دورية أكاديمية
أعرض في EDS

Laser-Assisted Removal of Embedded Vena Cava Filters: A First-In-Human Escalation Trial in 500 Patients Refractory to High-Force Retrieval.

التفاصيل البيبلوغرافية
العنوان: Laser-Assisted Removal of Embedded Vena Cava Filters: A First-In-Human Escalation Trial in 500 Patients Refractory to High-Force Retrieval.
المؤلفون: Kuo WT; Division of Vascular and Interventional Radiology Stanford University School of Medicine Stanford CA., Doshi AA; Division of Vascular and Interventional Radiology Stanford University School of Medicine Stanford CA., Ponting JM; Division of Vascular and Interventional Radiology Stanford University School of Medicine Stanford CA., Rosenberg JK; Division of Vascular and Interventional Radiology Stanford University School of Medicine Stanford CA., Liang T; Division of Vascular and Interventional Radiology Stanford University School of Medicine Stanford CA., Hofmann LV; Division of Vascular and Interventional Radiology Stanford University School of Medicine Stanford CA.
المصدر: Journal of the American Heart Association [J Am Heart Assoc] 2020 Dec 15; Vol. 9 (24), pp. e017916. Date of Electronic Publication: 2020 Nov 30.
نوع المنشور: Clinical Trial; Comparative Study; Journal Article
اللغة: English
بيانات الدورية: Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 101580524 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2047-9980 (Electronic) Linking ISSN: 20479980 NLM ISO Abbreviation: J Am Heart Assoc Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Oxford : Wiley-Blackwell
مواضيع طبية MeSH: Device Removal/*methods , Lasers, Excimer/*statistics & numerical data , Vena Cava Filters/*adverse effects , Vena Cava, Inferior/*surgery, Acute Disease ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anticoagulants/therapeutic use ; Device Removal/statistics & numerical data ; Device Removal/trends ; Endovascular Procedures/instrumentation ; Female ; Humans ; Lasers, Excimer/adverse effects ; Lasers, Excimer/therapeutic use ; Male ; Middle Aged ; Prospective Studies ; Safety ; Treatment Outcome ; Vena Cava, Inferior/pathology ; Venous Thrombosis/etiology ; Venous Thrombosis/prevention & control ; Venous Thrombosis/therapy ; Withholding Treatment ; Young Adult
مستخلص: Background Many patients are subject to potential risks and filter-related morbidity when standard retrieval methods fail. We evaluated the safety and efficacy of the laser sheath technique for removing embedded inferior vena cava filters. Methods and Results Over an 8.5-year period, 500 patients were prospectively enrolled in an institutional review board-approved study. There were 225 men and 275 women (mean age, 49 years; range, 15-90 years). Indications for retrieval included symptomatic acute inferior vena cava thrombosis, chronic inferior vena cava occlusion, and/or pain from filter penetration. Retrieval was also offered to prevent risks from prolonged implantation and potentially to eliminate need for lifelong anticoagulation. After retrieval failed using 3X standard retrieval force (6-7 lb via digital gauge), treatment escalation was attempted using laser sheath powered by 308-nm XeCl excimer laser system (CVX-300; Spectranetics). We hypothesized that the laser-assisted technique would allow retrieval of >95% of embedded filters with <5% risk of major complications and with lower force. Primary outcome was successful retrieval. Primary safety outcome was any major procedure-related complication. Laser-assisted retrieval was successful in 99.4% of cases (497/500) (95% CI, 98.3%-99.9%) and significantly >95% ( P <0.0001). The mean filter dwell time was 1528 days (range, 37-10 047; >27.5 years]), among retrievable-type (n=414) and permanent-type (n=86) filters. The average force during failed attempts without laser was 6.4 versus 3.6 lb during laser-assisted retrievals ( P <0.0001). The major complication rate was 2.0% (10/500) (95% CI, 1.0%-3.6%), significantly <5% ( P <0.0005), 0.6% (3/500) (95% CI, 0%-1.3%) from laser, and all were successfully treated. Successful retrieval allowed cessation of anticoagulation in 98.7% (77/78) (95% CI, 93.1%-100.0%) and alleviated filter-related morbidity in 98.5% (138/140) (95% CI, 96.5%-100.0%). Conclusions The excimer laser sheath technique is safe and effective for removing embedded inferior vena cava filters refractory to high-force retrieval. This technique may allow cessation of filter-related anticoagulation and can be used to prevent and alleviate filter-related morbidity. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01158482.
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فهرسة مساهمة: Keywords: IVC filter; endovascular; filter retrieval; laser
سلسلة جزيئية: ClinicalTrials.gov NCT01158482
المشرفين على المادة: 0 (Anticoagulants)
تواريخ الأحداث: Date Created: 20201130 Date Completed: 20210315 Latest Revision: 20210318
رمز التحديث: 20240829
مُعرف محوري في PubMed: PMC7955387
DOI: 10.1161/JAHA.119.017916
PMID: 33252283
قاعدة البيانات: MEDLINE
الوصف
تدمد:2047-9980
DOI:10.1161/JAHA.119.017916