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  1. Article ; Online: Identification of deliberate catheter motion at the left atrial posterior wall during pulmonary vein isolation: Validity of respiratory motion adjustment.

    Tomlinson, David R / Biscombe, Katie / True, John / Hosking, Joanne / Streeter, Adam J

    Journal of cardiovascular electrophysiology

    2021  Volume 32, Issue 4, Page(s) 994–1004

    Abstract: Background: During automated radiofrequency (RF) annotation-guided pulmonary vein isolation (PVI), respiratory motion adjustment (RMA) is recommended, yet lacks in vivo validation.: Methods: Following contact force (CF) PVI (continuous RF, 30 W) ... ...

    Abstract Background: During automated radiofrequency (RF) annotation-guided pulmonary vein isolation (PVI), respiratory motion adjustment (RMA) is recommended, yet lacks in vivo validation.
    Methods: Following contact force (CF) PVI (continuous RF, 30 W) using general anesthesia and automated RF annotation-guidance (VISITAG™: force-over-time 100% minimum 1 g; 2 mm position stability; ACCURESP™ RMA "off") in 25 patients, we retrospectively examined RMA settings "on" versus "off" at the left atrial posterior wall (LAPW).
    Results: Respiratory motion detection occurred in eight, permitting offline retrospective comparison of RMA settings. Significant differences in LAPW RF auto-annotation occurred according to RMA setting, with curves displaying catheter position, CF and impedance data indicating "best-fit" for catheter motion detection using RMA "off." Comparing RMA "on" versus "off," respectively: total annotated sites, 82 versus 98; median RF duration per-site, 13.3 versus 10.6 s (p < 0.0001); median force time integral 177 versus 130 gs (p = 0.0002); mean inter-tag distance (ITD), 6.0 versus 4.8 mm (p = 0.002). Considering LAPW annotated site 1-to-2 transitions resulting from deliberate catheter movement, 3 concurrent with inadvertent 0 g CF demonstrated < 0.6 s difference in RF duration. However, 13 deliberate catheter movements during constant tissue contact (ITD range: 2.1-7.0 mm) demonstrated (mean) site-1 RF duration difference 3.7 s (range: -1.3 to 11.3 s): considering multiple measures of catheter position instability, the appropriate indication of deliberate catheter motion occurred with RMA "off" in all.
    Conclusions: ACCURESP™ respiratory motion adjustment importantly delayed the identification of deliberate and clinically relevant catheter motion during LAPW RF delivery, rendering auto-annotated RF display invalid. Operators seeking greater accuracy during auto-annotated RF delivery should avoid RMA use.
    MeSH term(s) Atrial Fibrillation/diagnosis ; Atrial Fibrillation/surgery ; Catheter Ablation/adverse effects ; Catheters ; Humans ; Pulmonary Veins/diagnostic imaging ; Pulmonary Veins/surgery ; Retrospective Studies ; Treatment Outcome
    Language English
    Publishing date 2021-02-22
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1025989-2
    ISSN 1540-8167 ; 1045-3873
    ISSN (online) 1540-8167
    ISSN 1045-3873
    DOI 10.1111/jce.14945
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Improved Disease-Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer: Final Results of the POUT Trial.

    Birtle, Alison Jane / Jones, Robert / Chester, John / Lewis, Rebecca / Biscombe, Katie / Johnson, Mark / Blacker, Anthony / Bryan, Richard T / Catto, James W F / Choudhury, Ananya / Das, Prantik / Jagdev, Satinder / Powles, Thomas / Wagstaff, John / Cheung, Ka Ching / Cafferty, Fay / Hall, Emma

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    2024  Volume 42, Issue 13, Page(s) 1466–1471

    Abstract: Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial ... ...

    Abstract Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in
    MeSH term(s) Humans ; Nephroureterectomy/methods ; Chemotherapy, Adjuvant ; Female ; Disease-Free Survival ; Male ; Aged ; Middle Aged ; Carcinoma, Transitional Cell/drug therapy ; Carcinoma, Transitional Cell/mortality ; Carcinoma, Transitional Cell/surgery ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Urologic Neoplasms/drug therapy ; Urologic Neoplasms/mortality ; Urologic Neoplasms/surgery ; Urologic Neoplasms/pathology ; Ureteral Neoplasms/drug therapy ; Ureteral Neoplasms/mortality ; Ureteral Neoplasms/surgery ; Ureteral Neoplasms/pathology ; Kidney Neoplasms/drug therapy ; Kidney Neoplasms/mortality ; Kidney Neoplasms/surgery ; Kidney Neoplasms/pathology
    Language English
    Publishing date 2024-02-13
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Clinical Trial, Phase III ; Research Support, Non-U.S. Gov't ; Multicenter Study
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.23.01659
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Interim Toxicity Analysis From the Randomized HERMES Trial of 2- and 5-Fraction Magnetic Resonance Imaging-Guided Adaptive Prostate Radiation Therapy.

    Westley, Rosalyne Laura / Biscombe, Katie / Dunlop, Alex / Mitchell, Adam / Oelfke, Uwe / Nill, Simeon / Murray, Julia / Pathmanathan, Angela / Hafeez, Shaista / Parker, Chris / Ratnakumaran, Ragu / Alexander, Sophie / Herbert, Trina / Hall, Emma / Tree, Alison C

    International journal of radiation oncology, biology, physics

    2023  Volume 118, Issue 3, Page(s) 682–687

    Abstract: Purpose: Ultrahypofractionated radiation therapy (UHRT) is an effective treatment for localized prostate cancer with an acceptable toxicity profile; boosting the visible intraprostatic tumor has been shown to improve biochemical disease-free survival ... ...

    Abstract Purpose: Ultrahypofractionated radiation therapy (UHRT) is an effective treatment for localized prostate cancer with an acceptable toxicity profile; boosting the visible intraprostatic tumor has been shown to improve biochemical disease-free survival with no significant effect on genitourinary (GU) and gastrointestinal (GI) toxicity.
    Methods and materials: HERMES is a single-center noncomparative randomized phase 2 trial in men with intermediate or lower high risk prostate cancer. Patients were allocated (1:1) to 36.25 Gy in 5 fractions over 2 weeks or 24 Gy in 2 fractions over 8 days with an integrated boost to the magnetic resonance imaging (MRI) visible tumor of 27 Gy in 2 fractions. A minimization algorithm with a random element with risk group as a balancing factor was used for participant randomization. Treatment was delivered on the Unity MR-Linac (Elekta AB) with daily online adaption. The primary endpoint was acute GU Common Terminology Criteria for Adverse Events version 5.0 toxicity with the aim of excluding a doubling of the rate of acute grade 2+ GU toxicity seen in PACE. Analysis was by treatment received and included all participants who received at least 1 fraction of study treatment. This interim analysis was prespecified (stage 1 of a 2-stage Simon design) for when 10 participants in each treatment group had completed the acute toxicity monitoring period (12 weeks after radiation therapy).
    Results: Acute grade 2 GU toxicity was reported in 1 (10%) patient in the 5-fraction group and 2 (20%) patients in the 2-fraction group. No grade 3+ GU toxicities were reported.
    Conclusions: At this interim analysis, the rate of GU toxicity in the 2-fraction and 5-fraction treatment groups was found to be below the prespecified threshold (5/10 grade 2+) and continuation of the study to complete recruitment of 23 participants per group was recommended.
    MeSH term(s) Humans ; Male ; Gastrointestinal Diseases ; Magnetic Resonance Imaging ; Pelvis ; Prostate/pathology ; Prostatic Neoplasms/diagnostic imaging ; Prostatic Neoplasms/radiotherapy ; Prostatic Neoplasms/pathology ; Urogenital System/radiation effects ; Randomized Controlled Trials as Topic ; Clinical Trials, Phase II as Topic
    Language English
    Publishing date 2023-09-29
    Publishing country United States
    Document type Journal Article
    ZDB-ID 197614-x
    ISSN 1879-355X ; 0360-3016
    ISSN (online) 1879-355X
    ISSN 0360-3016
    DOI 10.1016/j.ijrobp.2023.09.032
    Database MEDical Literature Analysis and Retrieval System OnLINE

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