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Preventing Lower Extremity Distal Embolization Using Embolic Filter Protection:Results of the PROTECT Registry
- Source :
- Journal of Endovascular Therapy. 15:270-276
- Publication Year :
- 2008
- Publisher :
- International Society of Endovascular Specialists, 2008.
-
Abstract
- To report the results from a single-center prospective registry (PROTECT) established to evaluate the safety and effectiveness of embolic filter protection (EFP) in reducing distal embolization during percutaneous lower extremity interventions.Patients undergoing angioplasty, stenting, or SilverHawk atherectomy and adjunctive balloon angioplasty for infrainguinal occlusive disease were eligible if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification of any length, (2) total occlusions of any length, (3) a filling defect, (4) irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulcerated lesions at least 50 mm in length. The primary angiographic outcome was the ability of the filter to prevent angiographically visible distal embolization, slow flow, and loss of distal tibial runoff with or without capturing macrodebris.Forty patients (23 men; mean age 71.4+/-11.5 years) with 56 lesions (42 de novo and 14 restenotic) underwent treatment with angioplasty/stenting (group A, n = 29; 43 lesions) or SilverHawk atherectomy (group B, n = 11; 13 lesions). One filter was used per patient (25 SpiderFX and 15 EmboShield). Macroembolization occurred in 22 (55.0%) patients, 11 (37.9%) in group A and 11 (100%) in group B (p0.001). Clinically significant (or =2 mm in diameter) macrodebris was found in 18 (45.0%) patients: 8 (27.6%) in group A and 10 (90.9%) in group B (p0.001). All filters were retrieved successfully with no complications. One side-branch embolization occurred proximal to the filter. In another case, the filter was overfilled, resulting in no distal flow; it was retrieved, with subsequent tibial embolization when the procedure was continued without protection.Macroembolization is very frequent in patients undergoing lower extremity interventions, particularly with SilverHawk atherectomy. EFP appears to be very effective in capturing macrodebris, and its use is associated with good acute angiographic outcome. The clinical significance of these findings needs to be determined in future studies.
- Subjects :
- Male
medicine.medical_specialty
Atherectomy
Percutaneous
medicine.medical_treatment
Embolism
Balloon
Risk Assessment
Severity of Illness Index
Lesion
Risk Factors
Angioplasty
medicine
Humans
Radiology, Nuclear Medicine and imaging
Prospective Studies
Registries
Embolization
Prospective cohort study
Device Removal
Aged
Aged, 80 and over
Peripheral Vascular Diseases
business.industry
Stent
Equipment Design
Middle Aged
Surgery
Radiography
Logistic Models
Treatment Outcome
Lower Extremity
Female
Stents
Radiology
medicine.symptom
Cardiology and Cardiovascular Medicine
business
Angioplasty, Balloon
Filtration
Subjects
Details
- ISSN :
- 15451550 and 15266028
- Volume :
- 15
- Database :
- OpenAIRE
- Journal :
- Journal of Endovascular Therapy
- Accession number :
- edsair.doi.dedup.....304c19076ec7c84f038897583d8ff22e