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.
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.
Authors
Bakhtiary Bakhtiary, Granov Granov, Silaschi Silaschi, Lewe Lewe, Kruse Kruse, Rowlands Rowlands, Å ljivo Å ljivo, Velicki Velicki
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