Trends in Utilization and Outcomes of Orbital, Laser, and Excisional Atherectomy for Lower Extremity Revascularization

Purpose: The aim of this study is to analyze the utilization pattern of atherectomy modalities and compare their outcomes. Materials and Methods: All patients undergoing atherectomy in the 2010–2016 Vascular Quality Initiative Database were identified. Utilization of orbital, laser, or excisional atherectomy was obtained. Characteristics and outcomes of patients treated for isolated femoropopliteal and isolated tibial disease by different modalities were compared. Results: Atherectomy use increased from 10.3% to 18.3% of all peripheral interventions (n = 122 938). Orbital atherectomy was most commonly used and increased from 59.4% in 2010 to 63.2% of all atherectomies in 2016, while laser atherectomy decreased from 19.2% to 13.1%. Atherectomy was mostly used for treatment of isolated femoropopliteal disease (51.1%), followed by combined femoropopliteal and tibial disease (25.8%) and isolated tibial disease (11.7%). In isolated femoropopliteal revascularization, excisional atherectomy was associated with higher rate of perforation (1.2%) compared with laser (0.4%) and orbital atherectomy (0.5%). The technical success of orbital atherectomy (96.7%) was lower compared with excisional atherectomy (98.7%). Concomitant stenting was significantly higher with laser atherectomy (43.0%) compared with orbital (27.2%) and excisional (26.1%) atherectomy. Nevertheless, there was no difference in 1-year primary patency, reintervention, major amputation, improvement in ambulatory status, or mortality. Multivariable analysis also demonstrated no difference in 1-year primary patency and major ipsilateral amputation among the modalities. In isolated tibial revascularization, there were no differences in perioperative outcomes among the modalities. Excisional atherectomy was associated with the highest 1-year primary patency (88.1%). After adjusting for confounders, excisional atherectomy remained associated with superior 1-year primary patency compared with orbital atherectomy (odds ratio [OR] = 2.59, 95% confidence interval [CI] = [1.18–5.68]), and excisional atherectomy remained associated with a lower rate of 1-year major ipsilateral amputation compared with laser atherectomy (OR = 0.29, 95% CI = [0.09–0.95]). Conclusion: Atherectomy use has increased, driven primarily by orbital atherectomy. Despite significant variation in perioperative outcomes, there were no differences in 1-year outcomes among the different modalities when used for treating isolated femoropopliteal disease. In isolated tibial disease treatment, excisional atherectomy was associated with higher 1-year primary patency compared with orbital atherectomy and decreased major ipsilateral amputation rates compared with laser atherectomy. These differences warrant further investigation into the comparative effectiveness of atherectomy modalities in various vascular beds.

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Trends and perioperative outcomes of patients with human immunodeficiency virus (HIV) undergoing lower extremity revascularization

Vascular Medicine ◽

10.1177/1358863x20952856 ◽

2020 ◽

Vol 25 (6) ◽

pp. 527-533

Author(s):

Tanner I Kim ◽

Anand Brahmandam ◽

Timur P Sarac ◽

Kristine C Orion

Keyword(s):

Human Immunodeficiency Virus ◽

Lower Extremity ◽

Hospital Costs ◽

Major Amputation ◽

Perioperative Outcomes ◽

Hiv Status ◽

Immunodeficiency Virus ◽

Multivariable Regression ◽

Artery Disease ◽

Lower Extremity Revascularization

The development of highly active antiretroviral therapy (HAART) has significantly improved the life expectancy of patients with human immunodeficiency virus (HIV), but has led to the rise of chronic conditions including peripheral artery disease (PAD). However, trends and outcomes among patients with HIV undergoing lower extremity revascularization are poorly characterized. The aim of this study was to investigate the trends and perioperative outcomes of lower extremity revascularization among patients with HIV and PAD in a national database. The National Inpatient Sample (NIS) was reviewed between 2003 and 2014. All hospital admissions with a diagnosis of PAD undergoing lower extremity revascularization were stratified based on HIV status. Outcomes were assessed using propensity score matching and multivariable regression. Among all patients undergoing lower extremity revascularization for PAD, there was a significant increase in the proportion of patients with HIV from 0.21% in 2003 to 0.52% in 2014 ( p < 0.01). Patients with HIV were more likely to be younger, male, and have fewer comorbidities, including coronary artery disease and diabetes, at the time of intervention compared to patients without HIV. With propensity score matching and multivariable regression, HIV status was associated with increased total hospital costs, but not length of stay, major amputation, or mortality. Patients with HIV with PAD who undergo revascularization are younger with fewer comorbidities, but have increased hospital costs compared to those without HIV. Lower extremity revascularization for PAD is safe for patients with HIV without increased risk of in-hospital major amputation or mortality, and continues to increase each year.

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Below-knee endovascular interventions have better outcomes compared to open bypass for patients with critical limb ischemia

Vascular Medicine ◽

10.1177/1358863x16676901 ◽

2016 ◽

Vol 22 (1) ◽

pp. 28-34 ◽

Cited By ~ 10

Author(s):

Caitlin W Hicks ◽

Alireza Najafian ◽

Alik Farber ◽

Matthew T Menard ◽

Mahmoud B Malas ◽

...

Keyword(s):

Critical Limb Ischemia ◽

Multivariable Analysis ◽

Limb Ischemia ◽

Major Amputation ◽

Primary Patency ◽

Tissue Loss ◽

Vascular Intervention ◽

Below The Knee ◽

Endovascular Interventions ◽

One Year

Both open surgery and endovascular peripheral interventions have been shown to effectively improve outcomes in patients with peripheral artery disease, but minimal data exist comparing outcomes performed at and below the knee. The purpose of this study was to compare outcomes following infrageniculate lower extremity open bypass (LEB) versus peripheral vascular intervention (PVI) in patients with critical limb ischemia. Using data from the 2008–2014 Vascular Quality Initiative, 1-year primary patency, major amputation, and mortality were compared among all patients undergoing LEB versus PVI at or below the knee for rest pain or tissue loss. Overall, 2566 patients were included (LEB=500, PVI=2066). One-year primary patency was significantly worse following LEB (73% vs 81%; p<0.001). One-year major amputation (14% vs 12%; p=0.18) and mortality (4% vs 6%; p=0.15) were similar regardless of revascularization approach. Multivariable analysis adjusting for baseline differences between groups confirmed inferior primary patency following LEB versus PVI (HR 0.74; 95% CI, 0.60–0.90; p=0.004), but no significant differences in 1-year major amputation (HR 1.06; 95% CI, 0.80–1.40; p=0.67) or mortality (HR 0.71; 95% CI, 0.44–1.14; p=0.16). Based on these data, we conclude that endovascular revascularization is a viable treatment approach for critical limb ischemia resulting from infrageniculate arterial occlusive disease.

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One-Year Outcomes of Heparin-Bonded Stent-Graft Therapy for Real-World Femoropopliteal Lesions and the Association of Patency With the Prothrombotic State Based on the Prospective, Observational, Multicenter Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study

Journal of Endovascular Therapy ◽

10.1177/1526602820960445 ◽

2020 ◽

pp. 152660282096044

Author(s):

Osamu Iida ◽

Mitsuyoshi Takahara ◽

Yoshimitsu Soga ◽

Terutoshi Yamaoka ◽

Shinsuke Nanto ◽

...

Keyword(s):

Stent Graft ◽

Real World ◽

Platelet Reactivity ◽

Multivariable Analysis ◽

Major Amputation ◽

Primary Patency ◽

Surgical Reconstruction ◽

Prothrombotic State ◽

Graft Placement ◽

Full Coverage

Purpose: To evaluate the real-world primary patency of heparin-bonded stent-graft therapy for femoropopliteal (FP) occlusive disease and identify any clinical factors, including the prothrombotic state, associated with the loss of patency. Materials and Methods: This multicenter study prospectively enrolled 424 limbs of 371 patients (mean age 75±8 years; 247 men) scheduled for Viabahn stent-graft placement in the FP segment. A full-coverage strategy using only a Viabahn stent-graft was preferred, but “spot stenting” with the Viabahn was also allowed. The prothrombotic state was assessed by measuring platelet reactivity. Vascular morphology was evaluated using intravascular ultrasound (IVUS). Primary patency was estimated using the Kaplan-Meier method in the subgroup of patients having full lesion stent-graft coverage (n=343 limbs, 81.1%). The secondary outcomes were major amputation, surgical reconstruction, target lesion revascularization (TLR), and thrombotic occlusion. Regression analyses were used to explore associations of baseline and clinical variables with loss of patency; the results are given as the odds ratio (OR) and 95% confidence interval (CI). Results: The 1-year primary patency estimate was 80.3% (95% CI 75.5% to 85.1%) in the full-coverage group. There were 7 surgical reconstructions, 46 TLRs, 21 acute thrombotic occlusions, and 1 major amputation during the 1-year follow-up in the full-coverage group. Only angiography- and IVUS-determined vessel diameters were significantly associated with loss of patency, with crude ORs of 0.64 (95% CI 0.45 to 0.89, p=0.009) and 0.67 (95% CI 0.51 to 0.90, p=0.009), respectively, per 1-mm increase, whereas other variables, including the prothrombotic state (p=0.74), were not. Multivariable analysis demonstrated that only IVUS-determined vessel diameter was independently associated with loss of patency (adjusted OR per 1-mm increase 0.72, 95% CI 0.52 to 1.00, p=0.049). Conclusion: FP stent-graft placement achieved acceptable patency at 1 year in a real-world setting. A smaller vessel size was significantly associated with loss of patency, whereas the prothrombotic state was not.

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Complete Lower Extremity Revascularization via a Hybrid Procedure for Patients with Critical Limb Ischemia

Vascular and Endovascular Surgery ◽

10.1177/1538574418761723 ◽

2018 ◽

Vol 52 (4) ◽

pp. 255-261 ◽

Cited By ~ 6

Author(s):

Toshio Takayama ◽

Jon S. Matsumura

Keyword(s):

Lower Extremity ◽

Critical Limb Ischemia ◽

Patency Rate ◽

Limb Ischemia ◽

Major Amputation ◽

Primary Patency ◽

Hybrid Procedure ◽

Complete Revascularization ◽

Primary Patency Rate ◽

Lower Extremity Revascularization

Background: Complete revascularization, achieving inline flow to the foot through at least 1 patent tibioperoneal artery, is considered to be desirable for treating critical limb ischemia (CLI). Hybrid procedure, combined femoral endarterectomy and endovascular treatment, is commonly performed on patients with CLI because they often present with complicated lower extremity lesions involving the common femoral artery. This study aimed to investigate the efficacy of complete revascularization (CR) achieved by hybrid procedure on limb salvage in patients with CLI. Methods: Between February 2010 and January 2016, 95 limbs (82 patients) were treated by lower extremity hybrid procedure; of these 95 procedures, 61 were for patients with CLI. We defined CR as achieving inline flow to the foot through at least 1 patent tibioperoneal artery. Complete revascularization was performed on 37 limbs, and incomplete revascularization (IR) was performed on 24 limbs. Specific variables, including patient age, male–female ratio, Rutherford classification, preoperative and postoperative ankle–brachial pressure indices (ABIs), follow-up duration (months), primary patency rate, assisted primary patency rate, secondary patency rate, and major amputation rate, were analyzed. Results: The mean age was similar between the groups 67.2 years in the CR group and 70.7 years in the IR group ( P = .11). Limb ischemia severity was significantly higher in the CR group: 63% of the patients scored Rutherford 5 in the CR group, compared to 30% in the IR group ( P = .027). Mean postoperative ABI was significantly higher in the CR group (CR: 0.87, IR: 0.53; P = .0001). Major amputation rate was higher in the IR group (CR: 2.7%, IR: 13%; P = .29), and major amputation-free survival rate at 3 years after the index procedure was higher in the CR group (CR: 97%, IR: 81%; P = .054). Conclusion: Complete lower extremity revascularization was beneficial for patients with CLI, avoiding major amputation.

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Laser Atherectomy Combined With Drug-Coated Balloon Angioplasty Is Associated With Improved 1-Year Outcomes for Treatment of Femoropopliteal In-Stent Restenosis

Journal of Endovascular Therapy ◽

10.1177/1526602817745668 ◽

2017 ◽

Vol 25 (1) ◽

pp. 81-88 ◽

Cited By ~ 21

Author(s):

Damianos G. Kokkinidis ◽

Prio Hossain ◽

Omar Jawaid ◽

Bejan Alvandi ◽

T. Raymond Foley ◽

...

Keyword(s):

Balloon Angioplasty ◽

Cox Regression ◽

Multivariable Analysis ◽

Limb Ischemia ◽

Target Lesion ◽

Lesion Length ◽

Stent Restenosis ◽

Kaplan Meier ◽

Laser Atherectomy ◽

In Stent Restenosis

Purpose: To examine whether laser atherectomy combined with drug-coated balloons (laser + DCB) can improve the outcomes of femoropopliteal (FP) in-stent restenosis (ISR). Methods: A dual-center retrospective study was conducted of 112 consecutive patients (mean age 70.3±10.6 years; 86 men) with Tosaka class II (n=29; diffuse stenosis) or III (n=83; occlusion) FP-ISR lesions. Sixty-two patients (mean age 68.5±10 years; 51 men) underwent laser + DCB while the other 50 patients (mean age 72.5±10.8 years; 35 men) had laser atherectomy plus balloon angioplasty (laser + BA). Critical limb ischemia was the indication in 33% of the interventions. The average lesion length was 247 mm. A Cox regression hazard model was developed to examine the association between laser + DCB vs laser + BA; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). One-year target lesion revascularization (TLR) and reocclusion were estimated using the Kaplan-Meier method. Results: Overall procedure success was 98% and was similar between groups. Bailout stenting was less often required in the laser + DCB group (31.7% vs 58%, p=0.006). The combination of laser + DCB was associated with improved 12-month estimates for freedom from TLR (72.5% vs 50.5%, p=0.043) and freedom from reocclusion (86.7% vs 56.9%, p=0.003). Among patients with Tosaka III FP-ISR, combination therapy with laser + DCB was also associated with increased freedom from reocclusion (87.1% vs 57.1%, p=0. 028). On multivariable analysis, treatment with laser + DCB was associated with a significantly reduced risk of reocclusion (HR 0.08, 95% CI 0.17 to 0.38; p=0.002). Conclusion: When used for treatment of complex FP-ISR lesions, DCB angioplasty combined with laser atherectomy is associated with significantly reduced 1-year TLR and reocclusion rates.

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Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials

The Journal of Vascular Access ◽

10.1177/11297298211070125 ◽

2022 ◽

pp. 112972982110701

Author(s):

Yunfeng Li ◽

Zhenwei Shi ◽

Yunyun Zhao ◽

Zhanjiang Cao ◽

Zhengli Tan

Keyword(s):

Adverse Events ◽

Randomized Controlled Trials ◽

Balloon Angioplasty ◽

Meta Analysis ◽

Primary Patency ◽

Controlled Trials ◽

Technical Success ◽

Randomized Controlled ◽

All Cause Mortality ◽

Drug Coated Balloon

Purpose: To compare all-cause mortality and primary patency with drug-coated balloon angioplasty (DCBA) compared with plain balloon angioplasty (PBA) in people with hemodialysis-related stenosis. Materials and methods: PubMed, Embase, and Cochrane Library databases were searched from November 1966 to February 2021 to identify randomized controlled trials (RCTs) that assessed the use of DCBA versus PBA for stenosis in hemodialysis circuits. Data extracted from the articles were integrated to determine all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), 30-day adverse events, and technical success for the two approaches. We performed meta-analysis on these results using a fixed-effects model to evaluate odds ratios (ORs) and 95% confidence intervals (CIs) where I2 < 50% in a test for heterogeneity, or a random-effect model if otherwise. Sensitivity and subgroup analyses were also performed. Results: Sixteen RCTs of 1672 individuals were included in our meta-analysis, of which 839 individuals received DCBA and 833 received PBA. The pooled outcome showed no statistical difference between DCBA and PBA in all-cause mortality at 6 months (OR = 1.29, 95% CI = 0.72–2.32, p = 0.39, I2 = 4%), 12 months (OR = 1.02, 95% CI = 0.68–1.53, p = 0.91, I2 = 0%), and 24 months (OR = 1.50, 95% CI = 0.87–2.57, p = 0.15, I2 = 0%), 30-day adverse events (OR = 1.09, 95% CI = 0.30–3.98, p = 0.90, I2 = 66%), and technical success (OR = 0.18, 95% CI = 0.02–1.92, p = 0.16, I2 = 65%). The DCBA had significantly better outcomes versus PBA in TLPP at 6 months (OR = 2.37, 95% CI = 1.84–3.04, p < 0.001, I2 = 44%) and 12 months (OR = 1.77, 95% CI = 1.22–2.56, p = 0.002, I2 = 56%), and CAPP at 6 months (OR = 2.07, 95% CI = 1.21–3.54, p = 0.008, I2 = 67%) and 12 months (OR = 1.66, 95% CI = 1.29–2.15, p < 0.001, I2 = 0%). Conclusion: In hemodialysis circuit stenosis, DCBA appears to have similar safety but greater efficacy than PBA.

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Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC)

VASA ◽

10.1024/0301-1526/a000959 ◽

2021 ◽

pp. 1-7

Author(s):

Tanja Böhme ◽

Elias Noory ◽

Ulrich Beschorner ◽

Frederik Lerke ◽

Andrej Schmidt ◽

...

Keyword(s):

Primary Endpoint ◽

Ankle Brachial Index ◽

Target Lesion ◽

Primary Patency ◽

Small Sample ◽

Adverse Event Rate ◽

Control Cohort ◽

Procedural Success ◽

Laser Atherectomy

Summary: Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.

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Symptomatic Iliofemoral and Iliocaval Venous Thrombosis in Patients With Cancer: Endovascular Treatment

Vascular and Endovascular Surgery ◽

10.1177/1538574418789018 ◽

2018 ◽

Vol 52 (8) ◽

pp. 602-606 ◽

Cited By ~ 1

Author(s):

Martin Rabellino ◽

Pedro Moltini ◽

Vanesa Di Caro ◽

Ricardo García-Mónaco

Keyword(s):

Primary Objective ◽

Primary Patency ◽

Postthrombotic Syndrome ◽

Symptom Improvement ◽

Secondary Patency ◽

Technical Success ◽

Vein Thrombosis ◽

Patients With Cancer ◽

Long Term Follow Up

Introduction: Proximal (iliocaval and iliofemoral) deep vein thrombosis (DVT) and pulmonary thromboembolism are the second cause of death in patients with cancer. Material and Methods: A retrospective analysis was performed in 35 patients with cancer treated with endovascular therapy for proximal DVT. The primary objective was to evaluate the technical success of the procedure and the 30-day and long-term symptom improvement. Results: Thirty-five patients with a mean age of 57.7 years were treated. In 27 patients, DVT was due to tumor compression and/or invasion of the iliocaval venous axis, and in the remaining 8, it was secondary to their hypercoagulability state. The revascularization techniques used were manual catheter-directed aspiration of the thrombus plus angioplasty and stenting. Technical success was achieved in 33 patients. No complications occurred. Twenty-seven patients were followed up at 30 days posttreatment: 21 were free of postthrombotic syndrome, 4 (14.8%) had mild symptoms, and 2 (7.4%) had moderate symptoms. The mean long-term follow-up was 27.3 months, with a primary patency of 68.8% and assisted and secondary patency rates of 100%. Conclusion: Endovascular revascularization in patients with cancer with extensive and symptomatic proximal DVT is safe and efficient, with a low rate of complications. We consider that this therapy should be offered to patients with cancer with an average or long life expectancy.

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Use of the Orbital Atherectomy System in Isolated, Chronic Atherosclerotic Lesions of the Popliteal Artery

Vascular and Endovascular Review ◽

10.15420/ver.2020.08 ◽

2020 ◽

Vol 3 ◽

Author(s):

Patricia Torres Lebruno ◽

Konstantinos P Donas ◽

Stefano Fazzini ◽

Charlott Elise Köhler ◽

Arne Schwindt ◽

...

Keyword(s):

Popliteal Artery ◽

Primary Patency ◽

Stage Iii ◽

Ankle Brachial Pressure Index ◽

Technical Success Rate ◽

Pressure Index ◽

Atherosclerotic Lesions ◽

Orbital Atherectomy ◽

Artery Segment

The treatment of isolated calcified lesions involving the popliteal artery are demanding and they often require stent placement to achieve acceptable luminal gain. This study evaluates the safety and performance of the orbital atherectomy system (Cardiovascular Systems Inc.) and percutaneous transluminal angioplasty with a drug-coated balloon (PTA-DCB) for the treatment of chronic atherosclerotic lesions within the popliteal artery segment. From November 2018 to November 2019, a series of six patients with Rutherford classification stage III peripheral arterial disease with isolated, focal, calcified occlusions of the popliteal artery were treated with orbital atherectomy followed by PTA-DCB. No embolic protection devices were used. The technical success rate was 100%, the primary patency rate was 100% at 7.0 (±4.2) months of follow-up. The Rutherford classification improved in all patients from stage III to stage II and the mean ankle brachial pressure index after the procedure was 0.97 (±0.08), with a preoperative mean ankle brachial pressure index of 0.69 (±0.21). In one instance, spasm was noted in a distal arterial bed and it was successfully treated with local nitroglycerine. No distal embolisation, perforation or aneurysmal degeneration was observed. During follow-up there were no deaths, major amputations or revascularisation of target lesions. The use of orbital atherectomy system in combination with PTA-DCB was found to be safe and effective in modifying focal, chronic, calcified plaques in the popliteal artery segment in these six cases.

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