Evolocumab Treatment in Dyslipidemic Patients Undergoing Coronary Artery Bypass Grafting: One-Year Safety and Efficacy Results.

Background: The inhibition of PCSK9 lowered LDL cholesterol levels, reducing the risk of cardiovascular events. However, the effect on patients who have undergone surgical myocardial revascularization has not yet been evaluated. Methods: From January 2017 to December 2022, 180 dyslipidemic patients who underwent coronary artery bypass were included in the study. Until December 2019, 100 patients optimized therapy with statin ± ezetimibe (SG). Since January 2020, 80 matched patients added treatment with Evolocumab every 2 weeks (EG). All 180 patients were followed-up at 3 and 12 months, comparing outcomes. Results: The two groups are homogenous. At 3 months and 1 year, a significant decrease in the parameter mean levels of LDL cholesterol and total cholesterol is detected in the Evolocumab group compared to the standard group. No mortality was detected in either group. No complications or drug discontinuation were recorded. In the SG group, five patients (5%) suffered a myocardial infarction during the 1-year follow-up. In the EG group, two patients (2.5%) underwent PTCA due to myocardial infarction. There is no significant difference in overall survival according to the new treatment (p-value = 0.9), and the hazard ratio is equal to 0.94 (95% C.I.: [0.16-5.43]; p-value = 0.9397). Conclusions: The use of Evolocumab, which was started immediately after coronary artery bypass graft surgery, significantly reduced LDL cholesterol and total cholesterol levels compared to statin treatment alone and is completely safe. However, at one year of follow-up, this result did not have impact on the reduction in major clinical events.

Safety and Efficacy of PCSK9 Inhibitors in Patients with Acute Coronary Syndrome Who Underwent Coronary Artery Bypass Grafts: A Comparative Retrospective Analysis.

Background. The in-hospital reduction in low-density lipoprotein cholesterol (LDL-C) levels following acute coronary syndrome (ACS) is recommended in the current clinical guidelines. However, the efficacy of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors in those patients undergoing coronary artery bypass graft (CABG) has never been demonstrated. Methods. From January 2022 to July 2023, we retrospectively analyzed 74 ACS patients characterized by higher LDL-C levels than guideline targets and who underwent coronary bypass surgery. In the first period (January 2022-January 2023), the patients increased their statin dosage and/or added Ezetimibe (Group STEZE, 43 patients). At a later time (February 2023-July 2023), the patients received not only statins and Ezetimibe but also Evolocumab 140 mg every 2 weeks starting as early as possible (Group STEVO, 31 patients). After one and three months post-discharge, the patients underwent clinical and laboratory controls with an evaluation of the efficacy lipid measurements and every adverse event. Results. The two groups did not differ in terms of preoperative risk factors and Euroscore II (STEVO: 2.14 ± 0.75 vs. STEZE: 2.05 ± 0.6, p = 0.29). Also, there was no difference between the groups in terms of ACS (ST-, Instable angina, or NSTE) and time of symptoms onset regarding total cholesterol, LDL-C, and HDL-C trends from the preprocedural period to 3-month follow-up, but there was a more significant reduction in LDL-C and total cholesterol in the STEVO group (p = 0.01 and p = 0.04, respectively) and no difference in HDL-C rise (p = 0.12). No deaths were reported. In three STEZE group patients, angina recurrence posed the need for percutaneous re-revascularization. No STEVO patients developed significant adverse events. The statistical difference in these serious events, 7% in STEZE vs. 0% in STEVO, was not significant (p = 0.26). Conclusions. Evolocumab initiated "as soon as possible" in ACS patients submitted to CABG with high-intensity statin therapy and Ezetimibe was well tolerated and resulted in a substantial and significant reduction in LDL-C levels at discharge, 1 month, and 3 months. This result is associated with a reduction but without a statistical difference between groups.

Impact of Prosthesis-Patient Mismatch after Mitral Valve Replacement.

BACKGROUND: The study aim was to determine the impact of prosthesis-patient mismatch (PPM) on early and late clinical outcomes, left atrial and ventricular remodeling, late tricuspid valve regurgitation and pulmonary hypertension (PH) in patients after mitral valve replacement (MVR). METHODS: A total of 46 patients (mean age 66 ± 9.3 years) with mitral valve diseases and undergoing isolated MVR was enrolled in the study. The mitral valve effective orifice area (EOA) was determined using the continuity equation and indexed for the patient's body surface area (EOAi). PPM was defined as EOAi ≤1.2 cm2/m2. PH was defined as a systolic pulmonary artery pressure (sPAP) >40 mmHg. Both, clinical and echocardiographic follow up were performed. RESULTS: PPM was identified in 25% of patients, but no significant differences were observed in baseline and operative characteristics when comparing patients with and without PPM. The NYHA class was improved in most cases after surgery. Indeed, significant decreases in mean transvalvular gradient (from 8.6 ± 2.8 mmHg to 5 ± 1.3 mmHg, p = 0.001), left atrial dimension (LAD) (from 31.9 ±9.8 mm to 29.5 ± 7 mm, p = 0.011), left ventricular end-systolic diameter (from 42.6 ± 18.1 mm to 35.5 ± 6.6 mm, p = 0.044) and left ventricular end-diastolic diameter (from 55.8 ± 19.2 mm to 48.7 ± 6.1 mm, p = 0.024) were observed over time when comparing preoperative and postoperative echocardiographic data. In addition, at follow up (mean 6.9 ± 1.8 years) there were significant decreases in LAD (from 31.9 ± 9.8 mm to 28 ± 11.1 mm, p = 0.001), left ventricular enddiastolic volume (from 106.9 ± 32.9 ml to 92.3 ± 21.9 ml, p = 0.024), tricuspid regurgitation (TR) (from 87% to 27%, p = 0.002) and PH (from 78.3% to 58.7%, p = 0.043) in all patients. No significant differences were observed in hemodynamic, clinical outcome and atrial natriuretic peptide levels of patients with and without PPM. CONCLUSIONS: Mitral PPM does not appear to have any negative effect on ventricular and atrial remodeling, TR and PH during the early and late postoperative periods.

Valve prosthesis-patient mismatch: hemodynamic, echocardiographic and clinical consequences.

OBJECTIVES: The purpose is to evaluate in vivo at rest and under stress conditions hemodynamic performance of the small size St. Jude Medical Regent (SJMR) prosthetic valve in patients with a body surface area (BSA) of 1.8 ± 0.11 m(2) and to define the role of valve prosthesis- patient mismatch on left ventricular mass regression following aortic valve replacement. METHODS: We evaluated 25 cases (12 males and 13 females, mean age 65.2 ± 8 years) of aortic valve replacement (17 mm SJMR in three cases and 19 mm SJMR in 22 cases). All the patients underwent at rest Doppler echocardiography before and after surgery and both basal and dobutamine stress echocardiography (DSE) at follow-up. The mean duration of follow-up was 41.3 ± 24 months. RESULTS: A significant reduction in mean and peak transaortic gradients and peak transaortic velocity over time following valve replacement has been identified. After surgery, there was a significant increase of ejection fraction. DSE significantly increased heart rate, ejection fraction, peak transaortic gradient and peak transaortic velocity. All patients passed DSE without complication. Even if a significant mismatch was present in 76% of cases, the left ventricular mass decreased significantly from preoperative value of 278.7 ± 51.1 g to 181.5 ± 52.73 g, respectively. CONCLUSION: Aortic valve replacement with 17 mm SJMR or 19 mm SJMR prostheses appear to provide satisfactory clinical and hemodynamic results at rest and under DSE, even in those patients with BSA of 1.8 ± 0.11 m(2) where it was not possible to enlarge the aortic annulus. Prosthesis-patient mismatch is not associated with lesser regression of left ventricular mass. Dobutamine stress echocardiography should be a useful and effective means for evaluating prosthesis hemodynamic aspects.