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Safety and Success Rates of Excimer Laser Sheath–Assisted Retrieval of Embedded Inferior Vena Cava Filters

IMPORTANCE: Despite historically high rates of use, most inferior vena cava (IVC) filters are not retrieved. The US Food and Drug Administration safety communications recommended retrieval when the IVC filter is no longer indicated out of concern for filter-related complications. However, failure ra...

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Autores principales: Desai, Kush R., Kaufman, John, Truong, Parker, Lindquist, Jonathan D., Ahmed, Osman, Flanagan, Siobhan M., Garcia, Mark J., Ram, Rashmi, Gao, Yu-Rong, Lewandowski, Robert J., Ryu, Robert K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9856719/
https://www.ncbi.nlm.nih.gov/pubmed/36542378
http://dx.doi.org/10.1001/jamanetworkopen.2022.48159
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author Desai, Kush R.
Kaufman, John
Truong, Parker
Lindquist, Jonathan D.
Ahmed, Osman
Flanagan, Siobhan M.
Garcia, Mark J.
Ram, Rashmi
Gao, Yu-Rong
Lewandowski, Robert J.
Ryu, Robert K.
author_facet Desai, Kush R.
Kaufman, John
Truong, Parker
Lindquist, Jonathan D.
Ahmed, Osman
Flanagan, Siobhan M.
Garcia, Mark J.
Ram, Rashmi
Gao, Yu-Rong
Lewandowski, Robert J.
Ryu, Robert K.
author_sort Desai, Kush R.
collection PubMed
description IMPORTANCE: Despite historically high rates of use, most inferior vena cava (IVC) filters are not retrieved. The US Food and Drug Administration safety communications recommended retrieval when the IVC filter is no longer indicated out of concern for filter-related complications. However, failure rates are high when using standard techniques for retrieval of long-dwelling filters, and until recently, there have been no devices approved for retrieval of embedded IVC filters. OBJECTIVE: To evaluate the safety and success of excimer laser sheath–assisted retrieval of embedded IVC filters. DESIGN, SETTING, AND PARTICIPANTS: A retrospective, multicenter, clinical cohort study of excimer laser sheath–assisted IVC filter retrievals from 7 US sites was conducted between March 1, 2012, and February 28, 2021, among 265 patients who underwent IVC filter retrieval using the laser. Patients were substratified between a high-volume single center and a multicenter data set. A blinded physician committee adjudicated reported complications and their association with use of the laser. EXPOSURES: Retrieval of IVC filters using excimer laser sheath. MAIN OUTCOMES AND MEASURES: The primary safety end point was device-related major complication rate (Society of Interventional Radiology categories C to F, which included any adverse event associated with morbidity or disability that increases the level of care, results in hospital admission, or substantially lengthens the hospital stay). The primary success end point was technical success of IVC filter retrieval. The primary end points were compared with literature-derived, meta-analysis–suggested target performance goals. RESULTS: The single-center experience included 139 participants (mean [SD] age, 52 [16] years; 78 female participants [56.1%]), and the multicenter experience included 126 participants (mean [SD] age, 52 [16] years; 75 female participants [59.5%]). The device-related major complication rate was 2.9% (4 of 139; 95% CI, 0.8%-7.2%; P = .001) for the single-center experience and 4.0% (5 of 126; 95% CI, 1.3%-9.0%; P = .01) for the multicenter experience, both of which were significantly lower than the primary safety performance goal (10%). No major complications were considered to be definitively associated with use of the laser. The technical success rate was 95.7% (133 of 139; 95% CI, 90.8%-98.4%; P = .007) for the single-center experience and 95.2% (120 of 126; 95% CI, 89.9%-98.2%; P = .02) for the multicenter experience, both of which were significantly higher than the primary performance goal (89.4%). CONCLUSIONS AND RELEVANCE: This cohort study demonstrated high technical success and low complication rates of excimer laser sheath–assisted retrieval of embedded IVC filters in centers with variable case volume and experience, which suggests a wide applicability of the technique with proper training. The excimer laser sheath offers physicians a valuable tool for retrieval of challenging embedded IVC filters.
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spelling pubmed-98567192023-02-03 Safety and Success Rates of Excimer Laser Sheath–Assisted Retrieval of Embedded Inferior Vena Cava Filters Desai, Kush R. Kaufman, John Truong, Parker Lindquist, Jonathan D. Ahmed, Osman Flanagan, Siobhan M. Garcia, Mark J. Ram, Rashmi Gao, Yu-Rong Lewandowski, Robert J. Ryu, Robert K. JAMA Netw Open Original Investigation IMPORTANCE: Despite historically high rates of use, most inferior vena cava (IVC) filters are not retrieved. The US Food and Drug Administration safety communications recommended retrieval when the IVC filter is no longer indicated out of concern for filter-related complications. However, failure rates are high when using standard techniques for retrieval of long-dwelling filters, and until recently, there have been no devices approved for retrieval of embedded IVC filters. OBJECTIVE: To evaluate the safety and success of excimer laser sheath–assisted retrieval of embedded IVC filters. DESIGN, SETTING, AND PARTICIPANTS: A retrospective, multicenter, clinical cohort study of excimer laser sheath–assisted IVC filter retrievals from 7 US sites was conducted between March 1, 2012, and February 28, 2021, among 265 patients who underwent IVC filter retrieval using the laser. Patients were substratified between a high-volume single center and a multicenter data set. A blinded physician committee adjudicated reported complications and their association with use of the laser. EXPOSURES: Retrieval of IVC filters using excimer laser sheath. MAIN OUTCOMES AND MEASURES: The primary safety end point was device-related major complication rate (Society of Interventional Radiology categories C to F, which included any adverse event associated with morbidity or disability that increases the level of care, results in hospital admission, or substantially lengthens the hospital stay). The primary success end point was technical success of IVC filter retrieval. The primary end points were compared with literature-derived, meta-analysis–suggested target performance goals. RESULTS: The single-center experience included 139 participants (mean [SD] age, 52 [16] years; 78 female participants [56.1%]), and the multicenter experience included 126 participants (mean [SD] age, 52 [16] years; 75 female participants [59.5%]). The device-related major complication rate was 2.9% (4 of 139; 95% CI, 0.8%-7.2%; P = .001) for the single-center experience and 4.0% (5 of 126; 95% CI, 1.3%-9.0%; P = .01) for the multicenter experience, both of which were significantly lower than the primary safety performance goal (10%). No major complications were considered to be definitively associated with use of the laser. The technical success rate was 95.7% (133 of 139; 95% CI, 90.8%-98.4%; P = .007) for the single-center experience and 95.2% (120 of 126; 95% CI, 89.9%-98.2%; P = .02) for the multicenter experience, both of which were significantly higher than the primary performance goal (89.4%). CONCLUSIONS AND RELEVANCE: This cohort study demonstrated high technical success and low complication rates of excimer laser sheath–assisted retrieval of embedded IVC filters in centers with variable case volume and experience, which suggests a wide applicability of the technique with proper training. The excimer laser sheath offers physicians a valuable tool for retrieval of challenging embedded IVC filters. American Medical Association 2022-12-21 /pmc/articles/PMC9856719/ /pubmed/36542378 http://dx.doi.org/10.1001/jamanetworkopen.2022.48159 Text en Copyright 2022 Desai KR et al. JAMA Network Open. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the CC-BY-NC-ND License.
spellingShingle Original Investigation
Desai, Kush R.
Kaufman, John
Truong, Parker
Lindquist, Jonathan D.
Ahmed, Osman
Flanagan, Siobhan M.
Garcia, Mark J.
Ram, Rashmi
Gao, Yu-Rong
Lewandowski, Robert J.
Ryu, Robert K.
Safety and Success Rates of Excimer Laser Sheath–Assisted Retrieval of Embedded Inferior Vena Cava Filters
title Safety and Success Rates of Excimer Laser Sheath–Assisted Retrieval of Embedded Inferior Vena Cava Filters
title_full Safety and Success Rates of Excimer Laser Sheath–Assisted Retrieval of Embedded Inferior Vena Cava Filters
title_fullStr Safety and Success Rates of Excimer Laser Sheath–Assisted Retrieval of Embedded Inferior Vena Cava Filters
title_full_unstemmed Safety and Success Rates of Excimer Laser Sheath–Assisted Retrieval of Embedded Inferior Vena Cava Filters
title_short Safety and Success Rates of Excimer Laser Sheath–Assisted Retrieval of Embedded Inferior Vena Cava Filters
title_sort safety and success rates of excimer laser sheath–assisted retrieval of embedded inferior vena cava filters
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9856719/
https://www.ncbi.nlm.nih.gov/pubmed/36542378
http://dx.doi.org/10.1001/jamanetworkopen.2022.48159
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