000 03302nam a22003857a 4500
008 190521s20192019 xxu||||| |||| 00| 0 eng d
022 _a1753-4658
024 _a10.1177/1753466619841234 [doi]
024 _aPMC6454637 [pmc]
040 _aOvid MEDLINE(R)
099 _a30958102
245 _aFiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study.
251 _aTherapeutic Advances in Respiratory Disease. 13:1753466619841234, 2019 Jan-Dec.
252 _aTherap. adv. respir. dis.. 13:1753466619841234, 2019 Jan-Dec.
253 _aTherapeutic advances in respiratory disease
260 _c2019
260 _fFY2019
265 _sppublish
266 _d2019-05-21
520 _aBACKGROUND: Fiducial markers (FMs) help direct stereotactic body radiation therapy (SBRT) and localization for surgical resection in lung cancer management. We report the safety, accuracy, and practice patterns of FM placement utilizing electromagnetic navigation bronchoscopy (ENB).
520 _aCONCLUSION: ENB is an accurate and versatile tool to place FMs for SBRT and localization for surgical resection with low complication rates. The ability to perform a biopsy safely in the same procedure can also increase efficiency. The impact of practice pattern variations on therapeutic effectiveness requires further study.
520 _aMETHODS: NAVIGATE is a global, prospective, multicenter, observational cohort study of ENB using the superDimensionTM navigation system. This prospectively collected subgroup analysis presents the patient demographics, procedural characteristics, and 1-month outcomes in patients undergoing ENB-guided FM placement. Follow up through 24 months is ongoing.
520 _aRESULTS: Two-hundred fifty-eight patients from 21 centers in the United States were included. General anesthesia was used in 68.2%. Lesion location was confirmed by radial endobronchial ultrasound in 34.5% of procedures. The median ENB procedure time was 31.0 min. Concurrent lung lesion biopsy was conducted in 82.6% (213/258) of patients. A mean of 2.2 +/- 1.7 FMs (median 1.0 FMs) were placed per patient and 99.2% were accurately positioned based on subjective operator assessment. Follow-up imaging showed that 94.1% (239/254) of markers remained in place. The procedure-related pneumothorax rate was 5.4% (14/258) overall and 3.1% (8/258) grade 2 based on the Common Terminology Criteria for Adverse Events scale. The procedure-related grade 4 respiratory failure rate was 1.6% (4/258). There were no bronchopulmonary hemorrhages.
520 _aTRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02410837.
546 _aEnglish
650 _aIN PROCESS -- NOT YET INDEXED
651 _aMedStar Franklin Square Medical Center
656 _aAngelos Center for Lung Disease
657 _aJournal Article
657 _aResearch Support, Non-U.S. Gov't
700 _aKrimsky, William S
790 _aAnciano CJ, Bowling MR, Folch EE, Kazakov J, Khandhar SJ, Krimsky WS, LeMense GP, Linden PA, Murillo BA, Nead MA, Pritchett MA, Teba CV, Towe CW, Williams T
856 _uhttps://dx.doi.org/10.1177/1753466619841234
_zhttps://dx.doi.org/10.1177/1753466619841234
942 _cART
_dArticle
999 _c4281
_d4281