Medtronic received information from a literature article regarding a comprehensive assessment of long-term survival and reintervention outcomes after transcatheter aortic valve-in-valve (viv) implantation.All data were retrospectively collected from the multi-center vivid (valve in valve international data) registry between april 2007 and december 2014.The study population included 1,006 patients and was predominantly male with a mean age of 78 years and a mean weight of 75 kg.Of those, 525 underwent transcatheter aortic viv implantation with medtronic transcatheter valves: corevalve or evolut r (523), and melody (2).No serial numbers were provided.Among all patients, 10 intra-procedural deaths occurred.Of those, 0.8% were treated with corevalve or evolut r.No further details were provided.Based on the available information, medtronic product was not directly associated with the deaths.Among all patients, adverse events included: second transcatheter valve implanted during the index viv procedure; permanent pacemaker implantation; valve malposition; major stroke; coronary obstruction; mild to severe aortic regurgitation (observed with corevalve and evolut r); mild to moderate aortic regurgitation (observed with melody); major vascular complications (observed with corevalve and evolut r); major bleeding; and post-procedural mean gradient greater than or equal to 20 mmhg.Types of reintervention performed over the long-term follow-up: redo transcatheter aortic valve replacement; surgical aortic valve replacement; and balloon aortic valvuloplasty.The causes of reintervention included: stenosis; regurgitation; mixed stenosis/regurgitation; endocarditis; valve thrombosis; and unknown.Based on the available information, medtronic product was associated with the adverse events.No additional adverse patient effects or product performance issues were reported.
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