![]() ACC, aortic cross clamp AV, aortic valve AVR, aortic valve replacement CABG, coronary artery bypass grafting CPB, cardiopulmonary bypass DVR, double valve replacement MV, mitral valve MVR, mitral valve replacement. cIndicates significant difference between all 3 groups. bIndicates significant difference between AVR and the other 2 groups, respectively. The preoperative patient demographics and operative data are summarized inĪIndicates significant difference between DVR and the other 2 groups, respectively. ![]() There were 773 concomitant procedures including anti-arrhythmia procedures (n=281), tricuspid valve repairs (n=251), aorta procedures (n=148), mitral valve repairs (n=35), aortic valve repairs (n=31), and coronary artery bypass grafting (n=27) ( Table 2). The patients were divided into 3 groups: the aortic valve replacement group (AVR, n=344), the mitral valve replacement group (MVR, n=325), and the double valve replacement group (DVR, n=192) ( Table 1). Finally, a total of 861 patients (mean age=51.6☑0.9 years) were enrolled in this study. The following patients were excluded: 97 patients with a second valve implantation other than the On-X valve, 16 patients with triple valve replacement, 16 patients who underwent an emergency or urgent operation, 8 reoperation cases for enrolled patients during the study period, 3 patients with incomplete medical records, and 28 patients who underwent surgery for paravalvular leakage (PVL) of a previously implanted prosthetic valve. Between February 1999 and December 2015, 1,029 patients at our institution underwent prosthetic valve replacement using the On-X valve in the aortic or mitral position. Individual informed consent was not required based on the institutional guidelines for waiving consent. The study protocol of this retrospective observational study was reviewed and approved by our institutional review board (approval date: August 19, 2019, approval number: 190). Particularly in the aortic position, the On-X valve had better long-term non-structural durability. On-X valve implantation in the left side heart had favorable clinical outcomes with acceptable early and late mortality and a low incidence of prosthetic valve-related complications. Valve replacement in the mitral position was the only risk factor for NSVD (hazard ratio =5.247, P=0.006). NSVD and reoperation rates were significantly lower aortic valve replacement than after mitral or double valve replacement (P=0.001 and 0.002, P=0.001 and <0.001, respectively). Prosthetic valve endocarditis was more frequent after double valve replacement than after aortic or mitral valve replacement (P=0.008 and 0.005, respectively). Linearized thromboembolism, bleeding, prosthetic valve endocarditis, non-structural valve deterioration (NSVD), and reoperation rates were 0.8%/patient-year, 0.6%/patient-year, 0.2%/patient-year, 0.5%/patient-year, and 0.5%/patient-year, respectively. ![]() ![]() Operative mortality occurred in 26 patients (3.0%), and linearized late cardiac mortality was 0.9%/patient-year without an intergroup difference. The mean clinical follow-up duration was 10.5±5.3 (median 10.9) years. This study evaluated the long-term outcomes for up to 20 years after On-X mechanical valve implantation in the left side of the heart.īetween 19, 861 patients (mean age=51.6☑0.9 years) who underwent prosthetic valve replacement using the On-X valve in the aortic or mitral position were enrolled (aortic=344, mitral=325, double=192). ![]()
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