Three-year results of Ozaki surgery in patients aged ≥65 years: a multicentre study

<p><strong>Background.</strong> Currently, aortic valve stenosis is the most common disease of the native valve, which affects 5% of the elderly population. In symptomatic patients, aortic valve replacement is the ‘gold standard’. For patients aged ≥65 years, the use of biological prostheses is recommended. The Ozaki operation is an alternative to bioprostheses.</p><p><strong>Aim.</strong> The aim of this study was to evaluate the immediate and 3-year results of Ozaki surgery in patients aged ≥65 years.</p><p><strong>Methods.</strong> This was a prospective multicentre study conducted on 107 patients aged ≥65 years, who underwent the Ozaki procedure at three centres during 2016–2019. There were 46 (43%) men. The median age of the patients was 69 [67–74] years. Severe aortic stenosis was the major cause of aortic valve dysfunction (106 patients [99.1%]). Chronic heart failure III–IV functional class according to NYHA was diagnosed in 47 (43.9%) patients. The following complications were also registered: atrial fibrillation in 30 (28%) patients, a history of diabetes mellitus in 16 (15%) patients, chronic obstructive pulmonary disease in 14 (13.1%) patients and coronary artery disease in 42 (39.2%) patients. Bicuspid aortic valve was detected in 36 (34.6%) patients. There were 72 (67.2%) patients with a small annulus (≤21 mm) and 59 (55.14%) patients with a left ventricular ejection fraction of 64%. The median follow-up period was 23 [18–33] months. This study included all patients who underwent Ozaki surgery from 2016 to 2019.</p><p><strong>Results.</strong> No patient had any conversions. A total of 45 (42.1%) patients underwent combined interventions. The operation duration was 240 [214–300] min, cardiopulmonary bypass duration was 104 [93–120] min and aortic cross-clamp duration was 82 [72–95] min. The rate of hospital mortality was 1.9%, and the incidence rates of acute renal failure requiring haemodialysis, stroke, pacemaker implantation, sepsis and reoperation for bleeding were 1.9%, 0.9%, 1.9%, 0.9% and 0.9%, respectively. The hospitalisation duration was 14 [11–16] days. The gradients of peak and mean pressure on the aortic valve after surgery were 9 [7–13] and 4 [3–6] mmHg, respectively, and the effective valve opening area was 2.6 [2.3–2.9] cm². None of the patients had moderate and severe aortic regurgitation. The 3-year overall survival and freedom from reoperation were 88.6% and 97%, respectively.</p><p><strong>Conclusion.</strong> The Ozaki operation in patients aged ≥65 years has good immediate results, with a hospital mortality rate of 1.9%, excellent haemodynamic parameters with an average pressure gradient across the aortic valve of 4 [3–6] mmHg and a valve opening area of 2.6 [2.3–2.9] cm². The 3-year overall survival and freedom from reoperation were 88.6% and 97%, respectively. Further monitoring of these patients is required to evaluate long-term results, and there is also a need for randomised clinical trials comparing Ozaki operation with bioprostheses.</p><p>Received 4 February 2021. Revised 21 June 2021. Accepted 23 June 2021.</p><p><strong>Funding:</strong> The study did not have sponsorship.</p><p><strong>Conflict of interest:</strong> Authors declare no conflict of interest.</p><p><strong>Contribution of the authors<br /> </strong>Conception and study design: I.I. Chernov, R.N. Komarov, D.G. Tarasov, Yu.S. Sinelnikov, A.V. Marchenko, V.B. Arutyunayan, K.Yu. Zhigalov<br /> Data collection and analysis: B.K. Kadyraliev, A.M. Ismailbaev, B.M. Tlisov, D.A. Zorin, M.I. Tcheglov<br /> Statistical analysis: S.T. Enginoev<br /> Drafting the article: I.I. Chernov, S.T. Enginoev<br /> Critical revision of the article: I.I. Chernov, R.N. Komarov, D.G. Tarasov, Yu.S. Sinelnikov, A.V. Marchenko, V.B. Arutyunayan, K.Yu. Zhigalov<br /> Final approval of the version to be published: I.I. Chernov, S.T. Enginoev, R.N. Komarov, D.G. Tarasov, Y.S. Sinelnikov, A.V. Marchenko, V.B. Arutyunayan, B.K. Kadyraliev, A.M. Ismailbaev, B.M. Tlisov, D.A. Zorin, M.I. Tcheglov, K.Yu. Zhigalov</p>