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Novel Paired-ring Sizer Accurately Predicts Changes In Leaflet Coaptation Length: Validation In Cadaveric Swine Heart Model
Nikola Dobrilovic;
NorthShore University Hospital, Chicago, IL, USA
INTRODUCTION: A novel "paired-ring" mitral annuloplasty ring sizing device and technique were introduced at
AATS Mitral Conclave 2023 as proof-of-concept. This technique has the potential to dramatically improve ring selection during valve repair procedures by allowing the surgeon to predict/preview coaptation length prior to ring implantation. The proposed sizer can be designed to function in conjunction with any commercially available annuloplasty ring/band in any size. The most current prototype has been designed specifically to predict Physio 2 (Edwards Lifesciences, Irvine, California) physiologic performance for each size ring. This device has recently been approved for first-in-human trial at our institution.
METHODS: Cadaveric swine hearts (n=8) were used to validate ring sizing method/device performance. For each procedure, an ink mark was placed on the anterior mitral leaflet as an initial reference point (generally 10 mm from the annulus along the "12 o'clock" axis). Mitral annuloplasty sutures were placed in standard fashion. Saline pressure test was used to distend the left ventricle. Distance from the ink mark to the exact point of anterior leaflet coaptation was measured to establish a baseline point of reference. Paired-ring sizer was used to produce a moderate downsizing of the annulus. The left ventricle was distended with saline. Distance from the reference ink mark to the (new) point of anterior leaflet coaptation was measured under the influence of the sizer (
Figure). The difference between the two measurements represents the potential increase in coaptation length as predicted by the sizer. The temporary sizer was removed and a corresponding (size) Physio 2 ring implanted in standard fashion. "Predicted" and "actual" coaptation lengths were compared.
RESULTS: In seven hearts a moderate increase in coaptation length was achieved (2.0 -5.5 mm), and no change in one heart (because it was too small). Initial "predicted" coaptation lengths corresponded well (≤ 0.5 mm difference) with final "actual" coaptation lengths in all 8 hearts (
Table).
CONSCLUSIONS: Functionality of a novel paired-ring mitral sizing device and method was validated using a cadaveric swine heart model. Coaptation length predicted by the sizer corresponded accurately with coaptation length produced by a corresponding commercially available annuloplasty ring implant.
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