Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System

Simple item page
dc.contributor.authorHalena, Grzegorz
dc.contributor.authorKrievins, Dainis K.
dc.contributor.authorScheinert, Dierk
dc.contributor.authorSavlovskis, Janis
dc.contributor.authorSzopinski, Piotr
dc.contributor.authorKramer, Albrecht
dc.contributor.authorOuriel, Kenneth
dc.contributor.authorSchmidt, Andrej
dc.contributor.authorZdunek, Michal
dc.contributor.authorLyden, Sean P.
dc.date.accessioned2025-01-20T22:01:53Z
dc.date.available2025-01-20T22:01:53Z
dc.date.issued2022
dc.description.abstractPurpose: This study investigated the 2-year safety and effectiveness of the PQ Bypass DETOUR system as a percutaneous femoropopliteal bypass. Materials and Methods: Seventy-eight patients with 82 long-segment femoropopliteal lesions were enrolled in this prospective, single-arm, multicenter study. The DETOUR system deployed Torus stent grafts directed through a transvenous route. Eligible patients included those with lesions of >10 cm and average of 371 +/- 55 mm. Key safety endpoints included major adverse events (MAEs) and symptomatic deep venous thrombosis in the target limb. Effectiveness endpoints included primary patency defined as freedom from >= 50% stenosis, occlusion, or clinically-driven target vessel revascularization (CD-TVR), primary assisted, and secondary patency. Results: Chronic total occlusions and severe calcium occurred in 96% and 67% of lesions, respectively. Core laboratory-assessed total lesion length averaged 371 +/- 51 mm with a mean occlusion length of 159 +/- 88 mm. The rates of technical and procedural success were 96%, with satisfactory delivery and deployment of the device without in-hospital MAEs in 79/82 limbs. The MAE rate was 22.0%, with 3 unrelated deaths (4%), 12 CD-TVRs (16%), and 1 major amputation (1%). Deep venous thrombosis developed in 2.8% of target limbs, and there were no reported pulmonary emboli. Primary, assisted primary, and secondary patency rates by the Kaplan-Meier analysis were 79 +/- 5%, 79 +/- 5%, and 86 +/- 4%, respectively. Conclusions: The PQ Bypass DETOUR system is a safe and effective percutaneous alternative to femoropopliteal open bypass with favorable results through 2 years. The DETOUR system provides a durable alternative to conventional endovascular modalities and open surgery for patients with long, severely calcified, or occluded femoropopliteal lesions.
dc.description.funderPQ Bypass, Milpitas, CA, USA
dc.fuente.origenWOS
dc.identifier.doi10.1177/15266028211034862
dc.identifier.eissn1545-1550
dc.identifier.issn1526-6028
dc.identifier.urihttps://doi.org/10.1177/15266028211034862
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/93903
dc.identifier.wosidWOS:000691851000001
dc.issue.numero1
dc.language.isoen
dc.pagina.final95
dc.pagina.inicio84
dc.revistaJournal of endovascular therapy
dc.rightsacceso restringido
dc.subjectfemoropopliteal artery disease
dc.subjectbypass
dc.subjectendovascular
dc.subjectclaudication
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titlePercutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System
dc.typeartículo
dc.volumen29
sipa.indexWOS
sipa.trazabilidadWOS;2025-01-12
Files
Collections
Artículos de revistas