Combining left atrial appendage closure and catheter ablation for atrial fibrillation: 2-year outcomes from a multinational registry.

AIMS: Clinical practice guidelines do not recommend discontinuation of long-term oral anticoagulation in patients with a high stroke risk after catheter ablation for atrial fibrillation (AF). Left atrial appendage closure (LAAC) with Watchman has emerged as an alternative to long-term anticoagulation for patients accepting of the procedural risks. We report on the long-term outcomes of combining catheter ablation procedures for AF and LAAC from multicentre registries. METHODS AND RESULTS: Data were pooled from two prospective, real-world Watchman LAAC registries running in parallel in Europe/Middle-East/Russia (EWOLUTION) and Asia/Australia (WASP) between 2013 and 2015. Of the 1140 patients, 142 subjects at 11 centres underwent a concomitant AF ablation and LAAC procedure. The mean CHA2DS2-VASc score was 3.4 ± 1.4 and HAS-BLED score 1.5 ± 0.9. Successful LAAC was achieved in 99.3% of patients. The 30-day device and/or procedure-related serious adverse event rate was 2.1%. After a mean follow-up time of 726 ± 91 days, 92% of patients remained off oral anticoagulation. The rates of the composite endpoint of ischaemic stroke/transient ischaemic attack/systemic thromboembolism were 1.09 per 100 patient-years (100-PY); and for non-procedural major bleeding were 1.09 per 100-PY. These represent relative reductions of 84% and 70% vs. expected rates per risk scores. CONCLUSION: The long-term outcomes from these international, multicentre registries show efficacy for all-cause stroke prevention and a significant reduction in late bleeding events in a population of high stroke risk post-ablation patients who have been withdrawn from oral anticoagulation.

Botulinum Toxin-Chitosan Nanoparticles Prevent Arrhythmia in Experimental Rat Models.

Several experimental studies have recently demonstrated that temporary autonomic block using botulinum toxin (BoNT/A1) might be a novel option for the treatment of atrial fibrillation. However, the assessment of antiarrhythmic properties of BoNT has so far been limited, relying exclusively on vagal stimulation and rapid atrial pacing models. The present study examined the antiarrhythmic effect of specially formulated BoNT/A1-chitosan nanoparticles (BTN) in calcium chloride-, barium chloride- and electrically induced arrhythmia rat models. BTN enhanced the effect of BoNT/A1. Subepicardial injection of BTN resulted in a significant antiarrhythmic effect in investigated rat models. BTN formulation antagonizes arrhythmia induced by the activation of Ca, K and Na channels.

Combining Watchman left atrial appendage closure and catheter ablation for atrial fibrillation: multicentre registry results of feasibility and safety during implant and 30 days follow-up.

Aims: Long-term results from catheter ablation therapy for atrial fibrillation (AF) remain uncertain and clinical practice guidelines recommend continuation of long-term oral anticoagulation in patients with a high stroke risk. Left atrial appendage closure (LAAC) with Watchman has emerged as an alternative to long-term anticoagulation for patients accepting of the procedural risks. We report on the initial results of combining catheter ablation procedures for AF and LAAC in a multicentre registry. Methods and results: Data were pooled from two prospective, real-world Watchman LAAC registries running in parallel in Europe/Middle-East/Russia (EWOLUTION) and Asia/Australia (WASP) between 2013 and 2015. Of the 1140 patients, 139 subjects at 10 centres underwent a concomitant AF ablation and LAAC procedure. The mean CHA2DS2-VASc score was 3.4 ± 1.4 and HAS-BLED score 1.5 ± 0.9. Successful Watchman implantation was achieved in 100% of patients. The overall 30-day serious adverse event (SAE) rate was 8.7%, with the device and/or procedure-related SAE rate of 1.4%. One pericardial effusion required percutaneous drainage, but there were no strokes, device embolization, or deaths at 30 days. The 30-day bleeding SAE rate was 2.9% with 55% of patients prescribed NOAC and 38% taking warfarin post-procedure. Conclusion: The outcomes from these international, multicentre registries support the feasibility and safety of performing combined procedures of ablation and Watchman LAAC for patients with non-valvular AF and high stroke risk. Further data are needed on long-term outcomes for the hybrid technique on all-cause stroke and mortality.

Karyotype and COI gene sequence of Chironomusheteropilicornis Wülker, 1996 (Diptera, Chironomidae) from the Gydan Peninsula, Russia.

The karyotype features and gene COI sequence of Chironomusheteropilicornis Wülker, 1996 from the Gydan Peninsula are presented for the first time. Nine banding sequences were determined, eight of them hpiA2, hpiB1, hpiC1, hpiC2, hpiD1, hpiE1, hpiF3 and hpiG1 were previously known from European, Georgian (South Caucasus) and Siberian populations. One new banding sequence for Ch.heteropilicornis, hpiB2, was found. The hpiA2 banding sequence was found in all individuals, and this is its second finding after the Georgian population (Karmokov 2019). The hpiF3 banding sequence was found only in the homozygous state. Additional B-chromosomes are absent. The genetic distances (K2P) between Ch.heteropilicornis COI gene sequence from Gydan Peninsula and Norway are 1.1--1.3%, and Georgia - 1.8%, much lower than the commonly accepted threshold of 3% for species of genus Chironomus Meigen, 1803. The phylogenetic tree for COI gene sequences estimated by Bayesian inference showed geographically determined clusters of Norway and Gydan and a separate lineage of the Georgian population of Ch.heteropilicornis. The analysis of karyotype and COI gene sequences shows that the population of Ch.heteropilicornis from the Gydan Peninsula has an intermediate position within the Ch.pilicornis group between Georgian, Yakutian and Norwegian populations. The position of Ch.pilicornis Fabricius, 1787 from Canada and Greenland on the phylogenetic tree is discussed.

Platelet-Rich Plasma Therapy for Male Sexual Dysfunction: Myth or Reality?

INTRODUCTION: Platelet-rich plasma (PRP) found its use in treating different conditions and diseases, because concentrated plasma PRP consists of many growth factors. Their interaction with surrounding cells, intracellular matrix, and mediators at the site of injection leads to tissue regeneration. Angiogenic, vasculogenic, and regenerative effects of PRP may be used for erectile dysfunction (ED) and Peyronie's disease (PD) treatment. AIM: To present a current data review of preclinical and clinical trials on PRP use for treating ED and PD. METHODS: Up-to-date literature on PRP use for ED and PD treatment was analyzed. The search was based on Pubmed, Cochrane Library, clinicaltrials.gov databases, with the following key words: "platelet-rich plasma" and/or "erectile dysfunction" and/or "Peyronie's disease" and/or "sexual dysfunction." MAIN OUTCOME MEASURES: The main outcome measures for preclinical trials on ED were erectile function, assessed with intracavernous pressure, and pathologic analysis of penile tissue. The main outcome measures for clinical trials on ED included penile duplex Doppler ultrasound scanning and validated questionnaires. The main outcome measures on PD were pathologic analysis of penile tissue for preclinical trials, as well as penile duplex Doppler ultrasound scanning, penile curvature angle measuring, and validated questionnaires for clinical trials. RESULTS: 4 preclinical and 6 clinical trials were described and analyzed in this article. Limitations for both preclinical and clinical trials included small groups, short follow-up periods, a lack of control groups or groups with placebo, and the lack of quality and quantity analysis of PRP. CONCLUSION: Available data show the lack of adverse reactions with PRP treatment. The studies that we found were limited by small groups. This is why the data on safety and effectiveness should be taken carefully. However, it is important to mention that PRP therapy has the potential for treating male sexual dysfunction and may be useful in andrology. Epifanova MV, Gvasalia BR, Durashov MA, et al. Platelet-Rich Plasma Therapy for Male Sexual Dysfunction: Myth or Reality? Sex Med Rev 2020;8:106-113.

Does left atrial appendage closure improve the success of pulmonary vein isolation? Results of a randomized clinical trial.

PURPOSE: The combination of left atrial appendage (LAA) occlusion with pulmonary vein isolation (PVI) potentially represents a comprehensive treatment for atrial fibrillation (AF), controlling symptoms while at the same time reducing the risk of stroke and the need for chronic anticoagulation. The aim of this randomized clinical trial was to assess the impact of LAA closure added to PVI in patients with high-risk AF. METHODS: Patients with a history of symptomatic paroxysmal or persistent AF refractory to ≥ 2 antiarrhythmic drugs, CHA2DS2-VASc score ≥ 2, and HAS-BLED score ≥ 3 were randomized to PVI-only (n = 44) or PVI with LAA closure (n = 45). RESULTS: Six patients in PVI + LAA closure group crossed over to PVI-only group due to failure of LAA closure device implantation. On-treatment comparisons at the 24 month follow-up revealed that 33 (66%) of the 50 PVI group and 23 (59%) of the 39 PVI with LAA closure group were AF-free on no antiarrhythmic drugs (p = 0.34). The PVI + LAA closure treatment was significantly associated with a higher AF burden during the blanking period: 9.7 ± 10.8 vs 4.2 ± 4.1% (p = 0.004). At the end follow-up, there were no serious complications and no strokes or thromboembolic events in either group. CONCLUSIONS: The combination of LAA closure device implantation with PVI was safe but was not observed to influence the success of PVI in patients with symptomatic refractory AF. Early AF after ablation, however, is increased by LAA closure. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01695824.