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Background: The gold standard treatment for peripheral arterial disease (PAD) of the common femoral artery (CFA) is open common femoral endarterectomy (CFAE). Interest in the less invasive endovascular treatment (EVT) is growing due to PAD patients' frequent co-morbidities. Aims: We aimed to evaluate three-year EVT outcomes in multimorbid PAD patients with severe calcified CFA lesions. Methods: Using the prospectively maintained "all-comers" Duesseldorf PTA Registry, we analysed the three-year outcomes of 150 patients with EVT of the CFA. Between January 2017 and October 2023, 66 patients received a rotational excisional atherectomy (REA) followed by a drug-coated balloon angioplasty (DCB), and 84 patients received a DCB alone. Results: All procedures involved the CFA, 49% additionally involved the proximal superficial femoral artery (SFA), and 10% of the lesions involved the profunda femoris artery (PFA). The procedural success rate was 97% and independent of PAD stage, with a higher level of stent implantation in the DCB group (58% vs. 39%, p < 0.05). The primary patency rate at one year was 83% for REA + DCB and 87% for DCB (p = 0.576), while secondary patency after three years was 97%. The MALE rate at three years was mainly driven by cdTLR (REA + DCB: (20%) vs. DCB: (14%), p = 0.377), while major amputations were low in both groups (REA + DCB: 3% vs. DCB: 1%). Overall, the major adverse cardiovascular events (MACEs) rate at three years was low (REA + DCB: (5%) vs. DCB: (11%), p = 0.170). Conclusions: The EVT of severely calcified CFA lesions is safe and effective, with high three-year patency rates and low rates of major adverse limb events (MALEs) and MACEs. This registry demonstrates that vessel preparation with REA minimizes the need for stenting. [ABSTRACT FROM AUTHOR]

Background: This study investigated the midterm primary patency of drug-coated balloons (DCBs), directional atherectomy plus balloon angioplasty (DA), and bare metal stent (BMS) angioplasty for the treatment of femoropopliteal lesions. Methods: This two-center retrospective cohort study included 105 patients (110 limbs) undergoing DCB, DA, and BMS angioplasty—32 patients (34 limbs), 31 patients (32 limbs), and 42 patients (44 limbs), respectively. The demographic, baseline, and procedure data were collected, and the complications and midterm outcomes (patency, amputation-free survival, and clinically driven target lesion revascularization rates) were analyzed. Results: All three procedures achieved a 100% success rate. Significant improvements were noted in ankle brachial index, walking distance, and Rutherford classification at 30 days post-procedure (p < 0.001), with no differences or severe complications among the groups. The all-cause mortality rate during the follow-up period, was 5.5%, and amputation-free survival rates at 24 months were 97.0%, 90.6% and 90.9% in the DCB, DA, and BMS angioplasty groups, respectively. The primary patency rate for the DCB group (79.4%) exceeded those of the DA (56.2%) and BMS (52.2%) groups (p < 0.05), with no significant difference between the DA and BMS groups at 24 months. The secondary patency and clinically driven target lesion revascularization rates were similar among the three groups. A runoff number ≤1, Trans-Atlantic Intersociety Consensus (TASC) D, and severe calcification were found to be independent risk factors for primary patency. Conclusions: The DCB procedure demonstrated superior primary patency, compared to both BMS and DA procedures, in the treatment of femoropopliteal lesions. [ABSTRACT FROM AUTHOR]

BackgroundThis study aimed to systematically evaluate the efficacy and safety of atherectomy followed by drug-coated balloon angioplasty (A-DCB) in comparison with drug-coated balloon (DCB) angioplasty alone for the treatment of lower extremity artery disease (LEAD).MethodsSystematic literature search was performed using several online databases including MEDLINE (via PubMed), Europe PMC, and ScienceDirect databases from inception until February 21st, 2024. We included all studies comprised three main variables including A-DCB, DCB, and LEAD. The primary outcomes were primary patency and target lesion revascularization (TLR). Whereas secondary outcomes were all-cause mortality, post-procedural complications, and clinical characteristics.ResultsA total of 15 studies (10 cohort studies and 5 randomized controlled trials studies) consisting of 1,385 participants with mean age 68.7 ± 8.9 were included. In comparison with DCB alone, A-DCB was significantly associated with a higher risk of primary patency [RR = 1.16 (95% CI = 1.07–1.26); P

Background: The gold standard treatment for peripheral arterial disease (PAD) of the common femoral artery (CFA) is open common femoral endarterectomy (CFAE). Interest in the less invasive endovascular treatment (EVT) is growing due to PAD patients’ frequent co-morbidities. Aims: We aimed to evaluate three-year EVT outcomes in multimorbid PAD patients with severe calcified CFA lesions. Methods: Using the prospectively maintained “all-comers” Duesseldorf PTA Registry, we analysed the three-year outcomes of 150 patients with EVT of the CFA. Between January 2017 and October 2023, 66 patients received a rotational excisional atherectomy (REA) followed by a drug-coated balloon angioplasty (DCB), and 84 patients received a DCB alone. Results: All procedures involved the CFA, 49% additionally involved the proximal superficial femoral artery (SFA), and 10% of the lesions involved the profunda femoris artery (PFA). The procedural success rate was 97% and independent of PAD stage, with a higher level of stent implantation in the DCB group (58% vs. 39%, p < 0.05). The primary patency rate at one year was 83% for REA + DCB and 87% for DCB (p = 0.576), while secondary patency after three years was 97%. The MALE rate at three years was mainly driven by cdTLR (REA + DCB: (20%) vs. DCB: (14%), p = 0.377), while major amputations were low in both groups (REA + DCB: 3% vs. DCB: 1%). Overall, the major adverse cardiovascular events (MACEs) rate at three years was low (REA + DCB: (5%) vs. DCB: (11%), p = 0.170). Conclusions: The EVT of severely calcified CFA lesions is safe and effective, with high three-year patency rates and low rates of major adverse limb events (MALEs) and MACEs. This registry demonstrates that vessel preparation with REA minimizes the need for stenting.

Large-vessel vasculitides are well-recognized entities, affecting the aorta, supra-aortic branch vessels, cranial vessels, and less commonly, peripheral arteries. Giant cell arteritis (GCA) is one of the most frequent large-vessel vasculitides affecting elderly patients. Despite diagnostic criteria, the mainstay of definitive diagnosis has been temporal artery biopsies. More recently, adjuvant ultrasound has been used to identify skip lesions before the biopsy. Downstream ischemia affecting branch vessels has traditionally been managed by open revascularization due to patient age and risk of disease recurrence. Experience with endovascular strategies for the management of acute or chronic vasculitides has been steadily increasing. We present an unusual case of acute giant cell vasculitis, diagnosed and treated with the use of an endovascular atherectomy device. The patient was a 74-year-old woman, with prior history of polymyalgia rheumatica, long-standing immunosuppression, and new onset of significant left arm claudication and rest pain. She underwent treatment for a high-grade left axillary artery lesion with directional atherectomy and drug-coated angioplasty. She had a good angiographic result. The intraoperative atherectomy specimen revealed the presence of acute GCA which prompted treatment with an acute vasculitis regimen. She had good patency of the treated segment at 3-month follow-up with complete resolution of her symptoms.

Objective: Chronic arterial obstructive disease of the lower limbs is a significant global health issue. Directional atherectomy offers advantages in treating critical ischemia. The objective of this study is to determine the clinical outcomes of patients with critical ischemia who underwent directional atherectomy using the TurboHawkdevice., Methods: A retrospective review was conducted at Alma Mater Hospital in Medellín, Colombia, on all medical records of patients with critical limb ischemia (Rutherford Classes V and VI) who underwent directional atherectomy for infra-inguinal arterial disease., Results: A total of 42 atherectomies were performed in 41 patients, with 61% classified as Rutherford V and 24.4% as Rutherford VI. The average lesion length to be treated was 60 mm. Calcifications were found in 45.2% of cases, and predilatation angioplasty was used in 42.9% of cases. Atherectomy sites included femoropopliteal segment (40%), superficial femoral (29%), infrapopliteal vessels (14.2%), and more than one vessel in 50% of cases. Technical success was achieved in 78.6% of cases and procedural success in 97.6%, and the need for adjunctive conventional balloon angioplasty was 21.4%, while drug-coated balloon angioplasties were performed in 50% of limbs. The overall complication rate was 14.4%, with embolism at 4.8%, dissection at 4.8%, puncture at 2.4%, and perforation at 2.4%. The average follow-up duration was 12 months, and major amputations were required in 23.8% of cases. Improvement in ankle-brachial index to ≥0.1 was seen in 77% of limbs. Limb survival at 30 days was 85%, and at 90 days, it was 83%. The overall survival rate in the study was 79%., Conclusions: Directional atherectomy is a safe alternative for managing critical ischemia in Rutherford V and VI patients., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Research Ethics Committee of the Hospital Alma Mater de Antioquia issued approval 206/2023. This study was conducted in accordance with the principles outlined in the Declaration of Helsinki and subsequent amendments. The research protocol was carefully reviewed and approved by the Research Ethics Committee of the institution, ensuring that the rights and welfare of all participants were protected. In addition, the study adhered to the guidelines for good clinical practice and respected the autonomy and confidentiality of all participants. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Botero-Mora et al.)

Background: This study aimed to systematically evaluate the efficacy and safety of atherectomy followed by drug-coated balloon angioplasty (A-DCB) in comparison with drug-coated balloon (DCB) angioplasty alone for the treatment of lower extremity artery disease (LEAD)., Methods: Systematic literature search was performed using several online databases including MEDLINE (via PubMed), Europe PMC, and ScienceDirect databases from inception until February 21st, 2024. We included all studies comprised three main variables including A-DCB, DCB, and LEAD. The primary outcomes were primary patency and target lesion revascularization (TLR). Whereas secondary outcomes were all-cause mortality, post-procedural complications, and clinical characteristics., Results: A total of 15 studies (10 cohort studies and 5 randomized controlled trials studies) consisting of 1,385 participants with mean age 68.7 ± 8.9 were included. In comparison with DCB alone, A-DCB was significantly associated with a higher risk of primary patency [RR = 1.16 (95% CI = 1.07-1.26); P  < 0.001; I 2  = 20.9%, P -heterogeneity = 0.221] and lower risk of TLR [RR = 0.61 (95% CI = 0.46-0.81); P  < 0.001; I 2  = 0%, P -heterogeneity = 0.475]. Subgroup analysis showed that only directional, rotational, and laser atherectomy increased the probability of primary patency, but only rotational atherectomy decreased the risk of TLR. Regarding secondary outcomes, A-DCB was substantially associated with a lower likelihood of bailout stenting, any amputation, and major amputation, as well as higher ankle brachial index (ABI) following follow-up duration. Meta-regression analysis suggested that pre-intervention s ( p  = 0.015) and pre-intervention Rutherford classification ( p  = 0.038) were significantly affected the association between A-DCB and primary patency. Begg's funnel plot and Egger's test analyses indicated no publication bias in this meta-analysis., Conclusions: The addition of atherectomy improves primary patency and reduces the risk of TLR with similar safety outcomes., Systematic Review Registration: www.crd.york.ac.uk/prospero/display&#95;record.php?ID=CRD42022382831, PROSPERO (CRD42022382831)., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Suriyanto, Pranata, Kamarullah, Putra, Wahyudi, Karwiky, Sihite, Akbar, Martha and Hidayat.)

Background: This study investigated the midterm primary patency of drug-coated balloons (DCBs), directional atherectomy plus balloon angioplasty (DA), and bare metal stent (BMS) angioplasty for the treatment of femoropopliteal lesions., Methods: This two-center retrospective cohort study included 105 patients (110 limbs) undergoing DCB, DA, and BMS angioplasty-32 patients (34 limbs), 31 patients (32 limbs), and 42 patients (44 limbs), respectively. The demographic, baseline, and procedure data were collected, and the complications and midterm outcomes (patency, amputation-free survival, and clinically driven target lesion revascularization rates) were analyzed., Results: All three procedures achieved a 100% success rate. Significant improvements were noted in ankle brachial index, walking distance, and Rutherford classification at 30 days post-procedure ( p < 0.001), with no differences or severe complications among the groups. The all-cause mortality rate during the follow-up period, was 5.5%, and amputation-free survival rates at 24 months were 97.0%, 90.6% and 90.9% in the DCB, DA, and BMS angioplasty groups, respectively. The primary patency rate for the DCB group (79.4%) exceeded those of the DA (56.2%) and BMS (52.2%) groups ( p < 0.05), with no significant difference between the DA and BMS groups at 24 months. The secondary patency and clinically driven target lesion revascularization rates were similar among the three groups. A runoff number ≤1, Trans-Atlantic Intersociety Consensus (TASC) D, and severe calcification were found to be independent risk factors for primary patency., Conclusions: The DCB procedure demonstrated superior primary patency, compared to both BMS and DA procedures, in the treatment of femoropopliteal lesions., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2024 The Author(s). Published by IMR Press.)

Background: Carbon dioxide angiography with addition of optical coherence tomography imaging may improve procedural success and clinical outcomes in patients with peripheral artery disease and chronic kidney disease. Methods: Single-center, retrospective analysis of patients with chronic kidney disease who underwent carbon dioxide angiography and optical coherence tomography-guided chronic total occlusion crossing and/or optical coherence tomography-guided directional atherectomy was performed. Patient and procedure-related characteristics, along with peri- and one-year post-procedural major adverse events, were analyzed. Results: A total of 18 vessels in 11 patients, with mean age 70 years were treated. All had co-morbidities such as hypertension, hyperlipidemia, had history or were current smokers with baseline peripheral artery disease. Majority were diabetic with coronary disease (82%); 55% baseline chronic kidney disease IV, 55% Rutherford class III and 45% class IV. Contrast was used in only two patients. Mean total fluoroscopy time and radiation dose was 24.1 min and 249.2 mGY, respectively. Half of the lesions were femoro-popliteal chronic total occlusions, and Ocelot catheter was used to cross seven of nine chronic total occlusions and was successful in six. Adjunctive optical coherence tomography-guided directional atherectomy was performed in 8 of 11 patients. Only two adverse events occurred: one clinically significant event of slow-flow intra-procedurally and one target limb revascularization within one year of index procedure in a vessel different than prior treated. Optical coherence tomography imaging in both chronic total occlusion-crossing and atherectomy resulted in 10-min mean fluoroscopy reduction time and 32 mGY reduction in radiation dose. Conclusion: Carbon dioxide angiography with the addition of optical coherence tomography imaging for chronic total occlusion crossing and/or optical coherence tomography-guided directional atherectomy reduced the need for contrast agents, total fluoroscopy time, and radiation exposure in patients with peripheral artery disease and baseline chronic kidney disease. [ABSTRACT FROM AUTHOR]

Background: Our aim was to review the current literature of the use of directional atherectomy (DA) in the treatment of lower extremity critical-limb ischemia. Methods: A search for relevant literature was performed in PubMed and PubMed Central on 16 April 2020, sorted by best match. Three searches across two databases were performed. Articles were included that contained clinical and procedural data of DA interventions in lower extremity critical-limb ischemia patients. All studies that were systematic reviews were excluded. Results: Eleven papers were included in this review. Papers were examined under several parameters: primary patency and secondary patency, limb salvage/amputation, technical/procedural success, complications/periprocedural events, and mean lesion length. Primary and secondary patency rates ranged from 56.3% to 95.0% and 76.4% to 100%, respectively. Limb salvage rates ranged from 69% to 100%. Lesion lengths were highly varied, representing a broad population, ranging from 30 ± 33 mm to 142.4 ± 107.9 mm. Conclusions: DA may be a useful tool in the treatment of lower extremity critical-limb ischemia. [ABSTRACT FROM AUTHOR]

Purpose: This study investigated the 1-year clinical outcomes of directional atherectomy combined with drug-coated balloon (DA + DCB) in femoropopliteal artery disease (FPAD) from real-world experience. Materials and Methods: A retrospective study was conducted of patients treated between July 2016 and June 2019 using DA + DCB for FPAD. Patients' demographics, comorbidities, clinical characteristics and outcomes, and angiography and duplex ultrasound findings were analyzed. The 6-month and 1-year primary patency, primary assisted patency, secondary patency, and freedom from clinically-driven target lesion revascularization (CD-TLR) were evaluated. Univariate and multivariate analyses were performed to identify risk factors of primary patency loss or CD-TLR. Results: Seventy-nine consecutive patients (83 lesions, mean age 70.9 years, 52 men) were included. Twenty-seven limbs had lifestyle-limiting claudication and 56 limbs had critical limb ischemia. There were 73 and 10 limbs with de novo lesion and in-stent restenosis, respectively. The mean lesion length of all the patients was 22.1 cm. The mean length of chronic total occlusions (CTOs) was 8.3 cm. Severe calcification was found in 32.5% cases. The 1-year primary patency rate was 80.8% and freedom from CD-TLR was 92.2%. The bailout stenting rate was 2.4%. Patients with CTO >10 cm had significantly lower 1-year primary patency rate and freedom from CD-TLR than did patients with CTO ≤10 cm. Total length of CTO (stratified as ≤5 cm, 5–10 cm, >10 cm) was identified as an independent risk factor of 1-year primary patency loss and CD-TLR. Conclusion: DA + DCB appears to be a safe and effective endovascular therapy to treat FPAD in real-world clinical practice, with a promising 1-year patency rate with a low rate of bailout stenting. [ABSTRACT FROM AUTHOR]

Purpose: The optimal treatment for in-stent restenosis (ISR) of the superficial femoral artery (SFA) is still in debate. This study aimed to evaluate the safety and effectiveness of directional atherectomy (DA) as a primary treatment modality for ISR in SFA. Materials and Methods : : A retrospective single-center analysis was conducted. In total, 617 stents were deployed in 242 limbs for SFA diseases during the study period. ISR was identified in 29 limbs (12.0%); 14 limbs were treated with DA and 15 limbs with balloon angioplasty (BAP) alone. Technical success rate, target lesion revascularization (TLR) and patency rates (PRs) at 12 months, and any complications were evaluated. Results : : DA group included complete occlusions in 50% of patients and BAP group included in 40%. Mean improvement in the ankle-brachial index was 0.29 and 0.32, respectively (P=0.638). Technical success was achieved in all patients. The procedural success rates were 85.7% and 73.3%, respectively (P=0.651). There was no significant difference regarding residual stenosis, distal embolization, or flow-limiting dissection. Primary PRs at 1 year were 85.7% and 73.3%, secondary PRs were 100.0% and 93.3%, and TLR rates were 14.3% and 20.0% (P=0.411, 0.326, and 0.684, respectively). Conclusion : : Short-term outcomes after DA for ISR were not different from those after BAP but showed a tendency of better primary PR and TLR. Larger multicenter prospective studies are needed to define the role of DA in ISR treatment.

OBJECTIVE: To examine the difference in safety and effectiveness of directional atherectomy (DA) and plain balloon angioplasty with adjunctive stenting (BA-STENT) in the treatment of de novo femoropopliteal artery occlusive lesions. MATERIALS AND METHODS: This prospective, randomized trial of DA versus BA-STENT in femoropopliteal arteries was carried out in a single medical center. Demographic data, procedural characteristics, and follow-up information were recorded. The technical, procedural, and clinical outcomes were reported. The primary endpoint was the primary stenosis-free patency rate at 12 and 18 months after the intervention. The secondary endpoints included the rates of technical success, freedom from clinically driven target lesion revascularization (TLR), limb amputation, and all-cause mortality. RESULTS: A total of 188 patients were included in this study. The DA group consisted of 89 (47.3%) patients, and the BA-STENT group consisted of 99 (52.7%) patients. There were 134 males and 54 females with an average age of 68 years, all of which had lesions of Rutherford Grade 2 and above. There was no statistically significant difference in age, gender, smoking, or comorbidities between two groups. The technical success rates were 98.9% in the DA group and 100% in the BA-STENT group (P = 0.47). There was no statistically significant difference in primary stenosis-free patency (90.0% vs. 90.6% at 6 months, 76.7% vs. 77.8% at 12 months, and 72.3% vs. 68.9% at 18 months after the intervention) or freedom from TLR (96.3% vs. 95.8% at 6 months, 88.3% vs. 91.6% at 12 months, and 86.1% vs. 85.4% at 18 months after the procedure) between the DA and the BA-STENT groups. There was no statistically significant difference in terms of distal embolization, thrombosis, and mortality between two groups. No patient underwent major amputation. CONCLUSION: For the treatment of de novo Trans-Atlantic Inter-Society Consensus (TASC) II A-C femoropopliteal artery lesions, DA demonstrated comparable results with the plain balloon angioplasty with adjunctive stenting.

Objective: This study aims to elucidate the differences in vessel patency rates, procedural complications, and the need for repeat interventions between these two techniques, thereby providing insights into the optimal atherectomy strategy for managing peripheral arterial disease in the femoropopliteal segment. Material and Methods: This retrospective study investigated the long-term effectiveness of two atherectomy techniques, rotational atherectomy (RA) and directional atherectomy (DA), in treating lower extremity peripheral artery disease (LE-PAD) affecting the superficial femoral artery (SFA) and popliteal arteries. A total of 134 patients with symptomatic LE-PAD and significant stenosis (70%-99%) were included and divided into two groups based on the atherectomy method used. Both groups underwent similar pre- and post-atherectomy procedures, including drug-coated balloon angioplasty. The primary outcome measure was clinical success, defined as procedural success and an improvement in Rutherford classification at 1 year. Results: Baseline characteristics were similar between the two groups, with no significant differences in demographics or lesion characteristics, except for a higher proportion of right-sided lesions in the DA group. While both RA and DA effectively improved ankle-brachial index (ABI) and Rutherford classification at 12 months, RA demonstrated superior long-term benefits, with significantly higher ABI at 24 months and a greater proportion of asymptomatic patients. Although RA had a longer procedural duration and a higher incidence of dissection, it resulted in lower residual stenosis and fewer cases of treated segment thrombosis than DA. Both RA and DA are effective treatment options for femoropopliteal lesions, but RA may offer advantages in long-term symptom management and vessel patency. Conclusion: Both rotational and directional atherectomy effectively treat femoropopliteal lesions, with rotational atherectomy demonstrating superior long-term outcomes in terms of symptom management and vessel patency. Despite longer procedural times and a slightly higher risk of dissection, rotational atherectomy resulted in lower residual stenosis and fewer cases of treated segment thrombosis than directional atherectomy., Competing Interests: Declaration of conflicting interestsThe authors declare no conflicts of interest related to this study.

Objectives: This study aims to analyze the midterm results of directional atherectomy (DA) in patients with femoropopliteal occlusive disease. Patients and methods: Data of a total of 21 patients (20 males, 1 female; mean age 59.7±7.9 years; range, 45 to 77 years) who underwent DA between June 2014 and December 2016 were retrospectively analyzed. The demographic data, symptomatic classifications (pre- and postoperatively), and lesion types were recorded. The pre- and postoperative patency rates were compared using computed tomography angiography and Doppler ultrasonography. Results: Technical success and clinical improvement were obtained in all patients. One patient (4.8%) required reintervention of the target lesion and another patient (4.8%) required below-the-knee amputation during follow-up. The mean duration of amputation-free survival was 1.6±0.8 (range, 0.4 to 2.8) years. The six- and 12-month major amputation-free survival rates were 100% and 94.1%, respectively. No procedure-related mortality occurred. The mean duration of patency was 1.4±0.9 (range, 0.1-2.7) years. The mean duration of target vessel revascularization-free survival at one, two, and 2.5 years were 93.3±6.4%, 93.3±6.4%, and 62.2±25.8%, respectively. Claudication recurred in seven patients (33.3%). The mean duration of claudication-free survival was 1.4±0.9 years. Tobacco use was the only statistically significant factor for re-claudication (p=0.047). Conclusion: Based on our midterm results, DA can be used in the first-line treatment of femoropopliteal occlusive diseases in patients with multiple comorbidities and complex lesions with a high technical success rate, a low complication rate, and favorable patency rates. [Turk J Vasc Surg 2019; 28(1.000): 1-8]

Symptomatic peripheral arterial disease management involves medical treatment and interventional procedures. Intermittent claudication and critical limb threatened ischemia (CLTI) should be individually considered with specific outcomes and procedures. When intervention is required, an endovascular approach is usually the first-line option. Plain balloon angioplasty was previously used to dilate clinically significant femoropopliteal lesions with variable results. However, over recent years, the use of self-expanding nitinol stents has enabled treatment of long lesions, yielding significantly improved clinical results. Drug-eluting technology has also exhibited a capacity to limit in-stent restenosis and to drive target revascularization. Nevertheless, calcifications and elastic recoil of the arterial wall remain risk factors for early restenosis and failure. Therefore, vessel preparation using specific devices is required to modify vessel compliance and debulk obstructive calcification. In this short review, we provide an overview of the options for gaining lumen before stenting or dilation using drug-coated balloons.

Plaque modification (PM) for atherosclerotic peripheral vascular lesions includes a variety of device types to alter the vessel structure with the aim of enhancing procedural success. PM device utilization has expanded significantly in the United States in recent years despite limited high-quality clinical trials. This article reviews societal guidelines for PM, evaluates currently available trial evidence, examines various pathologic subsets in which PM may be used, and discusses future areas for research. [ABSTRACT FROM AUTHOR]

Purpose: To report the use of directional atherectomy to treat venous in-stent restenosis (ISR) and subsequent histopathological analysis of retrieved intrastent tissue. Case Report: A 55-year-old man presented with recurrent symptoms of venous congestion following iliofemoral stenting. The stents were found to be occluded on imaging. Directional atherectomy was used to recanalize the iliofemoral venous stents, which provided significant symptom relief. Tissue retrieved from within the stent demonstrated patterns of cellular components similar to arterial ISR. At 6-month follow-up, the stents remain patent, with no evidence of further ISR. Conclusion: Directional atherectomy is a potential treatment option for iliofemoral venous ISR. The pathological process of venous ISR demonstrates cellular changes similar to arterial ISR. [ABSTRACT FROM AUTHOR]

Purpose: This study examines the use and impact of directional atherectomy with antirestenotic therapy (DAART) versus angioplasty plus Supera stent implantation on the outcomes during endovascular treatment of popliteal lesions in clinical practice., Methods: Overall 143 consecutive patients (mean age 75.0±12.2 years, 72% male), with isolated atherosclerotic disease of the popliteal artery who underwent endovascular treatment using DAART therapy or percutaneous transluminal angioplasty (PTA)/Supera stenting of the popliteal artery between January 2016 and December 2021 were identified from a retrospectively database. Patient and plaque characteristics were collected. A propensity-score matched, case-control analysis was conducted to balance covariates between the group of patients who underwent DAART and the one treated by PTA/Supera stenting., Results: A total of 51 patients (35.7%) showed severe claudication and 92 (64.3%) critical limb ischemia. There was a trend toward longer treated lesions (90.4±81 vs 72.5±5.3 mm, p=0.089) and more chronic total occlusions (60.5% vs 46.8%, p=0.058) in the PTA/Supera stenting group, although not reaching statistically significance. Moderate-to-severe calcification was present in most lesions treated (75.8% of DAART group, 80.2% of PTA/Supera stenting group, and 78.3% of total cohort). Among the 53 case-matched pairs of patients treated with DAART or PTA/Supera stenting, there were no significant differences in short-term outcomes, including rate of technical success (96.2% vs 98.1%, p=0.232), procedural success (88.7% vs 90.1%, p=0.251), distal embolization (1.9% vs 1.9%, p=0.178), dissection (5.7% vs 1.9%, p=0.268), perforation (3.8% vs 5.6%, p=0.163), hospital discharge (1.2±0.1 vs 1.0±0.1, p=0.325), 30 day minor (28.3% vs 32.1%, p=0.264) or major amputation rates (7.5% vs 3.8%, p=0.107), and 30 day mortality (1.9% vs 1.9%, p=0.173). At 1 year, there was no difference in primary patency (73.6% vs 77.4%, p=0.233), primary assisted patency (81.3% vs 84.9%, p=0.167), secondary patency (86.8% vs 92.5%, p=0.094), ipsilateral minor (35.8% vs 39.6%, p=0.472) or major amputation (9.4% vs 7.5%, p=0.186), ankle brachial index improvement (0.32±0.12 vs 0.37±0.37, p=0.401), or mortality (5.7% vs 5.7%, p=0.121) rate between patients who underwent DAART or PTA/Supera stenting for popliteal lesions., Conclusion: Twelve-month results following DAART technique or PTA/Supera stenting of atherosclerotic lesions of the popliteal artery are not different, regardless of patient and plaque characteristics., Clinical Impact: The DAART technique for the treatment of popliteal artery atherosclerotic disease is presented as a "leave nothing behind" strategy with on-year clinical outcomes similar to ATP/Supera stenting.

Introduction: This study is an analysis of the therapeutic effects of directional atherectomy combined with drug-coated balloon angioplasty (DA+DCB) in treating superficial femoral arteriosclerosis obliterans., Methods: Patients in our hospital with superficial femoral arteriosclerosis obliterans who received DA+DCB during the period June 2016 to February 2019 were identified retrospectively. Preoperative demographics, operative details and postoperative follow-up outcomes were analysed statistically., Results: Between June 2016 and February 2019, 48 patients were enrolled in this retrospective study. The average age of the patients was 66.85 ± 11.28 years; 83.3% of the patients were male. During the procedure, flow-limiting dissection occurred frequently (9/48 patients) and there were six bailout stent implantations owing to flow-limiting dissections. The incidence rate of target artery thrombosis was 4.2% (2/48). There was no vessel perforation, embolism or operation-related death. The technical success rate was estimated at 100%. The mean ankle-brachial index of the patients was 0.54 ± 0.28 before the operation and 0.93 ± 0.13 before discharge ( p < 0.0001). The mean follow-up time was 19.6 ± 9.0 months. The primary patency rate was 89.4%, 82.4% and 76.5% at 12, 24 and 36 months. The freedom from target lesion revascularisation (TLR) was 97.9%, 93.8% and 84.4% at 12, 24 and 36 months., Conclusion: The use of DA+DCB showed good clinical benefit for superficial femoral arteriosclerosis obliterans, which had good primary patency and freedom from TLR. Multicentre randomised controlled trials with long-term follow-up are needed.

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Background--Studies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB. Methods and Results--DEFINITIVE AR study (Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency--A Pilot Study of Anti-Restenosis Treatment) was a multicenter randomized trial designed to estimate the effect of DA before DCB to facilitate the development of future end point-driven randomized studies. One hundred two patients with claudication or rest pain were randomly assigned 1:1 to DA+DCB (n=48) or DCB alone (n=54), and 19 additional patients with severely calcified lesions were treated with DA+DCB. Mean lesion length was 11.2±4.0 cm for DA+DCB and 9.7±4.1 cm for DCB (P=0.05). Predilation rate was 16.7% for DA+DCB versus 74.1% for DCB; postdilation rate was 6.3% for DA+DCB versus 33.3% for DCB. Technical success was superior for DA+DCB (89.6% versus 64.2%; P=0.004). Overall bail-out stenting rate was 3.7%, and rate of flow-limiting dissections was 19% for DCB and 2% for DA+DCB (P=0.01). One-year primary outcome of angiographic percent diameter stenosis was 33.6±17.7% for DA+DCB versus 36.4±17.6% for DCB (P=0.48), and clinically driven target lesion revascularization was 7.3% for DA+DCB and 8.0% for DCB (P=0.90). Duplex ultrasound patency was 84.6% for DA+DCB, 81.3% for DCB (P=0.78), and 68.8% for calcified lesions. Freedom from major adverse events at 1 year was 89.3% for DA+DCB and 90.0% for DCB (P=0.86). Conclusions--DA+DCB treatment was effective and safe, but the study was not powered to show significant differences between the 2 methods of revascularization in 1-year follow-up. An adequately powered randomized trial is warranted. [ABSTRACT FROM AUTHOR]

Background: Peripheral artery disease (PAD) is associated with high morbidity and mortality, particularly once patients develop critical limb threatening ischemia (CLTI). Minorities and vulnerable populations often present with CLTI and experience worse outcomes. The use of directional atherectomy (DA) and drug-coated balloon (DCB) during lower-extremity revascularization (LER) has not been previously described in a safety-net population., Objective: To review demographic and clinical characteristics, and short- intermediate term outcomes of patients presenting to a safety-net hospital with PAD treated with DA and DCB during LER., Methods: In this retrospective, observational cohort study, chart review was performed of all patients who underwent DA and DCB during LER for PAD from April 2016 to January 2020 in a safety-net hospital., Results: The analysis included 58 patients, with 41% female, 24% Black/African American, and 31% Hispanic. From this group, 17% spoke a non-English primary language and 10% reported current or previous housing insecurity. Most (65%) presented with CLTI and had undergone a previous index leg LER (58%). The combination of DA and DCB was efficacious, resulting in low rates of bail-out stenting (16%) and target-vessel revascularization (26%) at 2 years. Low complication rates (tibial embolism in 12% and vessel perforation in 2% of cases) were also observed. Most patients (67%) with Rutherford category 5 experienced wound healing by 2 years., Conclusion: In this safety-net population, the majority presented with CLTI and a previous LER of the index leg. The combination of DA and DCB resulted in low complication rates, and good short-intermediate outcomes in this frequently undertreated population.

Objective: We describe a novel approach for the endovascular treatment of femoral artery occlusion as a result of Angio-Seal closure device deployment. Background: Angio-Seal is the most commonly used vascular closure device following percutaneous coronary and peripheral catheterizations worldwide. A rare complication of Angio-Seal deployment is an occlusion of the femoral artery leading to limb ischemia requiring revascularization. Given its unique ability to cut both atherosclerotic plaque and the Angio-Seal anchor with a collagen plug at operator-directed planes, TurboHawk/HawkOne atherectomy device can be a fast and effective approach to treat Angio-Seal-associated femoral artery occlusions. Methods: We studied 13 consecutive patients who developed Angio-Seal-associated femoral artery occlusions that occurred from 3 hours to several weeks after catheterization. These patients were successfully treated with TurboHawk/HawkOne directional atherectomy followed by balloon angioplasty with no complications. During a mean follow-up period of 20.4 ± 17.3 months, 12 patients remained claudication free with no evidence of obstructive arterial disease of the treated segment on imaging studies. One patient developed restenosis that was treated with repeat atherectomy and balloon angioplasty following which he was asymptomatic at follow-up. Conclusion: The use of directional atherectomy followed by balloon angioplasty is a quick, safe, and effective endovascular approach to treating Angio-Seal-associated femoral artery occlusions. It is associated with an excellent success rate, no complications, and good midterm outcomes. [ABSTRACT FROM AUTHOR]

Purpose: To report a subset analysis that evaluated the hypothesis that directional atherectomy for peripheral artery disease in diabetic claudicants has noninferior primary patency at 12 months compared with nondiabetic claudicants. Methods: DEFINITIVE LE, a US/European multicenter study, assessed the effectiveness of directional atherectomy using SilverHawk/TurboHawk systems for treatment of peripheral artery disease in the superficial femoral, popliteal, and infrapopliteal arteries. Of the 800 patients enrolled in the study, only the 598 claudicant patients (mean age 69.5±10.4 years; 336 men) who were classified at baseline as Rutherford category 1-3 were eligible for this subset analysis. Of these, 46.8% (280/598) had diabetes. Follow-up to 12 months included duplex ultrasound examination, functional assessments, and adverse event evaluations. Independent angiographic and duplex ultrasound core laboratories assessed primary patency and secondary endpoints; a clinical events committee adjudicated adverse events. Results: Although diabetics had significantly more baseline comorbidities, 12-month primary patency (77.0%) was no different than for nondiabetics (77.9%; superiority p=0.98; noninferiority p<0.001) across all anatomic territories treated. Freedom from clinically driven target lesion revascularization was no different between diabetics (83.8%) and nondiabetics (87.5%) overall (p=0.19) or by lesion locations. Secondary clinical outcomes (Rutherford category, ankle-brachial index, and walking impairment) improved at 12 months for both diabetics and nondiabetics. Conclusion: Noninferior 12-month patency rates demonstrate that directional atherectomy is an effective treatment in diabetic as well as nondiabetic claudicants. Directional atherectomy remains an attractive treatment option, improving luminal diameters without stents, which preserves future treatment options for both diabetic and nondiabetic patients with progressive, diffuse vascular disease. [ABSTRACT FROM AUTHOR]

Objective: To investigate the 3-year outcome of patients with peripheral arterial disease (PAD) and heavily calcified stenotic lesions of the superficial femoral artery after directional atherectomy. Materials and Methods: Fifty-three patients (mean age 67 ± 10 years; 18 females, 35 males, TASC B and C, mean lesion length 7.9 ± 3.5 cm) with PAD (Rutherford 2-6) were enrolled into this prospective monocentric study. In total, 59 calcified lesions of the superficial femoral artery were treated with the Silverhawk atherectomy device (Covidien, Plymouth, MN, USA). Patients were followed-up for 36 months with a 6-month interval to perform clinical re-evaluation, including measurement of maximum walking distance and ankle-brachial index (ABI) as well as duplex-sonography. Results: The primary success rate of the procedure was 92 %. In five cases (8 %), additional balloon-PTA and/or stent-PTA was necessary. Procedure-related embolization occurred in seven cases (12 %), which were all successfully treated by aspiration. The primary patency rate after 3 years was 55 %. Median Rutherford score decreased significantly from 5 to 0 after 36 months ( p < 0.001). At the same time, the ABI increased from 0.65 to 1.12 (not significant). The limb-salvage rate after 3 years was 87 %. Conclusion: In this subgroup of patients with POD and calcified stenotic lesions, atherectomy was successfully applied to decrease the plaque burden. Results after 3 years showed a significant decrease of Rutherford score with persistent improvement of ABI and reasonable patency rate. [ABSTRACT FROM AUTHOR]

Purpose: To analyze differences in the application and outcomes of SilverHawk atherectomy (SH) and excimer laser ablation (ELA) in the treatment of femoropopliteal in-stent restenosis (ISR) in an unselected cohort of patients treated at a single center. Methods: Between January 2005 and June 2010, 81 consecutive patients (46 men; mean age 69.1 years, range 43-86) underwent directional atherectomy (41 SH, 40 ELA) for femoropopliteal ISR lesions. Data were reviewed retrospectively on procedural outcomes, major adverse events, and 1-year target lesion revascularization (TLR) obtained from medical records and supplemented with telephone calls. The primary endpoint was symptom-driven TLR at 1 year; secondary endpoints were death and amputation. Results: ELA was utilized more frequently than SH in longer lesions (210.4±104 vs. 126.2±79.3 mm, respectively; p=0.001), subacute presentation (55% vs. 14.6%, p=0.001), TASC D lesions (47.5% vs. 12.2%), and in patients with more angiographic thrombus (42.5% vs. 4.9%, p=0.001). Final angiographic success (<30% residual narrowing post final treatment) was similar between ELA and SH (92.5% vs. 100%, respectively, p=0.12). Bailout stenting was significantly higher with ELA vs. SH (50.0% vs. 24.4%, p=0.022). At 1 year, TLR had occurred in 48.7% of the ELA patients vs. 31.7% of the SH cases (p=0.171). Regression analysis confirmed that SH was a predictor of TLR at 1 year (hazard ratio 2.679, 95% CI 1.015 to 7.073, p=0.047). Conclusion: Both SH and ELA continue to have a high TLR rate in treating ISR of the femoral and popliteal arteries. A higher rate of delayed failure is seen with SH and an earlier, steeper loss of TLR-free survival is seen with ELA. [ABSTRACT FROM AUTHOR]

The present study evaluated the prognosis of directional atherectomy (DA)+drug-coated balloon (DCB) angioplasty for femoropopliteal artery lesions compared with bare nitinol stent (BNS). Background: The present study evaluated the prognosis of directional atherectomy (DA)+drug-coated balloon (DCB) angioplasty for femoropopliteal artery lesions compared with bare nitinol stent (BNS). Patients and methods: This retrospective cohort study included patients with femoropopliteal artery lesions who underwent percutaneous endovascular surgery between January 2016 and June 2019. The primary outcome was the primary patency rate after 12, 24, and 36 months; the secondary outcomes comprised incidence of flow-limiting dissections, technical success, limb salvage, and all-cause death. Results: During the study period, 110 (44%) patients underwent DA+DCB, and 140 (56%) patients underwent bare nitinol stent (BNS). There were no differences in the 12- and 24-month patency rates of the two groups (98.2% vs. 93.6% and 68.2% vs. 60.0%, both p >.05). The 36-month primary patency rate in the DA+DCB group was significantly higher than that of the BNS group (27.3% vs. 15.7%, p =.003). The technical success rate and all-cause death were similar between groups ( p >.05). Flow-limiting dissections occurred more frequently in the BNS group than in the DA+DCB group (27.9% vs. 10.9%, p =.033). After adjustment for potential confounders, such as sex, smoking, hypertension, hyperlipidemia, ABI after surgery, TASC II B, lesion length ≥15 cm, two-vessel runoff, and three-vessel runoff, the HR for primary patency rate comparing BNS to DA+DCB was 2.61 (95%CI: 1.61-4.25). Conclusions: In this retrospective cohort study, DA+DCB was associated with a higher 30-month primary patency rate and a lower flow-limiting dissection incidence than BNS.