Automated Suturing In Cardiac Surgery: The First 500+ Patients And Announcing An International Registry
Paul Werner1, Alfred Kocher1, Hossein Amirjamshidi2, Peter A. Knight2, Jude S. Sauer3, Guenther Laufer1, Martin Andreas1
1Division of Cardiac Surgery, Department of Surgery at Medical University of Vienna, Vienna, Austria, 2Division of Cardiac Surgery, University of Rochester Medical Center, Rochester, NY, USA, 3LSI SOLUTIONS, Victor, NY, USA
BACKGROUND: Automated remote suturing can offer rapid precision through less traumatic non-sternal access in minimally invasive cardiac surgery. The initial use of automated suturing in now over 500 patients in 10 countries is encouraging. Despite issues of durability, transcatheter interventions have reset patients’ expectations regarding acceptable levels of pain and protracted recovery; most heart surgeons have not progressed towards minimizing invasiveness often due to perceptions of technical and procedural difficulties. A proposed international registry covering automated suturing can help identify best options for patients needing heart valve replacement. METHOD: Two manually operated devices are employed; the first drives two curved needles (3.5mm or 5.0mm bite width) at the end of an adjustable shaft through the tissue targeted at the surgical site, while the second places these sutures through the cardiac prosthesis. The technology is intended to enable reliable suturing under direct and videoscopic viewing through small mini-thoracotomies between ribs without requiring iatrogenic bony injury. Custom suture management and tissue stabilizing devices are also developed. RESULTS: To date, 504 patients had operations including this technology performed by 56 surgeons in 48 medical centers in 10 countries (see Table 1). 57 (11.3%) had full sternotomy (FS), 8 (1.6%) had hemi-sternotomy (HS), while 439 (87.1%) had mini-thoracotomy access (Right Anterior Mini-thoracotomy, RAM 353, 70.0%; RLateralM, 69, 13.7%, LAM 3, 0.6% and LLM 14, 2.8%). 405 isolated Aortic Valve Replacements (AVR) were reported (FS=12.3%, HS=2.0% and RAM 85.7%); isolated mitral VR in 66 patients (FS=3.0% and RLM=97%) and 6 had AVR and MVR (FS=83.3% and RAM=16.7%). There are no reports of patient harm caused by this technology. Several surgeons reported aortic cross clamps times under 50 minutes for completely bone and cartilage sparing AVRs and MVRs. CONCLUSIONS: Patients are demanding non-sternotomy approaches to valve therapy either catheter based or MICS. Patients would benefit if their surgeon could routinely offer durable conventional valves placed in a truly minimally invasive approach. We propose a comprehensive International Registry based at the University of Vienna for analysis of the clinical outcomes of automated suturing via mini-thoracotomy access to provide evidence towards an improved understanding of prosthetic replacement options.
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