Impact of lesion location on procedural and acute angiographic outcomes in patients with critical limb ischemia treated for peripheral artery disease with orbital atherectomy: A CONFIRM registries subanalysis

Lee, Michael S.; Mustapha, Jihad; Beasley, Robert E.; Chopra, Paramjit; Das, Tony; Adams, George L.

doi:10.1002/ccd.26349

Cited by 20 publications

(19 citation statements)

References 18 publications

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“…The only study reporting clinical outcomes in the elderly who underwent orbital atherectomy was with patients with peripheral arterial disease. In the CONFIRM registry, elderly patients who underwent orbital atherectomy for severe peripheral arterial disease had similar outcomes despite having worse baseline symptoms and lesion characteristics compared to younger patients …”

Section: Discussionmentioning

confidence: 99%

Outcomes in Elderly Patients With Severely Calcified Coronary Lesions Undergoing Orbital Atherectomy

Lee

Shlofmitz

Lluri

et al. 2017

J Interven Cardiology

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Section: Discussionmentioning

confidence: 99%

Outcomes in Elderly Patients With Severely Calcified Coronary Lesions Undergoing Orbital Atherectomy

Lee

Shlofmitz

Lluri

et al. 2017

J Interven Cardiology

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“… 25 , 41 , 48 , 59 The use of OA has been associated with improved angioplasty results, with low bailout stenting rates, 31 , 60 and has provided similar clinical outcomes (ie, dissection, slow-flow, vessel spasm, distal embolization) in patients with higher RC status at baseline and complex lesions vs patients with milder disease. 33 , 34 , 60 , 61 This system employs a 360° rotational device with a diamond-coated crown that orbits eccentrically within the vessel. 43 This circumferential calcium removal by OA has been hypothesized to improve vessel compliance, facilitating angioplasty and as such leading to favorable periprocedural outcomes (ie, lower rates of complications, better vessel expansion).…”

Section: Discussionmentioning

confidence: 99%

Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of Infrainguinal Claudication or Chronic Limb-Threatening Ischemia

Giannopoulos

Secemsky

Mustapha³

et al. 2020

J Endovasc Ther

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Purpose: To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: The database from the LIBERTY study ( ClinicalTrials.gov identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up. The mean lesion lengths were 78.7±73.7, 131.4±119.0, and 95.2±83.9 mm, respectively, for the 3 groups. Results: After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small proportion (10.8%) of patients developed angiographic complications, without differences based on presentation. During the 3-year follow-up, claudicants were at lower risk for MAE, death, and major amputation/death than patients with CLTI. The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI patients only, the RC at baseline was correlated with the combined outcome of major amputation/death, whereas RC classification did not affect TVR, MAE, major amputation, or death rates. Conclusion: Peripheral artery angioplasty with adjunctive OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the utility of OA for patients across the spectrum of PAD.

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“…15 Other approaches have been attempted to improve outcomes of BTK interventions, such as atherectomy, which reduces the compliance of plaque by removing calcium. 16,17 Several atherectomy devices have been used in different trials, 18,19 but the high rate of complications and the absence of a real advantage have reduced the interest in this approach due to the inability to remove medial-intimal calcifications.…”

Section: Discussionmentioning

confidence: 99%

Six-Month Angiographic and Clinical Outcomes of Therapeutic Ultrasound Pretreatment Associated With Plain Balloon Angioplasty for Below-the-Knee Lesions in Patients With Critical Limb Ischemia: A Prospective, Single-Center Pilot Study

Giudice

Gandini

2019

J Endovasc Ther

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Purpose: To evaluate the safety and efficacy of low-frequency, high-intensity ultrasound energy delivered via a new dedicated ultrasound catheter followed by conventional balloon angioplasty to treat calcified infrapopliteal lesions. Materials and Methods: A prospective, nonrandomized, single-center pilot study enrolled 12 patients (mean age 72.2±5.3 years; 8 men) with critical limb ischemia (9 Rutherford category 5 and 3 category 6) between January and November 2017. Of the 19 target lesions, 11 had severe calcification. Patients were treated with the Kapani ultrasound system before conventional balloon dilation. Primary safety endpoints included 30-day death, major target limb amputation, and target vessel acute occlusion. The main efficacy outcome was primary patency at 6 months, defined as freedom from both clinically-driven target lesion revascularization (TLR) and angiographically-defined restenosis (>50% lumen reduction). Results: Technical success (<30% residual stenosis) was achieved in all lesions without complications or stent implantation. Ultrasound energy was delivered over a mean 185.2±67.3 seconds followed by low-pressure dilation (mean 6.1±1.9 atm). Angiography confirmed primary patency at 6 months in 18 (95%) of 19 lesions. No death, TLR, or amputation was reported in follow-up. Complete ulcer healing was observed in all 12 patients at 6 months. Conclusion: This pilot trial with a small number of patients suggests that low-frequency, high-intensity ultrasound energy delivery followed by plain balloon angioplasty is a safe approach to treat infrapopliteal atherosclerotic lesions. Angiographically-documented results at 6 months indicate a potential for this combined therapy in the treatment of CLI patients with calcified BTK lesions. Further studies on a larger randomized cohort are needed to confirm these positive clinical outcomes.

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Impact of lesion location on procedural and acute angiographic outcomes in patients with critical limb ischemia treated for peripheral artery disease with orbital atherectomy: A CONFIRM registries subanalysis

Cited by 20 publications

References 18 publications

Outcomes in Elderly Patients With Severely Calcified Coronary Lesions Undergoing Orbital Atherectomy

Outcomes in Elderly Patients With Severely Calcified Coronary Lesions Undergoing Orbital Atherectomy

Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of Infrainguinal Claudication or Chronic Limb-Threatening Ischemia

Six-Month Angiographic and Clinical Outcomes of Therapeutic Ultrasound Pretreatment Associated With Plain Balloon Angioplasty for Below-the-Knee Lesions in Patients With Critical Limb Ischemia: A Prospective, Single-Center Pilot Study

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