The DETOUR procedure: no more need for conventional bypass surgery?
Autor: | Janis Savlovskis, Dainis Krievins, Edgars Zellans, Andrew Hill, Kaspars Kisis, Marcis Gedins, Andrew Holden, Natalija Ezite |
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Rok vydání: | 2018 |
Předmět: |
Male
medicine.medical_specialty Time Factors Percutaneous Computed Tomography Angiography Deep vein medicine.medical_treatment Femoral vein Constriction Pathologic Femoral artery 030204 cardiovascular system & hematology 030218 nuclear medicine & medical imaging Blood Vessel Prosthesis Implantation Peripheral Arterial Disease 03 medical and health sciences 0302 clinical medicine Recurrence Blood vessel prosthesis medicine.artery medicine Humans Prospective Studies Vascular Patency Aged Aged 80 and over business.industry Endovascular Procedures Stent Phlebography General Medicine Middle Aged Latvia Popliteal artery Blood Vessel Prosthesis Surgery Femoral Artery Treatment Outcome medicine.anatomical_structure Bypass surgery Female Stents Cardiology and Cardiovascular Medicine business |
Zdroj: | The Journal of Cardiovascular Surgery. 59 |
ISSN: | 1827-191X 0021-9509 |
Popis: | Background Long segment occlusive disease in the superficial femoral artery remains a treatment challenge despite advances in open surgical and endovascular approaches. We report initial clinical results of an entirely new procedure to perform percutaneous femoro-popliteal bypass using the DETOUR System. First-in-human patients were performed in New Zealand from December 2013 to June 2014. After modifications to the technique and devices had significantly refined the procedure, the Detour I Trial commenced. Methods Review of initial results in the first five patients treated at a single site enrolled in IRB-approved, prospective clinical study using the DETOUR System. All patients signed informed consent with planned 2-year follow-up. The DETOUR System was used to create a stent graft bypass which originates in the SFA, travels through the femoral vein, and ends in the popliteal artery, bypassing the diseased segment. Results A cohort of patients were treated in Latvia from January 2015 to October 2015. The initial five patients in this cohort (age 67.2±11.4 years) with long femoral artery occlusions (29.5±14.1 cm) were treated at a single clinical site. TORUS stent grafts were successfully implanted in all 5 patients (100%) using an 8F delivery system. There were no perioperative 30-day major adverse events (death, major bleeding, deep vein thrombosis, target vessel revascularization or major amputation) observed. At 24 months' follow-up, the primary patency rate was 80% (4/5) and primary assisted patency was 100% (5/5). Significant improvement in ankle-brachial index and Rutherford class were observed in all patients. There was a single secondary procedure performed in these patients (proximal stent edge stenosis at 24 months). The venous function has not been damaged or compromised in any patient. Conclusions Early results suggest that properly-selected patients with long-segment occlusive disease above the knee can be safely treated using the DETOUR System for percutaneous bypass, with favorable clinical outcomes extending to 2 years. Further clinical investigation is warranted to evaluate the role of this approach in the treatment of long femoral lesions. |
Databáze: | OpenAIRE |
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