6533b851fe1ef96bd12a977f
RESEARCH PRODUCT
Early outcomes with a single-sided access endovascular stent
Marc Van SambeekGilbert PuippeRalf KolvenbachDavid PlanerRoberto ChiesaFranco NessiDominique BettexDjordje RadakMario LachatMichael HofmannEnrico VecchiatiRoberto SilingardiJan BrunkwallFelice PecoraroFelice PecoraroThomas PfammatterLyubov ChaykovskaGioacchino CoppiLazar DavidovicFrank J. VeithFrank J. Veithsubject
Malemedicine.medical_specialtyTime FactorsTime Factormedicine.medical_treatment030204 cardiovascular system & hematologyProsthesis DesignAortographySettore MED/22 - Chirurgia Vascolare03 medical and health sciencesAortic aneurysmBlood Vessel Prosthesis ImplantationPostoperative Complications0302 clinical medicineAneurysmBlood vessel prosthesismedicineStentHumansAged; Aortic Aneurysm Abdominal; Aortography; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Europe; Female; Humans; Male; Middle Aged; Postoperative Complications; Prospective Studies; Prosthesis Design; Time Factors; Tomography X-Ray Computed; Treatment Outcome; Blood Vessel Prosthesis; StentsProspective Studies030212 general & internal medicineStrokeAgedEndovascular Procedurebusiness.industryEndovascular ProceduresStentPerioperativeMiddle Agedmedicine.diseaseBlood Vessel ProsthesisSurgeryEuropeProspective StudieBlood Vessel ProsthesiTreatment OutcomeStentsFemaleSurgeryPostoperative ComplicationParaplegiabusinessTomography X-Ray ComputedCardiology and Cardiovascular MedicineAbdominal surgeryAortic Aneurysm AbdominalHumandescription
Abstract Objective The objective of this study was to report the 1-year follow-up study results of the new Horizon stent graft (Endospan, Herzliya, Israel) from two different prospective consecutive trials. The Horizon abdominal aortic aneurysm stent graft system is a 14F profile system requiring only a single access site. It consists of three modules, introduced separately: base limb (iliac to iliac limb); distal aortic limb; and proximal aortic limb with a bare suprarenal crown and active fixation. Methods Data from the first in man (FIM) clinical study with 10 patients enrolled and the pivotal study with 30 patients were analyzed. Outcomes measured were freedom from major adverse events (MAEs) including all-cause mortality, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, bowel ischemia, and procedural blood loss ≥1000 mL. Performance end points included successful delivery and deployment of the device, freedom from aneurysm growth ≥5 mm, type I or type III endoleak, stent graft occlusion, conversion to open surgery, rupture, and stent graft migration. Results In the FIM study, one conversion to open surgery with >1000 mL of blood loss was registered perioperatively. In the pivotal study, no perioperative MAE was registered. Overall, at 1-year follow-up, two deaths and one aneurysm growth unrelated to endoleak were registered. Conclusions The results of both the FIM and pivotal studies demonstrated that 39 of 40 procedures were successful for delivery and deployment of the Horizon stent graft. No MAE was registered during the follow-up. The primary safety and performance end points were met in both studies.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2018-01-01 |