsPatients with DM undergoing LER for chronic limb-threatening ischemia experienced a greater incidence of MALE or all-cause death compared with patients without DM. The impact of DM seems to be mediated by more severe wounds and infections at the time of presentation, and a higher prevalence of cardiac and renal disease.

Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers are Associated with Improved Amputation Free Survival in Chronic Limb-Threatening Ischemia

BackgroundIn the Heart Outcomes Prevention Evaluation (HOPE) study, investigators found that ramipril was associated with improved survival as well as decreased MI and stroke rates in patients with peripheral arterial disease. Nonetheless, their effect on chronic limb-threatening ischemia (CLTI)-specific outcomes is unclear. We aim to assess the effect of ACEIs/ARBs on amputation-free survival in CLTI patients undergoing peripheral vascular intervention (PVI) in a Medicare-linked database. MethodsPatients undergoing PVI in the VQI-VISION database were included. Primary outcome included amputation-free survival. Kaplan Meier survival and multivariable Cox regression analyses were used to assess one-year outcomes. ResultsA total of 34,284 patients were included, and 46.3% of whom were discharged on ACEIs/ARBs. Patients discharged on ACEIs/ARBs were more likely to be smokers, diabetics, and hypertensive. They were also more likely to present with rest pain. The overall one-year survival for patients on ACEIs/ARBs vs those who are not was (79.1% vs 69.4%, P<0.001). Freedom from amputation was 87.8% for patients on ACEIs/ARBs vs 84.2% for those who were not (P<0.001). Amputation-free survival was 70.5% vs 59.5% for ACEIs/ARBs vs no ACEIs/ARBs (P<0.001). After adjusting for potential confounders, ACEIs/ARBs use was associated with lower one-year mortality (HR: 0.77, 95%CI (0.7-0.8), P<0.001), amputation (HR: 0.89, 95%CI (0.8-0.9), P<0.001), and amputation or death (HR: 0.79, 95%CI (0.76-0.8), P<0.001). ConclusionsACEIs/ARBs were independently associated with lower amputation, improved survival, and amputation-free survival at one year in CLTI patients undergoing PVI. The fact that more than half the patients were not discharged on these medications presents an area for potential quality improvement.

Hemoglobin A1c levels are related to patency and adverse limb events in diabetics after revascularization

ObjectivePoor glycemic control in the perioperative period has been reported to be associated with early and late major adverse limb events (MALEs). However, these studies were mostly from large databases or lacked long-term outcomes. We examined the long-term effects of high hemoglobin A1c (HbA1c) level on patency, MALE, limb salvage (LS) and survival after lower extremity revascularization procedures in patients with diabetes. MethodsPatients with diabetes who underwent revascularization for Rutherford class 3 to 6 ischemia between May 2002 and December 2018 were identified. Patients with an HbA1c of ≤7% were compared with those with an HbA1c of >7% for patency, MALE, survival, LS, and amputation-free survival. ResultsOf 706 patients, 699 had HbA1c data (775 limbs), with 311 (357 limbs) in the HbA1c ≤7% and 388 (418 limbs) in the HbA1c >7% groups. Patients with an HbA1c of >7% were younger (69.9 ± 10.2 years vs 71.7 ± 9.5 years; P = .011), had higher lipid levels, insulin use (70% vs 49%; P < .01), American Society of Anesthesiologists classification of 4, and had a lower prevalence of chronic kidney disease (32% v s41%; P = .023). Patients with an HbA1c of >7% were more likely to present with chronic limb-threatening ischemia (CLTI) (79% vs 72%; P = .019) and undergo infrapopliteal interventions (49% vs 42%; P = .005), with no difference in anatomical complexity (TransAtlantic Inter Society Consensus class C/D, 75% vs 77%; P = .72) or type of revascularization (24% vs 18% open, 66% vs 70% endovascular, 10% vs 12% hybrid; P = .236). Patency and freedom from MALE were significantly lower in patients with an HbA1c of >7% for infrainguinal revascularizations, whereas amputation-free survival and overall survival were similar. In patients with chronic limb-threatening ischemia, LS rates at 5 years were significantly lower in patients undergoing open revascularization (HbA1c > 7%: 64% ± 6% vs HbA1c < 7%:86% ± 5%; P = .020), whereas it was similar after endovascular interventions (HbA1c > 7%:79% ± 4% vs HbA1c < 7%:77% ± 3%; P = .631). Seventy patients with an HbA1c of >7% lost limbs vs 38 patients with an HbA1c of ≤7% (P = .007). In multivariate analysis, HbA1c was associated significantly with primary patency. HbA1c, insulin use, level of intervention, and angiotensin-converting enzyme inhibitor use were associated with MALE. ConclusionsA perioperative HbA1c of >7% is associated with poorer patency rates and increased MALE, especially at the infrainguinal level revascularization in patients with diabetes, with no significant impact on survival. LS is impacted after open, but not after endovascular revascularization.

Early Tissue Resection Versus Watchful Waiting After Revascularization for Chronic Limb-Threatening Ischemia: A Meta-Analysis.

No consensus or guideline has been established regarding the optimal timing of tissue resection after revascularization in patients with chronic limb-threatening ischemia (CLTI). This study aimed to compare early tissue resection and watchful waiting after revascularization regarding the outcomes of patients with CLTI. We searched PubMed, the Cochrane Library, and EMBASE for relevant randomized trials and observational studies published from their inception to May 1, 2024. In total, five articles were analyzed. The results showed that the early tissue resection group had a higher wound healing rate than the watchful waiting group (I2 = 26%, odds ratio [OR] = 2.80, 95% confidence interval [CI] 1.32 to 5.92, P = 0.007). However, the rate of major amputation was significantly higher in the early tissue resection group than in the watchful waiting group (I2 = 5%, OR = 1.48, 95% CI 1.18 to 1.86, P < 0.001), and wound recurrence rate in the early tissue resection group was relatively higher than that in the watchful waiting group (I2 = 0%, OR = 2.42, 95% CI: 0.99 to 5.93, P = 0.05). No statistical significance was found in the rate of postoperative mortality (I2 = 2%, OR = 0.99, 95% CI: 0.69 to 1.41, P = 0.94) and wound healing time (I2 = 97%, standardized mean difference = -105.92, 95% CI -232.96 to 21.13, P = 0.10) between the early tissue resection and watchful waiting groups. For patients without signs of infection, a watchful waiting strategy could reduce the risk of major amputation.

Outcomes of revascularization of stenotic inframalleolar lesions in chronic limb-threatening ischemia.

For chronic limb-threatening ischemia, revascularization has been reported for occlusions but not for stenosis in the inframalleolar (IM) lesions. We investigated the clinical outcomes of balloon dilation for stenotic IM lesions distal to the treatment target in the infrapopliteal (IP) legion. We conducted a retrospective analysis of patients who had chronic limb-threatening ischemia and underwent revascularization of stenotic IM lesions distal to the target IP lesions between January 2015 and August 2022. The outcome measures were amputation-free survival, wound healing rate, and freedom from target IM reintervention. The 87 patients had a mean age of 72.7 ± 10.7 years and comprised 67.8% men, 74.7% with diabetes mellitus, 55.2% on dialysis, 33.3% who had Rutherford six classification. The amputation-free survival (AFS), wound healing, and freedom from target IM reintervention rates at 1 year were 82.9%, 53.3%, and 58.4%, respectively. On Cox proportional multivariate analysis, the predictors were Wound, Ischemia, and foot Infection (WIfI) ≥3 and diffuse stenosis in the target IM vessels for delayed wound healing and Global Limb Anatomic Staging System stage Ⅲ and ≥3 diseased IM vessels before endovascular therapy for target IM reintervention. At the time of reintervention, the lesion morphology had progressed from stenosis to occlusion in 50% of cases. In patients with chronic limb-threatening ischemia, revascularization of stenosis in IM lesions showed a high reintervention rate and progression of lesion morphology, although AFS and wound-healing rates were acceptable.

Inter- and Intra-observer Agreement of the Peripheral Arterial Calcium Scoring System in Patients Undergoing (Infra)Popliteal Endovascular Interventions

PurposePeripheral arterial calcification is an important predictor of outcomes after both conservative and endovascular treatment. Digital subtraction angiography (DSA)-based calcification scores are limited by low sensitivity and inter-observer agreement. The Peripheral Arterial Calcium Scoring System (PACSS) assesses the severity of target lesion calcification. The newly introduced modified PACSS (mPACSS) also evaluates target vessel calcification. This study aimed to assess the inter- and intra-observer reliability of PACSS and mPACSS on computed tomography angiography (CTA) in (infra)popliteal endovascular interventions.MethodsA random sample of 50 limbs from the prospective multicenter Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) were included. Three experienced independent raters scored PACSS on CTA. Three months later, one blinded rater assessed the same 50 CTA scans, keeping track of assessment time. The reliability of the original 5-step PACSS, a simplified binary PACSS (0–2 vs 3–4) and the 7-step mPACSS were tested using Cohen’s and Fleiss’ kappa statistics.ResultsIn total, 50 limbs (mean age 70.1 ± 11.0, 29 men) with 41 popliteal and 40 infrapopliteal lesions were scored. Inter-observer agreement of PACSS and binary PACSS were moderate (κ = 0.60) and substantial (κ = 0.72), respectively, while intra-observer agreement was almost perfect in both scores (κ = 0.86). Inter- and intra-observer agreement of mPACSS were moderate (κ = 0.48) and substantial (κ = 0.77), respectively. Mean assessment time for an experienced rater was 3.43 ± 0.93 min per CTA scan.ConclusionBoth the semi-quantitative PACSS and mPACSS scores for (infra)popliteal arteries can be performed reliably on pre-operative CTA.Graphic

Efficacy and Outcomes of Stenting Versus Balloon Angioplasty for Chronic Limb-Threatening Ischemia in Infrapopliteal Peripheral Arterial Disease: A Meta-Analysis of Randomized Controlled Trials.

Peripheral arterial disease (PAD) and its severe complication, chronic limb-threatening ischemia (CLTI) are associated with significant morbidity and mortality worldwide. Conventionally, balloon angioplasty has been regarded as superior to stenting in CLTI associated with infrapopliteal PAD. Stenting is often considered a "rescue" or "bail-out" procedure in managing CLTI. However, stenting using newer generation stents coated with antiproliferative drugs such as paclitaxel has demonstrated noninferior results compared with balloon angioplasty in terms of risk of restenosis. However, the current data comparing stenting to balloon angioplasty for other outcomes is rather inconsistent. Major bibliographic databases were searched systematically to identify randomized controlled trials (RCTs) comparing stenting to balloon angioplasty in CLTI in infrapopliteal PAD patients. Risk ratios (RR) with 95% confidence intervals (CI) were pooled in a random-effects model with statistical significance considered at P < 0.05. 9 RCTs with 1125 patients (634, stenting; 491, balloon angioplasty) were included. Stenting was associated with a statistically significant reduction in the risk of binary restenosis (RR, 0.61; 95% CI, 0.38-0.97; P = 0.04] compared with balloon angioplasty. However, no statistically significant difference in technical success, all-cause mortality, clinically driven target lesion revascularization, major limb amputation, and primary patency was observed between the 2 groups. In infrapopliteal PAD associated with CLTI, stenting is noninferior to balloon angioplasty. Future large multicentric RCTs are warranted, particularly evaluating the newer generation drug-eluting stents, in a diverse patient population with longer follow-up periods to corroborate the results of this meta-analysis.

Long-term clinical efficacy of drug-coated balloon angioplasty for TASCII C/D femoropopliteal lesions in older patients with chronic limb-threatening ischemia: A retrospective study.

This study aimed to evaluate the long-term clinical outcomes of drug-coated drug (DCB) angioplasty for long femoropopliteal lesions in older patients with chronic limb-threatening ischemia (CLTI). In this multi-center retrospective study, we enrolled 119 patients with CLTI due to Trans-Atlantic Inter-Society Consensus (TASCII) C/D femoropopliteal lesions who underwent DCB angioplasty. A total of 119 patients with 122 limbs (TASCII C = 67, 54.9%; TASCII D = 55, 45.1%) were enrolled. At 36-month follow-up, primary patency, assisted primary patency, secondary patency, and freedom from target lesion revascularization were 47.3%, 49.8%, 59.5%, and 62.7%, respectively, and there was a significant improvement over baseline in Rutherford class (P < .001) and ankle-brachial index measurements (P < .001). Complex target lesions (P = .017) and 1 stenosis-free outflow vessel (P = .001) were risk predictors of freedom from clinically driven target lesion revascularization. Complex target lesions (P = .044), diabetes (P = .007), and 1 stenosis-free outflow vessel (P = .003) were risk predictors of restenosis. At 2 months, the ulcer healing rate was 96.3% (26/27). At 36 months, the limb salvage and survival rates were 85.8% and 83.3%, respectively. DCB angioplasty were safe and effective for older patients with CLTI attributable to femoropopliteal TASCII C/D lesions.

Comparative Study between Mechanical Rotational Atherectomy Combined with Drug-Coated Balloon versus Drug-Coated Balloon Alone for Treatment of In-Stent Restenosis during Peripheral Endovascular Interventions: A Multicentric Trial

Purpose: To compare the efficacy and safety of percutaneous mechanical debulking (PMD) using mechanical rotational atherectomy combined with paclitaxel drug-coated balloon (DCB) versus using paclitaxel DCB alone in the treatment of in-stent restenosis. Material and Methods: This is a multicentric retrospective observational study conducted over a period of 2 years from 2020 to 2022. The study included 49 patients presented with chronic limb-threatening ischemia (CLTI) associated with in-stent restenosis, either acute (&lt;14 days), subacute (&lt;3 months) or chronic (&gt;3 months). The enrolled patients underwent endovascular revascularization using either PMD combined with paclitaxel DCB or paclitaxel DCB only. They were followed up for 6 months after the intervention clinically and by duplex evaluation. Results: The lesion length was about 14.2 mm in the group treated by PMD+ DCB and 9.3 mm in the group treated by DCB alone. The technical success rate was the same between the two groups. However, the follow-up after 6 months showed that patencies for PMD + DCB and DCB alone were 15 (68.2%) patients and 15 (55.6%) patients, respectively (significant p value = 0.028). Procedural-related complications for PMD + DCB are distal embolization (9%) of cases and no vessel perforation. Regarding the candidates who were treated by DCB alone, there were minor groin hematomas (11.1%), distal arterial thrombosis (11.1%) and contrast-induced nephropathy (CIN) (11.1%) cases. Conclusion: The endovascular management of in-stent restenosis using percutaneous mechanical debulking (PMD) in conjunction with paclitaxel drug-coated balloon (DCB) showed that PMD combined with DCB is a safe and effective modality for achieving recanalization. It gives a satisfactory outcome in terms of technical success, freedom from clinically driven target lesion revascularization rate (CD-TLR) and mortality. Despite these promising results, further research with a large enrolled population may be required to determine the cost/benefit.

Impact of Peripheral Angioplasty on Wound Oxygenation and Healing in Patients with Chronic Limb-Threatening Ischemia Measured by Near-Infrared Spectroscopy.

Managing chronic limb-threatening ischemia (CLTI) is challenging due to difficulties in assessing tissue oxygen saturation in ulcers. Near-infrared spectroscopy (NIRS) is a non-invasive method for measuring tissue oxygen saturation (StO2). This study evaluated the effects of endovascular treatment (EVT) on StO2 and wound healing in CLTI patients, comparing NIRS to standard ankle-brachial index (ABI) measurements. Using the Duesseldorf PTA Registry, 43 CLTI patients were analyzed: 27 underwent EVT, and 16 received conservative treatment. ABI assessed macrocirculation, while NIRS measured wound, wound area, and mean foot StO2 at baseline, post-EVT, and four-month follow-up. Wound severity was classified by wound area and wound, ischemia, and foot infection (WIfI) score. Wound StO2 increased significantly (median (interquartile range (IQR)), 38 (49.3) to 60 (34.5)%, p = 0.004), as did wound area StO2 (median (IQR), 70.9 (21.6) to 72.8 (18.3)%, p < 0.001), with no significant changes in the control group by four-month follow-up. Wound area decreased significantly after EVT (mean ± SD, 343.1 ± 267.8 to 178.1 ± 268.5 mm2, p = 0.01) but not in the control group. Changes in wound StO2, wound area StO2, and WIfI score correlated with wound area reduction, unlike ABI. This small exploratory study shows that NIRS-measured StO2 improvements after EVT correlate with reduced wound area and WIfI scores, highlighting NIRS as a potential enhancement for CLTI wound management in addition to ABI.

Below-the-Ankle Antegrade Teleferic Technique: New Approach for Below-the-Ankle Revascularization in Challenging Cases of Chronic Limb-Threatening Ischemia.

To describe a novel bailout technique to approach below-the-ankle (BTA) chronic total occlusions or plantar-arch severe disease where the balloon/catheter is unable to follow the crossing guidewire and no other described recanalization approach is feasible. When facing a complex BTA revascularization, if the guidewire crosses but the balloon cannot progress due to a lack of pushability, an antegrade puncture of the infrapopliteal vessel where the tip of the guidewire lays is performed. The guidewire is then carefully navigated through this distal BTA vessel into the needle to achieve its rendezvous and externalization. A low-profile balloon is inserted through the femoral access and advanced till the non-crossable point of the BTA vessels. A torque device is then attached to the proximal hub of the balloon, and the through-and-through guidewire is subsequently pulled from the new distal access, allowing the balloon to be dragged across the lesion together with the wire. The below-the-ankle antegrade teleferic (BAT) technique may be considered for highly complex BTA revascularization procedures where the wire crosses the lesion, but no other device can be tracked over it. The clinical impact of this article lies in the description of a bailout technique for BTA revascularization where the guidewire crosses, but no device can be advanced. This technique can be helpful in scenarios where failure to achieve success could result in limb loss. The BAT technique provides a solution in extremely challenging cases, enhancing technical success, improving outcomes and potentially preserving the limbs of patients who would otherwise face amputation, if not revascularized.The video shows the BAT technique performed with a support catheter under fluoroscopy: antegrate puncture of the DP, advancement of the support catheter over the wire, rendezvous of the guidewire in the catheter and subsequent externalization of the wire.

The impact of angiographic pedal circulation status on wound healing in chronic limb-threatening ischemia after bypass surgery

ObjectiveIn the treatment of chronic limb-threatening ischemia (CLTI), complete wound healing is an important goal. Although foot perfusion status seems to be important for wound healing, the Global Limb Anatomic Staging System (GLASS) of the Global Vascular Guidelines does not include pedal artery status for the staging process due to the lack of sufficient evidence of its importance. This study aimed to clarify the importance of pedal perfusion status after bypass surgery. MethodsAmong the 153 CLTI cases that underwent bypass distal to popliteal arteries from 2014 to 2018, 117 CLTI limbs with wounds and with sufficient pedal angiographic data were enrolled. They were classified into two groups, based on the wound status 6 months postoperatively; early wound healing group (EWG; n = 78), which achieved complete wound healing within 6 months postoperatively, and prolonged healing or unhealed wounds group (PWG; n = 39), which failed to achieve wound healing within 6 months. Various factors associated with wound healing, including the wound, ischemia, and foot infection (WIfI) classification, intraoperative graft flow, and pedal angiographic data, were analyzed. Regarding pedal angiographic data, in addition to the GLASS inframalleolar/pedal disease descriptor (IPD), newly formed classification system of the pedal circulation status in association with the location of wounds was included: pedal circulation status was classified into two groups as visualized arterial perfusion towards wounds (visualized perfusion) and non-visualized arterial perfusion towards wounds (non-visualized perfusion). ResultsUnivariate analysis showed preoperative albumin (Odds ratio [OR], 0.47; 95% confidence interval [CI], 0.24-0.94; P = .027), higher WIfI clinical stage (OR, 3.88; 95% CI, 1.74-10.1; P = .0005), higher IPD (OR, 2.16; 95% CI, 1.16-4.02; P = .012), and non-visualized perfusion to wounds (OR, 5.74: 95% CI, 2.45-14.0; P < .0001) as significant for prolonged wound healing. Multivariate analysis showed higher WIfI stage (OR, 5.04; 95% CI, 1.74-14.6; P = .0029) and non-visualized perfusion to wounds (OR, 4.34; 95% CI, 1.71-11.0; P = .0021) as significant, whereas IPD was not detected as significant. Regarding blood supply to the foot, although graft flow was significantly lower in IPD-P2 than IPD-P0/P1, graft flow was similar regardless of the status of angiographic circulation to wounds, suggesting that distribution of blood supply to the wound would be more important than total amount of blood supply to the foot for wound healing. ConclusionsWIfI clinical stage and pedal circulatory environment were important factors for wound healing after bypass surgery. Pedal anatomical classification system including perfusion status would be important for decision making in CLTI treatment.

Association of Controlling Nutritional Status Score With Mortality in Patients With Chronic Limb-Threatening Ischemia Following Endovascular Revascularization

Chronic limb-threatening ischemia (CLTI) represents the severest manifestation of peripheral artery disease. Malnutrition is closely associated with poor clinical outcomes in patients with chronic diseases. The Controlling Nutritional Status (CONUT) score is a tool to evaluate the systemic inflammation and nutritional status. This study aimed to investigate the association of baseline CONUT score with mortality in patients with CLTI following endovascular revascularization. A single-center retrospective analysis of patients with CLTI undergoing endovascular revascularization between January 2015 and December 2022 was performed. Preoperative nutritional status was evaluated using CONUT score, which was calculated using the serum albumin concentration, total peripheral lymphocyte count, and total cholesterol concentration. A CONUT score ≥5 indicates moderate or severe malnutrition. The Kaplan-Meier and multivariate Cox proportional hazards regression were used for survival analysis and to evaluate the risk factors associated with mortality. Among 232 enrolled patients, 20.7% of patients had moderate or severe malnutrition defined by the CONUT score. During a median follow-up of 2.1 (interquartile ranges, 1.0-3.5) years, 87 (37.5%) patients died. The 3-year overall survival rate in patients with CLTI who underwent endovascular revascularization was 63.7%. The high CONUT (≥5) group had significantly worse 3-year overall survival (42.0% versus 68.8%, P=0.004) and limb salvage (73.3% versus 84.1%, P=0.005) rates than the low CONUT (<5) group. Multivariate analysis showed that high CONUT score was significantly associated with increased risk for mortality in patients with CLTI after endovascular revascularization (hazard ratio, 1.687; 95% confidence interval, 1.031-2.759; P=0.037). The present study indicated that moderate or severe malnutrition defined by the CONUT score was significantly associated with increased mortality in patients with CLTI following endovascular revascularization. Future study is required to evaluate the efficacy of nutritional intervention in these patients.

Discrepancy in opioid prescription patterns for Black or African American patients following lower extremity bypass surgery for chronic limb-threatening ischemia

BackgroundDisparity in the allocation of medical services and resources based on race is present within the health care industry today, including the prescription of postoperative analgesics. The purpose of this study was to evaluate the presence of race-based disparity in the prescription of postdischarge opioids after lower extremity bypass (LEB) surgery for chronic limb-threatening ischemia (CLTI). MethodsRetrospective analysis was conducted on adult CLTI patients who underwent LEB from 2000 to 2023 in the TrinetX database. Patients were stratified into two groups based on race: White (group I) and black or African American (AA) (group II). Primary outcomes were defined as oral opioid prescriptions at 7 days and 30 days after discharge, and mortality at 1 year postoperatively. Secondary outcomes included length of stay and 30-day postoperative outcomes, including myocardial infarction, pulmonary embolism, cerebral vascular accident, deep vein thrombosis, acute kidney injury, major amputation, minor amputation, major adverse cardiac events, and major adverse limb events. Stratified analysis was conducted based on disease stage (rest pain vs lower extremity ulcer vs gangrene). Univariate analysis was performed via two-sample t test and χ2 test. Logistic regression was performed to estimate the association of Black or AA (vs White) race while controlling for pertinent preoperative potential confounders. ResultsThere were 3345 patients who met the inclusion criteria. Group I included 2661 White patients and group II included 684 Black or AA patients. Group II patients were more likely to be younger, female, present with gangrene, and have a history of hypertension, diabetes, chronic kidney disease, or diabetic neuropathy. At both 7 and 30 days after discharge, the Black or AA cohort had significantly lower rates of opioid prescriptions (33.2% vs 42.5% and 35.8% vs 47.2%, respectively) (all P < .05). Stratification by indication showed that opioid prescription disparity persisted despite black or AA patients presenting at worse stages of disease both at 7 and 30 days after discharge (7 days: rest pain 43.4% vs 33.7% [P = .013], ulcer 41.4% vs 31.7% [P = .027], gangrene, 42.7% vs 33.6% [P = .006] and 30 days: rest pain 47.8% vs 37.1% [P = .007], ulcer 45.4% vs 33.5% [P = .007], gangrene, 48.2% vs 36.1% [P < .001]). Adjusted analysis confirmed that Black or AA race was associated with lower rates of 7- (adjusted odds ratio, 0.607; P = .001) and 30-day (adjusted odds ratio, 0.56; P = .001) postdischarge opioid prescriptions. ConclusionsBlack or AA patients were less likely to receive postdischarge opioid prescriptions compared with their White counterparts at 7 and 30 days after LEB for CLTI.

Employing magnetic resonance histology for precision chronic limb-threatening ischemia treatment planning

ObjectiveRecent randomized controlled trials have demonstrated a notable prevalence of immediate technical failures in percutaneous vascular interventions (PVIs) for complex arterial lesions associated with chronic limb-threatening ischemia. Current imaging modalities present inherent limitations in identifying these lesions, making it challenging to determine the most suitable candidates for PVI. We present a novel preprocedural magnetic resonance imaging (MRI) histology protocol for identifying lesions that might present a higher rate of immediate and midterm PVI failure. MethodsWe enrolled 22 patients (13 females, average age 65.8 ± 9.72 years) scheduled for PVI were prospectively and underwent 3T MRI using ultrashort echo time and steady-state free precession contrasts to characterize target lesions before PVI. Lesions were scored as hard if >50% of the lumen was occluded by hard components (calcium/dense collagen) on MRI in the hardest cross-section. Two readers evaluated MRI datasets. Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)/Global Limb Anatomic Staging System (GLASS)/Wound, Ischemia and Foot infection scoring was performed based on intraprocedural angiograms and chart review. The relationship between MRI scoring, TASC/GLASS scoring, and procedural outcomes was investigated using univariate analysis. Midterm follow-up (revascularization and amputation rates) was recorded at 3 and 6 months after the intervention. ResultsOur cohort of 22 patients yielded 40 target lesions. Five lesions were excluded (two for nondiagnostic image quality; three PVIs were ultimately diagnostic only). Six lesions (17%) were scored as hard. MRI-scored hard lesions had a higher proportion of immediate technical failure (hard vs soft 83% [5/6] vs 3% [1/29]; P < .001). Hard vs soft MRI scoring was the only factor significantly associated with immediate PVI technical success (P < .001), as opposed to TASC/GLASS scoring. Both at 3 months and 6 months after PVI, the reintervention rate was significantly higher among those lesions which were scored hard on MRI (3 months hard, 80% vs soft, 16% [P =.011]; 6 months hard, 80% vs soft, 27%; P = .047). ConclusionsMRI histology could be a valuable tool for optimizing PVI patient selection and treatment strategies.

Treatment of chronic limb-threatening ischemia (CLTI) based on BEST-CLI and BASIL-2

The rate of vascular recanalizations in CLTI is increasing worldwide. Safety and efficacy of surgical versus endovascular treatment in CLTI patients was investigated in 2 prospective randomized trials with contrasting results. The BEST-CLI trial randomized 1830 patients with CLTI, the Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL-2) trial included 345 patients with CLTI. Best-CLI evaluated outcome events as the primary endpoint, which includes major reinterventions in addition to major amputations and death. Only half of the CLTI patients received a crural intervention or surgery. There were no differences in major amputations or death. After a median follow-up (FU) of 2,7 years, the surgery group showed significantly better results compared to the endovascular group, due to fewer re-interventions. BASIL-2 used amputation-free survival as the primary outcome and only included patients with lower leg lesions. After a median FU of 40 months, endovascular therapy was found to be superior. The extremely high mortality rate was remarkable in both studies. The BEST-CLI study represents CLTI patients only to a limited degree, whereas the BASIL-2 study presents the treatment of CLTI patients with below-the-knee-lesions quite well. Both studies confirm that patients with CLTI should be treated in specialized centers that offer both crural surgery and endovascular therapy. Cardiovascular risk factor management must play a more important role in reducing the high mortality associated with CLTI.

Clinical Outcomes of Transradial vs Nontransradial Aortoiliac Endovascular Therapy

BackgroundThe introduction of radial-specific equipment has made transradial (TR) aortoiliac (AI) endovascular therapy (EVT) more convenient. ObjectivesThe authors aimed to investigate the perioperative outcomes of the TR approach in patients undergoing AI EVT for symptomatic peripheral artery disease. MethodsThe COMFORT (Contemporary Strategy for Aortoiliac Intervention) registry was a prospective, multicenter, observational study enrolling patients with symptomatic peripheral artery disease undergoing AI EVT between January 2021 and June 2023. The primary outcome was perioperative complications, whereas the secondary outcomes included core laboratory–evaluated residual stenosis >30%, time to hemostasis, time to ambulation, 30-day patency, and 30-day limb symptoms. These outcomes were compared between TR and non-TR AI EVT after propensity score matching. ResultsThe TR approach was selected for 231 of the 947 patients (24.3%). The TR approach was chosen more in patients with a higher ankle-brachial index, chronic total occlusion, aortic lesion, bare nitinol stent implantation, and plain angioplasty, whereas it was chosen less in patients with dialysis, a history of AI EVT, chronic limb-threatening ischemia, bilateral calcification, and simultaneous infrainguinal EVT (all P < 0.05). After propensity score matching, the incidence of perioperative complications did not differ significantly between the groups (TR group: 6.0% vs non-TR group: 5.1%; P = 0.69). The proportions of residual stenosis, 30-day patency, and 30-day limb symptoms were not significantly different (all P > 0.05); however, the time to hemostasis and the time to ambulation were shorter in the TR group (both P < 0.05). ConclusionsNon-TR AI EVT and TR AI EVT using radial-specific equipment were associated with a similar risk of perioperative complications. The TR approach helps shorten the time required for hemostasis and ambulation.

Comparison of Subsequent Inframalleolar Bypass Surgery and Repeat Endovascular Therapy for Infrapopliteal Restenosis in Patients With Chronic Limb-Threatening Ischemia Undergoing Primary Endovascular Therapy.

Although endovascular therapy (EVT) is considered a vital strategy for treating infrapopliteal lesions in chronic limb-threatening ischemia (CLTI), the recurrence rate after EVT exceeds that after bypass surgery (BSX). The optimal approach for managing infrapopliteal lesion recurrence in patients with CLTI and unhealed ulcers remains uncertain. This study aimed to evaluate the clinical outcomes of repeat EVT and subsequent inframalleolar BSX for CLTI with infrapopliteal lesion recurrence. We conducted a retrospective analysis of 140 patients with CLTI (mean age, 70±10 years; male, 71.4%; diabetes mellitus, 73.6%; dialysis, 74.3%; Rutherford 5, 79.3%; and Rutherford 6, 20.7%) who had an unhealed wound due to the recurrence of infrapopliteal lesions between January 2015 and May 2020. We compared the clinical outcomes of 40 patients who underwent the subsequent inframalleolar BSX with those of 100 patients who underwent repeat EVT. The outcome measures were amputation-free survival (AFS) and wound healing rate. Propensity score matching analysis was conducted to minimize differences in baseline characteristics. Propensity score matching extracted 38 pairs (38 patients in the subsequent BSX group and 83 patients in the repeat EVT group). AFS was not significantly different between the repeat EVT and subsequent BSX groups (81.9% vs 82.6% at 1 year, p=0.97). Neither was cumulative wound healing (42.8% vs 43.3% at 1 year, p=0.55). No baseline characteristics had any significant interaction effect on the association between repeat EVT, subsequent BSX, and failure of AFS. This study using propensity score matching revealed that the clinical outcomes following repeat EVT were comparable with those following subsequent inframalleolar BSX, indicating that repeat EVT may be a viable treatment option for CLTI with infrapopliteal lesion recurrence. Although endovascular therapy (EVT) has expanded the treatment options for chronic limb-threatening ischemia (CLTI), the recurrence rate after EVT is higher than that after bypass surgery (BSX). This retrospective study compared the clinical outcomes of repeat EVT with those of subsequent BSX for CLTI with infrapopliteal lesion recurrence. After propensity score matching, amputation-free survival (AFS) was not significantly different between the repeat EVT and subsequent BSX groups (81.9% vs 82.6% at 1 year, p=0.97). Neither was cumulative wound healing (42.8% vs 43.3% at 1 year, p=0.55). There was no difference between the 2 revascularization strategies when treating infrapopliteal restenosis lesions.

Current Applications and Future Perspectives of Artificial and Biomimetic Intelligence in Vascular Surgery and Peripheral Artery Disease.

Artificial Intelligence (AI) made its first appearance in 1956, and since then it has progressively introduced itself in healthcare systems and patients' information and care. AI functions can be grouped under the following headings: Machine Learning (ML), Deep Learning (DL), Artificial Neural Network (ANN), Convolutional Neural Network (CNN), Computer Vision (CV). Biomimetic intelligence (BI) applies the principles of systems of nature to create biological algorithms, such as genetic and neural network, to be used in different scenarios. Chronic limb-threatening ischemia (CLTI) represents the last stage of peripheral artery disease (PAD) and has increased over recent years, together with the rise in prevalence of diabetes and population ageing. Nowadays, AI and BI grant the possibility of developing new diagnostic and treatment solutions in the vascular field, given the possibility of accessing clinical, biological, and imaging data. By assessing the vascular anatomy in every patient, as well as the burden of atherosclerosis, and classifying the level and degree of disease, sizing and planning the best endovascular treatment, defining the perioperative complications risk, integrating experiences and resources between different specialties, identifying latent PAD, thus offering evidence-based solutions and guiding surgeons in the choice of the best surgical technique, AI and BI challenge the role of the physician's experience in PAD treatment.

Clinical Comparison of Drug-Coated Balloon and Drug-Eluting Stent for Femoropopliteal Lesions in Chronic Limb-Threatening Ischemia With Wounds.

Endovascular therapy (EVT) with devices such as drug-coated balloons (DCBs) and drug-eluting stents (DESs) for atherosclerotic disease in the femoropopliteal (FP) artery has been established. However, EVT using drug-based devices for chronic limb-threatening ischemia (CLTI) remains challenging. The optimal device for FP lesions in patients with CLTI remains unknown. This study compared the clinical efficacy of DCB and DES in patients with CLTI and FP lesions.Methods and Results: This retrospective single-center study included 539 consecutive patients (562 lesions) treated with EVT between January 2018 and December 2022; 166 patients with CLTI and Rutherford Class 5 or 6 wounds underwent EVT with DCB or DES. Clinical outcomes were compared between 53 pairs after propensity score matching. There were no significant differences between the DCB and DES groups in the incidence of complete wound healing without death or major amputation (84.8% vs. 80.2%, respectively; P=0.99), primary patency (69.4% vs. 75.6%, respectively; P=0.65), and freedom from target lesion revascularization at 1 year (78.6% vs. 78.0%, respectively; P=0.92). Multivariate analysis showed that complete wound healing at 1 year is negatively associated with hemodialysis and Wound, Ischemia, and foot Infection Stage 4, but positively associated with Global Limb Anatomic Staging System FP Grade 3 or 4. No significant differences in clinical outcomes were found between DCB and DES for patients with CLTI and FP lesions.