Target Limb Research Articles

5-years patency results of Zilver PTX on the femoro-popliteal arterial segment: A Northern Sydney experience.

The burden of peripheral arterial disease is increasing. Treatment of femoro-popliteal lesions remains challenging despite novel endovascular devices. Drug-eluting stents suppress post-treatment inflammation and reducing neo-intimal hyperplasia to reduce in-stent restenosis. A multi-centre retrospective 5-years longitudinal study was undertaken to evaluate freedom from clinically driven target limb revascularisation (FF CD-TLR) and patency of Zilver PTX stents in treating symptomatic femoro-popliteal stenotic lesions. Kaplan-Meier survival curves were used to demonstrate FF CD-TLR, primary, primary assisted and secondary patency. There were 148 patients and 183 lesions treated with a mean age of 80.3years and 52% males. The all-cause 5-years mortality was 25%. FF CD-TLR yearly patencies to 5years were 81%, 67%, 62%, 57% and 52%, respectively, with significantly poorer outcomes for in-stent restenosis, longer stent lengths and lesions at the femoro-popliteal junction. Primary patencies were 63%, 47%, 40%, 34% and 24%, assisted primary patencies were 90%, 75%, 68%, 59% and 48% and secondary patencies were 96%, 94%, 94%, 92% and 92%. Major adverse limb events were 5% at 1-year and cumulative at 5-years was 16%. The clinical outcomes in this study population are comparable to recent publications with smaller cohorts. Our study confirms Zilver PTX has very good primary patency over 5years with no discernible effect on all-cause mortality in an elderly cohort with particularly long treated lesions. Our results are similar to those seen in younger patients with shorter lesions. Nonetheless, longer lesions required more reinterventions to maintain patency. Zilver PTX is a safe and durable drug-eluting stent when utilised in the management of femoro-popliteal stenotic lesions with good long-term patency and limited need for re-intervention.

Polymer Everolimus-Eluting Stent as Bailout Stenting for Below-the-Knee Artery Repair in Patients with Critical Limb-Threatening Ischemia: A Real-World National Registry.

Percutaneous old balloon angioplasty is still the preferred treatment for the treatment of below-the-knee (BTK) arteries in chronic limb-threatening ischemia (CLTI). In the case of a suboptimal angioplasty result, a bailout stenting is required. So far, few data are available to assess the outcomes of bailout stenting after BTK angioplasty. This study aims to investigate the 1-year efficacy and safety after implantation of a polymer everolimus-eluting stent (PEES) as bailout stenting for BTK repair in patients with CLTI in a real-world setting. This was a national multicenter prospective observational study. Patients with CLTI (Rutherford 4 to 6) BTK lesions (including P3) and requiring a bailout PEES due to dissection, thrombosis, or residual stenosis ≥30% after angioplasty were included. The freedom of a major adverse limb event at 12 months of the target limb was the primary endpoint. XIENCE assessed 106 limbs (CLTI, 96.2%; chronic total occlusion, 2.8%) in 106 patients (mean age 77.1 years; males, 71.7%; diabetes mellitus, 66.9%; chronic kidney failure, 36.8%) with CLTI undergoing PEES stenting as a bailout for BTK lesions. Bailout stenting was required after 75.5% and 26.4% of residual stenosis and dissection, respectively. The mean diameter and length of the PEES were 3 mm and 3.4 ± 0.5 cm, respectively. At 1 year, the freedom of a major adverse limb event was 79.6% (95% CI, 71.5%-88.7%), the major amputation rate was 6.2% (95% CI, 1.3%-11%), and the target revascularization rate was 14.9% (95% CI, 6.5%-22.5%). In CLTI patients with BTK lesions, PEES stenting showed safety and efficacy as bailout stenting for BTK arterial lesions. This confirms the need for PEES stenting in a real-world practice. The XIENCE study introduces the PEES as an effective bailout stenting option for patients with CLTI undergoing BTK revascularization, particularly for lesions under 4 cm. The study focuses on real-world cases where POBA alone is insufficient, demonstrating that PEES significantly improves outcomes by enhancing limb salvage and reducing the need for major amputations. For clinicians, this innovation offers a precise, size-adaptable solution, especially in cases where bailout stenting is required for short, focal lesions, improving both clinical and procedural results.

Atherectomy Followed by Drug-Coated Balloon Angioplasty Versus Surgery for Symptomatic Deep Femoral Artery Arteriosclerotic Disease.

Limited data are available regarding endovascular therapy of arteriosclerotic lesions of the deep femoral artery (DFA). In this study, we compare the outcomes of atherectomy combined with drug-coated balloon (DCB) angioplasty and open repair of DFA lesions. This is a multicenter retrospective registry of patients with peripheral artery occlusive disease Rutherford categories 2 to 5 treated by surgical profundaplasty (SP) or atherectomy followed by DCB for DFA lesions (symptomatic DFA). The primary endpoint was clinically driven target lesion revascularization (CD-TLR). Overall mortality, target limb reinterventions, major amputation, and major adverse limb events (MALEs) were additionally analyzed. A total of 373 patients treated for an arteriosclerotic lesion of the DFA between February 2015 and August 2021 were included, 301 treated by SP and 72 with atherectomy and DCB. The rates of chronic limb threatening ischemia (CLTI) were 42.2% and 22.2% (p<0.002) for the surgical and endovascular groups, respectively. A previous DFA intervention was more frequent in the endovascular group (30.6% vs 15.3%; p<0.003). Patients who had an open repair were more likely to have an occlusion of the profunda (34.9% vs 19.7%, p=0.014), severe calcified lesions (26.5% vs 5.6%, p=0.001), and lesions longer than 20 mm (95.7% vs 88.7%, p=0.024). After propensity score matching, no significant differences were found with regard to technical and hemodynamic success. At 24 months, no difference was found in terms of freedom from CD-TLR (95.7% vs 96.8%), freedom from all-cause mortality (94.2% vs 98.5%), freedom from MALE (90.4% vs 93.9%), and amputation-free survival (93.8% vs 97%). Following endovascular therapy, length of stay was significantly lower (p<0.001) and any reintervention on the index limb was more frequent (p=0.039). Patients with CLTI, occlusion of profunda, severe calcified lesions, and longer lesions are more frequently treated by open surgery, while reinterventions are more commonly treated by atherectomy and DCB. In patients with comparable clinical and lesion characteristics after matching, endovascular and surgical reconstruction of DFA lesions showed similar mid-term clinical outcomes. However, the risk of reintervention at the index limb is higher after endovascular treatment. Randomized studies are now warranted to compare both techniques in terms of medical and financial aspects. Atherectomy followed by DCB of symptomatic DFA is safe and effective. In patients with comparable clinical and lesion characteristics, outcomes are comparable with surgery. However, the risk of reintervention at the index limb is higher after endovascular treatment. Therefore, whenever possible an additional outflow vessel revascularization should be performed by the time of the primary intervention. Randomized studies are warranted to compare endovascular techniques and open surgery also under economic aspects.

Race and the treatment of in-stent restenosis of the femoral-popliteal artery with paclitaxel drug-coated balloon angioplasty

ObjectiveThe aim of this study was to report the impact of race on paclitaxel drug-coated balloon (DCB) angioplasty for the treatment of femoral-popliteal artery in-stent restenosis (ISR). MethodsA prospective, non-randomized, post-market study of a paclitaxel DCB for the treatment of ISR of femoral-popliteal artery was conducted at 43 sites within the Vascular Quality Initiative (December 2016-January 2020). The primary endpoint was freedom from target lesion revascularization (F-TLR) through 12 months. Secondary endpoints included freedom from target vessel revascularization (F-TVR), freedom from major limb amputation, and survival. In this sub-analysis, the results were stratified by self-identified Black vs White race. ResultsBlack patients (n = 63) had a lower mean age (64.3 ± 9.7 vs 68.2 ± 9.7 years; P = .006) and were more often female (57.1% vs 37.0%; P = .004) compared with White patients (n = 219). Most patients had claudication (80.9%), with Black patients presenting with a higher rate of ischemic rest pain (30.2% vs 16.0%; P = .012). By Kaplan-Meier estimates, F-TLR was 91.3% vs 89.1% (log-rank P = .63) and 66.4% vs 74.0% (log-rank P = .41) at 12 and 24 months for Black vs White race. F-TVR was 87.8% vs 87.6% (log-rank P = .96) and 61.3% vs 70.6% (log-rank P = .29) at 12 and 24 months for Black vs White race. Freedom from major target limb amputation was 100.0% vs 99.5% (log-rank P = .59) and 100.0% vs 99.0% (log-rank P = .45) at 12 and 24 months for Black vs White race. Survival was 93.7% vs 95.9% (log-rank P = .47) and 84.1% vs 91.3% (log-rank P = .11) at 12 and 24 months for Black vs White race. In multivariable analysis, no significant predictors were identified for TLR or TVR through 24- months. Dialysis (hazard ratio [HR], 27.69; 95% confidence interval [CI], 10.35-74.09; P < .001), coronary disease (HR, 2.80; 95% CI, 1.29-6.06; P = .009), and lesion length (HR, 1.04; 95% CI, 1.02-1.07; P = .001) were associated with increased mortality through 24 months. Race was not significantly associated with TLR, TVR, or mortality. ConclusionsIn this sub-analysis of a Vascular Quality Initiative-based study, the treatment of femoral-popliteal ISR with paclitaxel angioplasty was equally safe and effective for Black and White races. The trend in reduced survival for patients of Black race at 2 years requires longer observation in a larger study.

Outcomes of drug-coated balloon angioplasty in patients with dyslipidemia in the BIOLUX P-III registry: A subgroup analysis.

The aim of this study was to assess the mid-term outcomes of the use of drug-coated balloons (DCBs) to treat infrainguinal peripheral arterial disease (PAD) in patients with dyslipidemia. BIOLUX P-III is a prospective, international, multicenter, all-comers registry-based study that was conducted at 44 sites with follow-ups at 6, 12 and 24 months. The present study is a subgroup analysis comparing the outcomes associated with endovascular revascularization with those associated with Passeo-18 lux DCBs in patients with and without dyslipidemia. The proportions of patients free from major adverse events (defined as device- or procedure-related mortality within 30 days, clinically driven target lesion revascularization (CD-TLR) and major target limb amputation), target vessel revascularization, and patient-reported outcomes within 24 months postintervention were compared between the two groups. A total of 876 patients with symptomatic PAD who underwent peripheral revascularization with DCBs and had information on their dyslipidemia status were included; 588 of those patients had dyslipidemia. There was no difference in the proportion of patients free from MAEs between the groups. The percentages of patients who were 6, 12 and 24 months free from CD-TLR were significantly lower in the dyslipidemia group than in the nondyslipidemia group (86.3% vs 91.9% at 2 years, p = .0183). Similarly, the percentage of patients free from target vessel revascularization was lower in the dyslipidemia group at all timepoints (83.3% vs 89.3% at 2 years, p = .0203). There was no difference in mortality or major or minor limb amputation rates. Other secondary outcomes were similar between the groups. Compared to those without dyslipidemia, patients with symptomatic PAD and dyslipidemia who underwent revascularization with a Passeo-18 lux DCB had greater rates of CD-TLR and TVR. However, having dyslipidemia did not increase the risk of mortality or limb amputation. NCT02276313.

Efficacy of Supera Stent in the Treatment of Complex Femoropopliteal Artery Lesions: A Short-Term Result Analysis of Real-World Evidence

When dealing with complex femoropopliteal lesions, there is a growing preference for the utilization of drug-coated balloons (DCB) or stents. However, in real-world scenarios, a greater number of elderly patients with longer lesion lengths are encountered. The purpose of our study was to compare the efficacy and safety of different interventional strategies, including the utilization of Supera stent and DCB, in a real-world setting. This was a retrospective study that collected treatment and follow-up data of patients with complex femoropopliteal artery lesions treated between January 2019 and March 2022. All patients were categorized into three groups: "non-Supera stent group,""Supera stent group," and "Supera stent + DCB group." The primary effectiveness outcome was primary patency at 12 months, defined as duplex ultrasound peak systolic velocity ratio<2.5 at the 12-month visit. Other outcomes included improvements in Rutherford categories and safety. A total of 162 patients were enrolled in this study. Compared to non-Supera group (47.6%) in the primary patency rate at 12 months, Supera group (58.7%) or Supera + DCB group (60.0%) showed no significant difference. There were no significant differences in all-cause death, major amputation of the target limb, and target lesion revascularization (TLR) between the groups. Supera group showed a significant improvement in Rutherford category without TLR at 12 months compared to non-Supera group (73.3% vs. 54.8%, P=0.041). In 12-month follow-up, over 65% of patients maintained a Rutherford category of 3 or below, particularly in Supera group where 74.7% of patients had mild symptoms. The Supera stent has demonstrated its efficacy and safety in treating complex peripheral artery disease. However, combining Supera stent with DCB did not provide a significant advantage. Further research is necessary to validate these findings in a larger patient population.

Use of Esmarch bandage does not increase peripheral vein size in healthy volunteers: A randomized clinical trial

IntroductionUltrasound is used for peripheral intravenous (PIV) cannulation in patients with difficult landmark-guided IV access in the Emergency Department. Distal-to-proximal application of an Esmarch bandage on the target limb has been suggested as a method for increasing vein size and ease of cannulation. MethodsThis study was a single-blinded crossover randomized controlled trial comparing basilic vein size under ultrasound with use of an Esmarch bandage in addition to standard IV tourniquet (“tourniquet + Esmarch”) compared to use of a standard IV tourniquet alone. Participant discomfort with the tourniquet + Esmarch was also compared to that with standard IV tourniquet alone. ResultsTwenty-two healthy volunteers were used to measure basilic vein size with and without the Esmarch bandage. There was no difference in basilic vein size between the two groups, with a mean diameter of 6.0 ± 1.5 mm in the tourniquet + Esmarch group and 6.0 ± 1.4 mm in the control group, p = 0.89. Discomfort score (from 0 to 10) was different between the groups, with a mean discomfort score of 2.1 in the tourniquet + Esmarch group and 1.1 in the standard IV tourniquet alone group (p < 0.001). ConclusionsThis study showed that the use of an Esmarch bandage does not increase basilic vein size in healthy volunteers but is associated with a mild increase in discomfort.

One-year limb salvage and quality of life following mechanical aspiration thrombectomy in patients with acute lower extremity ischemia

ObjectiveLower extremity acute limb ischemia (LE-ALI) is associated with high morbidity and mortality rates, and a burden on patient quality of life (QoL). There is limited medium- to long-term evidence on mechanical aspiration thrombectomy (MT) in patients with LE-ALI. The STRIDE study was designed to assess safety and efficacy of MT using the Indigo Aspiration System in patients with LE-ALI. Thirty-day primary and secondary endpoints and additional outcomes were previously published. Here, we report 365-day secondary endpoints and QoL data from STRIDE. MethodsSTRIDE was a multicenter, prospective, single-arm, observational cohort study that enrolled 119 patients across 16 sites in the United States and Europe. Patients were treated first-line with MT using the Indigo Aspiration System (Penumbra, Inc). The study completed follow-up in October 2023. Secondary endpoints at 365 days included target limb salvage and mortality. Additionally, the VascuQoL-6 questionnaire, developed for evaluating patient-centered QoL outcomes for peripheral arterial disease, was assessed at baseline and follow-up through 365 days. ResultsSeventy-three percent of patients (87/119) were available for 365-day follow-up. Mean age of these patients was 65.0 ± 13.3 years, and 44.8% were female. Baseline ischemic severity was classified as Rutherford I in 12.6%, Rutherford IIa in 51.7%, and Rutherford IIb in 35.6%. In general, baseline and disease characteristics (demographics, medical history, comorbidities, target thrombus) of these patients are similar to the enrolled cohort of 119 patients. The secondary endpoints at 365 days for target limb salvage was 88.5% (77/87) and mortality rate was 12.0% (12/100). VascuQoL-6 improved across all domains, with a median total score improvement from 12.0 (interquartile range, 9.0-15.0) at baseline to 19.0 (interquartile range, 16.0-22.0) at 365 days. ConclusionsThese 365-day results from STRIDE demonstrate that first-line MT with the Indigo Aspiration System for LE-ALI portray continued high target limb salvage rates and improved patient-reported QoL. These findings indicate Indigo as a safe and effective therapeutic option for LE-ALI.

Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial

BackgroundEndovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions.MethodsThis prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months.DiscussionEndovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a “leaving nothing behind” endovascular approach combining directional atherectomy and DCB compared to surgical therapy.Trial registrationClinicalTrials.gov NCT02517827.

Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System.

An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths. The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure. A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88). In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.

Alignment in Total Knee Arthroplasty: Avoid Crossing Over From Varus to Valgus

BackgroundIdeal target limb alignment remains a debated topic in total knee arthroplasty (TKA). We aimed to determine the effect of limb alignment correction on patient-reported outcomes and knee range of motion (ROM) following TKA. MethodsIn this retrospective analysis, patients (N = 409) undergoing primary TKA at a single institution were studied. Using full leg-length radiographs, limb alignment was measured preoperatively and postoperatively. Patients were categorized by preoperative (Preop) alignment (varus > 0°; valgus < 0°). Preop varus patients were then divided as follows based on postoperative alignment: neutral (VAR-NEUT, 0°± 2), remaining in varus (VAR-rVAR, ≥3°), and cross-over to valgus (VAR-CO, ≤−3°). Similarly, Preop valgus patients were divided as follows for postoperative alignment: neutral (VAL-NEUT, 0°± 2), remaining in valgus (VAL-rVAL, ≤−3°), and cross-over to varus (VAL-CO, ≥3°). The Knee Injury and Osteoarthritis Outcome Score for Joint Replacement survey scores were collected at preoperatively as well as at 6 weeks, 3, 6, and 12 months postoperatively. Knee ROM was collected at 2 weeks, 6 to 12 weeks, and >6 months postoperatively. An analysis of variance repeated on time followed by a Bonferroni post hoc test was used to compare outcomes for the postoperative alignment subgroups. ResultsPreop Varus patients: Those in the VAR-CO group (overcorrected to −4.03° ± 1.95valgus) were observed to have lower Knee Injury and Osteoarthritis Outcome Score for Joint Replacement scores at 3, 6, and 12 months postoperatively compared to those in the NEUT group (P < .05). This finding was paired with reduced ROM at 6 to 12 weeks postoperatively in the VAR-CO group compared to VAR-NEUT and VAR-rVAR (P < .05). Preop Valgus patients: Those in the VAL-rVal group (left in −4.39° ± 1.39valgus) were observed to have reduced knee flexion at 6 to 12 weeks postoperatively compared to VAL-NEUT and VAL-CO. ConclusionsThese findings indicate that postoperative valgus alignment via either crossing over to valgus (VAR-CO) or remaining in valgus (VAL-rVAL) alignment may result in less preferable outcomes than correction to neutral or slightly varus alignment.

Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment.

Background: The BIO REACT study is designed to investigate the incremental value of Extravascular UltraSound (EVUS) added to conventional angiography, compared to conventional angiography only for the identification of Flow-Limiting Dissections (FLD) and to evaluate the safety and efficacy of the REsponse Adapted Combination Therapy (REACT) for the treatment of femoropopliteal lesions. Methods: The primary endpoints were the specificity and sensitivity of EVUS added to angiography for the detection of FLD. Secondary endpoints were primary patency of the REACT therapy within 12 months, fCD-TLR, freedom from MAE, major target limb amputations (mTLA) and survival rates within 24 months. Results: A total of 150 patients were included. EVUS added to angiography had an overall sensitivity of 29% and specificity of 93% for the detection of FLD. There was no PSVR cut-off offering a clinically acceptable trade-off between meaningful sensitivity and specificity values for the detection of FLD. At 12 months, treatment with the REACT resulted in primary patency and fCD-TLR of 81.6% and 94.3%, respectively. In addition, freedom from MAE was 94.3% at 12 months. At 24 months, the survival rate was 94.0%. No mTLA was reported up to the 24-month follow-up. Conclusions: The addition of DUS to angiography showed limited value for detecting FLD in femoropopliteal artery disease.

Short-term patency of iliofemoral to tibial bypass with vascular allografts in a minority population: A retrospective analysis of a single center acute care facility.

The aim of this study was to examine the short-term patency rates and associated factors of open lower limb, iliofemoral to tibial bypass using cryopreserved saphenous vein (CSV) in a minority population at an acute care hospital in New York City. A retrospective analysis of patients undergoing infra-inguinal bypass from iliofemoral vessels to tibial arteries with CSV between March 2020-April 2022 at an acute care facility (Harlem Hospital Center, Harlem, New York) was performed. Data including patient demographics, comorbidities, type of operation, follow-up surveillance, and salvage procedures were collected. Results were presented in patency line graphs and a life table. Target limb revascularization (TLR) and amputation free survival (AFS) were also calculated. Eleven bypass procedures were included in the analysis. Patients were followed for a mean of 10.8months. Cumulative primary patency rates at 1, 6, and 12months were 72.7%, 54.5%, and 40.9%, respectively. TLR was 36.4% and the AFS was 66.67% at the mean 10.8-month follow-up. The patency rates of minority patients undergoing bypass with CSV were analyzed with creation of a life table and calculation of patency rates, TLR and AFS. The short-term primary patency rates and post-operative outcomes were found to be comparable to larger studies in non-minority cohorts. These results suggest that larger studies as well as prospective analyses and randomized controlled trials in this patient cohort and demographic are needed, as well as optimal selection of patients to determine true clinical implications.

The BioMimics 3D Helical Centreline Nitinol Stent in Chronic Limb Threatening Ischaemia and Complex Lesions: Three Year Outcomes of the MIMICS-3D Registry

There is a need for improved outcomes in the endovascular treatment of patients suffering from chronic limb threatening ischaemia (CLTI), highly calcified lesions, and chronic total occlusions (CTOs). The helical centreline self expanding BioMimics 3D stent might be particularly useful in these high risk subsets, combining flexibility and fracture resistance with radial strength. Herein, the performance of the BioMimics 3D stent was assessed in these high risk subsets. MIMICS-3D is a prospective, multicentre, European real world registry. This was a post hoc analysis, comparing patients with CLTI vs. intermittent claudication (IC), lesions with bilateral calcification vs. those without (peripheral arterial calcium scoring system [PACSS] 3,4 vs. PACSS 0 - 2), and CTO vs. no CTO. Propensity score matching was performed to reduce the impact of baseline variables. The 36 month endpoints were clinically driven target lesion revascularisation (CD-TLR), death, major target limb amputation, and stent patency. A total of 507 patients were enrolled. At 36 months, patients with CLTI had lower freedom from major amputation than patients with IC (92.6% vs. 100%, p < .001). In terms of primary patency, patients with CTO had lower patency rates than those without (63.9% vs. 77.8%, p= .003), but the difference reduced after propensity score matching (70.5% vs. 76.8%, p= .43). Primary patency was not impaired for patients with PACSS 3,4 or patients with CLTI. Freedom from CD-TLR was not significantly different among the groups and was 73.8% for CLTI vs. 78.9% for IC (p= .15), 77.6% for PACSS 3,4 vs. 78.7% for PACSS 0 - 2 (p= .55), and 75.6% for CTO vs. 81.0% for no CTO (p= .11). The outcome of the MIMICS-3D registry suggests that the BioMimics 3D stent is effective in the endovascular treatment of complex femoropopliteal lesions and in CLTI. Future randomised controlled trials should confirm its non-inferiority or superiority compared with existing alternatives.

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

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

Five-Year Safety and Effectiveness of Paclitaxel Drug-Coated Balloons Alone or With Provisional Bare Metal Stenting for Real-World Femoropopliteal Lesions: IN.PACT Global Study Subgroup Analysis.

The treatment of complex infra-inguinal disease with drug-coated balloons (DCBs) is associated with a significant number of patients undergoing provisional stenting to treat a suboptimal result. To determine the potential long-term impact of DCB treatment with provisional bare metal stenting in complex lesions in real-world patients, a post hoc analysis was performed on data from the IN.PACT Global Study (The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral Drug-Eluting Balloon). Five-year outcomes were compared between participants who were stented after DCB treatment versus those treated with DCB alone. The IN.PACT Global Study enrolled 1535 participants with intermittent claudication and/or ischemic rest pain caused by femoropopliteal lesions; 1397 patients were included in this subgroup analysis (353 stented and 1044 nonstented). Effectiveness was assessed as freedom from clinically driven target lesion revascularization through 60 months. The primary safety composite end point was defined as freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and clinically driven target vessel revascularization through 60 months. Lesions in the stented group were longer (15.37 versus 10.98 cm; P<0.001) and had more total occlusions (54.7% versus 28.6%; P<0.001) compared with the nonstented group. The 5-year Kaplan-Meier estimated freedom from clinically driven target lesion revascularization was similar between groups (66.8% stented versus 70.0% nonstented group, log-rank P=0.22). The safety composite end point was achieved in 64.5% stented versus 68.2% nonstented participants (log-rank P=0.19) as estimated by the Kaplan-Meier method. No significant difference was observed in the cumulative incidence of major adverse events (49.1% stented versus 45.0% nonstented; log-rank P=0.17), including all-cause death (19.6% stented versus 19.3% nonstented, log-rank P=0.99). In this real-world study, revascularization of complex femoropopliteal artery lesions with DCB angioplasty alone or DCB followed by provisional bare metal stenting in certain lesions achieved comparable long-term safety and clinical effectiveness. URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609296.

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery

ObjectiveThe aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. MethodsWe conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. ResultsPatients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. ConclusionsThis post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

Role of laparoscopic lumbar sympathectomy in chronic limb-threatening ischemia due to nonreconstructable peripheral arterial disease

Background Lumbar sympathectomy (LS) was traditionally performed for intermittent claudication but is now eclipsed by revascularization for that indication. However, it retains a role in the management of chronic limb-threatening ischemia and other conditions causing lower limb pain with or without ischemia. In this study, we identify its role in the management of chronic limb-threatening ischemia in cases of nonreconstructable peripheral arterial disease. Aim The main aim of this study is to determine if LS procedure has an effective role in limb salvage and pain control for patients with nonreconstructable peripheral limb ischemia. The primary endpoint was limb salvage in the target limb, while the secondary endpoint targeted assessment of pain improvement in the same limb. Patients and methods This study is a prospective single-arm cohort study conducted using 21 patients between the January 1, 2021 and the January 1, 2023 at two hospitals, Ain Shams University Hospital and Nasser Institute Hospital. Patients complained of nonreconstructable peripheral arterial disease and there was no chance for revascularization either endovascular or surgical bypass. Results This study included 60 patients; one patient was excluded due to being lost to follow-up, and presented with nonconstructable critical limb ischemia between the January 1, 2021 and the January 1, 2023. There were 42 (70%) males and 18 (30%) females. Follow-up for all patients was subjected to measurement of ankle brachial pressure index, digital pulse oximetry, toe pressure and numerical rating scale for pain scoring preoperative and postoperative. On follow-up we noticed that there was no change in either ankle brachial pressure index or toe pressure immediately postoperatively and after 12 months. However, the digital pulse oximetry showed significant improvement immediately postoperatively from 68.40±7.36 to 81.15±12.23 with a P value of 0.001. The most remarkable improvement was found in pain scoring immediately, 1, 3, 6, and 12 months postoperatively with P values showing statistical significance. As for limb salvage, there was a 100% limb survival for 3 months. After 6 months, only nine cases underwent above-knee amputation, one of them was due to severe limb infection, and three cases had minor amputation ‘toe amputation.’ We noticed that three out of the nine cases suffering major amputations had femoropopliteal disease. Of the patients, 80% suffered no minor or major amputation, while 15% had major amputations beyond the tarsometatarsal joint and only 5% underwent minor toe amputation or debridement. Fortunately, there was no mortality among the studied cases. Conclusion Retroperitoneoscopic LS is significantly less invasive than open surgical technique with fewer wound complications and less hospital stay period and offers a longer duration of pain relief and less incidence of recurrence of manifestations.

Early outcomes of drug-coated balloon angioplasty of infrapopliteal lesions in diabetic foot

Abstract: PURPOSE: To evaluate 6-month outcomes of drug-coated balloon (DCB) angioplasty of infrapopliteal lesions in patients with diabetic foot. METHODS: We analyzed 6-month follow-up data from the prospective PRIME-WIFI study with 203 consecutive patientswith diabetic foot who underwent DCB angioplasty for infrapopliteal arterial occlusive disease. The primary outcome was freedom from major adverse event (MAE), a composite of major amputation, all-cause death, and clinically-driven target limb reintervention (CD-TLR). Secondary outcomes included amputation-free survival (AFS), freedom from each primary outcome component, and complete wound healing. RESULTS: The mean age was 69.78 ± 9.50 years and 61 were female. A total of 271 lesions, with an average length of 26.02 ± 12.94 cm, accepted DCB angioplasty. Both infrapopliteal runoff score and pedal runoff score improved significantly after procedure compared with baseline. The score changes were − 5.73 and − 0.39, respectively (P &lt; 0.001 for both). Within 6-month follow-up, 16 of the 203 patients died and 32 (15.76%) were lost to follow-up. By Kaplan–Meier analysis, at 6 months postprocedure, freedom from MAE was 85.77% (95% confidence interval [CI], 80.92%–90.91%); AFS was 88.88% (95% CI, 84.49%–93.49%); and freedom from major amputation, all-cause death, and CD-TLR were 95.65% (95% CI, 92.73%–98.65%), 92.57% (95% CI, 88.88%–96.4%), and 95.51% (95% CI, 92.51%–98.61%), respectively. During the 6-month follow up, complete wound healing was achieved in 67.11% patients. CONCLUSION: In patients with diabetic foot, DCB angioplasty of infrapopliteal lesions was effective and safe.

Sirolimus-Coated Balloon in Femoropopliteal Steno-Occlusive Disease: Efficacy, Safety, and 1-Year Outcomes. An All-Comers Registry

Purpose: The aim of this study was to assess the efficacy and safety of the novel SLR (SELUTION sustained-limus-release) drug-coated balloon (DCB) in the treatment of the femoropopliteal steno-occlusive disease. Materials and Methods: From February 2021 to March 2022, 80 consecutive patients (age: 69.5±8.23 years; total number of lesions: 80) with a steno-occlusive lesion of superficial femoral artery were enrolled at our center. A total of 60 patients (75%) had claudication, whereas 20 (25%) had chronic limb-threatening ischemia (CLTI). The mean lesion length was 171±82.22 mm. The primary efficacy outcome was primary patency at 12 months, defined as freedom from restenosis determined by a duplex ultrasound peak systolic velocity ratio ≤2.4. The secondary efficacy outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion urgent revascularization (endovascular or bypass graft) at 30 days and 12 months. Results: Device success was achieved in all 80 patients. One death on day 7 from cardiovascular complications was ruled procedure-related because it occurred within the first 30 days from the discharge. Two patients with CLTI experienced planned minor amputations of target limb, and one patient underwent urgent bypass graft of the target vessel for early occlusion at 60 days from the index procedure. The primary safety outcome was 98.7% and 97.5% at 30 days and 12 months, respectively. At 1 year, primary patency was 86.3%, and freedom from CD-TLR was 96.2%. Conclusion: These findings suggest that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions in a variety of clinical and anatomical settings. These results will need to be confirmed by long-term follow-up and randomized controlled trials. Clinical Impact In femoropopliteal steno-occlusive lesions paclitaxel drug-coated devices have been proved to be able to achieve a better vessel patency during follow-up compared with uncoated balloon, but according to a recent meta-analysis they may carry an elevated risk of late mortality. Sirolimus results in a wider therapeutic range with a 3-fold higher margin of safety. Sirolimus coated devices have recently been proposed as an alternative. This study suggests that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions.