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Can A New Sewing Ring Design Improve Clinical Outcomes In Patients Undergoing Mitral Valve Replacement?
GUILLERMO REYES1, DANIEL MUNOZ1, ELISABET BERASTEGUI2, EMILIO MONGUIO1, LUISA CAMARA2, NIEVES DE ANTONIO1, CLAUDIO FERNANDEZ2, FERNANDA AGUIRRE1, IGNASI JULIA2, CHRISTIAN MUNOZ2.
1HOSPITAL UNIVERSITARIO LA PRINCESA, MADRID, Spain, 2HOSPITAL UNIVERSITARIO GERMANS TRIAS I PUJOL, BARCELONA, Spain.

OBJECTIVE: The On-X mitral valve is currently under clinical evaluation to establish if patients can be safely maintained on lower anticoagulation. In addition, a new sewing ring was designed to improve implantation. In this series, we compare hemodynamic and clinical outcomes in patients undergoing mitral valve replacement (MVR) with the 25 Standard On-X valve (standard sewing ring) vs. the 25/33 Conform-X On-X valve (new sewing ring design).
METHODS: All patients undergoing MVR with the 25 Standard On-X valve size (n=28) and the 25/33 Conform-X On-X valve size (n=497) between 2001 and 2018 were selected. Baseline characteristics and clinical and valve-related outcomes were compared. A propensity matched analysis was performed.
RESULTS: Patients with a 25 Standard On-X valve were more likely to have higher levels of creatinine, diabetes, hypertension, severe pulmonary hypertension, ischemic mitral regurgitation, and endocarditis. Surgical mortality, although not statistically significant, was 1.92 times higher in 25 Standard On-X valves (OR 1.92; (95%CI [0.54-9.75]). Long-term survival was higher in 25/33 Conform-X On-X valves (OR 2.60 (95%CI [1.38-4.89]). After a propensity matched analysis, survival with Conform-X On-X valves was also higher although not statistically significant (OR 1.91 (95%CI [0.97-3.77]). There was no difference between valves regarding reoperation, freedom from anticoagulation-related events, or endocarditis. Presence of paravalvular leak was more common in Standard On-X valves (13% vs 5.1%; p=0.03). Postoperative mean transvalvular gradient was minimal in both valves (Standard On-X: 4.251.26 vs Conform-X On-X: 4.611.84mmHg; p=0.38).
CONCLUSIONS: While baseline clinical differences existed between the valve patient groups, gradients were low in both and paravalvular leaks were less common and survival may be improved in Conform-X patients. Additional studies are warranted to evaluate outcomes after implant of the Conform-X On-X mitral valve which is also currently under clinical evaluation to determine if patients can be safely managed on lower anticoagulation.


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