Comparison of apixaban versus aspirin for the prevention of latent bioprosthetic aortic valve thrombosis: study protocol for a prospective randomized trial.

BACKGROUND: The optimal antithrombotic strategy early after aortic valve replacement surgery with a biological valve remains controversial due to lack of high-quality evidence. Either oral anticoagulants or acetylsalicylic acid should be considered for the first 3 months. Hypo-attenuated leaflet thickening on cardiac computed tomography has been associated with latent bioprosthetic valve thrombosis and may be prevented with anticoagulation. We hypothesize that anticoagulation with apixaban is superior to single antiplatelet therapy with acetylsalicylic acid in reducing hypo-attenuated leaflet thickening of bioprosthetic aortic valve prostheses. METHODS: In this prospective, open-label, randomized trial, patients undergoing isolated aortic valve replacement surgery with rapid deployment bioprosthetic valves will be randomized. The treatment group will receive 5 mg of apixaban twice a day for the first 3 months and 100 mg of acetylsalicylic acid thereafter. The control group will be administered 100 mg of acetylsalicylic acid once a day, indefinitely. After the 3-month treatment period, a contrast-enhanced electrocardiogram-gated cardiac computed tomography will be performed to identify hypo-attenuated leaflet thickening of the bioprosthetic valve. The primary objective of the study is to assess the impact of apixaban on the prevention of hypo-attenuated leaflet thickening at 3 months. The secondary and exploratory endpoints will be clinical outcomes and safety profiles of the two strategies. DISCUSSION: Antithrombotic therapy after aortic valve replacement is used to prevent valve thrombosis and systemic thromboembolism. Latent bioprosthetic valve thrombosis is a precursor of clinically significant prosthetic valve dysfunction or thromboembolic events. The hallmark feature of latent bioprosthetic valve thrombosis is hypo-attenuated leaflet thickening on cardiac computed tomography. Subclinical leaflet thrombosis occurs frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. There is no evidence on the effect of direct oral anticoagulants on the incidence of hypo-attenuated leaflet thickening after surgical aortic valve replacement with rapid deployment bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov NCT06184113. Registered on December 28, 2023.

Recurrent HeartMate 3 Right Ventricular Assist Device Stoppages in a Biventricular Assist Device Carrier.

A 44-year-old female patient with chemotherapy-induced cardiomyopathy presented with acute cardiogenic shock requiring ECMO support. Multiple failed weaning trials from temporary mechanical circulatory assistance prompted a transition to staged durable biventricular support. Her course was complicated with recurrent RVAD stoppages. The initial event was treated with pump exchange, while for the subsequent RVAD standstill, we employed a device wash-out and reimplantation strategy. A brief period of circulatory arrest was employed to explore the right-sided cardiac chambers using a single-use bronchoscope.

Propensity-score matched comparison between minimally invasive and conventional aortic valve replacement.

AIM: To evaluate the impact of minimally invasive aortic valve replacement (mini-AVR) on clinical outcomes in comparison with the gold standard. METHODS: We retrospectively reviewed the records of all patients who underwent isolated AVR at the University Hospital Center Zagreb from 2010 to 2020. Patients undergoing mini-AVR were compared with patients undergoing conventional AVR (fs-AVR). The primary outcome measure was blood product consumption. Propensity score matching was used to create a balanced covariate distribution across treatment groups. Additionally, we compared the contemporary outcomes with a historical control. RESULTS: The final sample consisted of 1088 patients. In the unmatched cohorts, mini-AVR patients were younger (65±12 vs 68±10 years, P<0.001) and had lower risk profiles (EuroSCORE2 2.8±2.0 vs 3.5±3.1, P=0.003). After matching, mini-AVR patients required less blood transfusion than fs-AVR patients (270 [0-790] vs 510 [0-970] mL, P=0.029). The incidences of stroke, dialysis, new AV block, and mortality were comparable. Cross-clamp times were longer in the mini-AVR group (71 [60-87] vs 66 [53-83] minutes, P=0.013). Outcomes were improved in the contemporary mini-AVR era compared with our early mini-AVR experience across multiple metrics. Blood product consumption was reduced in the latter tercile of experience (0 [0-520] vs 500 [0-1018] mL, P<0.001), and the operation was performed more expeditiously (cross-clamp times: 63 [54,80] vs 74 [62,88] minutes, P<0.001) in comparison with earlier periods. CONCLUSIONS: We showed that mini-AVR was associated with less blood product requirement than conventional surgery. Our data supports wider adoption of minimally invasive techniques in dedicated centers of excellence.

Pneumatized Crista Galli: A Histopathologic Study.

OBJECTIVE: This is the first histopathologic study that investigates the incidence of the pneumatized crista galli. STUDY DESIGN: A prospective histopathologic study. SETTING: Tertiary academic medical center. SUBJECTS AND METHODS: A total of 109 specimens of crista galli were obtained postmortem during 2018 from randomly chosen patients who died at the University Hospital Centre Zagreb and had an autopsy at our Department of Pathology and Cytology. Specimens were surgically resected during the autopsy and then fixed, decalcinated, dehydrated, and embedded in paraffin. All slides were cut into 5-µm-thin sections and stained with a standard method (hematoxylin and eosin) for light microscope analysis. Specimens were histopathologically analyzed for the existence of pneumatization inside crista galli. The criterion to declare a specimen pneumatized was the presence of mucosa inside the cavity. RESULTS: Pneumatized crista galli was found in 5 of 109 specimens (4.59%). In 5 of 5 cases (100%) of pneumatized crista galli, there was evidence of chronic inflammation. CONCLUSION: We found that the incidence of pneumatized crista galli is significantly lower in our histopathologic study in comparison with the majority of previous radiologic studies. Our study also found that all 5 specimens with pneumatized crista galli had chronic inflammation in the mucosa, which is a considerably higher incidence than in the previous studies (7.7%-44%). Due to the emerging evidence of pneumatized crista galli being of clinical importance, we suggest that a larger study be conducted before the results are generalized to the general population.

Higher Post-Operative Serum Vitamin D Level is Associated with Better Survival Outcome in Colorectal Cancer Patients.

25-Hydroxyvitamin D (25-OHD) may have a prognostic value in colorectal cancer (CRC) patients. However, as 25-OHD concentration is strongly impacted by surgery, it is uncertain what is the most reliable time-point for 25-OHD assessment, pre- or post-operative. Therefore, we examined 515 CRC patients (AJCC I-III) who underwent surgery. Blood samples were collected either pre-operatively (n = 286; median = 1 day before surgery) or post-operatively (n = 229; median = 8 days). Serum 25-OHD concentration was determined by liquid chromatography-tandem mass spectrometry. Association between 25-OHD and survival was tested in the whole cohort, followed by stratified analyses in pre- and post-operatively sampled. Median 25-OHD in the cohort was 36.7 nmol/L and median follow-up time was 5.9 years. There were no differences between pre- and post-operative cohort in age, sex, 25-OHD, AJCC stage, or localization of tumor. After adjustment, higher 25-OHD (>50 nmol/L) was associated with better overall survival only in post-operative (HR = 0.53; 95% CI: 0.33-0.84; P = 0.006), but not in pre-operative cohort (HR = 1.13; 95% CI: 0.77-1.65; P = 0.53). In conclusion, higher post-operative 25-OHD levels were associated with better survival outcome in CRC patients, while no such association was found for pre-operative levels. Time-point of blood collection should be addressed carefully in future research as it might affect the prognostic value of 25-OHD in CRC.