Automated Annular Suturing In Cardiac Valve Replacement Surgery: The First 632 Valves
Eric Ndikumana1, Kyle Purrman2, Jude S. Sauer2, Peter A. Knight1.
1University of Rochester Medical Center, Rochester, NY, USA, 2LSI SOLUTIONS, Victor, NY, USA.
OBJECTIVE: For most patients needing new heart valves, surgically placed prosthetic valves remain the gold standard. Minimally invasive cardiac surgery may dramatically enhance outcome benefits over less time-tested alternative approaches especially regarding leaks, pacemakers, and durability. The success of deploying automated annular suturing technology with ergonomic and rapid precision to secure 632 prosthetic valves in 625 patients in 15 countries is reported.
METHOD: These manually operated suturing devices incorporate 5 mm rotating, articulating shafts integrating distal tissue receiving tips with either 3.5 mm or 5.0 mm bite widths. A squeeze of the lever simultaneously advances two ~11mm diameter curved needles through targeted annular tissue positioned in the tipís receiving gap to engage and pull back two ends of a pre-pledgeted 2-0 polyester suture creating a subannular suture configuration. A companion device passes these suture ends through the prosthesis sewing cuff. Direct or video assisted viewing enables accurate suturing even through small thoracotomy access sites. Additional customized tissue retractors, stabilizers and suture management devices further augment ergonomics.
RESULTS: May 2016 to December 2021: 640 patients received operations including this technology performed by 82 surgeons in 73 medical centers in 15 countries. Of the 632 valve replacements (15 patients had epicardial pacemaker lead placement) access included: 71 (11.2%), full sternotomy; 21 (3.3%), hemisternotomy; 17 (2.7%), microthoracotomy; 523 (82.8%), minithoracotomy for 519 isolated aortic valve, 86 isolated mitral valve replacements, 5 Mini-Bentall procedures; 5 minimally invasive tricuspid valves, and 3 pulmonic valve replacements. With an estimated average use of 12 to 14 sutures per valve, more than 7,500 sutures have been used clinically. There are no reports of patient harm caused by this technology. Many surgeons reported aortic cross-clamp times under 50 minutes for completely bone- and cartilage-sparing valve replacements.
CONCLUSION: The technical challenges of suturing through small access sites present a barrier against adoption of minimally invasive cardiac surgery and its potential patient benefits. Custom automated technology for annular suturing offers a reliable, ergonomic, and rapid advancement. The safe and effective results of the first 632 valves placed using this technology are encouraging.
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