title: Safety and feasibility of percutaneous delivery of a novel circulatory assist device (CircuLite® SYNERGY®) in the swine model.
abstract: OBJECTIVE
  To demonstrate the feasibility and safety of percutaneous delivery of the novel inflow cannula of the CircuLite® SYNERGY® pocket Micro-pump via transseptal access in the swine model.
  
  
  RESULTS
  After transseptal puncture, the inflow cannula system was advanced into the left atrium (LA) via the right external jugular vein and anchored onto the atrial septum under fluoroscopic and intracardiac echo guidance in 14 acute animals. Subsequently, chronic studies were performed to examine the long-term healing response to the cannula implantation with an artery-LA shunt (n=10) and overall safety of the Micro-pump components (n=6). Acute studies proved the concept of transcatheter delivery of the inflow cannula via superior venous access. The cannula tips were securely anchored in all chronic animals and appropriately endothelialised as early as two weeks. No thrombi or septal damage was observed. For the chronic pump group, device speed of 22,000 rpm (~2.0 L/min) was maintained without any adverse cardiac events. Plasma free haemoglobin assays confirmed the absence of clinically significant haemolysis.
  
  
  CONCLUSIONS
  The transcatheter delivery of the inflow cannula via superior venous access to the LA is feasible and safe. This percutaneous delivery presents a significantly less invasive alternative to deliver partial circulatory support devices.
authors.affiliation: Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, Orangeburg, NY 10962, USA.
authors.forename: Geng-Hua
authors.initials: GH
authors.lastname: Yi
authors.forename: Yanping
authors.initials: Y
authors.lastname: Cheng
authors.forename: Michael S
authors.initials: MS
authors.lastname: Aboodi
authors.forename: Robert
authors.initials: R
authors.lastname: Farnan
authors.forename: Saibal
authors.initials: S
authors.lastname: Kar
authors.forename: Daniel
authors.initials: D
authors.lastname: Burkhoff
authors.forename: Gail
authors.initials: G
authors.lastname: Farnan
authors.forename: Juan F
authors.initials: JF
authors.lastname: Granada
mesh_terms: D000818:Animals; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D005240:Feasibility Studies; D006353:Heart-Assist Devices; D023421:Models, Animal; D011474:Prosthesis Design; D013552:Swine; D013997:Time Factors; D014945:Wound Healing