Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment

<b>Background:</b> The BIO REACT study is designed to investigate the incremental value of Extravascular UltraSound (EVUS) added to conventional angiography, compared to conventional angiography only for the identification of Flow-Limiting Dissections (FLD) and to evaluate the safety and...

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Main Authors: Bibombe Patrice Mwipatayi, James Dodd, Joseph Hanna, Yann Gouëffic, Marianne Brodmann, Mercedes Guerra, Andrej Schmidt, Christian Loewe, Gerd Grözinger, Grigorios Korosoglou, Michael Lichtenberg, Koen Deloose
Format: Article
Language:English
Published: MDPI AG 2024-03-01
Series:Journal of Clinical Medicine
Subjects:
Online Access:https://www.mdpi.com/2077-0383/13/6/1635
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author Bibombe Patrice Mwipatayi
James Dodd
Joseph Hanna
Yann Gouëffic
Marianne Brodmann
Mercedes Guerra
Andrej Schmidt
Christian Loewe
Gerd Grözinger
Grigorios Korosoglou
Michael Lichtenberg
Koen Deloose
author_facet Bibombe Patrice Mwipatayi
James Dodd
Joseph Hanna
Yann Gouëffic
Marianne Brodmann
Mercedes Guerra
Andrej Schmidt
Christian Loewe
Gerd Grözinger
Grigorios Korosoglou
Michael Lichtenberg
Koen Deloose
author_sort Bibombe Patrice Mwipatayi
collection DOAJ
description <b>Background:</b> The BIO REACT study is designed to investigate the incremental value of Extravascular UltraSound (EVUS) added to conventional angiography, compared to conventional angiography only for the identification of Flow-Limiting Dissections (FLD) and to evaluate the safety and efficacy of the REsponse Adapted Combination Therapy (REACT) for the treatment of femoropopliteal lesions. <b>Methods:</b> The primary endpoints were the specificity and sensitivity of EVUS added to angiography for the detection of FLD. Secondary endpoints were primary patency of the REACT therapy within 12 months, fCD-TLR, freedom from MAE, major target limb amputations (mTLA) and survival rates within 24 months. <b>Results:</b> A total of 150 patients were included. EVUS added to angiography had an overall sensitivity of 29% and specificity of 93% for the detection of FLD. There was no PSVR cut-off offering a clinically acceptable trade-off between meaningful sensitivity and specificity values for the detection of FLD. At 12 months, treatment with the REACT resulted in primary patency and fCD-TLR of 81.6% and 94.3%, respectively. In addition, freedom from MAE was 94.3% at 12 months. At 24 months, the survival rate was 94.0%. No mTLA was reported up to the 24-month follow-up. <b>Conclusions:</b> The addition of DUS to angiography showed limited value for detecting FLD in femoropopliteal artery disease.
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spelling doaj.art-bc4edb49e6ae4dd7980127f7bc4796a52024-03-27T13:47:54ZengMDPI AGJournal of Clinical Medicine2077-03832024-03-01136163510.3390/jcm13061635Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal SegmentBibombe Patrice Mwipatayi0James Dodd1Joseph Hanna2Yann Gouëffic3Marianne Brodmann4Mercedes Guerra5Andrej Schmidt6Christian Loewe7Gerd Grözinger8Grigorios Korosoglou9Michael Lichtenberg10Koen Deloose11Department of Vascular Surgery, Royal Perth Hospital, Perth 6000, AustraliaDepartment of Vascular Surgery, Royal Perth Hospital, Perth 6000, AustraliaDepartment of Vascular Surgery, Royal Perth Hospital, Perth 6000, AustraliaDepartment of Vascular and Endovascular Surgery, Groupe Hospitalier Paris St. Joseph, 75014 Paris, FranceDepartment of Angiology and Vascular Medicine, Medical University Graz, 8010 Graz, AustriaVascular and Endovascular Surgery Department, University Hospital of Guadalajara, 19002 Madrid, SpainDepartment of Interventional Angiology, University Hospital Leipzig, 04103 Leipzig, GermanyDepartment of Bioimaging and Image-Guided Therapy, Division of Cardiovascular and Interventional Radiology, Medical University of Vienna, 1090 Vienna, AustriaAbteilung für Diagnostische und Interventionelle Radiologie, University Hospital Tübingen, 72076 Tübingen, GermanyCardiology and Vascular Medicine, GRN Hospital Weinheim, 69469 Weinheim, GermanyVascular Center, Klinikum Arnsberg, 59821 Arnsberg, GermanyVascular Surgery, AZ Sint Blasius Hospital, 9200 Dendermonde, Belgium<b>Background:</b> The BIO REACT study is designed to investigate the incremental value of Extravascular UltraSound (EVUS) added to conventional angiography, compared to conventional angiography only for the identification of Flow-Limiting Dissections (FLD) and to evaluate the safety and efficacy of the REsponse Adapted Combination Therapy (REACT) for the treatment of femoropopliteal lesions. <b>Methods:</b> The primary endpoints were the specificity and sensitivity of EVUS added to angiography for the detection of FLD. Secondary endpoints were primary patency of the REACT therapy within 12 months, fCD-TLR, freedom from MAE, major target limb amputations (mTLA) and survival rates within 24 months. <b>Results:</b> A total of 150 patients were included. EVUS added to angiography had an overall sensitivity of 29% and specificity of 93% for the detection of FLD. There was no PSVR cut-off offering a clinically acceptable trade-off between meaningful sensitivity and specificity values for the detection of FLD. At 12 months, treatment with the REACT resulted in primary patency and fCD-TLR of 81.6% and 94.3%, respectively. In addition, freedom from MAE was 94.3% at 12 months. At 24 months, the survival rate was 94.0%. No mTLA was reported up to the 24-month follow-up. <b>Conclusions:</b> The addition of DUS to angiography showed limited value for detecting FLD in femoropopliteal artery disease.https://www.mdpi.com/2077-0383/13/6/1635extravascular ultrasoundflow-limiting dissectiondrug-coated balloonfemoropopliteal artery
spellingShingle Bibombe Patrice Mwipatayi
James Dodd
Joseph Hanna
Yann Gouëffic
Marianne Brodmann
Mercedes Guerra
Andrej Schmidt
Christian Loewe
Gerd Grözinger
Grigorios Korosoglou
Michael Lichtenberg
Koen Deloose
Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment
Journal of Clinical Medicine
extravascular ultrasound
flow-limiting dissection
drug-coated balloon
femoropopliteal artery
title Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment
title_full Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment
title_fullStr Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment
title_full_unstemmed Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment
title_short Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment
title_sort intraoperative extravascular ultrasound in the identification of flow limiting dissections after balloon angioplasty in the femoropopliteal segment
topic extravascular ultrasound
flow-limiting dissection
drug-coated balloon
femoropopliteal artery
url https://www.mdpi.com/2077-0383/13/6/1635
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