Automated Suturing In Less Invasive Aortic And Mitral Valve Replacement Surgery: Reliable Surgical Ergonomics, Reduced Handling Of Exposed Needles And Shorter Cardiopulmonary Bypass Duration
Jude S. Sauer, MD1,2, Juan A. Siordia, Jr., MD2, Victor S. Costache, MD3, Charles J. Lutz, MD4, Peter A. Knight, MD2
1LSI Solutions, Victor, NY, USA, 2University of Rochester Medical Center, Rochester, NY, USA
3LB University of Sibiu, Next Cardio Project, Sibiu, Romania, 4St. Joseph's Hospital, Syracuse, NY, USA
To provide more patients with the unsurpassed durability of surgically implanted prosthetic heart valves coupled with the benefits of minimally invasive surgery, faster and more reliable suture delivery options are needed. This study highlights the first 44 patients treated with new automated precision suturing technology that can reduce procedure times and exposed needles.
Through extensive ex vivo tissue and cadaver experimentation, a manually controlled, adjustable shaft dual needle device was developed for placement of 2-0 polyester pledgeted horizontal mattress sutures in aortic and mitral annular tissue. A second device expedites suture placement through the prosthetic cuff. Automated device needles are retracted into protective sheaths until advanced by squeezing the lever. Forty-two isolated aortic and 2 mitral valve replacements were performed using ~5-6 cm intercostal right anterior or lateral mini-thoracotomy incisions and video guidance. Simulated valve replacements were studied using porcine hearts to compare prosthetic installation times of non-automated to second generation automated technology.
Automated aortic (Figs.1,2) and mitral (Fig. 3) annular suturing was effective in all patients and applicable for both bioprosthetic and mechanical valves. In several patients, aortic cross clamp times of approximately one hour were achieved with first generation automated suturing technology, which required more time for intra-operative loading than the current iteration. Recently released second generation technology demonstrated additional time savings. Targeted patient outcomes, including early extubation and ambulation, plus reduced intensive care and hospital duration, were observed. Simulator porcine heart model testing comparing automated vs. non- automated suturing for mitral valve replacements showed mean time savings of ~19 minutes (Table 1). The automated technology eliminated 24 to 44 exposed traditional needles, each handled at least six separate times during valve installation.
Procedure reliability and protracted cardiopulmonary bypass times have slowed the advancement of less invasive cardiac surgery. This new automated suturing technology for minimally invasive aortic and mitral valve replacement surgery enabled excellent outcomes in the initial 44 patients and offers encouragement regarding reliability, procedure duration and reduced exposure to unprotected sharp needles.