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Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF., (© 2024. The Author(s).)

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., Competing Interests: The authors report no conflicts of interest in this work.

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., Competing Interests: The authors report no conflicts of interest in this work.

Background: Atrial fibrillation is common in patients with structural heart disease who are undergoing cardiac surgery. Surgical CryoMaze has been shown to be an effective treatment in several trials, but success rates have varied considerably, between 47-95%. The sequential hybrid approach, combining surgical CryoMaze followed by radiofrequency catheter ablation, can achieve high freedom from atrial arrhythmias. However, in patients with concomitant surgical atrial fibrillation treatment, data comparing the hybrid approach to CryoMaze alone are lacking., Methods: The SurHyb study was designed as a prospective, open-label, multicentre randomized trial. Patients with non-paroxysmal atrial fibrillation who were scheduled for coronary artery bypass grafting or valve repair/replacement were randomized to either surgical CryoMaze alone or surgical CryoMaze followed by radiofrequency catheter ablation 3 months post-surgery. The primary outcome measure was arrhythmia-free survival without class I or III antiarrhythmic drugs, which has been evaluated using implantable cardiac monitors., Conclusions: This is the first randomized study that compares concomitant surgical CryoMaze alone with the staged hybrid surgical CryoMaze followed by catheter ablation, in patients with non-paroxysmal atrial fibrillation using rigorous rhythm monitoring. The results may contribute to the optimization of the treatment in patients undergoing concomitant CryoMaze for atrial fibrillation., Competing Interests: The authors report no conflicts of interest in this work.

Background: Anderson-Fabry disease (AFD) is an X-linked inherited lysosomal disease caused by a defect in the gene encoding lysosomal enzyme α-galactosidase A (GLA). Atrio-ventricular (AV) nodal conduction defects and sinus node dysfunction are common complications of the disease. It is not fully elucidated how frequently AFD is responsible for acquired AV block or sinus node dysfunction and if some AFD patients could manifest primarily with spontaneous bradycardia in general population. The purpose of study was to evaluate the prevalence of AFD in male patients with implanted permanent pacemaker (PM)., Methods: The prospective multicentric screening in consecutive male patients between 35 and 65 years with implanted PM for acquired third- or second- degree type 2 AV block or symptomatic second- degree type 1 AV block or sinus node dysfunction was performed., Results: A total of 484 patients (mean age 54 ± 12 years at time of PM implantation) were enrolled to the screening in 12 local sites in Czech Republic. Out of all patients, negative result was found in 481 (99%) subjects. In 3 cases, a GLA variant was found, classified as benign: p.Asp313Tyr, p.D313Y). Pathogenic GLA variants (classical or non-classical form) or variants of unclear significance were not detected., Conclusion: The prevalence of pathogenic variants causing AFD in a general population sample with implanted permanent PM for AV conduction defects or sinus node dysfunction seems to be low. Our findings do not advocate a routine screening for AFD in all adult males with clinically significant bradycardia., Competing Interests: Declaration of Competing Interest ZF and SH received the travel grants and speaker's honoraria from Takeda. GD received honoraria and travel funding from Sanofi Genzyme, Takeda, Protalix, and Greenovation Biotech GmbH. DG is a consultant for Amicus Therapeutics, Sanofi Genzyme, and Shire; has received research support from Sanofi Genzyme and Shire; and has received speaker honoraria and travel support from Amicus Therapeutics, Sanofi Genzyme, and Shire. AL received consultancy honoraria from Amicus Therapeutics, Sanofi Genzyme, Takeda, and speaker's honoraria from Sanofi Genzyme and Takeda., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Cannabis preparations are gaining popularity among patients with various skin diseases. Due to the lack of scientific evidence, dermatologists remain cautious about their prescriptions. So far, only a few studies have been published about the effects of high-potency cannabis extracts on microorganisms (especially dermatophytes) causing skin problems that affect more than 25% of the worldwide population. Even though, the high-potency cannabis extracts prepared by cold extraction are mostly composed of non-psychoactive tetrahydrocannabinolic acid (THCA) and only low amount of THC, their use in topical treatment can be stigmatized. The in vitro antimicrobial and antifungal activity of two high potent cannabis strains extracted by three solvents traditionally or currently used by cannabis users (ethanol; EtOH, butane; BUT, dimethyl ether; DME) was investigated by broth dilution method. The chemical profile of cannabis was determined by high-performance liquid chromatography with ultraviolet detection and gas chromatography with mass spectrometer and flame ionization detector. The extraction methods significantly influenced chemical profile of extracts. The yield of EtOH extracts contained less cannabinoids and terpenes compared to BUT and DME ones. Most of the extracts was predominantly (>60%) composed of various cannabinoids, especially THCA. All of them demonstrated activity against 18 of the 19 microorganisms tested. The minimal inhibitory concentrations (MICs) of the extracts ranged from 4 to 256 μg/mL. In general, the bacteria were more susceptible to the extracts than dermatophytes. Due to the lower content of biologically active substances, the EtOH extracts were less effective against microorganisms. Cannabis extracts may be of value to treat dermatophytosis and other skin diseases caused by various microorganisms. Therefore, they could serve as an alternative or supportive treatment to commonly used antibiotics., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Skala, Kahánková, Tauchen, Janatová, Klou  ˇ cek, Hubka and Fra  ˇ nková.)

Aims: Sub-analysis of a retrospective nation-wide observational analysis of heart failure (HF) epidemiology reported to the Czech National Registry of Reimbursed Health Services between 2012 and 2018 aimed at angiotensin-converting enzyme inhibitors (ACEI), angiotensin-II-receptor antagonists (ARB) and angiotensin receptor blocker/neprilysin inhibitor (ARNI) use., Methods and Results: ACEi and ARBs were generally used in 87.6% of all HF patients in 2012 (n=154 627); 84.5% in 2013 (n=170 861); 83.5% in 2014 (n=186 963); 81.6% in 2015 (n=198 844); 80.1% in 2016 (n=205 793); 78.0% in 2017 (n=212 152) and in 76.7% in 2018 (n=219 235). In a sub-analysis of patients with a medical procedure and/or examination using an I50.x ICD code accounted for in the given year, ACEi and ARBs were generally used in 99.3% in 2012 (n=63 250); 96% in 2013 (n=62 241); 95.2% in 2014 (n=64 414); 93.3% in 2015 (n=65 217); 91.8% in 2016 (n=65 236); 90.1% in 2017 (n=65 761) and in 88.6% in 2018 (n=66 332). In 2018, the majority of patients with HF were prescribed ramipril (n=49 909; 17.5%) and perindopril (n=44 332; 15.5%). The mostly prescribed ARBs in 2018 were telmisartan (n=18 669; 6.5%); losartan (n=13 935; 4.9%) and valsartan (n=4 849; 1.7%). In 24.5% of cases, ACEIs and ARBs were prescribed in a fixed combination with another drug. ARNI became gradually more prescribed from 2018 (n=9 659 in November 2020)., Conclusion: In an analysis of ACEIs, ARBs and ARNIs utilization in all patients treated for heart failure in the given year in the whole country, we found a comparable rate of drug prescription in comparison with specific heart failure registries. This indicates a good translation of current standard of care into common clinical practice. Ramipril and perindopril remained the mostly prescribed ACEIs and telmisartan became the mostly prescribed ARB. Since 2018, ARNIs began to be widely prescribed., Competing Interests: The authors report no conflicts of interest in this work.

Background: Primary preventive implantation of implantable defibrillator (ICD) is according to current guidelines indicated in patients with heart failure NYHA (New York Heart Association) class II/III and LVEF <35%. Thanks to advances in heart failure pharmacotherapy, a decrease in mortality could render a benefit of ICD insufficient to justify its implantation in some patients., Methods: Study design: multicenter, prospective, randomized, controlled trial evaluating the benefit of implantation of Cardiac Resynchronization and Defibrillator Therapy (CRT-D) or CRT Alone (CRT-P) in non-ischemic patients with reduced left ventricle ejection fraction (LVEF) and optimal pharmacotherapy without significant mid-wall myocardial fibrosis detected by cardiac magnetic resonance (CMR). The primary end-point: Re-hospitalization for heart failure, ventricular tachycardia, major adverse cardiac events (MACE). The secondary end-points: Sudden cardiac death, cardiovascular death, resuscitated cardiac arrest or sustained ventricular tachycardia, device-related complications, and change in quality of life. Course of the study: After a pharmacotherapy is optimized and significant mid-wall myocardial fibrosis excluded, patients will be randomized 1:1 to CRT-P or CRT-D implantation., Discussion: If our hypothesis is confirmed, this could provide evidence for the management of these patients with a significant impact on common daily praxis and health care expenditures., Clinicaltrials: gov, NCT04139460., Competing Interests: The authors report no conflicts of interest in this work.

Aims: Sub-analysis of a retrospective nation-wide observational analysis of heart failure (HF) epidemiology reported to the Czech National Registry of Reimbursed Health Services between 2012 and 2018 aimed at beta-blockers (BBs) utilization., Methods and Results: The beta-blockers were generally used in 81.8% of all patients treated for HF in 2012 (n=52 140); 81.8% in 2013 (n=53 058); 83.1% in 2014 (n=56 221); 82.1% in 2015 (n=57 421); 83.3% in 2016 (n=59 187); 82.2% in 2017 (60 058) and in 81.4% in 2018 (n=60 966). In 2018, the majority of patients treated for HF were prescribed metoprolol (22 974; 30.7%) and bisoprolol (21 001; 28%). Carvedilol was prescribed in 7 331 patients treated for HF (9.8%), nebivolol in 5 392 HF patients. Despite its primary indication, betaxolol was used in 2 341 patients treated for HF (3.1%). All other beta-blockers were used in less than 1% of HF patients. In some of the mostly used BBs, their prescription in patients treated for HF changed in the last years (metoprolol 32.4% in 2012, 30.7% in 2018; bisoprolol 20.3% in 2012, 28% in 2018; carvedilol 18.3% in 2012, 9.8% in 2018; nebivolol 2.5% in 2012, 7.2% in 2018; betaxolol 4.2% in 2012, 3.1% in 2018)., Conclusion: In an analysis of beta-blockers utilization in all patients treated for heart failure in the given year in the whole country, we have found only slightly lower amount of drug prescription in comparison with specific heart failure registries. This indicates a good translation of current standard of care into common clinical practice. Metoprolol remained the mostly prescribed drug. The prescription of bisoprolol and nebivolol has increased at the expense of carvedilol.