Embolic Protection Devices in Patients with Renal Artery Stenosis with Chronic Renal Insufficiency: A Clinical Study

Misra, Sanjay; Gomes, Manuel Teixeira; Barsness, Gregory W.; Textor, Stephen C.; Bjarnason, Haraldur; McKusick, Michael A.

doi:10.1016/j.jvir.2008.08.002

Cited by 17 publications

(11 citation statements)

References 20 publications

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“…Nonetheless, compared with historical results of conventional (unprotected) endovascular renal artery intervention, initial reports of patients treated with RA-PTAS and distal embolic protection have described a relatively lower frequency of postintervention decline in renal function (0% to 5%) and a greater frequency of postintervention improvement. 79,92,96,173,[176][177][178] Hypertension responses, perioperative morbidity, and perioperative mortality from these series are similar to those observed with unprotected RA-PTAS.…”

Section: Outcome Improvement Effortssupporting

confidence: 66%

Contemporary management of atherosclerotic renovascular disease

Edwards

Corriere

2009

Journal of Vascular Surgery

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Atherosclerotic renovascular disease (aRVD) is an increasingly recognized cause of severe hypertension and declining kidney function. Patients with aRVD have been demonstrated to have an increased risk of adverse cardiovascular events compared with patients without aRVD. For these reasons, >45,000 renal artery revascularization procedures are performed annually, with significant growth observed in the number of procedures performed each year. The efficacy of contemporary revascularization therapies in the treatment of aRVD is unproven and controversial, with no level I data to support current practices. Lower-level data suggest that kidney function improvement is a key indicator of subsequent improved survival free of adverse cardiovascular events and dialysis, and that observed improvements of hypertension confer, at best, limited benefit. This review focuses on existing data on the management of aRVD, including data from completed and ongoing randomized clinical trials. This review also examines other existing data regarding aRVD that may guide current treatment and future research efforts into this significant clinical and public health problem until widely accepted level I evidence emerges.

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Section: Outcome Improvement Effortssupporting

confidence: 66%

Contemporary management of atherosclerotic renovascular disease

Edwards

Corriere

2009

Journal of Vascular Surgery

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“…As a preventive measure, embolic protection devices (EPD) created for saphenous bypass grafts for coronary artery disease or carotid artery stenosis [57–60] also have been applied in conjunction with renal artery stent placement [61] [62–68]. Currently, there are many different embolic protection devices that can be used to prevent embolization during the placement of stents in the renal artery.…”

Section: Present: Endovascular Restoration Of Renal Blood Flowmentioning

confidence: 99%

“…Some devices (including SpideRx, Angioguard, and Accunet) had more favorable characteristics for arteries with a diameter of 4–8 mm and a stent length of 12 mm in order to meet needed diameters for introduction and size with an adequate “landing zone” before renal artery bifurcation. [44] Single arm observational studies using EPD report recovery of embolic debris and kidney function stabilization after revascularization [66] [62–68;68]. Most of these reports indicate stabilization or improvement of kidney function in 80–93% of the patients after the procedure with variable capture rates of atheroembolic debris (Fig 1C) [61].…”

Section: Present: Endovascular Restoration Of Renal Blood Flowmentioning

confidence: 99%

Percutaneous revascularization for ischemic nephropathy: the past, present, and future

Textor

Misra

Oderich

2013

Kidney International

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Occlusion of the renal arteries can threaten the viability of the kidney when severe, in addition to accelerating hypertension and circulatory congestion. Renal artery stenting procedures have evolved from a treatment mainly for renovascular hypertension to a maneuver capable of recovering threatened renal function in patients with “ischemic nephropathy” and improving management of congestive heart failure. Improved catheter design and techniques have reduced, but not eliminated hazards associated with renovascular stenting. Expanded use of endovascular stent grafts to treat abdominal aortic aneurysms has introduced a new indication for renal artery stenting to protect the renal circulation when grafts cross the origins of the renal arteries. Although controversial, prospective randomized trials to evaluate the added benefit of revascularization to current medical therapy for atherosclerotic renal artery stenosis until now have failed to identify major benefits regarding either renal function or blood pressure control. These studies have been limited by selection bias and have been harshly criticized. While studies of tissue oxygenation using blood oxygen level dependent (BOLD) MR establish that kidneys can adapt to reduced blood flow to some degree, more severe occlusive disease leads to cortical hypoxia associated with microvascular rarefication, inflammatory injury and fibrosis. Current research is directed toward identifying pathways of irreversible kidney injury due to vascular occlusion and to increase the potential for renal repair after restoring renal artery patency. The role of nephrologists likely will focus upon recognizing the limits of renal adaptation to vascular disease and identifying kidneys truly at risk for ischemic injury at a time point when renal revascularization can still be of benefit to recovering kidney function.

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“…No significant complications were reported in this study although the sample size was small. In another small study of 23 patients with chronic renal insufficiency and renal artery stenosis, renal artery stent placement combined with the use of SpideRX or FilterWire EZ demonstrated statistically significant improvement in renal function and reduction in systolic blood pressure …”

Section: Discussionmentioning

confidence: 98%

Adverse events and modes of failure related to the FilterWire EZ Embolic Protection System: Lessons learned from an analytic review of the FDA MAUDE database

Khalid

Javed

Rogers

et al. 2019

Cathet Cardio Intervent

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Objectives To assess the commonly reported complications and failure modes for FilterWire EZ Embolic Protection Devices (EPD) by analyzing the postmarketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Background EPDs prevent distal embolization of atheroembolic materials during percutaneous interventions resulting in reduced microvascular obstruction and improved microcirculation while maintaining tissue perfusion. The FilterWire EZ EPD (Boston Scientific, Natick, MA) is approved for use in interventions of de novo saphenous vein grafts (SVG) and carotid artery stenosis. Robust data on the commonly reported complications and failure modes associated with the FilterWire EZ device are limited. Methods The MAUDE database was queried from September 1, 2008, through September 30, 2018, for FilterWire EZ system, yielding 474 reports. After exclusion of duplicate and incomplete reports, 464 device reports were included in the final analysis. Results Device‐related adverse events were most commonly reported for carotid (n = 281) and SVG (n = 101) interventions. The most commonly reported major complications were: ischemic stroke (n = 57), vessel perforation or dissection (n = 12), death (n = 8), and myocardial infarction (n = 5). Minor complications included: hypotension (n = 68), bradycardia (n = 41), and vasospasm (n = 27). The most commonly reported failure modes were: detachment and/or damage of the device components (n = 118), device entrapment (n = 90), and stent‐related issues (n = 46). Conclusions Analysis of the MAUDE dataset is helpful in identifying the commonly reported adverse events and failure modes of FilterWire EZ devices. This platform serves as an important tool for both physicians and manufacturers to optimize device performance and clinical outcomes.

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Embolic Protection Devices in Patients with Renal Artery Stenosis with Chronic Renal Insufficiency: A Clinical Study

Cited by 17 publications

References 20 publications

Contemporary management of atherosclerotic renovascular disease

Contemporary management of atherosclerotic renovascular disease

Percutaneous revascularization for ischemic nephropathy: the past, present, and future

Adverse events and modes of failure related to the FilterWire EZ Embolic Protection System: Lessons learned from an analytic review of the FDA MAUDE database

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