title: First human implantation of a new rotary blood pump: design of the clinical feasibility study.
abstract: Surgical treatment of heart failure is emerging as one of the most challenging clinical dilemmas for patients with end-stage cardiac failure not amenable to medical treatment. One of the most intriguing techniques is the use of implantable left ventricular assist devices (LVADs) as a bridge to recovery. The early experience from our centre has shown that even short term post-cardiotomy mechanical assistance, after heart failure surgery, improves patient outcome; thus, a clinical feasibility study was designed. The hypothesis of the study is that reparative heart failure surgery combined with postoperative mechanical support, ventricular resynchronisation where indicated, and pharmacological treatment can maximise myocardial recovery. In the study a new, implantable, magnetically levitated, rotary pump will be used as a bridge to recovery. In this manuscript the first worldwide human implantation of a new, continuous-flow LVAD, the WorldHeart Rotary Pump (Levacor, WorldHeart Inc., Oakland CA), is reported. The design and the rationale of the feasibility study, the inclusion and exclusion criteria, and the primary and secondary end points of the clinical investigation, are delineated. In addition, the design of the new rotary pump, its general principles of operation, and the implantation technique are described.
authors.affiliation: Thessaloniki Heart Institute, St. Luke's Hospital, Thessaloniki, Greece. apitsis@otenet.gr
authors.forename: Antonios A
authors.initials: AA
authors.lastname: Pitsis
authors.forename: Aikaterini N
authors.initials: AN
authors.lastname: Visouli
authors.forename: Vassilis
authors.initials: V
authors.lastname: Vassilikos
authors.forename: Vlasis N
authors.initials: VN
authors.lastname: Ninios
authors.forename: Petros D
authors.initials: PD
authors.lastname: Sfirakis
authors.forename: Nikolaos E
authors.initials: NE
authors.lastname: Mezilis
authors.forename: Petros S
authors.initials: PS
authors.lastname: Dardas
authors.forename: Gerasimos S
authors.initials: GS
authors.lastname: Filippatos
authors.forename: Georgios I
authors.initials: GI
authors.lastname: Bougioukas
authors.forename: Dimitrios T
authors.initials: DT
authors.lastname: Kremastinos
authors.forename: James W
authors.initials: JW
authors.lastname: Long
mesh_terms: D006348:Cardiac Surgical Procedures / Q000295:instrumentation* / Q000379:methods*; D004867:Equipment Design; D005240:Feasibility Studies; D006333:Heart Failure / Q000601:surgery; D006353:Heart-Assist Devices; D006801:Humans; D011446:Prospective Studies; D015203:Reproducibility of Results; D018487:Ventricular Dysfunction, Left / Q000601:surgery