title: Suction catheter for enhanced control and accuracy of transseptal access.
abstract: OBJECTIVE
  Percutaneous structural heart therapies, such as mitral value repair, require site-specific transseptal access (TSA). This can be challenging for interventional cardiologists. We describe a TSA catheter (TSAC) that utilises suction for enhanced control and puncture accuracy. Here, we aim to evaluate the safety and efficacy of the device.
  
  
  RESULTS
  Ex vivo interatrial septum preparations were dissected from swine (n=8) and diseased human hearts (n=6) to quantify TSAC suction and needle puncture force. TSAC suction was 6.5-fold greater than the opposing needle puncture force, and thus provides sufficient stabilisation for punctures. The safety and efficacy of TSAC was evaluated in a chronic mitral regurgitation swine model (n=10) and compared to a conventional TSA device. MR was induced by disrupting one to three mitral chordae tendineae, and the progression of heart disease was followed for three weeks. During device testing, procedure time and fluoroscopy exposure were not statistically different between devices. TSAC reduced septal displacement from 8.7±0.30 mm to 3.60±0.19 mm (p<0.05) and improved puncture accuracy 1.75-fold.
  
  
  CONCLUSIONS
  TSAC provides controlled TSA and improves puncture accuracy, while maintaining procedure time and workflow. These findings provide a strong rationale for a first-in-man study to demonstrate the clinical utility of the device.
authors.affiliation: 3DT Holdings LLC, San Diego, CA, USA.
authors.forename: Matthew S
authors.initials: MS
authors.lastname: Sulkin
authors.forename: Zachary C
authors.initials: ZC
authors.lastname: Berwick
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.forename: Jose A
authors.initials: JA
authors.lastname: Navia
authors.forename: Ghassan S
authors.initials: GS
authors.lastname: Kassab
mesh_terms: D000818:Animals; D054087:Atrial Septum / Q000601:surgery*; D006328:Cardiac Catheterization / Q000295:instrumentation; D017115:Catheter Ablation / Q000295:instrumentation; D004867:Equipment Design; D005260:Female; D006346:Heart Septum / Q000601:surgery*; D006801:Humans; D008297:Male; D011677:Punctures / Q000379:methods; D013396:Suction / Q000379:methods; D013552:Swine