PMID- 34656103
OWN - NLM
STAT- MEDLINE
DCOM- 20220207
LR  - 20220207
IS  - 1471-2466 (Electronic)
IS  - 1471-2466 (Linking)
VI  - 21
IP  - 1
DP  - 2021 Oct 16
TI  - Shape-sensing robotic-assisted bronchoscopy for pulmonary nodules: initial 
      multicenter experience using the Ion Endoluminal System.
PG  - 322
LID - 10.1186/s12890-021-01693-2 [doi]
LID - 322
AB  - BACKGROUND: Traditional bronchoscopy provides limited approach to peripheral 
      nodules. Shape-sensing robotic-assisted bronchoscopy (SSRAB, Ion Endoluminal 
      System) is a new tool for minimally invasive peripheral nodule biopsy. We sought 
      to answer the research question: Does SSRAB facilitate sampling of pulmonary 
      nodules during bronchoscopists' initial experience? METHODS: The lead-in stage of 
      a multicenter, single-arm, prospective evaluation of the Ion Endoluminal System 
      (PRECIsE) is described. Enrolled subjects >/= 18 years old had recent computed 
      tomography evidence of one or more solid or semi-solid pulmonary nodules >/= 1.0 
      to </= 3.5 cm in greatest dimension and in any part of the lung. Subjects were 
      followed at 10- and 30-days post-procedure. This stage provided investigators and 
      staff their first human experience with the SSRAB system; safety and procedure 
      outcomes were analyzed descriptively. Neither diagnostic yield nor sensitivity 
      for malignancy were assessed in this stage. Categorical variables are summarized 
      by percentage; continuous variables are summarized by median/interquartile range 
      (IQR). RESULTS: Sixty subjects were enrolled across 6 hospitals; 67 nodules were 
      targeted for biopsy. Median axial, coronal and sagittal diameters were < 18 mm 
      with a largest cardinal diameter of 20.0 mm. Most nodules were extraluminal and 
      distance from the outer edge of the nodule to the pleura or nearest fissure was 
      4.0 mm (IQR: 0.0, 15.0). Median bronchial generation count to the target location 
      was 7.0 (IQR: 6.0, 8.0). Procedure duration (catheter-in to catheter-out) was 
      66.5 min (IQR: 50.0, 85.5). Distance from the catheter tip to the closest edge of 
      the virtual nodule was 7.0 mm (IQR: 2.0, 12.0). Biopsy completion was 97.0%. No 
      pneumothorax or airway bleeding of any grade was reported. CONCLUSIONS: 
      Bronchoscopists leveraged the Ion SSRAB's functionality to drive the catheter 
      safely in close proximity of the virtual target and to obtain biopsies. This 
      initial, multicenter experience is encouraging, suggesting that SSRAB may play a 
      role in the management of pulmonary nodules. Clinical Trial Registration 
      identifier and date NCT03893539; 28/03/2019.
CI  - (c) 2021. The Author(s).
FAU - Simoff, Michael J
AU  - Simoff MJ
AD  - Bronchoscopy and Interventional Pulmonology, Lung Cancer Screening Program, 
      Department of Pulmonary and Critical Care Medicine, Henry Ford Hospital, Wayne 
      State University School of Medicine, 2799 West Grand Blvd, Detroit, MI, 48202, 
      USA. MSimoff1@hfhs.org.
FAU - Pritchett, Michael A
AU  - Pritchett MA
AD  - Pulmonary Department, Pinehurst Medical Clinic, Pinehurst, NC, USA.
AD  - Pulmonary Department, First Health Moore Regional Hospital, Pinehurst, NC, USA.
FAU - Reisenauer, Janani S
AU  - Reisenauer JS
AD  - Department of Pulmonary Medicine and Thoracic Surgery, Mayo Clinic, Rochester, 
      MN, USA.
FAU - Ost, David E
AU  - Ost DE
AD  - Department of Pulmonary Medicine, The University of Texas MD Anderson Cancer 
      Center, Houston, TX, USA.
FAU - Majid, Adnan
AU  - Majid A
AD  - Department of Thoracic Surgery and Interventional Pulmonology, Beth Israel 
      Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
FAU - Keyes, Colleen
AU  - Keyes C
AD  - Department of Pulmonary and Critical Care Medicine, Massachusetts General 
      Hospital, Harvard Medical School, Boston, MA, USA.
FAU - Casal, Roberto F
AU  - Casal RF
AD  - Department of Pulmonary Medicine, The University of Texas MD Anderson Cancer 
      Center, Houston, TX, USA.
FAU - Parikh, Mihir S
AU  - Parikh MS
AD  - Department of Thoracic Surgery and Interventional Pulmonology, Beth Israel 
      Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
FAU - Diaz-Mendoza, Javier
AU  - Diaz-Mendoza J
AD  - Bronchoscopy and Interventional Pulmonology, Lung Cancer Screening Program, 
      Department of Pulmonary and Critical Care Medicine, Henry Ford Hospital, Wayne 
      State University School of Medicine, 2799 West Grand Blvd, Detroit, MI, 48202, 
      USA.
FAU - Fernandez-Bussy, Sebastian
AU  - Fernandez-Bussy S
AD  - Department of Pulmonary Medicine, Mayo Clinic, Jacksonville, FL, USA.
FAU - Folch, Erik E
AU  - Folch EE
AD  - Department of Pulmonary and Critical Care Medicine, Massachusetts General 
      Hospital, Harvard Medical School, Boston, MA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03893539
PT  - Journal Article
DEP - 20211016
PL  - England
TA  - BMC Pulm Med
JT  - BMC pulmonary medicine
JID - 100968563
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Biopsy/methods
MH  - Bronchoscopy/*methods
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multicenter Studies as Topic
MH  - Multiple Pulmonary Nodules/*pathology
MH  - Robotic Surgical Procedures/*methods
MH  - Solitary Pulmonary Nodule/*pathology
MH  - United States
PMC - PMC8520632
OTO - NOTNLM
OT  - Biopsy
OT  - Bronchoscopy
OT  - Ion
OT  - Pulmonary nodules
OT  - Robotic assistance
OT  - Shape sensing
COIS- MJS has received research and manuscript support from Intuitive Surgical and 
      consulting fees and research support from Gongwin Biopharm. MAP has received 
      consulting and speaker fees and research support from Johnson & Johnson, 
      Medtronic, BodyVision, and Intuitive Surgical; research support from Philips; 
      speaker fees and research support from Biodesix; consulting and speaker fees from 
      AstraZeneca; speaker fees from Boeinger-Ingleheim; speaker fees and research 
      support from United Therapeutics; speaker fees and research support from 
      Actelion; research support from Inivata; consulting fees from Boston Scientific; 
      consulting fees from OncoSec; consulting fees from Ambu; consulting fees and 
      stock from HealthMyne. JSR has received research support and an educational grant 
      from Intuitive Surgical. DEO has received research support, a research grant, and 
      consulting fees from Intuitive Surgical. AM has received research support from 
      Intuitive Surgical, consulting fees from Olympus America, and a research grant 
      from Bronchus Medical. CK has received consulting fees and research support from 
      Intuitive Surgical. RFC has received research support from Olympus, Concordia, 
      Intuitive Surgical, and Siemens and consulting fees from Olympus, Siemens, 
      Intuitive Surgical, Johnson & Johnson, and Bronx. MSP has received research 
      support and educational consultant fees from Intuitive Surgical. JD-M has 
      received research support from Intuitive Surgical. SF-B has received research 
      support from Intuitive Surgical. EEF has received a research grant from Intuitive 
      Surgical and consulting fees from Boston Scientific and Medtronic.
EDAT- 2021/10/18 06:00
MHDA- 2022/02/08 06:00
PMCR- 2021/10/16
CRDT- 2021/10/17 20:22
PHST- 2021/01/21 00:00 [received]
PHST- 2021/09/28 00:00 [accepted]
PHST- 2021/10/17 20:22 [entrez]
PHST- 2021/10/18 06:00 [pubmed]
PHST- 2022/02/08 06:00 [medline]
PHST- 2021/10/16 00:00 [pmc-release]
AID - 10.1186/s12890-021-01693-2 [pii]
AID - 1693 [pii]
AID - 10.1186/s12890-021-01693-2 [doi]
PST - epublish
SO  - BMC Pulm Med. 2021 Oct 16;21(1):322. doi: 10.1186/s12890-021-01693-2.