Prediction of non-resectability in tubo-ovarian cancer patients using Peritoneal Cancer Index - A prospective multicentric study using imaging (ISAAC study).

BACKGROUND: The aim was to evaluate the performance of the Peritoneal Cancer Index (PCI) using imaging (ultrasound, contrast-enhanced computed tomography (CT), and whole-body diffusion-weighted magnetic resonance imaging (WB-DWI/MRI) in assessing peritoneal carcinomatosis and predicting non-resectability in tubo-ovarian carcinoma patients. METHODS: This was a prospective multicenter observational study. We considered all patients with suspected primary ovarian/tubal/peritoneal cancer who underwent preoperative ultrasound, CT, and WB-DWI/MRI (if available). The optimal cut off value for assessing the performance of the methods in predicting non-resectability was identified at the point at which the sensitivity and specificity were most similar. The reference standard to predict non-resectability was surgical outcome in terms of residual disease >1 cm or surgery not feasible. Agreement between imaging methods and surgical exploration in assessing sites included in the PCI score was evaluated using the Intraclass Correlation Coefficient (ICC). RESULTS: 242 patients were included from January 2020 until November 2022. The optimal PCI cut-off for predicting non-resectability for surgical exploration was >12, which achieved the best AUC of 0.87, followed by ultrasound with a cut-off of >10 and AUC of 0.81, WB-DWI/MRI with a cut-off of >12 and AUC of 0.81, and CT with a cut-off of >11 and AUC of 0.74. Using ICC, ultrasound had very high agreement (0.94) with surgical PCI, while CT and WB-DWI/MRI had high agreement (0.86 and 0.87, respectively). CONCLUSION: Ultrasound performed by an expert operator had the best agreement with surgical findings compared to WB-DWI/MRI and CT in assessing radiological PCI. In predicting non-resectability, ultrasound was non-inferior to CT, while its non-inferiority to WB-DWI/MRI was not demonstrated.

Diabetes mellitus in stable chronic heart failure and the combination with humoral activation, their association, and prediction of 2-year adverse outcomes. Data from the FAR NHL registry.

BACKGROUND/AIM: The study aims to describe the role of diabetes in patients with heart failure. METHODS: In all, 1052 chronic heart failure patients were included in the FARmacology and NeuroHumoral Activation (FAR NHL) multicenter prospective registry. They had ejection fraction below 50% and were on stable medication for at least 1 month. RESULTS: More than one-third (38.9%) of the patients had diabetes mellitus (DM). Diabetic patients (N = 409) were older (median 67 vs. 64, p < 0.001), had higher body mass index (BMI) (30 vs. 28 kg/m2, p < 0.001), much more frequently had ischemic heart disease (71 vs. 47%, p < 0.001), hypertension (80 vs. 67%, p < 0.001), dyslipidemia (89 vs. 69%, p < 0.001), worse renal function (estimated glomerular filtration rate [eGFR] median 63 vs. 73 mL/min/1.73 m2, p < 0.001), and higher N-terminal pro-brain natriuretic peptide (NT-proBNP) (median 681 vs. 463 pg/mL, p = 0.003). All-cause death, left ventricle assist device implantation, and orthotopic heart transplantation were set as the combined primary end point, which was present in 15.5% (163 patients) within the 2-year follow-up. In the 2-year follow-up, 81.0% of patients with diabetes survived without a primary end point, while 85.4% of the patients without diabetes survived, the difference being on the verge of statistical significance (p = 0.089). DM is a statistically significant predictor of NT-proBNP value in univariate analysis, but it is not an independent predictor in a multivariate analysis. When the NT-proBNP level was high, the presence of DM did not influence the prognosis. CONCLUSION: The combination of diabetes and NT-proBNP levels may better stratify the prognosis of patients with chronic heart failure.

Preoperative electrocardiogram in prediction of 90-day postoperative mortality: retrospective cohort study.

BACKGROUND: There are conflicting data on the relationship between preoperative electrocardiogram and postoperative mortality. We aimed to assess the predictive value of preoperative ECG on postoperative all-cause mortality in patients undergoing non-cardiac surgery (NCS). METHODS: We retrospectively reviewed records of hospitalized patients who underwent an internal preoperative examination and subsequent NCS in the years 2015-2021. We recorded patient comorbidities, vital functions, results of biochemical tests, ECG. The primary end point was 90-day postoperative all-cause mortality, acquired from the hospital records and the nationwide registry run by the Institute of Health Information and Statistics of the Czech Republic. RESULTS: We enrolled a total of 2219 patients of mean age 63 years (48% women). Of these, 152 (6.8%) died during the 90-day postoperative period. There were statistically significant associations between increased 90-day postoperative all-cause mortality and abnormal ECG findings in resting heart rate (≥ 80 bpm, relative risk [RR] = 1.82 and ≥ 100 bpm, RR = 2.57), presence of atrial fibrillation (RR = 4.51), intraventricular conduction delay (QRS > 0.12 s, RR = 2.57), ST segment changes and T wave alterations, left bundle branch hemiblock (RR = 1.64), and right (RR = 2.04) and left bundle branch block (RR = 4.13), but not abnormal PQ and QT intervals, paced rhythm, incomplete right bundle branch block, or other ECG abnormalities. A resting heart rate (≥ 80 bpm, relative risk [RR] = 1.95 and ≥ 100 bpm, RR = 2.20), atrial fibrillation (RR = 2.10), and right bundle branch block (RR = 2.52) were significantly associated with 90-day postoperative all-cause mortality even in subgroup of patients with pre-existing cardiac comorbidities. CONCLUSIONS: Patients with abnormal preoperative ECG findings face an elevated risk of all-cause mortality within 90 days after surgery. The highest mortality risk is observed in patients with atrial fibrillation and left bundle branch block. Additionally, an elevated heart rate, right bundle branch block, and atrial fibrillation further increase the risk of death in patients with pre-existing cardiac conditions.

Significant hemolysis is present during irreversible electroporation of cardiomyocytes in vitro.

BACKGROUND: Pulsed field ablation (PFA) of atrial fibrillation is a new method in clinical practice. Despite a favorable safety profile of PFA in atrial fibrillation ablation, rare cases of renal failure, probably due to hemolysis, have recently been reported. OBJECTIVE: The aim of this study was to determine the rate of hemolysis and cardiac cell death during in vitro PFA with different electric field intensities. METHODS: Blood samples from healthy volunteers and mouse HL-1 cardiomyocyte cell lines were subjected to in vitro irreversible electroporation using 216 bipolar pulses, each lasting 2 µs with intervals of 5 µs, repeated 20 times at a frequency of 1 Hz. These pulses varied from 500 V to 1500 V. Cell-free hemoglobin levels were assessed spectrophotometrically, and red blood cell microparticles were evaluated by flow cytometry. Cardiomyocyte death was quantified with propidium iodide. RESULTS: Pulsed field energy (1000 V/cm, 1250 V/cm, and 1500 V/cm) was associated with a significant increase in cell-free hemoglobin (0.32 ± 0.16 g/L, 2.2 ± 0.96 g/L, and 5.7 ± 0.39 g/L; P < .01) and similar increase in the concentration of red blood cell microparticles. Significant rates of cardiomyocyte death were observed at electric field strengths of 750 V/cm, 1000 V/cm, 1250 V/cm, and 1500 V/cm (26.5% ± 5.9%, 44.3% ± 6.2%, 55.5% ± 6.9%, and 74.5% ± 17.8% of cardiomyocytes; P < .01). CONCLUSION: The most effective induction of cell death in vitro was observed at 1500 V/cm. This intensity was also associated with a significant degree of hemolysis.

Trends in the representation of specialties caring for patients with diabetes in the Czech Republic.

The increasing prevalence of diabetes mellitus (DM) leads to the differentiation of the registration of diabetics in individual specialties. Objective of this paper was the evaluation of changes in the representation of expertise providing care for patients with DM (pDM) in the Czech Republic, based on data analysis from the National Register of Paid Health Services (NRHZS) 2010-2021. In the entire pDM group, the number of patients treated by a diabetologist (DIA) increased from 491,490 (57.0 %) to 537,430 (50.4 %), with a general practitioner (GP) from 27,719 (3.2 %) to 181,330 (17.0 %) and by internist (INT) from 172,918 (20.0 %) to 161,291 (15.1 %). In 2021, 57.9 % DIA, 17 % GP, 12.2 % INT were treated from the group treated with antidiabetics (813,873). In 2021, 84,345 were treated with insulin alone (87.2 % DIA), 129,127 were treated with a combination of insulin and non-insulin antidiabetics; 115,604 (91.6 %) in DIA, 322 (0.3 %) in GP and 7,983 (6.3 %) in INT. 603,331 treated only with non-insulin antidiabetic drugs, of which 281,929 (46.7 %) DIA, 137,744 (22.8 %) GP and 85,273 (14.1 %) INT. For other specialties, 98,385 (16.3 %) persons. 185,838 patients without reported DIA/GP/INT control, of which 80,144 without therapy. The increasing prevalence of DM and changes in reimbursement conditions are reflected in the dynamic development of the distribution of diabetes care by individual specialties.

Prediction of nonresectability using the updated Predictive Index value model assessed by imaging and surgery in tubo-ovarian cancer: a prospective multicenter ISAAC study.

BACKGROUND: A laparoscopy-based scoring system was developed by Fagotti et al (Fagotti or Predictive Index value (PIV)score) based on the intraoperative presence or absence of carcinomatosis on predefined sites. Later, the authors updated the PIV score calculated only in the absence of one or both absolute criteria of nonresectability (mesenteric retraction and miliary carcinomatosis of the small bowel) (updated PIV model). OBJECTIVE: The aim was to demonstrate the noninferiority of ultrasound to other imaging methods (contrast enhanced computed tomography (CT) and whole-body diffusion-weighted magnetic resonance imaging (WB-DWI)/MRI) in predicting nonresectable tumor (defined as residual disease >1 cm) using the updated PIV model in patients with tubo-ovarian cancer. The agreement between imaging and intraoperative findings as a reference was also calculated. STUDY DESIGN: This was a European prospective multicenter observational study. We included patients with suspected tubo-ovarian carcinoma who underwent preoperative staging and prediction of nonresectability at ultrasound, CT, WB-DWI/MRI, and surgical exploration. Ultrasound and CT were mandatory index tests, while WB-DWI/MRI was an optional test (non-available in all centers). The predictors of nonresectability were suspicious mesenteric retraction and/or miliary carcinomatosis of the small bowel or if absent, a PIV >8 (updated PIV model). The PIV score ranges from 0 to 12 according to the presence of disease in 6 predefined intra-abdominal sites (great omentum, liver surface, lesser omentum/stomach/spleen, parietal peritoneum, diaphragms, bowel serosa/mesentery). The reference standard was surgical outcome, in terms of residual disease >1 cm, assessed by laparoscopy and/or laparotomy. The area under the receiver operating characteristic curve (AUC) to assess the performance of the methods in predicting nonresectability was reported. Concordance between index tests at the detection of disease at 6 predefined sites and intraoperative exploration as reference standard was also calculated using Cohen's kappa. RESULTS: The study was between 2018 and 2022 in 5 European gynecological oncology centers. Data from 242 patients having both mandatory index tests (ultrasound and CT) were analyzed. 145/242 (59.9%) patients had no macroscopic residual tumor after surgery (R0) (5/145 laparoscopy and 140/145 laparotomy) and 17/242 (7.0%) had residual tumor ≤1 cm (R1) (laparotomy). In 80/242 patients (33.1%), the residual tumor was>1 cm (R2), 30 of them underwent laparotomy and maximum surgery was carried out, and 50/80 underwent laparoscopy only, because cytoreduction was not feasible in all of them. After excluding 18/242 (7.4%) patients operated on but not eligible for extensive surgery, the predictive performance of 3 imaging methods was analyzed in 167 women. The AUCs of all methods in discriminating between resectable and nonresectable tumor was 0.80 for ultrasound, 0.76 for CT, 0.71 for WB-DWI/MRI, and 0.90 for surgical exploration. Ultrasound had the highest agreement (Cohen's kappa ranging from 0.59 to 0.79) than CT and WB-DWI/MRI to assess all parameters included in the updated PIV model. CONCLUSION: Ultrasound showed noninferiority to CT and to WB-DWI/MRI in discriminating between resectable and nonresectable tumor using the updated PIV model. Ultrasound had the best agreement between imaging and intraoperative findings in the assessment of parameters included in the updated PIV model. Ultrasound is an acceptable method to assess abdominal disease and predict nonresectability in patients with tubo-ovarian cancer in the hands of specially trained ultrasound examiners.

Periprocedural Intravascular Hemolysis During Atrial Fibrillation Ablation: A Comparison of Pulsed Field With Radiofrequency Ablation.

BACKGROUND: Hemolysis-related renal failure has been described after pulmonary vein isolation (PVI) with pulsed-field ablation (PFA). OBJECTIVES: This study sought to compare the potential for hemolysis during PVI with PFA vs radiofrequency ablation (RFA). METHODS: In consecutive patients, PVI was performed with PFA or RFA. Blood samples were drawn at baseline, immediately postablation, and 24 hours postablation. Using flow cytometry, the concentration of red blood cell microparticles (RBCµ) (fragments of damaged erythrocytes) in blood was assessed. Lactate dehydrogenase (LDH), haptoglobin, and indirect bilirubin were measured at baseline and 24 hours. RESULTS: Seventy patients (age: 64.7 ± 10.2 years; 47% women; 36 [51.4%] paroxysmal atrial fibrillation) were enrolled: 47 patients were in the PFA group (22 PVI-only and 36.4 ± 5.5 PFA applications; 25 PVI-plus, 67.3 ± 12.4 pulsed field energy applications), and 23 patients underwent RFA. Compared to baseline, the RBCµ concentration increased ∼12-fold postablation and returned to baseline by 24 hours in the PFA group (median: 70.8 [Q1-Q3: 51.8-102.5] vs 846.6 [Q1-Q3: 639.2-1,215.5] vs 59.3 [Q1-Q3: 42.9-86.5] RBCµ/µL, respectively; P < 0.001); this increase was greater with PVI-plus compared to PVI-only (P = 0.007). There was also a significant, albeit substantially smaller, periprocedural increase in RBCµ with RFA (77.7 [Q1-Q3: 39.2-92.0] vs 149.6 [Q1-Q3: 106.6-180.8] vs 89.0 [Q1-Q3: 61.2-123.4] RBCµ/µL, respectively; P < 0.001). At 24 hours with PFA, the concentration of LDH and indirect bilirubin increased, whereas haptoglobin decreased significantly (all P < 0.001). In contrast, with RFA, there were only smaller changes in LDH and haptoglobin concentrations (P = 0.03) and no change in bilirubin. CONCLUSIONS: PFA was associated with significant periprocedural hemolysis. With a number of 70 PFA lesions, the likelihood of significant renal injury is uncommon.

Long-term trajectory of renal dysfunction and related risk factors in patients with apparently treatment-resistant and non-resistant arterial hypertension.

Objectives: Evidence suggests that renal function increasingly deteriorates in patients with apparently treatment-resistant hypertension (ATRH) in comparison with those who have non-resistant arterial hypertension (NAH). We aimed to assess the long-term decline in renal function between these patient groups and identify specific risk factors contributing to the progression of renal dysfunction. Methods: Data for 265 patients with ATRH and NAH in a hypertension excellence centre were retrospectively evaluated. Demographic characteristics, co-morbidities, laboratory findings, secondary causes of hypertension, medication and exposure to contrast agents were assessed. To address differences between groups, adjustment with linear mixed-effect models was used. Results: Data from the first 4 years of follow-up were evaluated. After adjustment for age and diabetes, which were identified as independent risk factors for renal dysfunction progression in the study cohort, the mean decrease in estimated glomerular filtration rate per year was steeper with ATRH than with NAH (-1.49 vs. -0.65 mL/min/1.73 m2 per year; difference in slope, 0.83 mL/min/1.73 m2 per year; 95% confidence interval [CI]: 0.25-1.41, p = 0.005). In subgroup analyses, without Holm-Bonferroni correction, the prescription of MRA indicated a faster decline in renal function in ATRH. Following correction, no specific therapeutic risk factor was associated with faster progression of renal dysfunction. Conclusions: Renal function declines twice as fast with ATRH compared with NAH, independently of age and diabetes. Larger studies are needed to reveal risk factors for renal dysfunction in patients with hypertension.

High blood pressure (arterial hypertension) is a significant risk factor for kidney function decline. Resistant hypertension represents a subtype of hypertension that is difficult to treat and requires multiple antihypertensive agents to achieve effective blood pressure control. Recent research suggests that individuals with resistant hypertension are at greater risk of kidney dysfunction.This study analyses data from adult patients with arterial hypertension and resistant hypertension followed-up for a mean duration of 6.4 years.A faster decline in kidney function was observed in patients with resistant hypertension. This suggests that renal function in these patients should be closely monitored.After statistical evaluation, no medication was found to be associated with an increased risk of kidney failure progression. However, two specific medications, spironolactone and eplerenone, raised suspicion and require further exploration in larger prospective studies.

Myocardial Damage, Inflammation, Coagulation, and Platelet Activity During Catheter Ablation Using Radiofrequency and Pulsed-Field Energy.

BACKGROUND: Pulsed-field ablation (PFA) represents a new, nonthermal ablation energy for the ablation of atrial fibrillation (AF). Ablation energies producing thermal injury are associated with an inflammatory response, platelet activation, and coagulation activation. OBJECTIVES: This study aimed to compare the systemic response in patients undergoing pulmonary vein isolation (PVI) using pulsed-field and radiofrequency (RF) energy. METHODS: Patients with AF indicated for PVI were enrolled and randomly assigned to undergo PVI using RF (CARTO Smart Touch, Biosense Webster) or pulsed-field (Farapulse, Boston-Scientific) energy. Markers of myocardial damage (troponin I), inflammation (interleukin-6), coagulation (D-dimers, fibrin monomers, von Willebrand antigen and factor activity), and platelet activation (P-selectin, activated GpIIb/IIIa antigen) were measured before the procedure (T1), after trans-septal puncture (T2), after completing the ablation in the left atrium (T3), and 1 day after the procedure (T4). RESULTS: A total of 65 patients were enrolled in the pulsed-field ablation (n = 33) and RF ablation (n = 32) groups. Both groups were similar in baseline characteristics (age 60.5 ± 12.7 years vs 64.0 ± 10.7 years; paroxysmal AF: 60.6% vs 62.5% patients). Procedural and left atrial dwelling times were substantially shorter in the PFA group (55:09 ± 11:57 min vs 151:19 ± 41:25 min; P < 0.001; 36:00 ± 8:05 min vs 115:58 ± 36:49 min; P < 0.001). Peak troponin release was substantially higher in the PFA group (10,102 ng/L [IQR: 8,272-14,207 ng/L] vs 1,006 ng/L [IQR: 603-1,433ng/L]). Both procedures were associated with similar extents (>50%) of platelet and coagulation activation. The proinflammatory response 24 h after the procedure was slightly but nonsignificantly higher in the RF group. CONCLUSIONS: Despite 10 times more myocardial damage, pulsed-field ablation was associated with a similar degree of platelet/coagulation activation, and slightly lower inflammatory response. (The Effect of Pulsed-Field and Radiofrequency Ablation on Platelet, Coagulation and Inflammation; NCT05603637).

Clinical characteristics and mortality in all Czech patients after pacemaker implantation in the last decade.

Background and aims: Analysis of mortality from the national health registries and data from a specific central registry dealing with the implantation of pacemakers (REPACE) in Czech patients. Methods and results: Retrospective observational analysis of pacemakers' implantation in all Czech patients [n = 82,791; 47,070 (56.9%) men, 75.9 ± 10.4 years old] between 2010 and 2021. Almost 114,000 pacemakers were implanted between 2010 and 2021, of which 27.9% were single-chamber, 67.4% were dual-chamber and 4.6% were biventricular. The annual number of implantations has been steadily increasing with a 6% annual decline in 2020 with increased mortality and reductions in care provided, likely related to COVID-19. The observed 5-year relative survival was 88.6% (overall survival 60.6%) and the 10-year relative survival was 75.9% (overall survival 32.7%). Causes of death 5ary according to the age of the patient. The highest difference 1n the reported numbers in the REPACE Registry did not exceed 2% in comparison with the National Register of Reimbursed Health Services. Conclusion: This study followed all Czech patients with pacemaker's implantation in between 2010 and 2021. The annual number of 1mplantations has been steadily 1ncreasing. Patients with implanted pacemakers had a significantly higher mortality than the average population. Number of patients in the registry corresponded almost perfectly with the National Register of Reimbursed Health Services.

Challenges in prospective observational studies evaluating pressure ulcer costs: how to price the items correctly.

OBJECTIVE: Pressure ulcers (PUs) are a significant healthcare problem with a negative impact on patients' quality of life and incurring substantial healthcare expenses. Our study aimed to analyse the costs of treating PUs in hospitalised patients in the Czech Republic, in the context of current treatment procedures and price levels, and to pilot-test the detailed methodology developed. METHOD: A prospective, observational, non-interventional study was conducted at the Clinic of Anesthesiology, Resuscitation and Intensive Medicine, the Internal Medicine Department and the Surgical Department of the University Hospital Ostrava. The study included all hospitalised patients with a PU from March-May 2021. Data were collected using the hospital information system. A bottom-up, person-based approach to cost analysis was used, based on a comprehensive cost structure using accurate patient-specific consumption records. RESULTS: The length of hospitalisations ranged from 1-31 (mean: 12.7) days. The average cost of PU treatment per hospitalisation was calculated at €1579. The average daily cost of PU treatment was €179, including antibiotic therapy (ATB) and €112 without ATB. Most of the costs were associated with ATB (38.6%) and caregivers' time (35.9%). Based on the results, a predictive model was developed to estimate the cost of treating a hospitalised patient with a PU, which could be used in future research to assess the costs of treating these patients. CONCLUSION: We have faced many challenges in the methodology of preparation of cost analysis (e.g., how to count amorphous topical agents and sprays, how to properly identify PUs, how to price the positioning aids and mattresses, and how to relate the ATB treatment to the PU). This analysis provides important input for developing a comprehensive and more accurate methodology for monitoring PU costs in hospitalised patients, applicable in clinical practice for inpatient healthcare providers.

Nonprocedural bleeding after left atrial appendage closure versus direct oral anticoagulants: A subanalysis of the randomized PRAGUE-17 trial.

INTRODUCTION: Observational studies have shown low bleeding rates in patients with atrial fibrillation (AF) treated by left atrial appendage closure (LAAC); however, data from randomized studies are lacking. This study compared bleeding events among patients with AF treated by LAAC and nonvitamin K anticoagulants (NOAC). METHODS: The Prague-17 trial was a prospective, multicenter, randomized trial that compared LAAC to NOAC in high-risk AF patients. The primary endpoint was a composite of a cardioembolic event, cardiovascular death, and major and clinically relevant nonmajor bleeding (CRNMB) defined according to the International Society on Thrombosis and Hemostasis (ISTH). RESULTS: The trial enrolled 402 patients (201 per arm), and the median follow-up was 3.5 (IQR 2.6-4.2) years. Bleeding occurred in 24 patients (29 events) and 32 patients (40 events) in the LAAC and NOAC groups, respectively. Six of the LAAC bleeding events were procedure/device-related. In the primary intention-to-treat analysis, LAAC was associated with similar rates of ISTH major or CRNMB (sHR 0.75, 95% CI 0.44-1.27, p = 0.28), but with a reduction in nonprocedural major or CRNMB (sHR 0.55, 95% CI 0.31-0.97, p = 0.039). This reduction for nonprocedural bleeding with LAAC was mainly driven by a reduced rate of CRNMB (sHR for major bleeding 0.69, 95% CI 0.34-1.39, p = .30; sHR for CRNMB 0.43, 95% CI 0.18-1.03, p = 0.059). History of bleeding was a predictor of bleeding during follow-up. Gastrointestinal bleeding was the most common bleeding site in both groups. CONCLUSION: During the 4-year follow-up, LAAC was associated with less nonprocedural bleeding. The reduction is mainly driven by a decrease in CRNMB.

Mortality related to pressure ulcers in Czech Republic - Analyses of national health registries.

BACKGROUND: Pressure ulcers/pressure injuries (PUs/PIs) relate to decreasing quality of life, prolonged hospitalisation, the increased economic cost of care, and increased mortality. That's why this study focused on one of the mentioned factors - mortality. OBJECTIVES: The study analyses national data in the Czech Republic to map the mortality phenomenon comprehensively based on data from national health registries. METHOD: The retrospective, nationwide cross-sectional data analysis of data collected by the National Health Information System (NHIS) has been provided in the period 2010-2019 with a special focus on 2019. Hospitalisations with PUs/PIs were identified by reporting L89.0-L89.9 diagnosis as a primary or secondary hospitalisation diagnosis. We also included all the patients who died in the given year with an L89 diagnosis reported in 365 days prior the death. RESULTS: In 2019, 52.1% of patients with reported PUs/PIs were hospitalised, and 40.8% were treated on an outpatient basis. The most common underlying cause of death mortality diagnosis (43.7%) in these patients was the diseases of the circulatory system. Patients who die in a healthcare facility while hospitalised with an L89 diagnosis generally have a higher category of PUs/PIs than persons who die outside a healthcare facility. CONCLUSION: The proportion of patients dying in a health facility is directly proportional to the increasing PUs/PIs category. In 2019, 57% of patients with PUs/PIs died in a healthcare facility, and 19% died in the community. In 24% of patients who died in the healthcare facility, PUs/PIs were reported 365 days before the death.

Role of adjuvant therapy in intermediate-risk cervical cancer patients - Subanalyses of the SCCAN study.

OBJECTIVE: The "intermediate-risk" (IR) group of early-stage cervical cancer patients is characterized by negative pelvic lymph nodes and a combination of tumor-related prognostic risk factors such as tumor size ≥2 cm, lymphovascular space invasion (LVSI), and deep stromal invasion. However, the role of adjuvant treatment in these patients remains controversial. We investigated whether adjuvant (chemo)radiation is associated with a survival benefit after radical surgery in patients with IR cervical cancer. METHODS: We analyzed data from patients with IR cervical cancer (tumor size 2-4 cm plus LVSI OR tumor size >4 cm; N0; no parametrial invasion; clear surgical margins) who underwent primary curative-intent surgery between 2007 and 2016 and were retrospectively registered in the international multicenter Surveillance in Cervical CANcer (SCCAN) study. RESULTS: Of 692 analyzed patients, 274 (39.6%) received no adjuvant treatment (AT-) and 418 (60.4%) received radiotherapy or chemoradiotherapy (AT+). The 5-year disease-free survival (83.2% and 80.3%; PDFS = 0.365) and overall survival (88.7% and 89.0%; POS = 0.281) were not significantly different between the AT- and AT+ groups, respectively. Adjuvant (chemo)radiotherapy was not associated with a survival benefit after adjusting for confounding factors by case-control propensity score matching or in subgroup analyses of patients with tumor size ≥4 cm and <4 cm. In univariable analysis, adjuvant (chemo)radiotherapy was not identified as a prognostic factor in any of the subgroups (full cohort: PDFS = 0.365; POS = 0.282). CONCLUSION: Among patients with IR early-stage cervical cancer, radical surgery alone achieved equal disease-free and overall survival rates to those achieved by combining radical surgery with adjuvant (chemo)radiotherapy.

Stratification of lymph node metastases as macrometastases, micrometastases, or isolated tumor cells has no clinical implication in patients with cervical cancer: Subgroup analysis of the SCCAN project.

BACKGROUND: In cervical cancer, presence of lymph-node macrometastases (MAC) is a major prognostic factor and an indication for adjuvant treatment. However, since clinical impact of micrometastases (MIC) and isolated tumor-cells (ITC) remains controversial, we sought to identify a cut-off value for the metastasis size not associated with negative prognosis. METHODS: We analyzed data from 967 cervical cancer patients (T1a1L1-T2b) registered in the SCCAN (Surveillance in Cervical CANcer) database, who underwent primary surgical treatment, including sentinel lymph-node (SLN) biopsy with pathological ultrastaging. The size of SLN metastasis was considered a continuous variable and multiple testing was performed for cut-off values of 0.01-1.0 mm. Disease-free survival (DFS) was compared between N0 and subgroups of N1 patients defined by cut-off ranges. RESULTS: LN metastases were found in 172 (18%) patients, classified as MAC, MIC, and ITC in 79, 54, and 39 patients, respectively. DFS was shorter in patients with MAC (HR 2.20, P = 0.003) and MIC (HR 2.87, P < 0.001), while not differing between MAC/MIC (P = 0.484). DFS in the ITC subgroup was neither different from N0 (P = 0.127) nor from MIC/MAC subgroups (P = 0.449). Cut-off analysis revealed significantly shorter DFS compared to N0 in all subgroups with metastases ≥0.4 mm (HR 2.311, P = 0.04). The significance of metastases <0.4 mm could not be assessed due to limited statistical power (<80%). We did not identify any cut-off for the size of metastasis with significantly better prognosis than the rest of N1 group. CONCLUSIONS: In cervical cancer patients, the presence of LN metastases ≥0.4 mm was associated with a significant negative impact on DFS and no cut-off value for the size of metastasis with better prognosis than N1 was found. Traditional metastasis stratification based on size has no clinical implication.

Pharmacotherapy of diabetes mellitus in patients with heart failure - a nation-wide analysis of contemporary treatment.

AIM: Retrospective national sub-analysis of antidiabetic pharmacotherapy in patients with diabetes mellitus (DM) and heart failure (HF) based on data reported to the National Register of Paid Health Services in the Czech Republic between 2012-2018. METHODOLOGY AND RESULTS: In 2012, there were 75,022 patients with HF and DM (i.e. 42.5% of patients with HF), 6 years later 117,265 (i.e. 41.0% of HF patients in 2018). The most represented antidiabetic drug was metformin (45.6%). Of the insulins and analogues, glargine showed the largest positive trend (5.8% 2012; 14.8% 2018). Empagliflozin was the most prescribed SGLT-2 inhibitor (1.8% in 2018). A decrease in prescribing was observed for saxagliptin (0.5% 2012; 0.1% 2018) and for sulfonylurea derivates - gliclazide (13.0% 2012; 10.3% in 2018) and glimepiride (12.9% 2012; 9.0% 2018). Linagliptin was the most prescribed dipeptidyl peptidase inhibitor (0.7% 2012; 6.8% 2018). CONCLUSION: In the Czech Republic, between 2012 and 2008, there was an increase in prevalence of patients with heart failure and concomitant diabetes mellitus, their proportion being similar. In correspondence with other registries, metformin was used mostly. A positive trend was observed in prescription of DDP-4 and SGLT-2 inhibitors, while there was a significant decrease in patients taking sulfonylureas.

Effectiveness of ICD therapy in real clinical practice. The Olomouc ICD Registry.

BACKGROUND: Clinical parameters linked to a low benefit of ICD implantation and increased mortality risks are needed for an individualized assessment of potential benefits and risks of ICD implantation. METHODS: Analysis of a prospective registry of all patients hospitalized from 2009 to 2019 in a single centre for a first implantation of any type of ICD. RESULTS: A total of 2,681 patients were included in the registry. Until the end of follow-up (38.4 ± 29.1 months), 682 (25.4%) patients died. The one-year mortality in all patients, the one-year CV mortality, the three-year mortality in all patients, and the three-year CV mortality were 7.8%, 5.7%, 20.6%, and 14.8%, respectively. There was a statistically significant difference when the subgroups were compared according to the type of cardiomyopathy. No significant difference was found between primary and secondary prevention and between the types of devices. Male gender, age ≥ 75 years, diabetes mellitus, and atrial fibrillation were associated with a significantly increased mortality risk. CONCLUSION: In an analysis of a long-term follow-up of 2,681 ICD patients, we found no mortality difference between patients with ischemic or non-ischemic cardiomyopathy and in the device type. A higher mortality risk was found in men, patients older than 75 years, diabetics, and those with atrial fibrillation.

COVID-19 vaccine booster significantly decreases the risk of intensive care unit hospitalization in heart failure patients during the Omicron variant wave: A population-based study.

Background: Heart failure (HF) patients are at higher risk of severe coronavirus disease 2019 (COVID-19). The Omicron variant has many novel mutations including those in the spike protein, leading to questions about vaccine effectiveness. The aim of this analysis was to evaluate the effectiveness of the COVID-19 vaccine with or without a booster (i.e., after the third dose) during the Omicron variant wave. Methods: Chronic heart failure patients in the Czech Republic were included in the analysis. COVID-19 infection was monitored from January 1st 2022 to March 31st 2022. The analysis was conducted on data collected in the National Health Information System. Vaccine effectiveness of vaccinated (with or without booster) vs. unvaccinated patients was analyzed for incidence of COVID-19, COVID-19-related hospitalizations, COVID-19 related intensive care unit admissions, and COVID-19 related mechanical ventilation/extracorporeal membrane oxygenation treatment. Findings: From a total 165,453 HF patients in the Czech Republic, 9,728 contracted COVID-19 (22.9% of them not vaccinated, 23.2% vaccinated and 53.8% vaccinated and boosted). Risk of intensive care unit (ICU) hospitalization was 7.6% in the unvaccinated group, 4.8% in the vaccinated group and 2.9% in the boosted group. The calculated effectiveness of the COVID-19 vaccine in prevention of ICU hospitalization in the vaccinated group was 41.9 and 76.6% in the boosted group. Interpretation: The results demonstrated moderate vaccine effectiveness in the prevention of severe COVID-19 in vaccinated but not boosted HF patients. Much stronger effectiveness was found in those who were vaccinated and boosted.