Preventing Lower Extremity Distal Embolization Using Embolic Filter Protection:<b>Results of the PROTECT Registry</b>

Shammas, Nicolas W.; Dippel, Eric J.; Coiner, Denise; Shammas, Gail A.; Jerin, Michael; Kumar, Alisha

doi:10.1583/08-2397.1

Cited by 120 publications

(23 citation statements)

References 12 publications

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“…Although registry data have suggested that distal embolization is a rather frequent occurrence, its incidence was low in the contemporary nonrandomized DEFINITIVE-LE study. 118 Although no high-quality data are available to guide the use of distal protection for atherectomy, it is often used particularly in the presence of poor or single-vessel distal run-off.…”

Section: Rotational Atherectomymentioning

confidence: 99%

Endovascular Intervention for Peripheral Artery Disease

Thukkani

Kinlay

2015

Circulation Research

226

158

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Advances in endovascular therapies during the past decade have broadened the options for treating peripheral vascular disease percutaneously. Endovascular treatment offers a lower risk alternative to open surgery in many patients with multiple comorbidities. Noninvasive physiological tests and arterial imaging precede an endovascular intervention and help localize the disease and plan the procedure. The timing and need for revascularization are broadly related to the 3 main clinical presentations of claudication, critical limb ischemia, and acute limb ischemia. Many patients with claudication can be treated by exercise and medical therapy. Endovascular procedures are considered when these fail to improve quality of life and function. In contrast, critical limb ischemia and acute limb ischemia threaten the limb and require more urgent revascularization. In general, endovascular treatments have greater long-term durability for aortoiliac disease than femoral popliteal disease. Infrapopliteal revascularization is generally reserved for critical and acute limb ischemia. Balloon angioplasty and stenting are the mainstays of endovascular therapy. New well-tested innovations include drug-eluting stents and drug-coated balloons. Adjunctive devices for crossing chronic total occlusions or debulking plaque with atherectomy are less rigorously studied and have niche roles. Patients receiving endovascular procedures need a structured surveillance plan for follow-up care. This includes intensive treatment of cardiovascular risk factors to prevent myocardial infarction and stroke, which are the main causes of death. Limb surveillance aims to identify restenosis and new disease beyond the intervened segments, both of which may jeopardize patency and lead to recurrent symptoms, functional impairment, or a threatened limb.

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Section: Rotational Atherectomymentioning

confidence: 99%

Endovascular Intervention for Peripheral Artery Disease

Thukkani

Kinlay

2015

Circulation Research

226

158

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“…Contemporary studies have demonstrated a higher rate of DE in the filter of EPDs (20–58%) [3], [7], [11], or detected by Doppler ultrasound (100%) [8], [12], than angiographically (1%–5%) [1], [2]. The reported incidence of limb-threatening DE during routine lower extremity intervention is 1–2% [1], [13].…”

Section: Discussionmentioning

confidence: 99%

“…However, since these studies did not involve any control groups to confirm the short term or long term clinical efficacy of EPDs, so far it can only demonstrate that certain EPDs are safe and efficient in collecting debris during the procedure. In the Preventing Lower Extremity Distal Embolization Using Embolic Filter Protection (PROTECT) study recruiting 56 lesions treated in 40 patients all with EPDs, a side branch embolization occurred in one patient, and a no-flow phenomenon occurred in another as a result of an overfilled filter [3]. The potential benefit of EPDs must therefore be balanced against the associated complications.…”

Section: Discussionmentioning

confidence: 99%

“…The reported incidence of DE, detected angiographically or clinically, ranges from 1% to 5% [2]. DE may necessitate additional intervention, including thrombectomy or thrombolysis, resulting in longer procedure time, more contrast used, and greater radiation exposure [3]. The concern for DE in lower extremity interventions has led to a debate [4].…”

Section: Introductionmentioning

confidence: 99%

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Incidence, Risk Factors, Treatment and Prognosis of Popliteal Artery Embolization in the Superficial Femoral Artery Interventions

Hua

et al. 2014

PLoS ONE

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ObjectivePercutaneous transluminal angioplasty and stenting (PTA + stent) has gained acceptance as a primary treatment modality for the superficial femoral artery (SFA) diseases. Popliteal artery embolization (PAE) is a severe complication in SFA interventions. The purpose of this study was to evaluate the incidence, risk factors, treatment and prognosis of PAE in primary SFA PTA + stent.MethodsChronic SFA arteriosclerosis cases that underwent primary PTA + stent were reviewed from a retrospectively maintained database. Runoff vessels were evaluated in all cases before and after the interventions for PAE detection. The primary patency, secondary patency and limb salvage rates were calculated using Kaplan-Meier analysis and compared using log-rank analysis. Cox multivariate regression was performed to evaluate predictors of patency and limb salvage rates.ResultsThere were 436 lesions treated in 388 patients with 10 PAE events (2.3%) in total. PAE rate was significantly higher in Transatlantic Inter-Society Consensus (TASC) C/D group compared with TASC A/B group (OR = 8.91, P = .002), in chronic total occlusion (CTO) lesions compared with stenotic lesions (P<.0001), and in group with history of cerebral ischemic stroke (OR = 6.11, P = .007). PAE rates were not significantly affected by age, sex, smoking, hypertension, diabetes, hyperlipidemia and runoff status. The binary logistic regression showed that only the TASC C/D was an independent predictor of PAE (P = .031). The 12-month and 24-month primary patency, secondary patency and limb salvage rates in PAE group showed no significant differences comparing with non-PAE group.ConclusionsPAE is a rare event in primary SFA PTA + stent. TASC C/D lesion, CTO and cerebral ischemic stroke history are risk factors for PAE. PAE is typically reversible by comprehensive techniques. If the popliteal flow is restored in time, PAE has no significant effect on long-term patency and limb salvage rates.

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“…37,41,42 A 58-patient RCT of directional atherectomy to PTA in lower extremity PVD showed no difference in initial procedural success or target lesion revascularization (TlR); however, there was significantly more distal embolization with atherectomy. 43 Concern about distal embolization of atheromatous debris has prompted the use of embolic protection devices, 44 and their Food and Drug Administration clearance for use in this setting. Adding the expense of a protection device to the already substantial price of an atherectomy catheter puts equipment cost in the range of $5000, in excess of virtually every other percutaneous strategy.…”

Section: Atherectomymentioning

confidence: 99%

Drug-Eluting Stents Are the Default Strategy for Superficial Femoral Artery Intervention Now

Burket

2016

Circulation

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Preventing Lower Extremity Distal Embolization Using Embolic Filter Protection:Results of the PROTECT Registry

Cited by 120 publications

References 12 publications

Endovascular Intervention for Peripheral Artery Disease

Endovascular Intervention for Peripheral Artery Disease

Incidence, Risk Factors, Treatment and Prognosis of Popliteal Artery Embolization in the Superficial Femoral Artery Interventions

Drug-Eluting Stents Are the Default Strategy for Superficial Femoral Artery Intervention Now

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