Calcium Scoring System Research Articles

Comparative Outcomes of Supera Interwoven Nitinol Versus Eluvia Fluoropolymer-Based Drug-Eluting Stents for the Treatment of Severely Calcified Femoropopliteal Artery Lesions: Results of the ELDORADO Study.

Supera interwoven nitinol stents (IWNS) and Eluvia fluoropolymer-based drug-eluting stents (DES) were designed to improve the patency of the femoropopliteal (FP) artery; however, which type of stent yields superior outcomes in calcified FP lesions remains unclear. To compare the safety and efficacy of Supera IWNS and Eluvia DES in severely calcified FP lesions. This study retrospectively analyzed 257 consecutive patients who underwent endovascular therapy using either IWNS (n = 123) or DES (n = 134) for FP lesions with peripheral arterial calcium scoring system (PACSS) grade 3 or 4 severe calcification between April 2018 and December 2021 at eight cardiovascular centers in Japan. Propensity score (PS) matching extracted 138 matched patients with no remarkable intergroup difference in patient and lesion characteristics. The 1-year primary patency rates in the matched population were not significantly different between the IWNS and DES groups (85.4% vs. 89.8%, p = 0.320). A significant interaction between the stents used and the number of below-the-knee (BTK) runoff vessels was observed (interaction p = 0.048). The hazard ratio for restenosis was 2.68 (95% confidence interval, 0.51-14.2) in the group with no BTK runoff, favoring DES. In PS-matched patients with severely calcified FP lesions, 1-year primary patency was not significantly different between treatments using Supera IWNS and Eluvia DES.

Impact of the lower extremity arterial calcification score on clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease

Abstract Background Severe calcification, assessed using the peripheral artery calcification scoring system (PACCS), is associated with poor clinical outcomes after endovascular treatment (EVT) for de novo femoropopliteal lesions. However, the PACCS classification is a qualitative assessment performed in the angiographic room, and there are no established indicators for the quantitative assessment of calcification prior to treatment. Purpose We aimed to investigate the impact of the lower extremity arterial calcification score (LEACS) calculated using non-contrast lower limb computed tomography on clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease. Methods We retrospectively analyzed the clinical outcomes of 141 consecutive patients treated at our center for de novo femoropopliteal artery disease using a drug-coated balloon between April 2018 and December 2022. Patients who did not undergo lower limb computed tomography before EVT were excluded from the analyses. LEACS was determined based on the method used to calculate the Agatston score for the coronary arteries. Each patient’s score consisted of a sum of calcification scores from ostium of superficial artery to the popliteal artery at the knee joint of treated limb. The primary and secondary outcomes measured were primary patency and clinically-driven target vessel revascularization (CD-TVR) at 1 year. Cox proportional hazards analysis was used to explore independent predictors of clinical outcomes. The study population was divided into higher and lower LEACS groups based on the cut-off value (1750), which best discriminated patency, and the outcomes were compared between the two groups. Results In the higher and lower LEACS groups, the mean age was 75.1 ± 9.1 years and 75.5 ± 11.0 years (p = 0.87) and the mean lesion length was 170.3±102.8 mm and 157.7±112.1 mm (p = 0.64), respectively. The higher LEACS group showed significantly lower 1-year patency than the lower LEACS group (53.5% vs. 84.3%, log-rank, p = 0.041). In addition, freedom from 1-year CD-TVR was significantly lower in the higher LEACS group than in the lower LEACS group (66.8% vs. 93.7%, p = 0.047). The Cox proportional hazard analysis showed that the higher LEACS group was an independent predictor of 1-year restenosis (odds ratio: 2.80, 95% confidence interval: 1.24–8.84, p=0.037), along with a small (< 5 mm) reference vessel diameter (odds ratio: 3.55, 95% confidence interval: 1.44–9.53, p=0.028). Conclusion Higher LEACS scores were independently associated with clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease. Non-contrast lower limb computed tomography is an acceptable and feasible option for predicting the outcomes in patients with de novo femoropopliteal artery disease prior to treatment.

Effectiveness of Atherectomy and Drug-Coated Balloon Angioplasty in Femoropopliteal Disease: A Comprehensive Outcome Study.

Atherectomy has been reintroduced for debulking calcified atheroma to enhance the efficacy of drug-coated balloons (DCBs); however, its efficacy in severe calcification and related outcomes have not been fully evaluated. This study aimed to evaluate the outcomes of atherectomy and DCB angioplasty for treating femoropopliteal occlusive disease (FPOD). From 2014 to July 2022, 85 limbs in 76 patients with FPOD underwent atherectomy with DCB angioplasty. We evaluated the efficacy of this procedure using primary patency (PP) and clinically driven target lesion revascularization (CD-TLR)-free survival. PP was defined as the duration of uninterrupted patency without occlusion or a peak systolic velocity ratio more than 2.5 at the target lesion. Lesion calcification was evaluated according to Peripheral Arterial Calcium Scoring System, and Grade 4 was classified as severe. Seventy-one (84%) cases were male, and 56 limbs (66%) were treated for claudication. Rotational and directional atherectomies were performed in 62 (73%) and 23 limbs, respectively. The improvement in the median ankle-brachial index was 0.36 (interquartile range, 0.25-0.48). Median follow-up duration was 19.4 months. The overall PP and CD-TLR-free survival rates were 77% and 93% at 1 year and 64% and 83% at 2 years, respectively. On multivariable analysis, female sex (adjusted hazard ratio [aHR], 3.77; 95% confidence interval (CI), 1.30-10.87, P=0.014), dialysis (aHR, 4.35; 95% CI, 1.33-13.22, P=0.015), and severe calcification (aHR, 2.42; 95% CI, 1.07-5.46, P=0.033) were independent risk factors for poor PP. Dialysis (aHR, 11.07; 95% CI, 3.72-32.92, P<0.001) and severe calcification (aHR, 3.19; 95% CI, 1.15-8.84, P=0.026) were identified as independent risk factors for CD-TLR. Atherectomy with DCB angioplasty for FPOD did not work well in female patients, patients with lesions with severe calcification, and patients undergoing dialysis. Therefore, careful monitoring of these patients is crucial for patency loss and the requirement for revascularization. Additionally, for these patients requiring revascularization, surgical bypass may be appropriate for suitable candidates; whereas more proactive conservative management may be justified for claudicants.

Intratumoral calcification on CT assists in distinguishing benign and malignant upper abdomen neoplasm.

The significance of calcification and microcalcification in diagnosing malignant tumors is well established, but their role in the upper abdomen is less explored in routine radiology. To assess the effectiveness of computed tomography (CT) imaging in detecting intratumoral calcification within upper abdominal tumors. This study retrospectively enrolled patients with upper abdominal tumors featuring intratumoral calcifications who underwent plain and contrast-enhanced CT scans between January 2016 and December 2019. We examined the imaging characteristics of calcifications, including location, edges, shape, CT values, and association with necrosis. The diagnostic utility of calcification for distinguishing benign and malignant tumors was assessed using receiver operating characteristic curves. Univariate and multivariate logistic regression analyses were conducted to identify independent predictive factors for the diagnosis of malignancy characterized by intratumoral calcification. This study included 153 patients (median age 49 ± 21years; 83 men) with pathologically confirmed tumors of the upper abdomen (including liver, pancreas, and gastrointestinal tract) with intratumoral calcifications. Significant differences in CT values between benign and malignant tumors were observed (P < .001), with high diagnostic accuracy of calcification in CT imaging (receiver operating characteristic area = 0.884, sensitivity = 0.815, specificity = 0.976). The characteristics of calcification, including its edge and shape, were significantly correlated with tumor differentiation (P < .01). Multivariate logistic regression analysis revealed that the presence of adjacent necrosis around intracalcification is an independent predictor of malignancy (odds ratio = 5.48; 95% confidence interval: 1.55, 19.41; P = .008). Intratumoral calcification in CT imaging is a key marker for distinguishing between benign and malignant epigastric tumors, offering high specificity. Key message • What is already known on this topic - Intratumoral calcification, as a highly sensitive radiological marker, has shown potential in differentiating between benign and malignant tumors in thyroid and breast cancers. However, its discriminatory role in upper abdominal tumors is often overlooked. Therefore, assessing the diagnostic accuracy of intratumoral calcification on CT scans is crucial for improving diagnostic efficiency and avoiding unnecessary examinations. • What this study adds - Intratumoral calcification on CT exhibits high specificity in differentiating between benign and malignant upper abdominal tumors, providing a simple and reliable criterion for improving diagnostic accuracy. • How this study might affect research, practice or policy - This study highlights the significance of intratumoral calcification characteristics observed on CT in determining whether upper abdominal tumors are benign or malignant. The findings could pave the way for the development of a CT-based calcification scoring system, which would facilitate rapid and accurate diagnostics in clinical practice, thereby optimizing treatment strategies and enhancing patient prognosis.

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

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

Establishing a Classification System for Predicting Flow-Limiting Dissection After Balloon Angioplasty Using Explainable Machine-Learning Models: A Multicenter Retrospective Cohort Study.

Percutaneous transluminal angioplasty (PTA) is the primary method for treatment in peripheral arterial disease. However, some patients experience flow-limiting dissection (FLD) after PTA. We utilized machine learning and SHapley Additive exPlanations to identify and optimize a classification system to predict FLD after PTA. This was a multi-center, retrospective, cohort study. The cohort comprised 407 patients who underwent treatment of the femoropopliteal (FP) arteries in 3 institutions between January 2021 and June 2023. Preoperative computed tomography angiography images were evaluated to identify FP artery grading, chronic total occlusion (CTO), and vessel calcification (peripheral artery calcium scoring system [PACSS]). After PTA, FLD was identified by angiography. We trained and validated 6 machine-learning models to estimate FLD occurrence after PTA, and the best model was selected. Then, the sum of the Shapley values for each of CTO, FP, and PACSS was calculated for each patient to produce the CTO-FP-PACSS value. The CTO-FP-PACSS classification system was used to classify the patients into classes 1 to 4. Univariate and multivariate analyses were performed to validate the effectiveness of the CTO-FP-PACSS classification system for predicting FLD. Overall, 407 patients were analyzed, comprising 189 patients with FLD and 218 patients without FLD. Differences in sex (71% males vs 54% males, p<0.001), CTO (72% vs 43%, p<0.001), FP (3.26±0.94 vs 2.66±1.06, p<0.001), and PACSS (2.39±1.40 vs 1.74±1.35, p<0.001) were observed between patients with and without FLD, respectively. The random forest model demonstrated the best performance (validation set area under the curve: 0.82). SHapley Additive exPlanations revealed CTO, PACSS, and FP as the 3 most influential FLD predictors, and the univariate and multivariate analyses confirmed CTO-FP-PACSS classification as an independent FLD predictor (multivariate hazard ratio 4.13; p<0.001). The CTO-FP-PACSS classification system accurately predicted FLD after PTA. This user-friendly system may guide surgical decision-making, helping choose between PTA and additional devices to reduce FLD in FP artery treatment. We utilised machine-learning techniques in conjunction with SHapley Additive exPlanations to develop a clinical classification system that predicts the probability of flow-limiting dissection (FLD) after plain old balloon angioplasty. This classification system categorises lesions into Classes 1-4 based on three factors: chronic total occlusion, femoropopliteal grading, and peripheral artery calcium scoring. Each class demonstrated a different probability of developing FLD. This classification system may be valuable for surgeons in their clinical practice, as well as serving as a source of inspiration for other researchers.

Detection of Coronary Artery Disease Using a Peripheral Arterial Calcium Scoring System in Patients With Severe Aortic Stenosis

Detection of Coronary Artery Disease Using a Peripheral Arterial Calcium Scoring System in Patients With Severe Aortic Stenosis

Prospective investigation of calcium score in optical coherence tomography-guided revascularization to identify lesions with low risk for stent under expansion: the CORAL study.

The optical coherence tomography (OCT)-based calcium scoring system was developed to guide optimal lesion preparation strategies for percutaneous coronary intervention (PCI) of calcified lesions. However, the score was derived retrospectively, and a prospective investigation is lacking. The CORAL (UMIN000053266) study was a single-arm, prospective, multicenter study that included patients with calcified lesions with OCT-calcium score of 1-2 to investigate whether these lesions could be optimally treated with a balloon-only preparation strategy using a non-compliant/scoring/cutting balloon. The primary endpoint was strategy success (successful stent placement with a final percent diameter stenosis [%DS] < 20% and Thrombolysis In Myocardial Infarction flow grade III without crossover to rotational atherectomy/orbital atherectomy/intravascular lithotripsy [RA/OA/IVL]). A superiority analysis for the primary endpoint was performed by comparing the study cohort with a performance goal of 83.3%. One hundred and eighteen patients with 130 lesions were enrolled. The mean age was 79.0 ± 10.3years, and 79 patients (66.9%) were male. The OCT-calcium score was 1 for 81 lesions (62.3%) and 2 for 49 lesions (37.7%). The %DS improved from 47.0 ± 14.8% preprocedure to 11.1 ± 5.6% postprocedure. Stent expansion ≥ 70% was achieved in 90.2%. The strategy success rate was 93.1% (95% confidence interval: 87.3-96.8), and superiority against the performance goal was achieved without any crossover to RA/OA/IVL (P = 0.0027). The OCT-calcium score could identify mild/moderately calcified lesions treatable by PCI with the balloon-first strategy using a non-compliant/scoring/cutting balloon for predilatation, with a high strategy success rate. These results support the intravascular imaging-based treatment algorithm for calcified lesions proposed by CVIT.

Twenty-Four-Month Safety and Effectiveness of TCD-17187 Drug-Coated Balloon for Treatment of Atherosclerotic Lesions in Superficial Femoral and Proximal Popliteal Artery

PurposeIn the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients.MethodsThis was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate.ResultsAge was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD.ConclusionThis trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months.Level of EvidenceLevel 3, Cohort study.Clinical Trial Registration: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.

Intravascular Iliac Artery Lithotripsy to Facilitate Aortic Endograft Delivery: Midterm Results of a Dual-Center Experience.

To assess the feasibility and safety of intravascular lithotripsy (IVL) for enabling transfemoral abdominal (EVAR), thoracic (TEVAR), and thoracoabdominal (BEVAR) endovascular aneurysm repair in patients with narrow and calcified iliac arteries. Consecutive patients treated with IVL for severe calcified and narrowed iliac access before EVAR, TEVAR, or BEVAR between November 2020 and June 2022 were retrospectively evaluated. All anatomical iliac characteristics were acquired by multi-planar reconstruction of preoperative computed tomography angiography (CTA). The hostility of the vascular accesses was classified based on Peripheral Arterial Calcium Scoring System (PACSS) and calcified access severity score (CASS), a new score considering both anatomical (calcium grade and length, minimum lumen diameter [MLD], and tortuosity index) and aortic stent-graft (SG/MLD index) parameters. Primary endpoint was technical success defined as successful aortic endograft delivery and deployment without iliac rupture. Freedom from complications and primary patency were additionally analyzed. Twenty-eight iliac axes were treated with IVL (8 bilateral) in 20 patients (mean age 74.5±6.7 years) with a mean follow-up of 26.5±6.2 (range 17-36) months. Ten patients underwent EVAR: 3 TEVAR, and 7 BEVAR procedures. In 14 patients (70%), aneurysm disease was associated with symptomatic aorto-iliac occlusive disease (AIOD), with Rutherford class III to IV. The PACSS was grade IV in 89% of the cases and the CASS (mean 14±2) was grade III to IV in all cases. The stent-graft (SG) outer diameter (5.60±1.65 mm) was significantly larger by 50% than MLD (3.96±1.20 mm), with an SG/MLD index of 1.50±0.51 (p<0.001). Technical success was 100%. No dissection, rupture, or distal embolization occurred. One (3.4%) bail-out stenting was necessary as endoconduit after IVL treatment. One month CTA showed that postoperative luminal gain increased by 93% (p<0.001). An improvement of 2 Rutherford classes occurred in all AIOD patients with a primary patency of 100% at last follow-up. This study shows the safety and feasibility of IVL as a valuable option to treat narrow and calcified iliac arteries to facilitate endograft delivery. Further studies will be useful to confirm these results. In this article, the use of intravascular iliac artery lithotripsy to facilitate aortic endograft delivery is explored. The presence of iliac severe calcifications still represents a contraindication for aortic endovascular repair. Intravascular lithotripsy increases the feasibility and safety of endovascular aortic procedures, facilitating endograft delivery and reducing the risk of iliac rupture and/or dissections by improving vessel compliance and luminal gain. This novel vessel preparation could be an alternative to "paving and cracking" and/or iliac conduits. This study describes a new score to classify the severity of iliac calcifications, considering anatomical parameters and the profile of aortic endografts delivery system.

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.

Repeat drug-coated balloon angioplasty for femoropopliteal lesions: 12-month results from a retrospective observational study

BackgroundThe clinical implications of restenosis after drug-coated balloon (DCB) treatment remain unclear. We compared the clinical outcomes between DCB angioplasty for restenosis and de novo femoropopliteal artery lesions. This single-center retrospective study included 571 patients (737 limbs) who underwent either repeat (54 patients, 64 limbs) or de novo DCB (517 patients, 673 limbs) without bailout stenting. After propensity score matching, 49 matched pairs were analyzed. The primary endpoint was the 1-year primary patency, with secondary endpoints including the freedom from target lesion revascularization (TLR), major adverse limb events (MALE), and early restenosis. Predictors of restenosis were identified using multivariable Cox regression analysis.ResultsThe repeat-DCB group displayed significantly lower rates of 1-year primary patency and freedom from TLR compared to those of the de novo-DCB group (50.1% vs. 77.4%, p = 0.029 and 54.9% vs. 83.6%, p = 0.0.44, respectively). No significant differences were observed in early restenosis or MALE (10.7% vs. 5.9%, p = 0.455 and 48.3% vs. 73.4%, p = 0.055, respectively). Restenosis after DCB angioplasty was associated with repeat DCB (hazard ratio [HR], 5.13; 95% confidence interval [CI], 1.43–18.4; p = 0.012) and small vessel size of < 4.5 mm (HR, 6.25; 95% CI, 1.17–33.4; p = 0.032). Furthermore, restenosis after repeat DCB angioplasty was associated with the Peripheral Artery Calcification Scoring System (PACSS) grade 4 (HR, 4.20; 95% CI, 1.08–16.3; p = 0.038), small vessel size of < 4.5 mm (HR, 9.44; 95% CI, 1.21–73.7; p = 0.032), and intravascular ultrasound (IVUS) use (HR, 0.05; 95% CI, 0.01–0.44; p = 0.007).ConclusionsThe 1-year primary patency rate following repeat DCB angioplasty for femoropopliteal lesions was notably lower than that of DCB treatment for de novo lesions. Repeat DCB strategy was associated with an increased risk of patency loss. Regarding repeat restenosis after DCB treatments, PACSS grade 4 calcification and small vessel diameter of < 4.5 mm were associated with an increased risk of restenosis, whereas IVUS use correlated with a decreased risk of restenosis.

Impact of Calcification on the Outcomes of Femoropopliteal Artery Endovascular Treatment Using a Polymer Coated Drug-Eluting Stent.

The aim of this study was to analyze the impact of calcification on the 12 and 24 months outcomes of the Eluvia™ (Boston Scientific®) drug-eluting stent (DES) for femoropopliteal occlusive disease using three different calcium scoring systems. A single-center, retrospective cohort-study (March-2016 to December-2018) of patients treated with the Eluvia™ DES for femoropopliteal atherosclerosis was performed. Outcomes included primary and secondary patency rates and freedom from target lesion revascularization (FTLR) and were analyzed by comparing the impact of calcium burden according to the following calcium scores: Peripheral Arterial Calcium Scoring System (PACSS) score, number of vessel quadrants affected (0-4) and calcification score per Peripheral Academic Research Consortium (PARC) definitions. In total, 111 Patients were included (mean age: 71.2 ± 7.9; 64% male). Most patients presented with Rutherford class 3 (79.9%), followed by class 5 (12.7%), class 4 (10%) and class 6 (6.4%). The mean lesion length was 197.6 ± 108.5mm and 74.3% of patients had chronic total occlusions. There were no differences in primary patency between the calcification scores at 12months (PACSS, LogRank = 0.28; quadrants, LogRank = 0.29; PARC, LogRank = 0.42) and 24months (PACSS, LogRank = 0.13; quadrants, LogRank = 0.42; PARC, LogRank = 0.13). FTLR was significantly lower at 12months in patients with calcification affecting 3 or 4 quadrants (LogRank = 0.022) but not at 24months (LogRank = 0.36). In this study, the Eluvia™ DES showed promising performance in calcified disease and the analysis according to the quadrant model predicted an increased risk for TLR at 12months.

Retrospective Case Control Matched Comparison of the Antegrade Versus Retrograde Strategy After Antegrade Recanalisation Failure in Complex de novo Femoropopliteal Occlusive Lesions

To investigate dissection severity, need for bailout stenting and limb outcomes in patients undergoing antegrade vs. retrograde revascularisation. Consecutive patients who underwent antegrade vs. retrograde revascularisation after antegrade recanalisation failure of long femoropopliteal chronic total occlusion (CTO) due to symptomatic peripheral artery disease between January 2017 and June 2022 were studied. Retrospective case-control matching was used to adjust for lesion length and calcification using the peripheral artery calcification scoring system (PACSS). Procedural outcomes included severity of dissection (Type A to F dissections, numerically graded on a scale from 0 - 6 with increasing severity) after angioplasty and number and localisation of stents needed to be implanted during the index procedure. Additionally, clinically driven target lesion revascularisation (CD-TLR) and major (above the ankle) amputation rates were assessed during follow up. A total of 180 patients were analysed who underwent antegrade (n = 90) vs. retrograde after failed antegrade (n = 90) recanalisation. Median patient age was 76.0 (interquartile range [IQR] 67.0, 82.0) years and 76 (42.2%) were female. Moreover, 78 patients (43.3%) had intermittent claudication, whereas 102 (56.7%) exhibited chronic limb threatening ischaemia (CLTI). Mean lesion length was 30.0 (IQR 24.0, 36.0) cm with moderate to severe (3.0 [IQR 2.0, 4.0]) lesion calcification. Dissection severity after angioplasty was higher in antegrade vs. retrograde after failed antegrade recanalisation (4.0 [IQR 3.0, 4.0] vs. 3.0 [IQR 2.0, 4.0]; p < .001). Additionally, the number of stents in all segments and the rate of bailout stenting in popliteal segments was significantly higher with the antegrade strategy (2.0 [IQR 1.0, 3.0] vs. 1.0 [IQR 0, 2.0], p < .010; and 37% vs. 14%, p < .001). During median follow up of 1.48 (IQR 0.63, 3.09) years, CD-TLR rates (p = .90) and amputation rates in patients with CLTI (p = .15) were not statistically significant. In complex femoropopliteal CTOs, retrograde after failed antegrade recanalisation is safe for endovascular revascularisation, which in experienced hands may result in less severe dissections and lower rates of stent placement. However, considering the relatively short follow up duration, CD-TLR and amputation rates were not statistically different between the two approaches. [German Clinical Trials Register: DRKS00015277.].

Clinical outcomes of MANTA closure device in percutaneous endovascular aortic aneurysm repair

ObjectiveThe MANTA device is a plug-based vascular closure device (VCD) designed for large bore femoral arterial access site closure. It showed promising results in transcatheter aortic valve replacement cases. In this study, we report our results and evaluate the MANTA VCD in percutaneous endovascular aortic aneurysm repair (pEVAR). MethodsAll data of consecutive patients who underwent an elective pEVAR between October 2018 and December 2022 were retrospectively reviewed. In all patients at least one common femoral artery was intended to close with the MANTA VCD. Depending on the sheath size, the 14Fr or 18Fr MANTA VCD was used. On the preoperative computed tomography scan, the diameter of the common femoral artery (CFA) was measured and the amount of calcification based on the Peripheral Arterial Calcium Scoring System (PACSS) was scored. Primary outcome was procedural technical success. Procedural technical success was defined as placement of the MANTA closure device resulting in vascular closure with patent CFA, without requiring immediate open or endovascular surgery. The secondary outcomes were access site complications requiring reintervention and all-cause mortality at 30-day follow-up. ResultsIn total, 152 consecutive patients underwent pEVAR with 291 common femoral artery closure procedures with the Manta VCD. Mean age was 74.1 ± 6.4 years, with a mean body mass index of 27.7 ± 4.4 kg/m2. The mean diameter of the CFA was 10.5 ± 1.9 mm. In 52.6% of the cases, there were no calcification on the preoperative computed tomography scan. The 18Fr and 14Fr Manta VCD were used 169 and 122 times, respectively. The technical success rate was 96.6%. Major vascular complications were reported in 4.5% of the cases, without any death-related events. ConclusionsThis single-center retrospective cohort study analyzed the procedural technical success, major vascular complications and all-cause mortality at 30-day follow-up of the MANTA vascular closure device in 152 pEVAR patients with 291 common femoral artery closure procedures. The technical success rate was 96,6%. Major vascular complications were reported in 4.5% of the cases, without any death related events. We concluded that the MANTA device is a safe and feasible option with a high rate of technical success in patients undergoing pEVAR.

Infrapopliteal 3-Vessel Occlusive Disease Is the Only Predictor of Wound Recurrence After Complete Wound Healing via Endovascular Therapy in Patients With Chronic Limb-threatening Ischemia.

To determine the predictors of wound recurrence after complete wound healing in patients with chronic limb-threatening ischemia (CLTI) who underwent endovascular therapy (EVT) for infrapopliteal (IP) lesions with consideration of IP arterial anatomic severity, including classification by the Global Limb Anatomic Staging System (GLASS). This retrospective single-center study assessed patients with de novo CLTI limbs with tissue loss treated via EVT for IP lesions from September 2016 to May 2021. Among these patients, 149 consecutive limbs from 133 patients who achieved complete wound healing were enrolled. The Kaplan-Meier method was used to estimate the wound recurrence rate after complete wound healing. The Cox proportional hazard model was used to assess the association between baseline characteristics and wound recurrence. The cumulative wound recurrence rate 1 year after complete wound healing was 30%. The mean time for wound recurrence was 7±5 months. Only IP arterial anatomic characteristics remained as a predictor of wound recurrence, whereas wound status and management, including the Wound, Ischemia, and foot Infection (WIfI) clinical stage and minor amputation, were not associated with wound recurrence. Multivariate analysis revealed independent associations between wound recurrence and IP 3-vessel occlusive disease (hazard ratio, 2.97; 95% confidence interval, 1.39-6.35), but not poor below-the-ankle runoff, IP Peripheral Arterial Calcium Scoring System (PACSS) grade, and the GLASS IP grade. The only independent predictor of wound recurrence after complete wound healing via EVT in patients with CLTI was IP 3-vessel occlusive disease. In patients with chronic limb-threatening ischemia (CLTI), wound recurrence after complete wound healing remains a challenge, and studies focused exclusively on wound recurrence are still limited. The present study aimed to determine the risk factors for wound recurrence after complete wound healing in patients with CLTI who underwent endovascular therapy (EVT) for infrapopliteal (IP) lesions, with consideration of IP arterial anatomic severity for the first time. The results showed that IP 3-vessel occlusive disease was the only predictor of wound recurrence, whereas wound status/management and other arterial anatomic characteristics including WIfI clinical stages and GLASS grades were not predictors.

Endovascular Therapy with Interwoven Nitinol Stent Placement after Predilation for Heavily Calcified Femoropopliteal Artery Disease: Results of the BURDOCK Study

PurposeTo investigate the 1-year and 2-year clinical outcomes of interwoven stent (IWS) implantation for symptomatic femoropopliteal arterial disease with calcification. Material and MethodsThis prospective multicenter study evaluated 308 limbs (63% with the peripheral arterial calcium scoring system 3 and 4 severe calcification and 87% with ≥180° calcification on intravascular ultrasound) of 299 patients (diabetes in 66.9%, chronic renal failure in 52.8%, and dialysis in 49.2%) who underwent IWS (Supera; Abbott, Abbott Park, Illinois) implantation after sufficient predilation (residual stenosis < 30%) for calcified femoropopliteal lesions. The primary outcome measure was primary patency (freedom from restenosis) at 1 and 2 years, whereas the secondary outcome measure included freedom from clinically driven target lesion revascularization (CD-TLR). Clinical parameters associated with loss of patency were explored. ResultsKaplan–Meier analysis showed that primary patency was 88.2% (95% confidence interval [CI], 84.5%–92.1%) at 1 year and 80.8% (95% CI, 76.1%–85.8%) at 2 years. The CD-TLR–free rate was 96.5% and 94.8% at 1 and 2 years, respectively. The characteristics associated with loss of patency were restenotic lesion with and without stent implantation (adjusted hazard ratio, 1.96 and 2.40; P = .047 and .041, respectively), chronic total occlusion (adjusted hazard ratio, 1.88; P = .022), and popliteal involvement (adjusted hazard ratio, 2.60; P = .002). ConclusionsThe implantation of IWS after sufficient predilation for calcified femoropopliteal atherosclerotic disease demonstrated clinically acceptable primary patency.

Endovascular treatment of femoro‐popliteal occlusions with retrograde tibial access after failure of the antegrade approach

Despite the development in endovascular technologies and the introduction of new tools in clinical practice, the endovascular crossing of femoropopliteal occlusions is not always possible with the antegrade approach, with a failure rate that can be up to 20%. This study aims to assess the feasibility, safety, and efficacy in terms of acute outcome of the endovascular retrograde crossing of femoro-popliteal occlusions with tibial access. This study is a single-centre, retrospective analysis of prospectively collected data of 152 consecutive patients, who had undergone, from September 2015 to September 2022, endovascular treatment of femoro-popliteal arterial occlusions with retrograde tibial access after the failure of the antegrade approach. The median lesion length was 25 cm and 66 patients (43.4%) had a calcium grading according to the peripheral arterial calcium scoring system of 4. Angiographically, 44.7% of the lesions were TASC II category D. In all cases, successful cannulation and sheath introduction were performed with an average cannulation time of 150.4 s. Femoropopliteal occlusions were successfully crossed with the retrograde route in 94.1% of cases; the intimal approach was performed in 114 patients (79.7%). The mean time from puncture to retrograde crossing was 20.5 min. Acute vascular access-site complications were noted in 7 (4.6%) patients. Thirty-day major adverse cardiovascular events rate and 30-day major adverse limb events rate of 3.3% and 2%, respectively, were observed. The results of our study indicate that retrograde crossing of femoro-popliteal occlusions with tibial access is a feasible, effective, and safe approach in case of failed antegrade approach. The results presented represent one of the largest investigations ever published on tibial retrograde access and contribute to the small body of literature present on this topic to date.

Novel Therapeutic Concepts for Complex Femoropopliteal Lesions Using the Jetstream Atherectomy System

Introduction: The presence of severe arterial calcification is associated with less favorable outcomes in terms of procedural and clinical success as well as higher rates of major adverse limb events. Recent studies incorporating rotational atherectomy for effective preparation of severely calcified lesions demonstrate beneficial procedural outcomes by obtaining maximal luminal gain and improved long-term outcomes. Methods: This prospective single-center, observational study includes patients with severely calcified femoropopliteal lesions with chronic limb ischemia Rutherford 1–5 between January 2017 and July 2019, who underwent atherectomy using the Jetstream Atherectomy system, followed by drug-coated balloon angioplasty. Lesion calcification was categorized by the Peripheral Arterial Calcium Scoring System (PACSS), whereas lesion complexity was classified by the Transatlantic Inter-Society Consensus (TASC). Safety and efficacy aspects in terms of vessel injury, thromboembolism, and clinical success were systematically analyzed up to 12 months of follow-up (FU). Results: In 162 consecutive patients, 210 non-stented and 22 stented lesions were treated. Twelve (7.4%) patients received bail-out stenting. Mean lesion length was 24.2±4.8 cm; 51% were chronic total occlusions (mean occlusion length 18.2±5.1 cm). TASC C lesions were present in 38 patients (23.5%) and TASC D lesions in 124 patients (76.5%). The mean PACCS score was 3.3±0.9. Device success was achieved in 88%; procedural success was noted in 99% of the lesions. Embolic protection device was used in 11.7%. Perforation or dissection occurred in none of the cases. Asymptomatic peripheral embolization was noted in 10 patients (6.2%). Clinical FU at 12 months was available in 157 of 162 patients (96.9%). At 12 month FU, (1) mean Rutherford classification at baseline of 3.7±0.6 significantly dropped to 1.0±0.9 (p<0.05), (2) baseline mean anke-brachial index (ABI) of 0.4±0.1 significantly increased to 0.8±0.2 (p<0.05), (3) 92.6% were free from target lesion revascularization (TLR), (4) 95.1% were free from target vessel revascularization (TVR), and (5) binary restenosis measured by duplex occurred in 22 patients (13.6%). Multivariate analyses showed lesion length as predictive of stent placement (p=0.02), whereas both lesion length (p=0.006) and PACCS score (p=0.02) are predictive of clinical success. Conclusion: Rotational atherectomy in combination with drug-coated balloon (DCB) can be safely performed in long, calcified (non-) occlusive lesions with a relatively low rate of bail-out stenting and favorable clinical mid-term results. Clinical Impact: In this prospective, single arm study we demonstrated that combination treatment using rotational atherectomy and DCB is safe and effective in complex and calcified TASC C/D femoropopliteal lesions in patients with claudication or CLTI in a real-world clinical setting. Despite mean lesion length of >20cm and a relatively high rate of chronic total occlusions, the rate of bail-out stenting was surprisingly low (7.4%), whereas the rates of freedom from TLR and TVR were surprisingly high. Thus, our study may encourage vascular specialists to choose an endovascular -first approach even in such complex and calcified femoropopliteal lesions and occlusions in daily clinical practice.

Impact of calcification on clinical outcomes after drug‐coated balloon angioplasty for superficial femoral artery disease: Assessment using the peripheral artery calcification scoring system

To investigate whether the severity of calcification assessed by the peripheral artery calcification scoring system (PACSS) was associated with clinical outcomes of drug-coated balloon (DCB) angioplasty for femoropopliteal lesions. We retrospectively analyzed 733 limbs with intermittent claudication of 626 patients, who underwent DCB angioplasty for de novo femoropopliteal lesions between January 2017 and February 2021 at sevencardiovascular centers in Japan. The patients were categorized using the PACSS classification (grades 0-4: no visible calcification of the target lesion, unilateral wall calcification < 5 cm, unilateral calcification ≥ 5 cm, bilateral wall calcification < 5 cm, and bilateral calcification ≥ 5 cm, respectively). The main outcome was primary patency at 1 year. The Cox proportional hazards analysis was used to explore whether the PACSS classification was an independent predictor of clinical outcomes. The distribution of PACSS was grade 0 in 38%, grade 1 in 17%, grade 2 in 7%, grade 3 in 16%, and grade 4 in 23%. The 1-year primary patency rates in these grades, respectively, were 88.2%, 89.3%, 71.9%, 96.5%, and 82.6%, respectively (p < 0.001). Multivariate analysis disclosed that PACSS grade 4 (hazard ratio: 1.82, 95% confidence interval 1.15-2.87, p = 0.010) was associated with restenosis. The PACSS grade 4 calcification was independently associated with poor clinical outcomes after DCB angioplasty for de novo femoropopliteal lesions.