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

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 Adapt...

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Bibliographic Details
Published in:Journal of clinical medicine 2024-03, Vol.13 (6), p.1635
Main Authors: Mwipatayi, Bibombe Patrice, Dodd, James, Hanna, Joseph, Gouëffic, Yann, Brodmann, Marianne, Guerra, Mercedes, Schmidt, Andrej, Loewe, Christian, Grözinger, Gerd, Korosoglou, Grigorios, Lichtenberg, Michael, Deloose, Koen
Format: Article
Language:English
Subjects:
Amputation
Angioplasty
Arterial occlusions
Atherosclerosis
Diagnosis
Diagnosis, Ultrasonic
Dissection
Femoral artery
Health aspects
Ischemia
Medical imaging
Patient outcomes
Patients
Popliteal artery
Stents
Success
Surgery, Experimental
Surgical research
Transluminal angioplasty
Ultrasonic imaging
Veins & arteries
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Summary: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. 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. 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. The addition of DUS to angiography showed limited value for detecting FLD in femoropopliteal artery disease.
ISSN:2077-0383
2077-0383
DOI:10.3390/jcm13061635