Peripheral Arterial Lesions Research Articles

Intravascular lithotripsy in peripheral lesions with severe calcification and its use in TAVI procedure - a meta-analysis.

Background: Heavily calcified peripheral artery lesions increase the risk of vascular complications, constituting a severe challenge for the operator during catheter-based cardiovascular interventions. Intravascular Lithotripsy (IVL) technology disrupts subendothelial calcification by using localized pulsative sonic pressure waves and represents a promising technique for plaque modification in patients with severe calcification in peripheral arteries. Purpose: Our aim was to systematically review and summarize available data regarding the safety and efficacy of IVL in preparing severely calcified peripheral arteries and its use in Transcatheter Aortic Valve Implantation (TAVI). Patients and methods: This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL in the peripheral vasculature. The diameter of the vessel lumen before and after IVL was estimated. The occurrence of peri-procedural complications was assessed using a random-effects model. Results: 20 studies with a total of 1,223 patients with heavily calcified peripheral lesions were analysed. The mean age of the cohort was 70.6 ± 17.4 years. Successful IVL delivery achieved in 100% (95% CI: 100%-100%, I2 = 0%), with an increase in the luminal diameter (SMD: 4.66, 95% CI: 3.41-5.92, I2 = 90.8%) and reduction in diameter stenosis (SMD: -4.15, 95% CI: -4.75 to -3.55, I2 = 92.8%), and a concomitant low rate of complications. The procedure was free from dissection in 97% (95% CI: 91%-100%, I2 = 81.4%) while dissections of any type (A, B, C, or D) were observed in 6% (95% CI: 2%-10%, I2 = 85.3%) of the patients. Several rare cases of abrupt closure, no-reflow phenomenon, perforation, thrombus formation, and distal embolization were recorded. Finally, the subgroup analysis of patients who underwent a TAVI with IVL assistance presented successful implantation in 100% (95% CI: 100%-100%, I2 = 0%) of the cases, with only 4% (95% CI: 0%-12%, I2 = 68.96%) presenting dissections of any sort. Conclusions: IVL seems to be an effective and safe technique for modifying severely calcified lesions in peripheral arteries and it is a promising modality in TAVI settings. Future prospective studies are needed to validate our results.

Retrograde Access for Revascularization of Difficult Peripheral Artery Lesions in Patients with Chronic Limb-threatening Ischemia: A Periprocedural Outcome Analysis of a Single-center Case Series

Abstract Background: Endovascular interventions are a standard treatment approach for patients suffering chronic limb threatening ischemia. This approach however can be complicated in some cases owing to difficult anatomy of the lesion that hinders successful crossing and recanalization of the diseased artery. Hence retrograde access and recanalization technique was described and used. Aims and Objectives: The aim of this study was to assess the procedural success, periprocedural complications and evaluate the safety of retrograde popliteal access for SFA and iliac lesions and tibial and pedal access for difficult tibial lesions. Materials and Methods: This is a case series of 60 patients who underwent percutaneous retrograde access (SFA, popliteal, tibial, pedal) for the recanalization of difficult lesions (aorto-iliac, SFA, tibial) between November 2018 to December 2022. We analyzed the technical success and number of periprocedural complications following successful revascularization through a prospective, nonrandomized, single–center, observational study conducted at Jain Institute of Vascular Sciences, Bengaluru, Karnataka, India. We have also analyzed safety of retrograde access and hemodynamic success (based on post-operative ABI improvement) following revascularization. Results: Of the 60 cases, retrograde access was successfully performed in all 60 patients, SFA in 3.3% (n=2), popliteal in 30% (n=18) (3 were primary PA retrograde access and remaining 15 were secondary), ATA was utilized in 35% (n=21), PTA in 20% (n=12), DPA in 6.7% (n=4) and peroneal in 5% (n=3). Technical success was achieved in 92% (n=55). Hemodynamic success was achieved in 75% (n=45). The recorded complication rate was 8.3% which included perforation of artery in 3% (n=2), iatrogenic AV fistula in 1.7% (n=1), arterial thrombosis in 1.7% (n=1) and peri-operative death in 1.7% (n=1). Conclusions: Hence, we recommend that retrograde access angioplasty is a safe and effective approach for revascularization when antegrade access fails and should be considered after proper anatomic evaluation, under US or fluoroscopic guidance.

Unsupervised classification of multi-contrast magnetic resonance histology of peripheral arterial disease lesions using a convolutional variational autoencoder with a Gaussian mixture model in latent space: A technical feasibility study

PurposeTo investigate the feasibility of a deep learning algorithm combining variational autoencoder (VAE) and two-dimensional (2D) convolutional neural networks (CNN) for automatically quantifying hard tissue presence and morphology in multi-contrast magnetic resonance (MR) images of peripheral arterial disease (PAD) occlusive lesions. MethodsMulti-contrast MR images (T2-weighted and ultrashort echo time) were acquired from lesions harvested from six amputated legs with high isotropic spatial resolution (0.078 mm and 0.156 mm, respectively) at 9.4 T. A total of 4014 pseudo-color combined images were generated, with 75% used to train a VAE employing custom 2D CNN layers. A Gaussian mixture model (GMM) was employed to classify the latent space data into four tissue classes: I) concentric calcified (c), II) eccentric calcified (e), III) occluded with hard tissue (h) and IV) occluded with soft tissue (s). Test image probabilities, encoded by the trained VAE were used to evaluate model performance. ResultsGMM component classification probabilities ranged from 0.92 to 0.97 for class (c), 1.00 for class (e), 0.82–0.95 for class (h) and 0.56–0.93 for the remaining class (s). Due to the complexity of soft-tissue lesions reflected in the heterogeneity of the pseudo-color images, more GMM components (n=17) were attributed to class (s), compared to the other three (c, e and h) (n=6). ConclusionCombination of 2D CNN VAE and GMM achieves high classification probabilities for hard tissue-containing lesions. Automatic recognition of these classes may aid therapeutic decision-making and identifying uncrossable lesions prior to endovascular intervention.

Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: A multicenter systematic review and meta-analysis.

With heavily calcified coronary and peripheral artery lesions, lesion preparation is crucial before stent placement to avoid underexpansion, associated with stent thrombosis or restenosis and patency failure in the long-term. Intravascular lithotripsy (IVL) technology disrupts superficial and deep calcium by using localized pulsative sonic pressure waves, making it to a promising tool for patients with severe calcification in coronary bed. The aim of the study is to systematically review and summarize available data regarding the safety and efficacy of IVL for lesion preparation in severely calcified coronary arteries before stenting. This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL before stent implantation. The diameter of the vessel lumen before and after IVL, as well as stent implantation, were analyzed. The occurrence of major adverse cardiovascular events (MACE) was assessed using a random-effects model. This meta-analysis comprised 38 studies including 2977 patients with heavily calcified coronary lesions. The mean age was 72.2 ± 9.1 years, with an overall IVL clinical success of 93% (95% confidence interval [CI]: 91%-95%, I2 = 0%) and procedural success rate of 97% (95% CI: 95%-98%, I2 = 73.7%), while the in-hospital and 30-days incidence of MACE, myocardial infarction (MI), and death were 8% (95% CI: 6%-11%, I2 = 84.5%), 5% (95% CI: 2%-8%, I2 = 85.6%), and 2% (95% CI: 1%-3%, I2 = 69.3%), respectively. There was a significant increase in the vessel diameter (standardized mean difference [SMD]: 2.47, 95% CI: 1.77-3.17, I2 = 96%)and a decrease in diameter stenosis (SMD: -3.44, 95% CI: -4.36 to -2.52, I2 = 97.5%) immediately after IVL application, while it was observed further reduction in diameter stenosis (SMD: -6.57, 95% CI: -7.43 to -5.72, I2 = 95.8%) and increase in the vessel diameter (SMD: 4.37, 95% CI: 3.63-5.12, I2 = 96.7%) and the calculated lumen area (SMD: 3.23, 95% CI: 2.10-4.37, I2 = 98%), after stent implantation. The mean acute luminal gain following IVL and stent implantation was estimated to be 1.27 ± 0.6and 1.94 ± 1.1 mm, respectively. Periprocedural complications were rare, with just a few cases of perforations, dissection, or no-reflow phenomena recorded. IVL seems to be a safe and effective strategy for lesion preparation in severely calcified lesions before stent implantation in coronary arteries. Future prospective studies are now warranted to compare IVL to other lesion preparation strategies.

Efficacy of Intravascular Lithotripsy (IVL) in peripheral lesions with severe calcification and its use in TAVI procedure: A systematic review and meta-analysis

Abstract Background Heavily calcified peripheral artery lesions increase the risk of vascular complications, constituting a severe challenge for the operator. Intravascular Lithotripsy (IVL) technology disrupts subendothelial calcification by using localized pulsative sonic pressure waves and is a promising technique for patients with severe calcification in peripheral arteries. Purpose Our aim was to systematically review and summarize available data regarding the safety and efficacy of IVL in preparing severely calcified plaques in peripheral arteries and its use in Transcatheter Aortic Valve Implantation (TAVI). Methods This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL in peripheral vasculature. The diameter of the vessel lumen before and after IVL was estimated. The occurrence peri-procedural complications were assessed using a random-effects model. Results 20 studies with a total of 1,223 patients with heavily calcified peripheral lesions were analyzed. The mean age of the cohort was 73.8 ± 8.9 years. Successful IVL delivery achieved in 100% (95% CI: 100%-100%, I2=0%), with an increase in the luminal diameter (SMD: 4.66, 95% CI: 3.41-5.92, I2=90.8%) and reduction in diameter stenosis (SMD: -4.15, 95% CI: -4.75 to -3.55, I2=92.8%), and a described low rate of complications. There was not observed any dissection in 97% (95% CI: 91%-100%, I2=81.4%), while dissections of any type (A, B, C, or D) were observed in 6% (95% CI: 2%-10%, I2=85.3%) of the patients. Several rare cases of abrupt closure, no-reflow phenomenon, perforation, thrombus formation, and distal embolization were recorded. Finally, the subgroup analysis of patients who underwent a TAVI with IVL assistance presented successful implantation in 100% (95% CI: 100%-100%, I2=0%) of the cases, with only 4% (95% CI: 0%-12%, I2=68.96%) presented dissections of any sort. Conclusions IVL seems to be an effective and safe technique for preparing severely calcified lesions in peripheral vessels during TAVI interventions. These results support the use of IVL for amelioration of overall outcome in high vascular risk TAVI settings.

РЕГУЛЯЦИЯ СИСТЕМНОГО ВОСПАЛИТЕЛЬНОГО ОТВЕТА У ПАЦИЕНТОВ С МУЛЬТИФОКАЛЬНЫМ АТЕРОСКЛЕРОЗОМ

Introduction. Data on the role of inflammation in the progression and manifestation of multifocal atherosclerosis (MFA) are contradictory. The systemic process of multiple lesions of different vascular beds in patients with an established diagnosis of coronary heart disease (CHD) is due to several parallel pathological mechanisms. In general, in the pathogenesis of both coronary atherosclerosis and atherosclerosis of peripheral arteries, one of the factors is the variability of immune response genes and cytokines, regulators of the inflammatory response. The aim of this work was to determine the role of variability in the genes of cytokines and innate immune response receptors in the structure of mechanisms associated with the development of MFA in patients with coronary artery atherosclerosis. Materials and methods. 260 patients with CAD (mean age 58 years) were examined. Of all those included in the study, at the time of the survey, MFA was found in 180 people (69.23%), while the incidence of MFA in men and women is comparable (70.33 vs. 64.71%, respectively). There is also no significant difference in the incidence of MFA in the two age groups (up to 60 years, 45% have lesions of two or more vascular beds, and in people older than 60 years, MFA was found in 55% of cases). All patients were informed about the course of the study and voluntarily signed an informed consent. Blood was collected from the cubital vein into Vacutainer tubes with K3EDTA. DNA isolation was carried out using the phenol-chloroform extraction method. Genotyping of 47 polymorphic sites with a single nucleotide change (SNV) of 19 genes proven to be associated with the regulation of the systemic inflammatory response (cytokines, innate immunity receptors) was performed in a 96-well format using TaqMan technology (LifeTechnologies, USA) and real-time result detection with using the ViiATM 7 RealTime PCR System (LifeTechnologies, USA) for polymerase chain reaction in accordance with the instructions. Associations were analyzed using Snpstats (https://www.snpstats.net/start.htm). Odds ratio (OR) and 95% CI for OR were calculated for risk assessment. Results. One association has been established that demonstrates a negative impact and increases the risk of developing MFA in young and middle age. Carriage of the G rs11685424 IL1RL1 allele increases the risks of earlier development of peripheral arterial lesions by 2 times (OR 2.11 (95% CI 1.09-4.06), p = 0.024) according to the recessive inheritance model. At the same time, variability in three sites (rs1974675; rs6758936; rs3755276) of the IL18 receptor gene (IL18R1) reduces the risk of MFA detection by three times (p=0.12; p=0.034: p=0.026, respectively) and this pattern is also observed in patients older age group. In the carriers of the A/A rs1974675, T/T rs3755276 and A/A rs6758936 genotypes in persons over 60 years of age, MFA was diagnosed less frequently (p=0.024; p=0.037; p=0.011, respectively). Conclusion. It has been shown that in patients with significant coronary atherosclerosis, the progression of peripheral vascular atherosclerosis is more associated with the variability of the genes responsible for the regulation of the systemic inflammatory response, rather than genes and their variants that determine the severity and strength of the immune response.

Early results of endovascular treatment using percutaneous vacuum-assisted thromboaspiration in acute lower limb ischemia

Introduction. Open balloon thrombectomy and embolectomy remain the preferred initial option in the management of acute lower limb ischemia (ALI), but various endovascular techniques have become accessible and are growing in popularity. The aim of the study was to assess our early experience with percutaneous vacuum-assisted thromboaspiration using the Penumbra/Indigo® system for non-traumatic ALI. Material and methods. The study group comprised 13 patients with ALI who received treatment between September 2022 and June 2023; with 7 (53.8%) being males. The median age was 71 years (25%-75%IQR 62.5-77.5). ALI cases were classified according to the Rutherford scale: grade I – 2 (15.3%), grade IIA – 7 (53.8%), and grade IIB – 4 (30.7%). In 10 (76.9%) cases, ischemia was classified as “acute-on-chronic.” The occluded native vascular segment, determined through preoperative computer tomography angiography (n=4; 30.7%), duplex scanning (n=5; 38.4%), or both examinations (n=4; 30.7%), were as follows: superficial femoral artery (n=7) and popliteal artery (n=2). In two patients, thrombosis of the below-knee femoropopliteal bypass with autogenous vein was identified, while two others presented with femoral artery stent thrombosis. An embolic etiology of ALI was observed in 4 (30.7%) cases, and thrombotic etiology in 9 (69.2%) cases. Endovascular access was established via the ipsilateral common femoral artery (n=10), crossover (n=2), or brachial artery (n=1). Thromboaspiration was carried out using dedicated CAT6™ and CAT8™ catheters. Results. The technical success rate of vacuum-assisted thromboaspiration was 92.3%. Subsequent angiography revealed accompanying occlusive-stenotic lesions in all instances, necessitating transluminal angioplasty, and in 8 (61.5%) patients, additional stenting was required. Catheter-directed thrombolysis was utilized as an adjunct in one patient. There were 2 (15.3%) instances of distal embolization, both addressed within the same surgical session. Survival and limb salvage rates at the 30th-day follow-up stood at 100%. Conclusions. Utilizing the Penumbra/Indigo® system, percutaneous vacuum-assisted thromboaspiration appears to be a safe and effective minimally invasive technique for treating ALI. This method allows for the concurrent correction of coexisting chronic peripheral arterial lesions.

Objective Evaluation With Noncontrast Computed Tomography Can Reveal Calcified Plaque Solidity in Peripheral Artery Diseases.

The presence of severely calcified plaque remains problematic in endovascular therapy, and no specific endovascular treatment strategy has been established. Estimating plaque solidity before the procedure may help operators penetrate calcified plaque with a guide wire. The aim of this study was to establish a method of measuring plaque solidity with noncontrast computed tomography (CT). This retrospective, single-center study included consecutive patients who, between October 2020 and July 2022, underwent noncontrast 5 mm and 1 mm CTs before endovascular therapy to penetrate calcified plaque with a wire in the common femoral, superficial femoral, and popliteal arteries. Three cross-sectional CT slices were selected. To target a calcified plaque lesion, the operator identified a region of interest, which corresponded to 24×24 pixels, and Hounsfield unit (HU) values of each pixel were displayed on the CT image. The average HU values and the ratio of number of pixels of lower values (130-599 HU) represented plaque solidity. We used the Mann-Whitney-Wilcoxon rank-sum test and the chi-square test to compare the solidity of plaques penetrated and not penetrated by the wire. We evaluated 108 images of 36 calcified plaque lesions (in 19 patients). The wire penetrated 28 lesions (77.8%) successfully. The average HU value was significantly lower in the lesions that the wire penetrated than in the others, in both the 5 mm CT slices (434.7±86.8 HU vs 554.3±112.7 HU, p=0.0174) and 1 mm slices (497.8±103.1 HU vs 593.5±114.5 HU, p=0.0381). The receiver operating curve revealed that 529.9 and 533.9 HU in the 5 and 1 mm slices, respectively, were the highest values at which wires could penetrate. Moreover, at the lesions that were penetrates successfully, the ratio of number of lower HU value pixels was significantly higher both in 5 mm slice CTs (74.7±13.4 vs 61.7±13.1%, p=0.0347) and 1 mm (68.7±11.8 vs 57.1±11.4%, p=0.0174). The use of noncontrast CT to evaluate plaque solidity was associated with successful wire penetration of calcified lesions in peripheral arteries. This study revealed an association between the wire penetration inside calcified plaque and plaque solidity estimated using non-contrasted computed tomography. The mean Hounsfield unit values of three cross-sections in calcified plaques were associated with the successful wire penetration. This wire penetration difficulty is associated with extended procedure time, excessive radiation exposure, usage of extra contrast agents, and increased medical costs. Therefore, estimating calcified plaque solidity before procedure enables us to choose effective and lean procedures. In addition, to predict the success of dilating calcified plaque from the inside is also beneficial when the operator wants to avoid extra scaffold implantation for target lesions.

Apolipoprotein A-IV of diabetic-foot patients upregulates tumor necrosis factor α expression in microfluidic arterial models.

Diabetic peripheral arterial atherosclerosis is one of the important characteristics of diabetic foot syndrome. Apolipoprotein (Apo A-IV) participates in various physiological processes, and animal studies have shown that it has roles of anti-atherosclerosis, prevention of platelet aggregation and thrombosis. Apo A-IV glycosylation is closely related to the occurrence and development of diabetic peripheral atherosclerosis. This study aimed to explore the mechanism of diabetic peripheral arterial lesions caused by glycosylated Apo A-IV. Type 2 diabetes mellitus (T2DM) and T2DM with diabetic foot patients (T2DM-F; n = 45, 30) were enrolled in this study, and individuals without diabetes (n = 35) served as normal controls (NC). In T2DM group, serum Apo A-IV content was higher than those in NC and T2DM-F group, as carboxymethyl lysine (CML) glycosylation of Apo A-IV in mixed serum from T2DM-F group was identified to be more significant than those in two other groups. Within a microfluidic arterial chip model, Apo A-IV from T2DM and T2DM-F group significantly increased transcription and protein levels of tumor necrosis factor alpha (TNF-α) in chip arteries, and CML expression was observed in T2DM-F group, which were associated with increased nuclear receptor subfamily 4 group A member 3 (NR4A3) expression. Recombinant human Apo A-IV could reverse the stimulating effect of serum Apo A-IV from T2DM-F group on TNF-α expression, and NR4A3 blocking peptide downregulated TNF-α expression by inhibiting NR4A3 expression. In the chip arteries, Apo A-IV from T2DM and T2DM-F increased TNF-α expression and turn them into a pre-atherosclerotic state, which might be one of the important mechanisms of glycosylated Apo A-IV to induce diabetic peripheral arterial lesions and eventually lead to diabetic foot.

Intravascular lithotripsy for heavily calcified peripheral artery lesions. Preliminary experience

Intravascular lithotripsy for heavily calcified peripheral artery lesions. Preliminary experience

Tibio-pedal arterial pressure assessment during endovascular intervention to improve quality-of-life in patients with intermittent claudication.

The aim of this study is to compare the quality-of-life (QOL) outcomes and the tibio-pedal arterial pressure post-endovascular intervention. Physiological assessment of peripheral arterial lesions is infrequently performed during endovascular interventions. We retrospectively reviewed all 343 patients with intermittent claudication who underwent an endovascular intervention via tibio-pedal artery access from October 2018 to May 2021. The baseline and post-intervention tibio-pedal arterial pressures from the pedal sheaths were measured. QOL was assessed using a pre-validated Walking Impairment Questionnaire (WIQ) score before and at 30-day after intervention. We compared the baseline tibio-pedal arterial pressure, post-intervention tibio-pedal arterial pressure, delta pressure (post-intervention minus baseline), baseline WIQ scores, 30-day WIQ scores, and delta score (30-day minus baseline). All 343 patients had successful tibio-pedal accesses. The average tibio-pedal arterial pressure at baseline was 87.0 ± 1.8 mmHg vs. 135.5 ± 1.7 mmHg post-intervention (p < 0.001). Average baseline and 30-day WIQ scores were summation (99.8 ± 3.3 vs. 115.0 ± 3.1, p < 0.001), walking distance (35.7 ± 1.3 vs. 42.5 ± 1.3, p < 0.001), walking speed (21.1 ± 0.9 vs. 23.6 ± 0.8, p = 0.036), stair climbing (4.7 ± 1.4 vs. 24.2 ± 1.4, p = 0.019), and symptoms (18.8 ± 0.2 vs. 20.1 ± 0.2, p < 0.001), respectively. When comparing the increased post-intervention tibio-pedal arterial pressure <60 mmHg vs. ≥60 mmHg, the average delta WIQ scores were all significantly improved with summation (10.0 ± 3.9 to 25.8 ± 5.5, p = 0.01), walking distance (4.1 ± 1.7 to 9.8 ± 2.5, p = 0.02), walking speed (1.5 ± 1.1 to 4.3 ± 1.5, p = 0.02), stair climbing (2.3 ± 1.8 to 9.4 ± 2.5, p = 0.02), and symptoms (1.0 ± 0.3 to 1.8 ± 0.4, p = 0.04), respectively. Increasing the post-intervention tibio-pedal arterial pressure by 60 mmHg can enhance QOL as suggested by improvement of WIQ scores.

Peripheral arterial lesions of Marfan’s the disease: Analysis of a multicentric 138 patients cohort

The prevalence and the clinical impact of primary peripheral arterial lesions (PPAL) in the disease of Marfan (MFS) are poorly documented. The objective of this study was to determine the prevalence of PPALs and their relation with the occurrence of aortic events in a national cohort of MFS patients.

Intravascular Lithotripsy for Peripheral Artery Calcification: Mid-term Outcomes From the Randomized Disrupt PAD III Trial.

Endovascular treatment of calcified peripheral artery lesions may be associated with suboptimal vessel expansion, increased complication risk, and reduced long-term patency. The primary endpoint from the Disrupt PAD III randomized controlled trial (RCT) demonstrated superior procedural success in patients treated with intravascular lithotripsy (IVL) vs percutaneous transluminal angioplasty (PTA). The present study evaluates primary patency after 1 and 2 years in this randomized population. The Disrupt PAD III RCT enrolled 306 patients with moderately-to-severely calcified femoropopliteal arteries treated with IVL (n = 153) or PTA (n = 153) prior to DCB treatment or stenting. The powered secondary effectiveness endpoint was primary patency at 1 year, defined as freedom from clinically driven target lesion revascularization plus freedom from restenosis determined by duplex ultrasound. Acute PTA failure requiring stent placement during the index procedure was prespecified as a loss of primary patency. Primary patency at 1 year was significantly greater in the IVL arm (80.5% vs 68.0%, P = .017). The requirement for provisional stenting was significantly lower in the IVL group (4.6% vs 18.3%, P < .0001). Freedom from clinically driven target lesion revascularization (IVL: 95.7% vs PTA: 98.3%, P = .94) and restenosis rates (IVL: 90.0% vs PTA: 88.8%, P = .48) were similar between the 2 groups at 1 year. At 2 years, primary patency remained significantly greater in the IVL arm (70.3% vs 51.3%, P = .003). The Disrupt PAD III RCT secondary endpoint of superior 1-year primary patency was achieved, confirming the consistent safety and effectiveness of IVL followed by DCB treatment to facilitate a durable approach for patients with heavily calcified femoropopliteal arteries largely without stent requirement.

LB-1 | Intravascular Lithotripsy for Peripheral Artery Calcification: 1-year Outcomes from the Randomized Disrupt PAD III Trial

Endovascular treatment of calcified peripheral artery lesions may be associated with suboptimal vessel expansion, increased complication risk, and reduced long-term patency. The primary endpoint from the Disrupt PAD III randomized controlled trial (RCT) demonstrated superior procedural success in patients receiving vessel preparation with intravascular lithotripsy (IVL) vs percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) treatment in moderately-to-severely calcified femoropopliteal arteries, but comparative longer-term primary patency (PP) results have not been reported.

Generalization of a clinical diagnosis support tool for lumbar spinal stenosis: Can the ankle brachial pressure index be replaced by palpation of the posterior tibial artery in the lumbar spinal stenosis diagnostic support tool? (DISTO project)

BackgroundThe Japanese Society for Spine Surgery and Related Research previously developed a diagnostic support tool for lumbar spinal stenosis (LSS-DST). Using the LSS-DST, general physicians can identify potential cases of LSS. However, in the LSS-DST, measurement of the ankle brachial pressure index (ABI) is required to exclude peripheral artery lesions in the lower limbs. We can expect further application of the LSS-DST if we can identify a simpler and easier method than ABI measurement. Therefore, in this large-scale, multicenter, cross-sectional study, we verified whether palpation of the posterior tibial (PT) artery could be used instead of ABI in the LSS-DST. MethodsThis survey was conducted at 2177 hospitals and included 28,883 participants. The sensitivity and specificity of the original LSS-DST method using the ABI and that of the LSS-DST ver2.0 with PT artery palpation were assessed to screen their ability for diagnosing LSS, using the physicians' final diagnosis based on the patients’ history, physical examination and radiographic findings as the gold standard. ResultsThe sensitivity and specificity [95%CI] of the LSS-DST were 88.2% [87.5, 88.8] and 83.9% [83.4, 84.5], respectively, whereas the sensitivity and specificity of the LSS-DST ver2.0 were 87.7% [87.0, 88.3] and 78.3% [77.7, 78.9], respectively, indicating that LSS-DST ver2.0 is a useful screening tool for LSS with good sensitivity. ConclusionWhen the item of ABI in the LSS-DST is replaced by palpation of the PT artery (LSS-DST ver2.0), its sensitivity is maintained as a screening tool for LSS. Level of evidenceLevel 3.

Mathematical Modeling of Blood Flow to Evaluate the Hemodynamic Significance of Peripheral Vascular Lesions

Background: Evaluating the severity of peripheral artery lesions is challenging. Image-based blood flow modeling from peripheral Computed Tomographic Angiography (pCTA) may provide a non-invasive method to determine the hemodynamic significance of lesions. This pilot study evaluates the performance of pCTA-based blood flow modeling in diagnosing functionally significant peripheral lesions in comparison with Digital Subtraction Angiography (DSA). Methods: Ten patients undergoing DSA and pCTA were included. The peripheral arteries were divided into 8 segments per extremity and stenosis severity was graded by visual estimation from DSA. Each segment was graded 0 to IV (normal, mildly-stenotic, moderately-stenotic, severely-stenotic, occluded) or non-evaluable. Independent from DSA review, a Resting Pressure Drop (RPD) and an Exercise Pressure Drop (ExPD) for each segment was calculated from pCTA-based blood flow modeling. A functionally significant (FS) lesion was defined as grade III or IV by DSA and RPD &gt; 5 mmHg from pCTA-based modeling. Analysis was repeated with an ExPD &gt; 20 mmHg. Sensitivity, specificity and accuracy were calculated for RPD &gt; 5 mmHg and ExPD &gt; 20 mmHg using DSA as the standard. Results: Mean age was 52±16 years, 4 patients were male, 8 patients presented with critical limb ischemia, mean ankle brachial index was 0.60±0.29, and 66 arterial segments were available for both assessment methods. Twenty-two segments had FS lesions by DSA. Using an RPD &gt; 5 mmHg, sensitivity was 80%, specificity was 85% and accuracy was 79%. Using an ExPD &gt; 20 mmHg, sensitivity was 84%, specificity was 89% and accuracy was 88%. Conclusion: Use of a resting pressure drop &gt; 5 mmHg and an exercise pressure drop &gt; 20 mmHg, measured by blood flow modeling from CT angiography, can accurately identify functionally significant stenosis in patients with peripheral vascular disease. This information motivates the need for a larger-scale prospective imaging trial to further validate this novel non-invasive approach.

Clinical Safety and Efficacy of Rotational Atherectomy in Japanese Patients with Peripheral Arterial Disease Presenting Femoropopliteal Lesions: The J-SUPREME and J-SUPREME II Trials

Purpose: The purpose of the J-SUPREME (J-S) and J-SUPREME II (J-SII) trials was to evaluate the performance of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in the superficial femoral and popliteal arteries. Materials and Methods: The J-S and J-SII trials were both prospective, multicenter, single-arm clinical trials. Patients in J-S underwent Jetstream atherectomy followed by percutaneous transluminal angioplasty (PTA), whereas those in J-SII had adjunctive drug-coated balloon (DCB) treatment following atherectomy. Patients were adults with Rutherford category 2, 3, or 4 and had stenotic, restenotic, or occlusive lesion(s) with a degree of stenosis ≥70 in the superficial femoral artery and/or proximal popliteal artery. In J-S, lesions were required to be calcified, and in J-SII lesions were required to be severely calcified. Results: A total of 50 patients were enrolled in J-S (mean age 72.3±8.7 years, lesion length 82.0±41.5 mm, 36% calcification PACSS Grade 3, 22% Grade 4) and 31 patients in J-SII (mean age 72.5±7.7 years, lesion length 122.6±55.6 mm, 19.4% calcification PACSS Grade 3, 77.4% Grade 4). No bailout stenting or bypass conversions were required. No major adverse events (MAEs) were reported for either trial through 1 month. The 6-month primary patency for J-S, with PTA alone following atherectomy, was 40.4% (19/47). The 6-month primary patency for J-SII, with DCB treatment following atherectomy, was 96.7% (29/30). At 6-month post-procedure, 79.2% (38/48) of patients in J-S, and 100% (30/30) of patients in J-SII had improved by at least 1 Rutherford category. Conclusion: J-SUPREME trial results demonstrate procedural safety and efficacy of the Jetstream Atherectomy System and J-SII showed sustained patency through 6 months following combination treatment with Jetstream atherectomy and DCB.

Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial.

The study sought to compare short-term outcomes in patients with femoropopliteal artery calcification receiving vessel preparation with intravascular lithotripsy (IVL) or percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) for symptomatic peripheral artery disease. Endovascular treatment of calcified peripheral artery lesions is associated with suboptimal vessel expansion and increased complication risk. Although initial results from single-arm studies with IVL have been reported, comparative evidence from randomized trials is lacking for most devices in the presence of heavy calcification. The Disrupt PAD III (Shockwave Medical Peripheral Lithoplasty System Study for PAD) randomized trial enrolled patients with moderate or severe calcification in a femoropopliteal artery who underwent vessel preparation with IVL or PTA prior to DCB or stenting. The primary endpoint was core lab-adjudicated procedural success (residual stenosis≤30% without flow-limiting dissection) prior to DCB or stenting. In patients receiving IVL (n=153) or PTA (n=153), procedural success was greater in the IVL group (65.8% vs. 50.4%; p=0.01) and the percentage of lesions with residual stenosis≤30% (66.4% vs. 51.9%; p=0.02) was greater in the IVL group, while flow-limiting dissections occurred more frequently in the PTA group (1.4% vs. 6.8%; p=0.03). Post-dilatation (5.2% vs. 17.0%; p=0.001) and stent placement (4.6% vs. 18.3%; p<0.001) were also greater in the PTA group. The rates of major adverse events (IVL: 0% vs. PTA: 1.3%; p=0.16) and clinically driven target lesion revascularization (IVL: 0.7% vs. PTA: 0.7%; p=1.0) at 30days were comparable between groups. IVL is an effective vessel preparation strategy that facilitates definitive endovascular treatment in calcified femoropopliteal arteries in patients with peripheral artery disease. (Shockwave Medical Peripheral Lithoplasty System Study for PAD [Disrupt PAD III]; NCT02923193).

A clinical case of staged endovascular treatment of a patient with coronary heart disease and multiple lesions of peripheral arteries

A clinical case of successful treatment of a patient with atherosclerotic peripheral artery disease and clinically significant lesion of the coronary and carotid arteries. Patients underwent multi-stage surgical treatment. The first stage performed endovascular treatment the left internal carotid artery, the second — myocardial revascularization, the third — endovascular treatment of the left iliac arteries, the fourth — rotational atherectomy with stenting of the right superficial femoral artery. There were no complications in the perioperative period. The technique of operations is described, explanations are given for the chosen treatment strategy. The conclusion is drawn about the advantage of endovascular techniques in the treatment of patients with multifocal atherosclerosis.

Abstract 16856: Mathematical Modeling of Blood Flow to Evaluate the Hemodynamic Significance of Peripheral Vascular Lesions

Introduction: Evaluating the severity of lesions in peripheral arteries is challenging. Image-based blood flow modeling from peripheral computed tomographic angiography (pCTA) may provide a non-invasive method to determine the hemodynamic significance of lesions. The objective of this study was to evaluate the diagnostic performance of a trans-lesion pressure drop computed from pCTA-based blood flow modeling in the peripheral arteries. Methods: Ten patients undergoing digital subtraction angiography (DSA) and pCTA were included. The peripheral arteries were divided into 8 segments per extremity and stenosis severity was visually graded by DSA as non-stenosed (grade 0), mild (grade I), moderate (grade II), severe (grade III), occluded (grade IV) or non-evaluable. A functionally significant lesion was defined as grade III or IV by DSA. Independent from the DSA review, a resting pressure gradient (rPG) and exercise PG (ExPG) for each segment was calculated from pCTA-based blood flow modeling (Figure), and a functionally significant lesion was defined as having an rPG &gt; 5 mm Hg or an ExPG &gt; 20 mm Hg. Results: Mean age was 52±16 years, 4 patients (40%) were male, 8 patients (80%) presented with critical limb ischemia, mean ankle brachial index was 0.60±0.29 and 66 arterial segments were available for both assessment methods. Twenty-two segments had functionally significant lesions by DSA. For rPG, sensitivity was 80%, specificity was 85% and accuracy was 79% with DSA as the standard; for ExPG, sensitivity was 84%, specificity was 89% and accuracy was 88%. Conclusions: Use of a resting pressure gradient &gt; 5 mm Hg and an exercise pressure gradient &gt; 20 mm Hg measured by peripheral computed tomography-based blood flow modeling accurately identifies functionally significant stenosis in patients with advanced peripheral vascular disease. These results support a prospective imaging trial to further validate this novel approach.