Retrograde Pedal Access via Occluded Arteries in Endovascular Treatment of Critical Limb Ischemia

PurposeTo evaluate the feasibility and technical outcomes of retrograde access via occluded pedal arteries in endovascular treatment of critical limb ischemia (CLI) when the conventional antegrade approach fails.Materials and MethodsOne hundred fifty-one patients with CLI (age 69 y ± 10.5; 116 men) who were not surgical candidates and were treated via retrograde pedal access between January 2016 and January 2018 were evaluated retrospectively. Seventy patients in whom retrograde access was performed through occluded arteries constituted the occluded group, and 81 patients who were treated via retrograde access from patent arteries constituted the nonoccluded group. Pedal access success, lesion crossing success, angiographic success, overall technical success, and procedure-related complications were evaluated and compared between groups.ResultsPedal access success (74 of 78 vs 83 of 87 attempts; P = .873) and lesion crossing success (64 of 78 vs 77 of 87 lesions; P = .340) were comparable between subgroups. Angiographic success (54 of 78 vs 77 of 87 lesions; P = .012) and overall technical success (48 of 70 vs 72 of 81 patients; P = .004) rates were lower in the occluded group. Procedure-related complications were similar between groups (P = .096).ConclusionsRetrograde pedal access from occluded pedal arteries is a feasible option when an antegrade approach fails in endovascular treatment of CLI. Although it has lower technical success, its use enables angiosome-directed therapy and has the potential to improve the outcomes of the procedure.     

Below-the-Ankle Angioplasty in Patients with Critical Limb Ischemia: A Systematic Review and Meta-Analysis

PurposeTo evaluate the safety and effectiveness of below-the-ankle (BTA) angioplasty and to assess whether additional BTA angioplasty after below-the-knee (BTK) angioplasty would improve clinical outcomes in patients with critical limb ischemia.Materials and MethodsTwo authors independently performed the search, study selection, assessment of methodological quality, and data extraction for this systematic review and meta-analysis. MEDLINE, Embase, and the Cochrane Database of Systematic Reviews were searched. Articles were eligible if it was reported that BTA angioplasty was performed and if the articles were published in English and had the full text available. Methodological quality was assessed using the Methodological Index for Non-Randomized Studies (MINORS) score. The primary outcome was 12-month limb salvage rate. Secondary outcomes were 12-month amputation-free survival, technical success, complications, survival, and freedom from reintervention.ResultsTen articles met the inclusion criteria, reporting a total of 478 patients with BTA angioplasty performed in 524 legs. Three of the 10 included studies compared BTK angioplasty only to BTK angioplasty and additional BTA angioplasty. The pooled 12-month limb salvage rate was 92% (95% confidence interval [CI], 0.88–0.96). No statistically significant difference was found in limb salvage when additional BTA angioplasty was compared to BTK angioplasty only (odds ratio [OR], 1.23; 95% CI, 0.61–2.49). The pooled 12-month amputation-free survival was 78% (95% CI, 0.69–0.87). No statistically significant difference was found in amputation-free survival rate when additional BTA angioplasty was compared to BTK angioplasty only (OR, 1.58; 95% CI, 0.95–2.64). The methodological quality of the studies included was moderate, according to the MINORS score.ConclusionsThis systematic review and meta-analysis showed that additional BTA angioplasty is a safe and feasible procedure, with a 92% pooled proportion of limb salvage at 12 months.     

Predictors for Nonhome Patient Discharge following Lower Extremity Arterial Interventions

PurposeTo identify the variables associated with patient discharge disposition to optimize postprocedural care and discharge planning following lower extremity arterial interventions for peripheral artery disease (PAD).Materials and MethodsThe 2014–2017 American College of Surgeons National Surgical Quality Improvement Program database was queried using current procedural terminology codes for endovascular infrainguinal interventions for PAD. The main outcome variable of interest was nonhome discharge. Covariates included patient sociodemographic variables, age quartile (upper quartile, ≥77 years), comorbidities (diabetes, renal disease, bleeding disorder, congestive heart failure [CHF], and chronic obstructive pulmonary disease), presence of an open wound before a procedure, type of procedure, operative time, symptom severity, American Society of Anesthesiologists class, and baseline functional status. Univariate analysis and multivariate logistic regression were performed on Stata/SE 15.1.ResultsA total of 3,190 patients met the inclusion criteria, of whom 664 (20.8%) had nonhome discharge. Multivariate regression revealed that age (odds ratio [OR], 1.9 for the upper age quartile [>77 years]; 95% confidence interval [CI], 1.46–2.50), operative time (OR, 1.2 per increase in quartile; 95% CI, 1.09–1.30), preoperative wound (OR, 1.5; 95% CI, 1.24–1.90), renal failure (OR, 1.7; 95% CI, 1.30–2.14), CHF (OR, 2.2; 95% CI, 1.51–3.24), symptom severity (OR, 1.7; 95% CI, 1.46–1.98), and independent functional status (OR, 0.74; 95% CI, 0.59–0.92; P = .007) were associated with nonhome discharge. All P values were ≤.001 unless otherwise stated.ConclusionsProlonged procedural time, the presence of preprocedural wound and patient comorbidities, symptomatology, and baseline functional status may be used to identify patients who will require a nonhome discharge and early discharge planning.     

Clinical Impact and Predictors of the Slow-Flow Phenomenon after Endovascular Treatment of Infrapopliteal Lesions Using the Crosser Catheter in Patients with Critical Limb Ischemia

PurposeTo determine the clinical impact and predictors of slow flow after endovascular treatment (EVT) using the Crosser catheter for debulking infrapopliteal lesions associated with critical limb ischemia.Materials and MethodsThis retrospective study included 65 patients with critical limb ischemia (70 limbs, 90 infrapopliteal lesions), who underwent EVT using the Crosser catheter between November 2011 and February 2017. The Crosser catheter was used when the balloon catheter could not be passed through the lesion or could not be dilated sufficiently. Slow flow was evaluated after atherectomy using Crosser and was defined as delayed antegrade flow to the foot (total number of cine frames >35).ResultsFollowing atherectomy, slow flow developed in 37 infrapopliteal lesions (41.1%). Despite secondary treatment, slow flow persisted in 29 of 37 lesions (78%). After atherectomy using the Crosser catheter, the balloon could be passed through the lesion in all cases. The wound healing rate at 1 year after EVT (overall, 67.8%) was significantly poorer in the presence of slow flow (rate with vs. without slow flow, 45.3% vs. 84.4%, respectively; P = .006), especially among patients with stage ≥3 baseline wound, ischemia, and foot infection. The active length of the Crosser catheter was a predictor of slow flow (odds ratio, 1.05; 95% confidence interval, 1.03–1.08; P < .001), with an optimal cutoff of 100 mm.ConclusionsSlow flow is associated with a poorer wound healing rate at 1 year, especially for patients with severe baseline ischemia. To reduce the risk of slow flow, the active length of the Crosser catheter should be kept at <100 mm.     

Closing the Gaps in Racial Disparities in Critical Limb Ischemia Outcome and Amputation Rates: Proceedings from a Society of Interventional Radiology Foundation Research Consensus Panel

Minority patients such as Blacks, Hispanics, and Native Americans are disproportionately impacted by critical limb ischemia and amputation due to multiple factors such as socioeconomic status, type or lack of insurance, lack of access to health care, capacity and expertise of local hospitals, prevalence of diabetes, and unconscious bias. The Society of Interventional Radiology Foundation recognizes that it is imperative to close the disparity gaps and funded a Research Consensus Panel to prioritize a research agenda. The following research priorities were ultimately prioritized: (a) randomized controlled trial with peripheral arterial disease screening of at-risk patients with oversampling of high-risk racial groups, (b) prospective trial with the introduction of an intervention to alter a social determinant of health, and (c) a prospective trial with the implementation of an algorithm that requires criteria be met prior to an amputation. This article presents the proceedings and recommendations from the panel.     

Endovascular Management of Iatrogenic Arterial Injuries after Orthopedic Surgery of the Lower Limb

PurposeTo evaluate the safety and effectiveness of embolization, and to identify the contributory factors of failures in patients treated for iatrogenic arterial injuries after orthopedic surgery of the lower limb.Materials and MethodsIn this retrospective study, data from patients treated from December 2008 to March 2022 for an arterial injury due to orthopedic surgery of the lower limb were analyzed from a single center. Demographic, clinical, and procedure-related data were collected. Perioperative and 30-day mortalities were estimated. Odds ratios and hazard ratios were calculated for several potential risk factors: age of >75 years, atherosclerosis, preexisting infection, urgency of surgery (trauma vs elective), previous surgery, multiple distant injuries, and multiple vascular supplies to the same injury.ResultsEighty-six procedures performed on 78 patients were included in the study. The rates of technical and clinical success were 100% and 92.3%, respectively. Six (7.7%) patients were retreated because of persistent bleeding. The perioperative mortality was 1.3%, and the 30-day mortality rate was 7.7%. The presence of multiple arterial supplies, multiple injuries, previous surgery, presence of atherosclerosis, or a preexisting musculoskeletal infection resulted in a higher risk of retreatment.ConclusionsEmbolization is safe and effective in the management of iatrogenic arterial injuries after orthopedic surgery. The number of involved vascular territories was the most critical factor in determining technical failure.     

Dual-Energy Computed Tomography as an Adjunct in the Evaluation of Peripheral Chronic Total Occlusions: A Feasibility Study

This study investigated the role of dual-energy computed tomography (CT) for lesion characterization in patients with peripheral arterial disease manifesting with chronic total occlusions (CTOs). Forty-one symptomatic patients with CTOs underwent dual-energy CT angiography before endovascular treatment. The lesions were subsequently analyzed in a dedicated workstation, and 2 indexes—dual-energy index (DEI) and effective Z (Z_eff)—were calculated, ranging from 0.0027 to 0.321 and from 6.89 to 13.02, respectively. Statistical analysis showed a significant correlation between the DEI and Z_eff values (P < .001). The interobserver intraclass correlation coefficient was 0.91 for the mean Z_eff values and 0.86 for the mean DEI values. This technique could potentially provide useful information regarding the composition of a CTO.     

“Angioplasty-First” Approach for Limb Salvage in Asian Patients with Critical Limb Ischemia: Outcomes from 3,303 Angioplasties on 2,402 Limbs in a Single Tertiary Hospital

PurposeTo review outcomes of patients with critical limb ischemia (CLI) who underwent conventional percutaneous transluminal angioplasty (PTA) as first-line treatment for revascularization.Materials and MethodsRetrospective review of 3,303 angioplasty procedures on 2,402 limbs in 1,968 patients with CLI was conducted. Mean patient age was 68 years ± 11, and 1,057 patients (54%) were male. Diabetes mellitus (DM) was present in 1,736 patients (88%), and end-stage renal disease (ESRD) in 579 (29%). A majority of patients (90%) had tissue loss. Limb salvage rates were generated by Kaplan–Meier plot. Univariate and multivariate Cox regression analysis was conducted to investigate associations between clinical predictors and time-to-event outcome.ResultsLimb salvage rates at 1, 3, 5, and 10 years were 75%, 73%, 72%, and 62%, respectively, and overall survival rates were 79%, 64%, 56%, and 34%, respectively. In multivariable Cox regression analysis with the outcome of major amputation, significant predictors included age < 69 years (P = .032), Malay race (P = .029), DM (P < .001), history of cerebral vascular disease (P = .003), ESRD (P < .001), Rutherford classification (P = .042), repeat intervention (P = .034), and number of straight-line flows (P < .001) and plantar arch integrity (P < .001) on completion angiography. Significant associations with mortality were age < 69 years (P < .001), male sex (P = .030), Malay race (P = .027), history of ischemic heart disease (P < .001), ESRD (P < .001), and repeat intervention (P < .001).ConclusionsPTA as first-line revascularization for patients with CLI is safe and effective. Further studies are suggested to validate the outcome predictive model.     

Comparison of Anticoagulation Regimens Following Stent Placement for Nonthrombotic Lower Extremity Venous Disease

PurposeTo determine whether subtherapeutic anticoagulation regimens are noninferior to therapeutic anticoagulation regimens following stent placement for nonthrombotic lower extremity venous disease.Materials and MethodsFifty-one consecutive patients (88% women; mean age, 44 years) who underwent stent placement for nonthrombotic lower extremity venous disease between 2002 and 2016 were retrospectively identified. The patients were divided into 2 cohorts: those who received prophylactic enoxaparin or no anticoagulation (subtherapeutic) after the procedure and those who received therapeutic doses of anticoagulation with enoxaparin, warfarin, and/or rivaroxaban (therapeutic) after the procedure. Baseline demographic characteristics, procedure characteristics, and outcomes were compared between the 2 groups using the Student t test, Fisher exact test, and χ² test. The subtherapeutic and therapeutic anticoagulation groups did not differ significantly in the baseline demographic characteristics (eg, sex, race, and age) or procedure characteristics (eg, number of stents placed, stent brand, stent diameter, etc).ResultsThe mean clinical follow-up time was 4.4 years (range, 0–16.3 years). There were no thrombotic adverse events or luminal obstructions due to in-stent restenosis in either group. There were 5 minor bleeding adverse effects in the therapeutic group and no bleeding adverse effects in the subtherapeutic group (P = .051). There were no statistically significant differences in subjective symptom improvement (P = .75).ConclusionsIn this retrospective cohort, the subtherapeutic and therapeutic anticoagulation regimens produced equivalent outcomes in terms of adverse event rates, reintervention rates, and symptomatic improvement, suggesting that therapeutic doses of anticoagulation do not improve outcomes compared with subtherapeutic anticoagulation regimens following nonthrombotic venous stent placement.     

Long-Term Clinical Outcomes after Endovascular Therapy for Anti-Centromere Antibody-Positive Patients with Critical Limb-Threatening Ischemia

PurposeTo examine the long-term clinical outcomes of patients with anti-centromere antibody (ACA)-positive critical limb-threatening ischemia (CLTI) who were treated with endovascular therapy (EVT).Materials and MethodsThis was a retrospective analysis using a database of 423 consecutive CLTI patients (543 limbs, Rutherford class 4–6) who underwent EVT between January 2011 and March 2013. The patients were divided into 2 groups: an ACA-positive group (10 limbs, 8 patients) and a control group (46 limbs, 43 patients). The control group was defined as female, non-dialysis, and those who were able to obtain a below-knee angiogram.ResultsNone of the 8 ACA-positive CLTI patients had previously been diagnosed as ACA positive. No significant difference was observed in the below-the-knee lesion distribution and severity between the ACA-positive group and the control group. The median observational period was 51 months. The survival rate was 54% in the ACA-positive group and 76% in the control group at 5 years after EVT (P = .732). The freedom from major amputation rate was 60% in the ACA-positive group and 91% in the control group at 5 years after EVT (P = .029). The technical EVT success rate in the ACA-positive group was 70% (7/10). Of the successful EVT cases, 71% (5/7) of patients achieved complete wound healing or rest pain relief; however, 60% (3/5) had a recurrence of wounds.ConclusionsIn a series of ACA-positive patients with CLTI, successful EVT had acceptable outcomes with respect to wound healing with short-term results. However, the major amputation rate for ACA-positive patients was high in long-term follow-up.     

Safety and Efficacy of a Truncated Deflation Algorithm for Distal Transradial Access

PurposeTo assess safety and efficacy of a modified rapid hemostasis protocol for distal transradial access (TRA).Materials and MethodsA single-center retrospective study of patients undergoing percutaneous image-guided procedures from a distal TRA with rapid deflation hemostasis protocol was performed. Between March 2017 and August 2019, 593 procedures in 434 patients were performed. Mean patient age was 63.5 y (range, 18–94 y).ResultsThe most common procedures were transarterial chemoembolization (218; 36.8%), abdominal and pelvic embolization (116; 19.6%), yttrium-90 mapping (115; 19.4%), yttrium-90 administration (84; 14.2%), and diagnostic angiography (44; 7.4%). Mean (range) values for clotting parameters were international normalized ratio 1.2 (0.9–3.2), partial thromboplastin time 33.5 s (26–44 s), and platelets 23.4 × 10⁹/L (37–552 × 10⁹/L). A hematoma developed in 7 (1.2%) patients. No radial artery occlusions were encountered during follow-up. Nursing intensity was defined as the number of minutes after the procedure required for assessing and managing the access site for bleeding. The mean nursing intensity was 25.1 min (range, 25–40 min).ConclusionsThe rapid deflation hemostasis protocol for distal TRA at the anatomical snuffbox was feasible and safe. No significant difference or association was found between hematoma formation and clotting parameters after the procedure or type of vascular access equipment used.     

Distal Radial Artery Access for Noncoronary Endovascular Treatment Is a Safe and Feasible Technique

PurposeTo evaluate safety and feasibility of distal radial artery (DRA) access for noncoronary interventional radiology procedures.Materials and MethodsAll interventional radiology procedures by means of DRA puncture from July 2017 to August 2018 were retrospectively reviewed. Eighty-two punctures in 56 patients were included, mostly in male patients (84% vs 16%). Mean age was 67.8 years (range, 33.3–87.3 years); mean height was 172 cm (range, 142–190 cm); and mean weight was 83 kg (range, 43–120 kg). Procedural characteristics, technical success, and complication rates were gathered from the medical records and follow-up ultrasound when available. Prerequisites for DRA access were adequate radioulnar collateral circulation, sufficient radial artery diameter, and informed consent in patients initially intended for conventional transradial access.ResultsProcedures included transarterial chemoembolization (n = 34), yittrium-90 pretreatment angiography (n = 21), yittrium-90 administration (transarterial radioembolization; n = 20), and embolization of visceral organs (n = 7). Both 4-Fr (n = 35) and 5-Fr (n = 46) sheaths were used. Technical success of DRA access was 97.6%, with conversion to transfemoral access in 2 cases (2.4%). No major complications were reported as a result of DRA access.ConclusionDRA access is a feasible and safe technique for abdominal interventional radiology embolization procedures. No radial artery occlusion or other major complications were observed in patients who underwent follow-up ultrasound.     

A Multinational,Single-Arm Pivotal Study Assessing the Performance of the SoundBite Crossing System for Peripheral Chronic Total Occlusions (The PROSPECTOR Study)

PurposeThis study aimed to demonstrate the efficacy and safety of the SoundBite Crossing System?Peripheral (SCS-P) to facilitate crossing chronic total occlusions (CTOs) of infrainguinal arteries.Materials and MethodsThis clinical trial was approved by the Ethics Committees of all 4 participating centers and enrolled 52 patients with symptomatic de novo infrainguinal CTOs. Technical device success, the primary efficacy endpoint, was defined as the ability to facilitate the treatment of the target lesion by crossing a portion or the whole length of the CTO. Freedom from SCS-P–related major adverse events (MAEs) at 30 days after the procedure was the primary safety endpoint.ResultsThe SCS-P met the primary efficacy and safety endpoints in 92.3% (48/52) and 100% (52/52) of subjects, respectively. Technical device success with postprocedural patency and freedom from SCS-P–related MAEs was achieved in 88.5% (46/52) of subjects. The mean CTO crossing time was 20.0 minutes ± 30.8, and the SCS-P was able to traverse the whole CTO and enter the distal true lumen without the need of any other device in 59.6% (31/52) of subjects. The mean Rutherford category and ankle-brachial index improvement at the 30-day follow-up was 2.4 ± 1.17 and 0.23 ± 0.22, respectively.ConclusionsThe SCS-P demonstrated a satisfactory safety and performance profile to cross peripheral CTOs and enter the distal true lumen of infrainguinal CTOs.     

Ultrasound-Guided Subgluteal Sciatic Nerve Block for Pain Management during Endovascular Treatment for Below-the-Knee Arterial Occlusions

PurposeTo evaluate the ability of subgluteal sciatic nerve block (SSNB) to provide pain control during endovascular treatment of below-the-knee (BTK) occlusions.Materials and MethodsThis randomized prospective controlled study evaluated 60 consecutive adult patients who underwent endovascular treatment for BTK occlusions. The patients were randomized into 2 equal groups; the SSNB group underwent SSNB in the subgluteal space under ultrasound guidance, while the control group received fentanyl as an analgesic. The visual analog scale (VAS) and Face, Legs, Activity, Cry, Consolability (FLACC) scale scores were recorded.ResultsCompared with the control group, the SSNB group showed significantly lower median VAS (0 [range, 0–30] vs 70 [range, 20–100], P < .001) and median FLACC scale (0 [range, 0–2] vs 6 [range, 3–10], P < .001) scores. There was no statistically significant difference between the 2 groups regarding the remaining parameters. There was a very strong correlation between the VAS and FLACC scale scores in both the SSNB (r = 0.805, P < .001) and control (r = 0.950, P < .001) groups. The procedure time and total balloon inflation time correlated with the VAS (r = 0.411, P = .024, and r = 0.402, P = .031, respectively) and FLACC scale (r = 0.431, P = .017, and r = 0.414, P = .022, respectively) scores in the control group but not in the SSNB group (r = 0.364, P = .056, and r = 0.300, P =.085, respectively, for correlation with VAS score and r = 0.730, P = .068, and r = 0.704, P = .075, respectively, for correlation with the FLACC scale score).ConclusionsSSNB is a highly effective and safe pain management modality for the endovascular treatment of BTK occlusions.     

Digital Variance Angiography in Selective Lower Limb Interventions

PurposeTo evaluate the potential benefits of digital variance angiography (DVA) in selective lower limb angiography and to compare the performance of 2 DVA algorithms (conventional DVA1 and the recently developed DVA2) to that of digital subtraction angiography (DSA).Materials and MethodsFrom November 2019 to May 2020, 112 iodinated contrast media (ICM) and 40 carbon dioxide (CO₂) angiograms were collected from 15 and 13 peripheral artery disease patients, respectively. The DVA files were retrospectively generated from the same unsubtracted source file as DSA. The objectively calculated contrast-to-noise ratio (CNR) and the subjective visual image quality of DSA, DVA1, and DVA2 images were statistically compared using the Wilcoxon signed-rank test. The images were evaluated by 6 radiologists (R.P.T., S.V., A.M.K., S.S.A., O.E., and J.S.) from 2 centers using a 5-grade Likert scale.ResultsBoth DVA algorithms produced similar increase (at least 2-fold) in CNR values (P < .001) and significantly higher image quality scores than DSA, independent of the contrast agent used. The overall scores with ICM were 3.61 ± 0.05 for DSA, 4.30 ± 0.04 for DVA1, and 4.33 ± 0.04 for DVA2 (each P < .001 vs DSA). The scores for CO₂ were 3.10 ± 0.14 for DSA, 3.63 ± 0.13 for DVA1 (P < .001 vs DSA), and 3.38 ± 0.13 for DVA2 (P < .05 vs DSA).ConclusionsDVA provides higher CNR and significantly better image quality in selective lower limb interventions irrespective of the contrast agent used. Between DVA algorithms, DVA1 is preferred because of its identical or better image quality than DVA2. DVA can potentially help the interventional decision process and its quality reserve might allow dose management (radiation/ICM reduction) in the future.     

Effectiveness and Safety of Atherectomy versus Plain Balloon Angioplasty for Limb Salvage in Tibioperoneal Arterial Disease

PurposeTo evaluate the effectiveness and safety of atherectomy versus plain balloon angioplasty (POBA) for treatment of critical limb ischemia (CLI) due to tibioperoneal arterial disease (TPAD).Materials and MethodsPatients enrolled in the Vascular Quality Initiative registry who had CLI (Rutherford Class 4–6) and underwent atherectomy versus POBA alone for isolated TPAD were retrospectively identified. Of eligible patients, a cohort of 2,908 patients was propensity matched 1:1 by clinical and angiographic characteristics. The atherectomy group comprised 1,454 patients with 2,183 arteries treated, and the POBA group comprised 1,454 patients with 2,141 arteries treated. The primary study endpoint was major ipsilateral limb amputation. Secondary endpoints were minor ipsilateral amputations, any ipsilateral amputation, primary patency, target vessel reintervention (TVR), and wound healing at 12 months.ResultsThe median follow-up period was 507 days, the mean patient age was 69 years ± 11.7, and the mean occluded length was 6.9 cm ± 6.5. There was a trend toward higher technical success rates with atherectomy than with POBA (92.9% vs 91.0%, respectively; P = .06). The rates of major adverse events during the procedure were not significantly different. The 12-month major amputation rate was similar in the atherectomy and POBA groups (4.5% vs 4.6%, respectively; P = .92; odds ratio, 0.97; 95% CI, 0.68–1.37). There was no difference in 12-month TVR (17.9% vs 17.8%; P = .97) or primary patency (56.4% vs 54.5%; P = .64) between the atherectomy and POBA groups.ConclusionsIn a large national registry, treatment of CLI from TPAD using atherectomy versus POBA showed no significant differences in procedural adverse events, major amputations, TVR, or vessel patency at 12 months.     

Risk of Death and Amputation with Use of Paclitaxel-Coated Balloons in the Infrapopliteal Arteries for Treatment of Critical Limb Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

A formal systematic review and study-level meta-analysis of randomized controlled trials investigating treatment of the infrapopliteal arteries with paclitaxel-coated balloons compared with conventional balloon angioplasty for critical limb ischemia (CLI) was conducted. Medical databases and online content were last screened in September 2019. The primary safety and efficacy endpoint was amputation-free survival defined as freedom from all-cause death and major amputation. Target lesion revascularization (TLR) constituted a secondary efficacy endpoint. Summary effects were synthesized with a random-effects model. Some 8 randomized controlled trials with 1,420 patients (97% CLI) were analyzed up to 1 year follow-up. Amputation-free survival was significantly worse in case of paclitaxel (13.7% crude risk of death or limb loss compared to 9.4% in case of uncoated balloon angioplasty; hazard ratio 1.52; 95% confidence interval: 1.12–2.07, p = .008). TLR was significantly reduced in case of paclitaxel (11.8% crude risk of TLR versus 25.6% in control; risk ratio 0.53; 95% confidence interval: 0.35–0.81, p = .004). The harm signal was evident when examining the high-dose (3.0-3.5 μg/mm²) devices, but attenuated below significance in case of a low-dose (2.0 μg/mm²) device. Actual causes remain largely unknown, but non-target paclitaxel embolization is a plausible mechanism.     

Lower Extremity Venous Stent Placement: A Large Retrospective Single-Center Analysis

PurposeTo study short-term and long-term outcomes of lower extremity venous stents placed at a single center and to characterize changes in vein diameter achieved by stent placement.Materials and MethodsA database of all patients who received lower extremity venous stents between 1996 and 2018 revealed 1,094 stents were placed in 406 patients (172 men, 234 women; median age, 49 y) in 513 limbs, including patients with iliocaval stents (9.4% acute thrombosis, 65.3% chronic thrombosis, 25.3% nonthrombotic lesions). Primary, primary assisted, and secondary patency rates were assessed for lower extremity venous stents at 1, 3, and 5 years using Kaplan-Meier analyses and summary statistics. Subset analyses and Cox regression were performed to identify risk factors for patency loss. Vein diameters and Villalta scores before and up to 12 months after stent placement were compared. Complication and mortality rates were calculated.ResultsPrimary, primary assisted, and secondary patency rates at 5 years were 57.3%, 77.2%, and 80.9% by Kaplan-Meier methods and 78.6%, 90.3%, and 92.8% by summary statistics. Median follow-up was 199 days (interquartile range, 35.2–712.0 d). Patency rates for the subset of patients (n = 46) with ≥ 5 years of follow-up (mean ± SD 9.1 y ± 3.4) were nearly identical to cohort patency rates at 5 years. Patients with inferior vena cava stent placement (hazard ratio 2.11, P < .0001) or acute thrombosis (hazard ratio 3.65, P < .0001) during the index procedure had significantly increased risk of losing primary patency status. Vein diameters were significantly greater after stent placement. There were no instances of stent fracture, migration, or structural deformities. In patients with chronic deep vein thrombosis, Villalta scores significantly decreased after stent placement (from 15.7 to 7.4, P < .0001). Perioperative mortality was < 1%, and major perioperative complication rate was 3.7%.ConclusionsCavo-ilio-femoral stent placement for venous occlusive disease achieves improvement of vein disease severity scores, increase in treated vein diameters, and satisfactory long-term patency rates.