Mean Lesion Length Research Articles

Safety and Efficacy of All Comers Treated with a Paclitaxel Coated Balloon for Below Knee Intervention

Data on paclitaxel coated balloons (PCBs) for below knee (BTK) angioplasty exhibited conflicting efficacy results, and previous meta-analyses suggested an increased mortality and amputation risk highlighting the need for further research. The aim of this study was to investigate safety and efficacy of PCBs for BTK interventions in a real world cohort. Within a single centre cohort study, 552 consecutive patients were included undergoing BTK interventions with and without PCB use. Two year safety and efficacy results were compared in unadjusted and propensity score matched (PSM) analysis. BTK interventions were performed in 157 patients with PCB angioplasty (100% Lutonix 0.014 inch drug coated balloon; Bard Lutonix, New Hope, MN, USA) and 395 patients with plain old balloon angioplasty (POBA). The majority of interventions (> 70%) were performed for chronic limb threatening ischaemia. Mean lesion length was 20.8 ± 12.6 cm; 61.2% in the PCB and 66.7% in the POBA group were occlusions. In the PCB group, more procedures were performed for re-stenotic lesions than POBA (28.5 vs. 17.2%). In PSM analysis (128 matched pairs), the primary efficacy endpoint was freedom from clinically driven target lesion revascularisation (CD TLR), which occurred in 70.1% in the PCB and 73.1% in the POBA group at one year (p= .85; McNemar test). Survival analysis suggested lower rates of major amputations in the PCB group in unadjusted (94.4% ± 2.1 vs. 89.2% ± 1.9 in the POBA group) and PSM analyses (97.2% ± 1.6 vs. 89.3% ± 3.5) through two years, while no differences were seen for CD TLR and all cause mortality between the groups. In this all comer analysis, PCBs were found to be safe for BTK interventions with a signal towards lower amputation rates but no benefit was seen for repeat revascularisation.

The RANGER II superficial femoral artery trial: 1-year results of the long lesion cohort

Background:The objective of the RANGER II SFA long lesion cohort analysis was to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) in patients with lesion lengths greater than 100 mm.Methods:Patients from the RANGER II SFA randomized controlled trial and long balloon sub-study were included in the long lesion cohort if their baseline lesion measurement was > 100 mm and if they had been treated with a RANGER DCB. Patients had symptomatic lower limb peripheral artery disease and Rutherford classification 2–4 symptomatology. The endpoints of interest included the 12-month target lesion primary patency and freedom from major adverse events (MAEs).Additional patient outcomes including changes in Rutherford classification were also evaluated.Results:A total of 129 patients met the inclusion criteria and were included in the long lesion cohort. Mean lesion length was 144.5 ± 31.7 mm. Seventy-five lesions had Peripheral Arterial Calcium Scoring System (PACSS) grades 3 (33.3%, 43/129) and 4 (24.8%, 32/129). The Kaplan–Meier estimate of the primary patency rate at 12 months was 88.0%. The rate of freedom from MAEs at 12 months was 95.1% (117/123; 95% CI: 89.7%, 98.2%); all MAEs were clinically driven target lesion revascularization (4.9%, 6/123). The 12-month mortality rate was 2.4% (3/125).Conclusions:Patients with lesions > 100 mm treated with Ranger DCBs demonstrated excellent 1-year safety and efficacy results, comparable to those of the overall RANGER II SFA randomized clinical trial. This suggests that the Ranger DCB can provide consistent results regardless of lesion length. (ClinicalTrials.gov Identifier: NCT03064126)

Phoenix atherectomy for patients with peripheral artery disease.

Endovascular atherectomy enables minimally invasive plaque removal in peripheral artery disease (PAD). We aimed to evaluate the safety and the long-term effectiveness of the Phoenix atherectomy for the treatment of complex and calcified lesions in PAD patients. Consecutive all-comer patients with PAD underwent the Phoenix atherectomy. Device safety in terms of perforation and distal embolisation were evaluated. Lesion calcifications were categorised by the Peripheral Arterial Calcium Scoring System (PACSS) and lesion complexity was assessed by the Transatlantic Inter-Society Consensus (TASC). Clinically driven target lesion revascularisation (TLR) was assessed. A total of 558 lesions were treated in 402 consecutive patients. Clinical follow-up was available at 15.7±10.2 months for 365 (91%) patients. Of 402 patients, 135 (33.6%) had claudication, 37 (9.2%) had ischaemic rest pain and 230 (57%) exhibited ischaemic ulcerations. Lesions were mostly identified in the femoropopliteal segments (55%), followed by below-the-knee (BTK) segments (32%). Complex TASC C/D lesions and moderate to severe calcifications (PACSS score ≥2) were present in 331 (82%) and 323 (80%) patients, respectively. The mean lesion length was 20.6±14.3 cm. Five (1%) perforations and 10 (2%) asymptomatic embolisations occurred. Bail-out stenting was performed in 4%, 16% and 3% of patients with common femoral artery, femoropopliteal and BTK lesions, respectively. During follow-up, 5 (3.9%) patients with claudication and 52 (21.9%) patients with critical limb-threatening ischaemia (CLTI) died (hazard ratio [HR] 3.7; p<0.001). Freedom from TLR was 87.5% (112 of 128) in patients with claudication and 82.3% (195 of 237) in patients with CLTI, respectively (HR 1.8; p=0.03). The Phoenix atherectomy can be safely performed in patients with complex lesions with a relatively low rate of bail-out stenting and clinically acceptable TLR rates. DRKS00016708.

Exploring variation in susceptibility to Phytophthora ramorum in Japanese larch (Larix kaempferi)

AbstractPhytophthora ramorum is an invasive pathogen responsible for extensive mortality in larches in the United Kingdom. There is great interest from the forestry industry in the possibility of selection for resistance to P. ramorum in Japanese larch in order to retain it as a commercially viable species. This study is the first to investigate variation in resistance to P. ramorum among planted populations of Japanese larch in the UK. Our study uses inoculation of excised material from putatively resistant survivor trees and known susceptible trees. We found variation in susceptibility to P. ramorum within Japanese larch stands planted in the Galloway forest of Scotland with some trees showing significantly shorter lesion development than others, from a mean lesion length of 34.7 mm in the least susceptible clone to 135 mm in the most susceptible. Although clones from the putatively resistant and known susceptible groups were not significantly different (p = .055), we propose that survivor trees include a higher proportion of resistant or low susceptibility trees and would be a useful starting point for further work investigating natural resistance in larch.

Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel?

The application of 2 distinct and simultaneously applied drug-delivery platforms for the treatment of peripheral artery disease (PAD) has not been studied. This study investigated the outcomes of femoropopliteal disease treated with drug-coated balloon (DCB) followed by placement of drug-eluting stent (DES) when a bail-out procedure is required. This was a single-center, retrospective study enrolling 22 consecutive patients (23 limbs) treated with DCB + DES. Bail-out stenting was performed for flow-limiting postangioplasty dissections and/or suboptimal angiographic result, such as residual stenosis. Procedural success (<30% residual stenosis) and the incidence of major adverse limb event (MALE) during an average follow-up of 15.2 months were estimated. Among the 22 patients (23 limbs), 14 presented with claudication and 8 with critical limb ischemia. The majority of the lesions were Trans-Atlantic Inter-Society Consensus class C/D, with a mean lesion length of 321 ± 130 mm. DCB angioplasty was performed with Stellarex (Philips) in 6 cases and In.Pact DCB (Medtronic) in 16 cases. Eluvia DES (Boston Scientific) was used for bail-out stenting in all cases (in 10 limbs for flow-limiting dissection and in 13 limbs for suboptimal angiographic result due to significant residual stenosis and/or recoil). A single Eluvia DES was used in 15 cases, while multiple Eluvia DESs were used in 8 cases. Procedural success was achieved in all but 1 case where persistent recoil occurred in a heavily calcified lesion. During an average follow-up of 15 months, restenosis or reocclusion of the target vessel was observed in 6 cases (26.1%), although only 3 patients required repeat revascularization (13.0%). During follow-up, 1 death and 1 major amputation occurred, both in patients who had originally presented with critical limb ischemia. Additionally, on routine duplex ultrasound, there were no cases of aneurysm formation at the sites of Eluvia stent placement. DCB with provisional DES implantation could be a viable treatment option for cases of suboptimal DCB results, without apparent additional cardiovascular or limb-related risks. Additional studies are needed to determine the risks and benefits of double-dose paclitaxel approach, especially for those patients with significant residual stenosis after DCB.

Early oxidative burst and anthocyanin-mediated antioxidant defense mechanism impart resistance against Sclerotinia sclerotiorum in Indian mustard

The current study builds on our prior findings that anthocyanin buildup around the pathogen inoculation site confers resistance to S. sclerotiorum resistance in Indian mustard. However, the mechanism by which anthocyanin accumulation confers resistance is largely unknown. To better understand this mechanism, we compared the disease responses and biochemical profiling of two contrasting and wild type genotypes of Indian mustard [Sclerotinia stem rot-resistant RH 1222–28 (WR) and susceptible Varuna (WS)], as well as two anthocyanin contrasting mutants [anthocyanin-more (PM) and anthocyanin-devoid (AM) mutant] during different infection phases. Regardless of the inoculation time, disease examination revealed that WR and PM had considerably (P ≤ 0.05) lower mean lesion length (MLL) and rate of lesion expansion than WS and AM. Compared to WS and AM, biochemical results showed that WR and PM responses to infection were earlier, more timely regulated, and more robust. In the resistant WR and PM, hydrogen peroxide (H2O2) and superoxide anions (O2−1) accumulated rapidly and peaked during the early infection stage (2 days after inoculation; DAI), whereas in the susceptible WS and AM, accumulation was stronger and more intense in the later infection stage (8 DAI). Compared to the susceptible genotype (WS), the resistant genotype (WR) had significantly higher anthocyanin accumulation, a lower rate of lipid peroxidation, and a strong, efficient, and timely regulated antioxidant system that limited pathogen colonization and disease development. The anthocyanin-rich mutant (PM) is more resistant to ROS-induced oxidative damage. It has a slower rate of lesion development than the anthocyanin-deficient (AM) mutant, which has lower anthocyanin accumulation and higher oxidative stress with weak antioxidative potential, resulting in significantly (P ≤ 0.05) longer stem lesion length and rate of lesion expansion. These findings imply that during distinct infection phases of S. sclerotiorum, a well-coordinated oxidants/antioxidants system in terms of intensity and timing regulates Sclerotinia stem rot resistance/susceptibility. Overall, anthocyanin accumulation around the pathogen infection site appears to play a critical role in altering the ROS producing and scavenging machinery in Indian mustard, which contributes to resistance to S. sclerotiorum.

Optimal Intraluminal Drug-Coated Balloon Versus Drug-Eluting Stent in Patients With Chronic Total Occlusion of the Superficial Femoral Artery: A Retrospective Analysis

BackgroundPaclitaxel-eluting technologies improve the clinical outcome of femoropopliteal (FP) occlusive disease. Several studies reported efficacy of the high-dose (nominal paclitaxel density of 3.5 μg/mm2) drug-coated balloon (DCB) for complex FP lesions. However, previous studies of DCB have shown a high rate of bailout stents, and few studies have compared the high-dose DCB with successful lesion pre-dilation without bailout stent and drug-eluting stent (DES) in chronic total occlusion (CTO) of the superficial femoral artery (SFA). This study aimed to compare the clinical outcome of high-dose DCB with successful lesion preparation and DES in CTO of the SFA. MethodsThis was a single-center, retrospective study. From June 2018 to November 2020, we compared 41 patients (43 lesions) treated with high-dose DCB and 36 patients (37 lesions) treated with DES. The study period was defined as the period after DCB and DES became available simultaneously at our hospital, when all surviving patients had at least 1 year of follow-up. The primary endpoint was 12-month primary patency. The secondary endpoints were 12-month freedom from: (1) clinically driven target lesion revascularization (CD-TLR), and (2) re-occlusion. ResultsBaseline clinical data were comparable between the two groups. Reference vessel diameter was smaller in the DCB group. The mean lesion and occlusion lengths were about the same in both groups. The subintimal angioplasty and bailout stent rate was 0% in the DCB group. The Kaplan–Meier estimate for 12-month primary patency was 92.0% in the DCB group and 87.2% in the DES group (p = 0.47). Freedom from CD-TLR also did not differ significantly between the two groups. The 12-month freedom from re-occlusion rate tended to be higher in the DCB group than in the DES group. ConclusionsHigh-dose DCB with successful lesion preparation showed 12-month clinical outcomes comparable with DES for CTO of the SFA, even without bailout stents.

Risk Factor Analysis for Crossing Failure in Primary Antegrade Wire-Catheter Approach for Femoropopliteal Chronic Total Occlusions

Introduction: Antegrade wire-catheter crossing remains the primary approach for femoropopliteal interventions. Nonetheless, data reporting on crossing failure are limited. Aim of this study is to identify risk factors for antegrade crossing failure in patients with femoropopliteal chronic total occlusions (CTOs). Methods: This is a single-center, retrospective analysis. Patients with femoropopliteal CTOs treated between May 2018 and February 2020 were included into this study. Primary endpoint of this analysis was primary crossing success defined as successful antegrade crossing without the use of retrograde access, crossing or re-entry devices. The assisted crossing success was additionally analyzed. A logistic regression analysis identified risk factors for failed primary antegrade crossing. Results: Data from 300 patients were analyzed. The majority (n=183, 61%) presented with lifestyle limiting claudication. The mean lesion length was 180 mm [interquartile range (IQR) 100–260 mm], whereas the median CTO length was 100 mm (IQR=50–210 mm). A chronic total occlusion crossing approach based on plaque morphology (CTOP) type I configuration was observed in 9% (n=26) of the lesions, type II in 61% (n=183), type III in 8% (n=25), and type IV in 66 CTOs (n= 66, 22%). Severe calcification based on the Peripheral Arterial Calcium Scoring Scale (PACSS), Peripheral Academic Research Consortium (PARC), and 360° grading systems was identified in 17%, 24%, and 28% of the lesions, respectively. A contralateral femoral access was used in 278 cases (93%). The primary crossing success amounted to 70% (n=210). The use of a re-entry device in 28 patients (9%) or of a combined antegrade–retrograde approach in 11% (n=34) of the cases increased the assisted crossing success to 89% (n=267). The presence of calcification (odds ratio [OR]=4.2, 95% CI=1.7–10.2) or of circumferential calcium (OR=2.5, 95% CI=1.3–4.9), a CTOP class ΙΙΙ or ΙV (OR=1.9, 95% CI=1.4–2.6), a proximal superficial femoral artery (SFA) occlusion (OR=3.5, 95% CI=1.7–7.4) and a CTO at P3 (OR=4.1, 95% CI=1.5–10.8) were associated with an increased risk for antegrade crossing failure. Conclusions: In this study, chronic total occlusions (CTO) morphology, calcification burden, and lesion’s location were identified as independent risk factors for failed antegrade crossing. Nonetheless, the use of alternative crossing strategies significantly increased the overall crossing success.

The effectiveness of enterprise stent use on the treatment of intracranial atherosclerosis disease.

To examine the clinical outcome of Enterprise stent in patients with severe and symptomatic intracranial atherosclerosis. Twenty-five patients who underwent Enterprise stenting between January 2012 and March 2019 were included in this study. Exclusion criteria were previous intracranial stenting and inadequate follow-up. Technical success rates of the procedures were recorded. Clinical outcome was evaluated with pre- and post-treatment modified Rankin Scale scores. The patients were monitored for 18months clinically and for 14.3months radiologically. The mean age of the 15 males and 10 females was 61.6 ± 8.19. Of these 25 patients, 6 (24%) were in the anterior system and 19 (76%) were in posterior system. The mean degree of pre-treatment stenosis was 86.4% ± 7 with the mean lesion length of 12.5 ± 7.5mm. The residual stenosis rate was 23.8% ± 8.81. Technical success rate was 100%. There were two major complications within the first 30 days (8%). Late major complications (after 30days) occurred in one case (4%). Stent restenosis was detected in two patients (8%). No intracranial bleeding or mortality was observed. In this single-center study, we achieved high technical success and tolerable complication rates. Enterprise stent may be a good treatment alternative for severe intracranial stenosis especially in patients resistant to medical treatment when correct patient selection is made. However, further randomized controlled studies, including more cases should be carried out.

Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions: the IN.PACT BTK randomised trial.

Data are mixed concerning the safety and effectiveness of drug-coated balloons (DCBs) for treating below-the-knee (BTK) lesions. The aim of this study was to assess the safety and effectiveness of the IN.PACT 014 paclitaxel-coated balloon catheter versus conventional percutaneous transluminal angioplasty (PTA) for infrapopliteal chronic total occlusions (CTOs) in patients with chronic limb-threatening ischaemia (CLTI). The IN.PACT BTK randomised study is a prospective, multicentre, randomised pilot study. Fifty CLTI participants (Rutherford clinical category 4-5) with BTK CTOs were randomised 1:1 to DCB (N=23) or PTA (N=27). The primary effectiveness endpoint was late lumen loss (LLL) at 9 months post procedure. Safety outcomes up to 9 months included all-cause mortality, major target limb amputation, and clinically driven target lesion revascularisation (CD-TLR). Mean lesion length was 215.41±83.81 mm in the DCB group and 218.19±80.43 mm for PTA (p=0.806). The 9-month angiographic LLL was 0.892±0.774 mm for the DCB group and 1.312±0.720 mm for the PTA group (p=0.070) in a classic analysis, and 0.592±0.944 mm for DCB and 1.260±0.810 mm for PTA (p=0.017) in a subsegmental analysis. The Kaplan-Meier estimated freedom from CD-TLR up to 9 months was 91.1% for DCB and 91.8% for PTA (log-rank p=0.942). At 9 months, 1 patient died in the DCB group and 2 in the PTA group (p=1.000); there were no major target limb amputations in either arm. The 9-month subsegmental LLL was lower after treatment with the IN.PACT 014 DCB compared with PTA with no differences in safety or revascularisation events in a small complex population of patients with BTK CTOs. gov: NCT02963649.

A Novel Laser Energy Ablation Catheter for Endocardial Cavo-Tricuspid Isthmus Ablation and Epicardial Ventricular Lesion Formation: An in vivo Proof-of-Concept Study.

AimThis proof-of-concept study aimed to investigate atrial and ventricular lesion formation by a 20-mm linear laser ablation catheter, regarding lesion depth and tissue damage.MethodsIn total, 6 female swines underwent standard femoral vein access to introduce a novel 20-mm linear laser ablation catheter in the right atrium to perform endocardial cavotricuspid isthmus (CTI) ablations. The navigation took place under fluoroscopy with additional visualization by intracardiac echocardiograph. Via a sternotomy, epicardial ablations were performed on the surface of the left ventricle (LV), right ventricle (RV), and right atrial appendage (RAA). Procedural safety was assessed by registration of intraprocedural adverse events and by macroscopic examination of the excised hearts for the presence of charring or tissue disruption at the lesion site.ResultsAltogether 39 lesions were created, including 8 endocardial CTI (mean lesion length 20.6 ± 1.65 mm), 26 epicardial ventricle (mean lesion length LV: 25.3 ± 1.35 mm, RV: 24.9 ± 2.40 mm), and 5 epicardial appendage ablations (mean lesion length RAA: 26.0 ± 3.16 mm). Transmurality was achieved in all CTI and atrial appendage ablations, in 62% of the RV ablations and in none of the LV ablations. No perforation or steam pop occurred, and no animal died during the procedure.ConclusionIn this porcine study, the 20-mm linear laser ablation catheter has shown excellent results for endocardial cavotricuspid isthmus ablation, and it resulted in acceptable lesion depth during atrial and ventricular epicardial ablation. The absence of tissue charring, steam pops, or microbubbles under the experimental conditions suggests a high degree of procedural safety.

Treatment of Atherosclerotic Femoropopliteal Artery Disease with Supera Interwoven Nitinol Stent: A Real-World Study in China

To analyze the outcomes of Supera stent deployment in Chinese patients with atherosclerotic femoropopliteal artery (FPA) disease in a real-world setting. This retrospective cohort study collected and analyzed the medical records of 246 consecutive patients who received Supera stents for FPA disease at the China Academy of Chinese Medical Sciences Xiyuan Hospital between February 2017 and December 2019. All study patients underwent balloon angioplasty and were treated with Supera stents (Abbott Vascular, Santa Clara, CA, USA). The primary outcome was the rate of primary patency 12months after discharge. The analyses included 246 consecutive patients and 260 lesions. The mean±SD age was 73.2±9.9years and most patients (60.2%) were males. Of the 260 treated lesions, Supera stents were deployed in eight (3.1%) cases after a previous stent fracture. Critical limb ischemia was diagnosed in 87.3% of the limbs, and 84 (32.3%) and 83 (31.5%) cases were classified as TransAtlantic Inter-Society Consensus (TASC) C and D, respectively. Most of the lesions were in situ (80.8%) and located in the superficial femoral artery (45.0%) or the FPA (45.8%). The mean lesion length was 147.7mm. Nominal deployment (-10 to 10% compression) was the most common deployment scenario (84.1%). The 1-year primary patency rate was 80.6%. Lesions that occurred as restenosis (odds ratio [OR]:=3.34, 95% confidence interval [CI]: 1.03-10.85, P=0.045) or in-stent restenosis (OR:=2.88, 95% CI: 1.03-8.07, P=0.045) were independently associated with occlusion or stenosis after stent deployment. No stent fracture was observed in this study. Our study indicates that the use of Supera stents is feasible for the treatment of Chinese patients with FPA disease. The long-term results reveal high primary patency.

Clinical Impact of the Size of Drug-Coated Balloon Therapy on Restenosis Rate in Femoropopliteal Lesions

Purpose: Although the size of drug-coated balloons (DCBs) is determined according to the vessel diameter during femoropopliteal (FP)-endovascular therapy (EVT), the measurements of the vessel diameter vary among modalities and its definitions. The aim of this study was to reveal whether the DCB size fitting (1) angiographically-measured lumen diameter (Angio-lumen size), (2) intravascular ultrasound (IVUS)-measured lumen diameter (IVUS-lumen size), or (3) IVUS-measured external elastic membrane (EEM) diameter (IVUS-EEM size) would be beneficial in restenosis occurrence. Materials and Methods: This retrospective, single-center study included 231 de novo FP lesions in 165 patients with peripheral artery disease treated with IN.PACT Admiral DCB under IVUS evaluation. The reference vessel diameter was evaluated as the lumen or EEM diameter at the healthy site distal to the lesion. We retrospectively determined whether the DCB size was close to (ie, equal to or different by <0.5 mm from) Angio-lumen size, IVUS-lumen size, and IVUS-EEM size. The association of the size of DCB with restenosis risk was investigated. Results: The mean lesion length was 13 ± 9 cm and the prevalence of chronic total occlusion was 18%. During a mean follow-up period of 17 ± 9 months, restenosis occurred in 26% of lesions. Lesions treated with a DCB of IVUS-EEM size had a lower 2 year restenosis rate than those treated with a DCB over/under IVUS-EEM size (19.7 ± 5.7% vs 34.5 ± 4.7%, p=0.02 by the log-rank test), while the restenosis rate was not significantly different between DCBs of Angio-lumen size or IVUS-lumen size and those over/under the size (both p>0.05). The multivariate Cox regression analysis revealed that DCBs of IVUS-EEM size were independently associated with a reduced risk of restenosis (adjusted hazard ratio 0.50; 95% confidence interval 0.27–0.95; p=0.03). Conclusion: The DCBs of IVUS-EEM size, but not of Angio-lumen size or IVUS-lumen size, were associated with a reduced risk of restenosis after FP-EVT. Determining the DCB size according to IVUS-evaluated EEM diameter would be potentially beneficial in restenosis occurrence.

Long-term outcomes of paclitaxel-coated balloons for non-malignant ureteral strictures.

To evaluate the clinical efficacy and safety of drug-coated balloon (DCB) ureteroplasty for the management of non-malignant ureteral strictures. A prospective "off-label" monocentric single-arm pilot study investigating the safety and efficacy of drug-coated balloon (DCB) (Lutonix®; BD, USA) was performed. Twenty-five patients with benign ureteral strictures related to uretero-enteric anastomosis (n = 13); lithiasis (n = 5), post-surgical complications (iatrogenic n = 5), transplanted kidney (n = 1) and post-radiotherapy (n = 1) were included. Following lesion crossing, predilatation was performed using 4-7mm high-pressure balloon catheter (5-6Fr) with a balloon pressure of 6-7atm based on the manufacturer's recommendation. In the absence of rupture of the ureteral wall, the DCB was dilated for 4min. across the lesion. The process was repeated if deemed necessary to a maximum of three stricture dilatations. We analysed both clinical and radiological primary patency (no signs of ipsilateral hydronephrosis or improvement of the existing residual dilatation at the follow-up examinations) and secondarily safety endpoints. Mean lesion length was 40 ± 28.5mm. Mean time follow up was 36months ± 10.46months. Strictures were located at upper ureteric (12%), lower ureteric (32%), ureterovesical anastomosis (4%) and uretero-enteric anastomosis (52%) levels. The overall radiological success at 1-year follow-up was 88% (22/25 patients). In 56% patients (14/25 patients with primary patency) the nephrostomy catheter was removed 21days following a single DCB procedure. In 32% (8/25 patients) an additional dilatation sessions were required for maintaining the ureteral patency. The overall failure rate at 1-year follow-up was 12% (3/25 patients). Only one case of febrile urinary tract infection in a female patient (acute pyelonephritis) was encountered after the first dilatation. Paclitaxel-coated balloon ureteroplasty proved to be safe and effective for the treatment of non-malignant ureteral strictures. Larger studies are warranted to validate these promising initial results.

1-Year Outcomes of Fluoropolymer-Based Drug-Eluting Stent in Femoropopliteal Practice: Predictors of Restenosis and Aneurysmal Degeneration.

This study aimed to investigate the 1-year risk of restenosis and aneurysmal degeneration and explore the associated factors after femoropopliteal implantation of fluoropolymer-based drug-eluting stents (FP-DESs) for symptomatic atherosclerotic peripheral artery disease in real-world practice. Although clinical trials have demonstrated that FP-DES implantation has favorable 1-year outcomes, its performance in real-world practice has not been well elucidated. This multicenter, prospective, observational study evaluated 1,204 limbs (chronic limb-threatening ischemia: 34.8%, mean lesion length: 18.6 ± 9.9cm, chronic total occlusion: 53.2%, bilateral wall calcification: 41.9%) of 1,097 patients with peripheral artery disease (age: 75 ± 9 years, men: 69.4%, diabetes mellitus: 60.8%, chronic kidney disease: 66.2%) undergoing Eluvia (Boston Scientific) drug-eluting stent implantation for femoropopliteal lesions. The primary outcome measure was 1-year restenosis, whereas the secondary outcome measures were 1-year occlusive restenosis, stent thrombosis, target lesion revascularization, and aneurysmal degeneration. The 1-year occurrence rates of restenosis (12.9%), occlusive restenosis (9.2%), stent thrombosis (3.3%), target lesion revascularization (6.2%), and aneurysmal degeneration (16.8%) were found. Multivariate analysis demonstrated that dialysis, chronic limb-threatening ischemia, history of revascularization, a smaller reference vessel diameter, chronic total occlusion, and spot stenting were significantly associated with an increased risk of 1-year restenosis, whereas intravascular ultrasound use and subintimal wire passage were significantly associated with an increased risk of 1-year aneurysmal degeneration. This study documented the 1-year clinical outcomes after femoropopliteal endovascular therapy with FP-DES implantation in real-world practice. The 1-year restenosis rate would be clinically acceptable, whereas the occurrence of occlusive restenosis and aneurysmal degeneration should be noted.

2-Year Results With a Sirolimus-ElutingSelf-Expanding Stentfor Femoropopliteal Lesions: The First-in-Human ILLUMINA Study.

The aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics. DES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating. Within a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, functional, and clinical outcomes. At 24months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95%CI: 73.9%-89.6%) and 93.1% (95%CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24months, which was associated with preserved improvements in all walking disability questionnaire scores. The 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676).

Distal Endarterectomy Combined With Endovascular Proximal Treatment: The Hybrid DEEP Retrograde Technique for High-Complexity Infrainguinal Disease

Purpose: We present a hybrid technique for the treatment of chronic limb-threatening ischemia (CLTI) due to complex, multilevel infrainguinal disease. It consists of an open distal endarterectomy combined with endovascular proximal treatment (the DEEP technique). Materials and Methods: This was a prospective cohort study. Thirty-three limbs (30 patients) were treated. Main inclusion criteria were absence of significant disease in femoral bifurcation associated with a complex infrainguinal pattern. This approach was specially considered in absence of suitable vein for bypass, obesity, hostile groin, and overall high surgical risk. Results: Mean age was 72.8 ± 10 years (ranging 50–93). Most cases presented with severe limb threatening onset (90.9% Rutherford >4 and 81.8% WIfi >3) due to high-complexity infrainguinal disease pattern (Global Limb Anatomic Staging System [GLASS] stage III) in 31/33 (93.9%), chronic total occlusions (CTOs) in 24/33 (72.7%), and severe calcification (Peripheral Arterial Calcium Scoring System [PACSS] grade 4) in 22/33 (66.6%). Mean lesion length was 228.2 mm ± 83 (ranging 40–340 mm). In all procedures, a covered-stent (25 cm length Viabahn) was implanted in a retrograde fashion as the endovascular component. Effective revascularization was achieved in all cases, showing significant clinical and hemodynamic improvement (median pre- and postprocedure ankle-brachial index [ABI]: 0.3 and 0.9, respectively). Results at 12 months follow-up were as follows: 93.9% limb salvage ratio, 75.7% primary patency, 84.6% assisted primary patency, and 90.9% secondary patency. Major adverse limb events (MALE) and cardiovascular events (MACE) occurred in 8/33 (24.2%) and 2/33 (6%), respectively. Mean length of postoperative stay was 7.5 ± 6.92 days (3–27). Conclusion: This less invasive hybrid technique has promising short-term results for limb salvage and it is worth to be included in vascular armamentarium for CLTI revascularization in selected patients.

Outcomes of Stented vs Nonstented Femoropopliteal Lesions Treated With Drug-Coated Balloon Angioplasty

Purpose: Drug-coated balloon (DCB) angioplasty has been increasingly used for the treatment of lower limb peripheral artery disease (PAD). However, bail-out stenting may be necessary in cases of suboptimal angioplasty. This study investigated the outcomes of femoropopliteal disease treated with DCB with/without bail-out stenting. Materials and Methods: This was a single-center retrospective study enrolling 166 consecutive patients (DCB+stent: n=81 vs DCB: n=85) with 253 femoropopliteal lesions (DCB+stent: n=99 vs DCB: n=154) treated with DCB with/without stenting. Bail-out stenting was performed at the operator discretion for postangioplasty dissections or otherwise suboptimal angiographic result (>30% residual stenosis). Cox regression analysis was performed to examine the outcomes of DCB with/without stenting during 2-year follow-up. Results: The baseline clinical characteristics were similar between the 2 groups. About half of the patients presented with critical limb ischemia, with most of the lesions located at the superficial femoral artery. The overall mean lesion length was 147±67 mm. The most frequent bail-out stent types were bare metal stents (BMS) (53.5%) followed by drug-eluting stents (DES) (41.4%). Lesions requiring bail-out stenting were on average longer (177±67 mm vs 127±59 mm; p<0.01) and on average had higher prevalence of flow-limiting postangioplasty dissections. The overall procedural success rate was 94% without any differences between the 2 groups. Both the stented and nonstented treatment modalities were effective and safe, demonstrating similar rates of 2-year freedom from major adverse limb event (stented: 71.3% vs nonstented: 64.4%) and 2-year freedom from target lesion revascularization (stented: 77.1% vs nonstented: 72.3%) during following up. The use of DES as bail-out therapy was associated with a lower risk of 2-year death compared with the use of BMS (DES: 97.2% vs BMS: 75.8%; p=0.01). Conclusion: Drug-coated balloon with bail-out stenting is a viable treatment option for cases of suboptimal DCB results, promising similar efficacy with DCB-alone procedures. However, as the patency of stents at the femoropopliteal segment may be a challenge due to the biomechanical stress of the artery, the efficacy of DCB+bail-out stenting should be further evaluated. In addition, future studies are needed to determine which grades of post-DCB dissections should be treated and optimize current bail-out strategies.

Intravascular lithotripsy during percutaneous coronary intervention for calcified coronary lesions: analysis of patient and procedural characteristics and clinical outcomes

Abstract Funding Acknowledgements Type of funding sources: None. Background/Introduction Coronary artery calcification is frequently encountered during percutaneous coronary intervention (PCI). It can reduce PCI success and increase intra-procedural and post-procedural complications, including stent embolization, under-expansion and mal-apposition. Intravascular lithotripsy (IVL) is a new tool developed to treat calcified coronary lesions. Purpose Retrospective analysis of all cases of intravascular lithotripsy performed within our local health district to examine patient and procedural characteristics and clinical outcomes. Methods All patients undergoing PCI with intravascular lithotripsy between September 2019-August 2021 within our local health district were analysed. Patient and procedural characteristics and clinical outcomes were recorded. Results 67 patients (50 men) were included with mean age 71.4 ± 8.7years. Risk factors prevalence included smoking (34%), hypertension (82%), dyslipidaemia (69%) and diabetes (46%). Trans-radial artery access was used in 38 patients (57%). IVL was performed most commonly in the left anterior descending artery (52%),[Figure 1]. IVL was utilised in 9 chronic total occlusions and 12 bifurcation lesions. Intracoronary (IC) imaging was performed in 59 patients (88%), intravascular ultrasound in 41(61%) and optical coherence tomography in 18 (27%). 41 (69%) patients had imaging performed pre and post IVL and post PCI. IC imaging identified 14 cases with 270º calcification arc and 45 cases with 360º arc. Nine cases (13.4%) required rotational atherectomy prior to IVL (most commonly 1.75mm burr). Mean reference vessel diameter was 3.2 ± 0.3mm. Mean lesion length was 36.3 ± 16.5mm. Mean pre-PCI stenosis was 85.5 ± 10.8%. Drug eluting stents were successfully deployed in 57 cases (85%), 10 had balloon angioplasty alone. Mean stent length was 39.2 ± 17.8mm. Mean post-PCI stenosis was 4.5 ± 13.3% (median 0%). Figure 2 shows a statistically significant increase in minimum lumen diameter and minimum lumen area post-IVL and minimal-stent-area (MSA) post-PCI. Mean stent expansion was 83%. Mean screening time 35.8 ± 17.8 minutes with mean contrast used 207.3 ± 78.7mL. No sustained arrhythmias or side-branch loss occurred. Vessel rupture was recorded in one patient necessitating urgent cardiac surgery (due to oversized balloon) and in 4 cases the IVL balloon could not cross the lesion. Conclusion Our experience shows that IVL is safe and effective and facilitates stent delivery and expansion. Intracoronary imaging is important to determine the need for calcium modification and evaluate its success prior to stent delivery and to confirm optimised stent expansion. Abstract Figure. Breakdown of PCI Artery Abstract Figure. IC Dimensions Pre/Post IVL/Post PCI

Treatment of Long Femoropopliteal Lesions With Self-Expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA Trial

Purpose: The performance of self-expanding interwoven nitinol stent (Supera) in femoropopliteal interventions has been proven through trials with short lesions and with relatively low proportion of occlusions. There is limited evidence of Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral arterial disease (PAD). Methods: The STELLA SUPERA (STEnting Long de L’Artère fémorale superficielle par le stent métallique Supera) is a prospective, 2-center, single-arm study. Patients with symptomatic (Rutherford stages 2–6) de novo and TASC C/D lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the primary sustained clinical improvement at 12 months. Follow-up included clinical examination, duplex scan, and biplane X-ray up to 24 months. Results: Between December 2016 and October 2018, 48 symptomatic patients with 49 femoropopliteal lesions (TASC D = 32, 65%) were treated. The mean lesion length was 234 ± 123 mm, and 78% were total occlusion. The mean stented lesion length was 273 ± 127 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 87.2% and 79.7%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). At 24 months, the primary patency and freedom from target lesion revascularization (TLR) rates were 77.9% and 86.9%, respectively. The ankle-brachial pressure index increased from 0.62 ± 0.15 at baseline to 0.93 ± 0.15 at 24 months (p<0.0001). There were no stent fractures at 24 months. Conclusion: The use of Supera stent in long lesions (TASC C/D) is a safe and effective endovascular alternative. These results reinforce the need for randomized clinical trials to assess the value of interwoven stents for long femoropopliteal lesions.