Fifteen-year Outcomes of 1,196 Ozaki Procedures

ABSTRACT Background Introduced in 2007, the Ozaki procedure has become an attractive option for aortic valve disease. Our objective was to investigate outcomes of the Ozaki procedure in the original Ozaki cohort. Methods From April 2007 to May 2021, 1,196 consecutive Ozaki procedures were performed at Toho University Ohashi Medical Center. Patient age ranged from 11 to over 90 years, 484 (60%) were male, 50 (4.2%) had previous cardiac surgery, and 155 (13%) were on dialysis. 322 (27%) had bicuspid valves and 28 (2.3%) had infective endocarditis. 651 (54%) had aortic stenosis, 289 (24%) aortic regurgitation, and 87 (7.2%) mixed. 546 (46%) underwent concomitant procedures. Clinical outcomes, echocardiograms, and follow-up data were collected and analyzed for valve performance, and time-to-event analyses were performed for reoperation and mortality. 5023 patient-years of follow-up were available for analysis, with 50% of patients followed >3.2 years and 10% >9 years. Results Mean cardiopulmonary bypass and aortic clamp times for isolated Ozaki procedures were 151 ± 37 and 105 ± 29 minutes, respectively. Thirty-day mortality was 1.7% (n=20), new stroke 14 (2.6%), new dialysis 41(4.0%), and permanent pacemaker implantation 18 (1.5%). At 6 months, 5 years, and 10 years, peak/mean aortic valve gradients were 14.0/7.4, 15.5/8.0 and 15.5/8.2 mmHg, respectively, and ≥moderate regurgitation was 0.30%/2.9%/6.6%. Left ventricular mass index decreased from 141 ± 52 g/m 2 preoperatively to 100 ± 1.1 g/m 2 at 6 months and 90 ± 1.8 g/m 2 at 10 years. At 10 years, freedom from reoperation was 91.2% and survival 75%. Conclusion The Ozaki procedure creates good aortic valves with stable low gradients. Regurgitation increased over time, but risk of reoperation was low, supporting continued use.