<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] cm<sup>2</sup>. 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] cm<sup>2</sup>. 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>
AIM: This study aimed to conduct a comparative analysis of clinical, electrocardiographic, and echocardiographic factors in patients with chronic heart failure (CHF) with different hemodynamic responses to cardiac resynchronization (CRT) to assess the possibility of their use in predicting the positive effect of CRT. MATERIALS AND METHODS: The study included 136 patients with New York Heart Association grade 34 CHF with a left ventricular ejection fraction of 35%, QRS duration of 150 ms, QRS duration of 130149 ms, and QRS morphology of left bundle branch block (LBBB). For CHF treatment and primary prevention of sudden cardiac death, a cardioverter-defibrillator with CRT (CRT-D) function was implanted. The enrolled patients were followed up prospectively for 1 year to record the endpoint, namely, hemodynamic response to CRT, assessed by a decrease in the end-systolic volume of the left ventricle by 15%. RESULTS: During the 1-year follow-up, the primary endpoint was registered in 62 (46%) patients. With a one-way logistic regression, four indicators with the highest predictive potential (p 0.05) and associated with the occurrence of the studied endpoint were identified. Based on the results of the multivariate regression analysis, a prognostic model was developed, which included three factors with the highest levels of statistical significance, namely, a history of indications of a previous correction of valvular insufficiency, QRS duration, and LBBB criteria according to Strauss. The diagnostic efficiency of the model was 73% (sensitivity, 80%; specificity, 68%). The electrocardiographic parameters of the Strauss LBBB criteria and QRS duration were independent predictors of the studied endpoint. CONCLUSIONS: The developed multivariate prognostic model may be useful in the selection of patients with CHF reduced ejection fraction for implantation of devices with CRT function; the lack of external validation limits its application in practice.
According to current clinical guidelines, the risk of life-threatening ventricular tachyarrhythmias (VTAs) in patients with heart failure (HF) is determined by left ventricular ejection fraction (LVEF). The available clinical and experimental data indicate the imperfection of this one-factor approach, which specifies the need to search for new predictors of VTAs. In this prospective study, we performed a comparative analysis of surface electrocardiographic parameters in HF patients with LVEF ≤35% without syncope or sustained ventricular arrhythmias in history, who were implanted with cardioverter defibrillator as a primary prevention of sudden cardiac death. During the two-year follow-up, the primary endpoint (new-onset persistent VTA episode, or VTA/ventricular fibrillation that required electrotherapy) was recorded in 42 patients (25,5%). The secondary endpoint (an increase in LVEF by 5% or more of the initial level against the background of cardiac resynchronization therapy) was more often recorded in the group of patients without VTAs (41 (33%) vs 4 (9,5%), p=0,005). The studied cohort of patients was characterized by a left axis deviation (72%), LV hypertrophy signs (84%), impaired intra-atrial (P wave duration of 120 (101-120) ms) and intraventricular conduction (QRS duration of 140 (110-180) ms), ventricular electrical systole prolongation (QTcor — 465 (438-504) ms). Differences between the groups divided depending on reaching the primary endpoint in terms of the Cornell product, Cornell voltage index and ICEB, as well as the detection rate of complete left bundle branch block morphology had levels of significance close to critical (p=0,09; p=0,05; p=0,1; p=0,09, respectively). The multivariate predictive model included following factors: Cornell product, Tp-Te/ QRS, P wave duration (diagnostic efficiency of the model was 60%: sensitivity, 61,1%, specificity, 59,6%; p=0,007).
Highlights. A retrospective analysis of the patients’ data after Ozaki operation in four Russian Medical Centers was carried out. A comparative gender assessment of the immediate and medium-term results of Ozaki operation was performed.Aim. Gender assessment of Ozaki operation immediate and mid-term results in patients with aortic valve (AV) pathology.Methods. A retrospective multicenter study enrolled 251 patients (135 women, median age 66 (60–70) years old) who underwent Ozaki operation (2017–2020) was carried out in four centers in Russia. After propensity score matching, 92 patients were selected (mean age 65.8±10.8 years old). Two groups were formed in the gender structure: 46 females (average age 67.8±6.3 years old), 46 males (average age 63.8±15.4 years old). The main cause of AV dysfunction was severe aortic stenosis – in 86 (93.5%) cases. Chronic heart failure of III–IV functional class according to NYHA was observed in 26 (28.3%) patients. A bicuspid AV was in 24 cases (26.1%). The primary endpoint was hospital mortality. Postoperative complications and mid-term results (three-year overall survival and freedom from reoperation on AV) were assessed as secondary endpoints; the median follow-up period was 23 (18–33) months.Results. There was no statistically significant difference between the groups in the duration of surgery (275 minutes for females and 285 minutes for males, p = 0.4), cardiopulmonary bypass (98 minutes for females and 115 minutes for males, p = 0.3), aortic clamping (80 minutes for females and 93 minutes for males, p = 0.7). Hospital mortality among the studied patients did not differ: in the female group – 2.2% (1 case) and 0 in the male one, p = 0.9. There were no significant differences in postoperative complications: sepsis (2.2% in women and 0 in men, p = 0.9), superficial wound infection (8.7% in women and 6.5% in men, p = 0.9). Acute kidney injury, stroke, pacemaker implantation, resternotomy for bleeding were not observed in any patient. Three-year overall survival was 91.8% in females and 91.6% in males, p = 0.8; three-year freedom from reoperation – 94.4% for females and 100% for males, p = 0.1.Conclusion. Ozaki operation is equally reproducible with the same hospital mortality, postoperative complications, and medium-term outcomes in both females and males.
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