Investigating Titanium Fastener Technology: Results from the Multi-center Prospective CRIMP Study

Titanium fastener technology is increasingly adopted for use in minimally invasive valve surgery and open procedures to facilitate faster operative times and reproducible fastening of sutures. The objective of this study was to evaluate the technical feasibility and short-term safety of automated titanium fastener technology for securing sutures in heart valve repair and/or heart valve replacement procedures. The CRIMP study is a multicenter, prospective study that enrolled patients undergoing heart valve repair or replacement via open or minimally invasive approaches at three centers (n = 120). The primary endpoints were device success and prosthesis implantation time. Mean age was 62.5 (SD 11.1) years, 33.3% of patients was female and the cohort was characterized as low surgical risk (EuroSCORE II 1.6%; SD 2.3%). Predominant valve disease was mitral regurgitation. Median procedure time was 178 (IQR 145–210) min. Median aortic cross-clamp time was 82 (IQR 59–107) min. The majority of procedures was minimally invasive (76.7%). In aortic valve procedures, median prosthesis implantation time (first stitch until last COR-KNOT placement) was 25 (IQR 18–46) min and in mitral valve procedures median implantation time was 50 (IQR 48–52) min. Device success was 100%, since no automated titanium fastener failed to grip or crimp appropriately. Median number of COR-KNOTS used was 14 (IQR 12–16) per valve. In-hospital mortality was 0.8%. All observed adverse events were considered unrelated to the device and there was no valve prosthesis dehiscence at 30-days of follow-up. The use of automated titanium fastener technology for suture fixation in heart valve surgery was technically feasible and showed short-term safety in all patients, with no obvious device-related adverse events observed. Graphical abstract available for this article. Clinical trial registration number: DRKS00038956. Heart valve surgery often requires surgeons to tie many small sutures to secure repaired or replaced valves. Automated titanium fastener devices can replace manual knot tying and may help surgeons work faster and more consistently. This study evaluated whether this technology is safe during short-term observation and technically feasible when used in heart valve repair or replacement surgery. The CRIMP study was a prospective study conducted at three hospitals and included 120 patients undergoing heart valve surgery. Procedures included mitral, tricuspid, and aortic valve repair or replacement. The average patient age was about 63 years, one-third were women, and overall surgical risk was low. Researchers measured if the fastener device worked and how long it took to implant the valve prostheses. The automated titanium fasteners functioned successfully in all cases, meaning every fastener properly secured the sutures. In aortic valve procedures, placing and fastening the sutures took about 25 min, while in mitral valve procedures it took about 50 min. Around 14 fasteners were used per valve. In-hospital mortality was low (0.8%), and no complications were related to the fastener device. At 30 days after surgery, no patients experienced loosening of the implanted valve. However, the study only had one group, which was observed without a comparative group of patients undergoing manual knot tying, and the follow-up period was relatively short, which are important limitations. Overall, the results suggest that automated titanium fastener technology show short-term safety and are technically feasible for securing sutures in heart valve surgery.