A Novel System For Enhanced Annulus Access And Visualization During Minimally-invasive Aortic Valve Replacement
Paul Werner1, Thomas Poschner1, Christoph Gross1, Andrea Gaster1, Anna Bartunek1, Sabine Scherzer1, Günther Laufer1, Jude S. Sauer2, Martin Andreas1.
1Medical University of Vienna, Vienna, Austria, 2University of Rochester Medical Center, Rochester, NY, USA.
BACKGROUND Minimally-invasive valve replacement is increasingly performed worldwide toward improved patient comfort and reduced morbidity. However, limited space and visualization often increase technical complexity and surgical times. We evaluate a novel system to improve aortic annular orientation, stability, suturing and visualization during minimally-invasive aortic valve replacement (SAVR). METHODS The aortic root retraction system (ARR; LSI Solutions, Rochester, NY, USA) consists of a ARR collapsed retractor pre-loaded onto the ARR delivery device. The ARR flexible retractor is a three lobed plastic frame that is deployed by expansion and suture fixation suspended in the aortic root below the sino-tubular junction. Three different size ARR retractors are available. The ARR frame is removed from the surgical site just prior to parachuting down the prosthetic valve. A pilot trial was initiated for safety evaluation in twenty SAVR patients regarding ARR use with automated suturing devices. RESULTS So far, three patients (71.3±2.9 years, one female, 27.2±2.4 BMI kg/m2, EuroSCORE II 1.54±1.30%) underwent SAVR either via Anterior Right Thoracotomy (ART, n=2) or Upper Hemi-Sternotomy (UHS, n=1). Mean aortic cross-clamp and cardiopulmonary bypass time were 80±13 min and 98±21 min, respectively, for ART and 58 min and 65 min for UHS. ARR placement was successful in all patients and took a mean of 03:32±00:24 min. Placement of the ARR system helped to facilitate aortic root stabilization and orientation for improved intra-operative annulus visualization and suturing. There was no device-related adverse event. Automated annular suture placement with the RAM® device required 20:24±06:32 min, and valve cuff suturing with the SEW EASY® device took 05:16±01:09 min. The total time for AVR (first annular suture till last suture fixation) was 32:17±09:16 min. No patient required permanent pacemaker implantation, and the outcome was satisfactory with no paravalvular leakage. 30-day survival was 100%. CONCLUSIONS This ARR device represents a novel and effective approach to enhance visualization exposure and annular stability in minimally-invasive SAVR. Device handling requires a short learning curve and appears intuitive and straightforward. The aortic root retraction system represents a promising tool for minimally-invasive access. 
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