Longer Hospitalizations and Higher In-Hospital Mortality for Acute Heart Failure during the COVID-19 Pandemic in Larger vs. Smaller Cardiology Departments: Subanalysis of the COV-HF-SIRIO 6 Multicenter Study.

Background: The coronavirus disease-2019 (COVID-19) pandemic is surging across Poland, leading to many direct deaths and underestimated collateral damage. We aimed to compare the influence of the COVID-19 pandemic on hospital admissions and in-hospital mortality in larger vs. smaller cardiology departments (i.e., with ≥ 2000 vs. < 2000 hospitalizations per year in 2019). Methods: We performed a subanalysis of the COV-HF-SIRIO 6 multicenter retrospective study including all patients hospitalized in 24 cardiology departments in Poland between January 1, 2019 and December 31, 2020, focusing on patients with acute heart failure (AHF) and COVID-19. Results: Total number of hospitalizations was reduced by 29.2% in larger cardiology departments and by 27.3% in smaller cardiology departments in 2020 vs. 2019. While hospitalizations for AHF were reduced by 21.8% and 25.1%, respectively. The length of hospital stay due to AHF in 2020 was 9.6 days in larger cardiology departments and 6.6 days in smaller departments (p < 0.001). In-hospital mortality for AHF during the COVID-19 pandemic was significantly higher in larger vs. smaller cardiology departments (10.7% vs. 3.2%; p < 0.001). In-hospital mortality for concomitant AHF and COVID-19 was extremely high in larger and smaller cardiology departments accounting for 31.3% vs. 31.6%, respectively. Conclusions: During the COVID-19 pandemic longer hospitalizations and higher in-hospital mortality for AHF were observed in larger vs. smaller cardiology departments. Reduced hospital admissions and extremely high in-hospital mortality for concomitant AHF and COVID-19 were noted regardless of department size.

A new approach to the continuous monitoring of transvenous lead extraction using transesophageal echocardiography-Analysis of 936 procedures.

AIMS: The usefulness of transesophageal echocardiographic (TEE) monitoring for transvenous lead extraction (TLE) procedures is still controversial. The purpose of the current study was to present new TEE values in detecting invisible events in fluoroscopy and preventing the development of dangerous complications. METHODS: From 2015 to 2019, a total of 1026 procedures were performed in single TLE center. In total, 1108 leads had been extracted with a mean lead dwell time of 115.8 ± 77.6 months. Continuous TEE was used in 936 patients with a mean age of 67.1 ± 14.4 years. RESULTS: Preprocedure examination revealed looped leads in 181 (19.3%) patients, dry cardiac perforation in 151 (16.1%), lead-to-lead adhesion in 172 (18.4%), lead adhesion to the myocardium in 317 (33.9%), and vegetations in 119 (12.7%) patients. Intra-procedural TEE demonstrated pulling on the atrial wall, ventricular wall, or tricuspid valve in 380 (40.5%), 235 (25.1%), and 78 (8.3%) patients, respectively. Acute tamponade requiring sternotomy occurred in 11 (1.1%) patients. Migration of vegetation or connective tissue fragments were seen in 69 (7.3%) and 111 (11.8%) patients, respectively. After procedure, TEE was helpful in navigating an implantation, a new lead in 97 (10.3%) patients, and removing the remnants of lead/silicone insulation in 50 (5.3%) patients. CONCLUSION: Real time transesophageal echocardiography for the guidance of transvenous lead extraction informs the operator about the danger of manipulations close to delicate cardiac structures and whether immediate modification to the plan of lead removal is necessary in order to prevent the occurrence of unwanted events.

Quality of life of a healthy polish population due to sociodemographic factors during the COVID-19 pandemic - a cross-sectional study.

Introduction: The quality of life should be studied in every person, both among the sick and healthy. Sociodemographic factors affect the level of the perceived quality of life (QoL), and especially in the situation of the COVID-19 pandemic, which forced the enforcement of certain behaviours in society, such as social distancing, as well as introduced panic and fear for one's own health and life. The main aim of the study was to assess the quality of life in the group of people without the disease, to assess the impact of sociodemographic factors on QoL during the pandemic. Material and method: 3,511 healthy people were included in the study. The inclusion criteria of the study were: age of respondents over 18 years, no continuously administered medicaments, no diagnosed chronic diseases and no treatment in specialist clinics as well as lack of positive COVID-19 test in 4 weeks before the examination. The SF-36 questionnaire was used to assess the quality of life. The student's t-test and intergroup comparisons were used in 7 age groups. Factors such as age, gender, place of residence, education, civil status, employment status, smoking, and physical activity were assessed. Results: The lowest average QoL level in the studied population was recorded in the Mental Component Summary (MCS) dimension (X = 47.9;Cl:47.6-48.3). A high correlation between age and the SF-36 spheres was noted in the following spheres: physical functioning (PF), role physical (RP), Physical Component Summary (PCS), and ILQ (p < 0.001). The highest chance of a better QoL in the PCS dimension among men was recorded in the 30-39 age group (OR = 3.65;Cl:1.13-11.79). In the group of people over 50 years of age living in the village, there was a greater chance of a better QoL in the PCS dimension in each age group. Practicing physical activity was significantly more often conditioned by a higher chance of developing a better QoL (p < 0.05). In the group of people ≥80 years of age, there was a greater than 4 times higher chance of developing a better quality of life in terms of MCS among physically active people (OR = 4.38;Cl:1.62-11.83). Conclusion: With age, QoL decreases among people with disabilities. Men are more likely to assess their health better. A better QoL among women occurs at age 80 and later. A higher level of education often determined a significantly higher level of QoL felt. The practising of recreational physical activity and the lack of smoking habit determined a higher level of QoL more often. Smoking provided a greater chance of a better QoL in ILQ in the group of people ≥80 years.

Anticoagulation for Atrial Fibrillation in Acute Coronary Syndrome Survivors Reduces Major Cardiovascular Events and Mortality.

The prevalence of atrial fibrillation (AF) in acute coronary syndrome (ACS) patients is increasing. Data on outcomes of anticoagulation in ACS patients with AF are lacking.The aim of our study was to investigate the prevalence of stroke, myocardial infarction, bleeding complications, and all-cause mortality in this population.PL-ACS and AMI-PL registries gather an all-comer population of ACS patients in Poland, exceeding half a million records. We have selected ACS survivors with concomitant AF on admission, divided them into subgroups with regard to the administered anticoagulation, and followed up with them for a 12-month period (n = 13,973). Subsequently, groups were propensity score matched for age, sex, ejection fraction, diabetes, heart failure, renal impairment, and type of ACS.The study population was divided with regard to the administration of anticoagulation. Anticoagulation was prescribed in 2,466 patients (17.6%). The (D)OAC+ patients were younger; however, comorbidities were more prevalent in this group. The 12-month follow-up showed that the (D)OAC+ patients had significantly lower rates of all-cause mortality, myocardial infarction, and ischemic stroke, with no significant increase in bleeding events. After matching, the study groups consisted of 2,194 patients each and showed no differences in baseline characteristics. The outcomes of the 12-month observation were similar to the findings before matching.This all-comer national registry analysis shows that the use of guideline-recommended therapy and anticoagulation in ACS survivors with AF is associated with a lower rate of all-cause mortality, recurrent myocardial infarction, and ischemic stroke.

Comparison of reorganized versus unaltered cardiology departments during the COVID-19 era: A subanalysis of the COV-HF-SIRIO 6 study.

BACKGROUND: Since the beginning of the coronavirus disease 2019 (COVID-19) pandemic, numerous cardiology departments were reorganized to provide care for COVID-19 patients. We aimed to compare the impact of the COVID-19 pandemic on hospital admissions and in-hospital mortality in reorganized vs. unaltered cardiology departments. METHODS: The present research is a subanalysis of a multicenter retrospective COV-HF-SIRIO 6 study that includes all patients (n = 101,433) hospitalized in 24 cardiology departments in Poland between January 1, 2019 and December 31, 2020, with a focus on patients with acute heart failure (AHF). RESULTS: Reduction of all-cause hospitalizations was 50.6% vs. 21.3% for reorganized vs. unaltered cardiology departments in 2020 vs. 2019, respectively (p < 0.0001). Considering AHF alone respective reductions by 46.5% and 15.2% were registered (p < 0.0001). A higher percentage of patients was brought in by ambulance to reorganized vs. unaltered cardiology departments (51.7% vs. 34.6%; p < 0.0001) alongside with a lower rate of self-referrals (45.7% vs. 58.4%; p < 0.0001). The rate of all-cause in-hospital mortality in AHF patients was higher in reorganized than unaltered cardiology departments (10.9% vs. 6.4%; p < 0.0001). After the exclusion of patients with concomitant COVID-19, the mortality rates did not differ significantly (6.9% vs. 6.4%; p = 0.55). CONCLUSIONS: A greater reduction in hospital admissions in 2020 vs. 2019, higher rates of patients brought by ambulance together with lower rates of self-referrals and higher all-cause in-hospital mortality for AHF due to COVID-19 related deaths were observed in cardiology departments reorganized to provide care for COVID-19 patients vs. unaltered ones.

Health-Related Quality of Life (HRQoL) of People over 65 Years of Age.

Quality of life is an important indicator of the treatment process, lifestyle, and influence of many other factors, both exogenous and endogenous, on the body. Determining the quality of life of healthy people (health-related quality of life (HRQoL), considering the influence of various factors, is important due to the possibility of making subsequent comparative analyses regarding the quality of life of people diagnosed with diseases. In addition, it allows us to identify the most crucial factors influencing the HRQoL in the process of "good aging". The purpose of the study was to present the HRQoL level of healthy people over 65 years of age. HRQoL was measured in five-year age groups (66-70, 71-75, 76-80, >80 years), considering the analyzed factors. Finally, 1038 healthy people were included in the study. The inclusion criteria were as follows: no diagnosed chronic diseases, no permanent treatment in specialist clinics, and no constant administration of medicaments. A comparative analysis was carried out, assuming a 5% conclusion error. The SF-36 questionnaire assessing the main dimensions of the quality of life was the tool used in the study to assess the HRQoL: the physical component summary (PCS), mental component summary (MCS) and index of life quality (ILQ). The factors significantly differentiating the average level of HRQoL were as follows: gender, place of residence, education, employment status, smoking and physical activity. Relationship status (p > 0.05) was one of the analyzed factors that did not influence the differences in the average level of the perceived HRQoL. More than a twofold greater chance of a higher HRQoL was reported in the group of men under 75 years of age (66-70: OR = 2.01; 71-75: OR = 2.52) compared to the group of women. The same relationship was noted in the case of higher education in respondents up to the age of 80 (66-70: OR = 1.56; 71-75: OR = 2.16; 76-80: OR = 2.74). Smoking by people over 80 years of age significantly increased the chances of a higher HRQoL in each of the dimensions (PCS: OR = 4.09; MCS: OR = 12.64; ILQ: OR = 5.79). Age as a non-modifiable factor significantly differentiates the level of the HRQoL of healthy people over 65 years of age. The results of the conducted study on HRQoL can be helpful when comparing the HRQoL of healthy people with a group of people with chronic diseases.

Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction-The REC-DUT-002 Trial.

Patients with acute myocardial infarction are at high risk for developing heart failure due to scar development. Although regenerative approaches are evolving, consistent clinical benefits have not yet been reported. Treatment with dutogliptin, a second-generation DPP-4 inhibitor, in co-administration with filgrastim (G-CSF) has been shown to enhance endogenous repair mechanisms in experimental models. The REC-DUT-002 trial was a phase 2, multicenter, double-blind placebo-controlled trial which explored the safety, tolerability, and efficacy of dutogliptin and filgrastim in patients with ST-elevation Myocardial Infarction (STEMI). Patients (n = 47, 56.1 ± 10.7 years, 29% female) with STEMI, reduced left ventricular ejection fraction (EF ≤ 45%) and successful revascularization following primary PCI were randomized to receive either study treatment or matching placebo. Cardiac magnetic resonance imaging (cMRI) was performed within 72 h post-PCI and repeated after 3 months. The study was closed out early due to the SARS-CoV-2 pandemic. There was no statistically significant difference between the groups with respect to serious adverse events (SAE). Predefined mean changes within cMRI-derived functional and structural parameters from baseline to 90 days did not differ between placebo and treatment (left ventricular end-diastolic volume: +13.7 mL vs. +15.7 mL; LV-EF: +5.7% vs. +5.9%). Improvement in cardiac tissue health over time was noted in both groups: full-width at half-maximum late gadolinium enhancement (FWHM LGE) mass (placebo: -12.7 g, treatment: -19.9 g; p = 0.23). Concomitant treatment was well tolerated, and no safety issues were detected. Based on the results, the FDA and EMA have already approved an adequately powered large outcome trial.

Impact of COVID-19 pandemic on acute heart failure admissions and mortality: a multicentre study (COV-HF-SIRIO 6 study).

AIMS: The coronavirus disease-2019 (COVID-19) pandemic has changed the landscape of medical care delivery worldwide. We aimed to assess the influence of COVID-19 pandemic on hospital admissions and in-hospital mortality rate in patients with acute heart failure (AHF) in a retrospective, multicentre study. METHODS AND RESULTS: From 1 January 2019 to 31 December 2020, a total of 101 433 patients were hospitalized in 24 Cardiology Departments in Poland. The number of patients admitted due to AHF decreased by 23.4% from 9853 in 2019 to 7546 in 2020 (P < 0.001). We noted a significant reduction of self-referrals in the times of COVID-19 pandemic accounting 27.8% (P < 0.001), with increased number of AHF patients brought by an ambulance by 15.9% (P < 0.001). The length of hospital stay was overall similar (7.7 ± 2.8 vs. 8.2 ± 3.7 days; P = not significant). The in-hospital all-cause mortality in AHF patients was 444 (5.2%) in 2019 vs. 406 (6.5%) in 2020 (P < 0.001). A total number of AHF patients with concomitant COVID-19 was 239 (3.2% of AHF patients hospitalized in 2020). The rate of in-hospital deaths in AHF patients with COVID-19 was extremely high accounting 31.4%, reaching up to 44.1% in the peak of the pandemic in November 2020. CONCLUSIONS: Our study indicates that the COVID-19 pandemic led to (i) reduced hospital admissions for AHF; (ii) decreased number of self-referred AHF patients and increased number of AHF patients brought by an ambulance; and (iii) increased in-hospital mortality for AHF with very high mortality rate for concomitant AHF and COVID-19.

Physiologic resynchronization therapy: a case of his bundle pacing reversing physiologic conduction in a patient with CHF and LBBB during 2 years of observation.

This is a case of a patient with congestive heart failure and left bundle branch block who was referred for cardiac resynchronization therapy implantation. Instead, a His bundle pacing was achieved with a narrow QRS complex. During 27 months of observation, the patient improved dramatically from NYHA class IV to I. Echo parameters improved significantly the LV diameter from 75/50 to 60/40 mm, EF from 28 to 50%, and mitral regurgitation from 4 to 2°.

The role of transesophageal echocardiography in predicting technical problems and complications of transvenous lead extractions procedures.

BACKGROUND: Transesophageal echocardiography (TEE) is a useful tool in preoperative evaluation of patients undergoing transvenous lead extraction (TLE). HYPOTHESIS: Echocardiographic phenomena may determine the difficulty and safety of the procedure. METHODS: Data from 936 transesophageal examinations (TEE) performed at a high volume center in patients awaiting TLE from 2015 to 2019 were assessed. RESULTS: TEE revealed a total of 1156 phenomena associated with the implanted leads in 697 (64.85%) patients, including: asymptomatic masses on endocardial leads (AMEL) (58.65%), vegetations (12,73%), fibrous tissue binding the lead to the vein or heart wall (33.76%), lead-to-lead binding sites (18.38%), excess lead loops (19.34%), intramural penetration of the lead tip (16.13%) and lead-dependent tricuspid dysfunction (LDTD) (6.41%). Risk factors for technical difficulties during TLE in multivariate analysis were: fibrous tissue binding the lead to atrial wall (OR = 1.738; p < 0.05), to right ventricular wall (OR = 2.167; p < 0.001), lead-to-lead binding sites (OR = 1.628; p < 0.01) and excess lead loops (OR = 1.488; p < 0.05). Lead-to-lead binding sites increased probability of major complications (OR = 3.034; p < 0.05). Presence of fibrous tissue binding the lead to the superior vena cava (OR = 0.296; p < 0.05), right atrial wall (OR = 323; p < 0.05) and right ventricular wall (OR = 0.297; p < 0.05) reduced the probability of complete procedural success, whereas fibrous tissue binding the lead to the tricuspid apparatus decreased the probability of clinical success (OR = 0.307; p < 0.05). CONCLUSIONS: Careful preoperative TEE evaluation of the consequences of extended lead implant duration (enhanced fibrotic response) increases the probability of predicting the level of difficulty of TLE procedures, their efficacy and risk of major complications.

The prognostic value of transesophageal echocardiography after transvenous lead extraction: landscape after battle.

BACKGROUND: In patients undergoing transvenous lead extraction (TLE) transesophageal echocardiography (TEE) provide valuable information after procedure. METHODS: We analyzed data from 936 TEE performed in patients undergoing TLE between 2015 and 2019 (mean follow-up 566.23±224.47 days) and assessed the role of echocardiographic phenomena after procedure. RESULTS: Increment in tricuspid regurgitation (TR) was observed in 9% of patients after TLE. Factors increasing the risk of TR were: binding sites between lead and right ventricle (RV) (OR: 5.429), tricuspid valve (TV) (OR: 3.42), superior vena cava (SVC) (OR: 3.30) and lead-to-lead adhesions (OR: 2.88). Predisposing factors of residual structures after TLE were: asymptomatic masses on the leads (AMEL) (OR: 1.68), binding sites between SVC and cardiac structures (OR: 1.72), and multiple leads (OR: 1.30). Probability of vegetation remnants increased in the presence of abandoned leads (OR: 7.91). The risk factors of tamponade were: dwell time of the oldest lead (OR: 1.17), lead-to-lead adhesion (OR: 22.47), binding sites between lead and TV (OR: 6.08), RA (OR: 11.50), SVC (OR: 4.47), higher LVEF (OR: 2.35; P=0.006), female gender (OR: 5.43), multiple leads (OR: 2.11), looped leads (OR: 4.90) and AMEL (OR: 6.42). The risk of lead fracture was increased by: lead-to-lead adhesion (OR: 5.69), fibrosis binding the lead to RV (OR: 5.16), RA (OR: 2.39) and dwell time of the oldest lead (OR: 1.068). The mortality rate was 11.97% during follow-up. The risk of death was increased by: severe TR and vegetation remnants. CONCLUSIONS: The most important phenomena evaluated after TLE are: tricuspid valve function, residual fibrosis and vegetation remnants, progression of pericardial effusion and retained lead fragments. Postoperative TEE provides information about the results of TLE and helps establish further management.

Prognostic Value of Preoperative Echocardiographic Findings in Patients Undergoing Transvenous Lead Extraction.

(1) Background: In patients referred for transvenous lead extraction (TLE) transesophageal echocardiography (TEE) often reveals abnormalities related to chronically indwelling endocardial leads. The purpose of this study was to determine whether the results of pre-operative TEE might influence the long-term prognosis. (2) Methods: We analyzed data from 936 TEE examinations performed at a high volume center in patients referred for TLE from 2015 to 2019. The follow-up was 566.2 ± 224.5 days. (3) Results: Multivariate analysis of TEE parameters showed that vegetations (HR = 2.631 [1.738-3.983]; p < 0.001) and tricuspid valve (TV) dysfunction unrelated to the endocardial lead (HR = 1.481 [1.261-1.740]; p < 0.001) were associated with increased risk for long-term mortality. Presence of fibrous tissue binding sites between the lead and the superior vena cava (SVC) and/or right atrium (RA) wall (HR = 0.285; p = 0.035), presence of penetration or perforation of the lead through the cardiac wall up to the epicardium (HR = 0.496; p = 0.035) and presence of excessive lead loops (HR = 0.528; p = 0.026) showed a better prognosis. After adjustment the statistical model with recognized poor prognosis factors only vegetations were confirmed as a risk factor (HR = 2.613; p = 0.039). A better prognosis was observed in patients with fibrous tissue binding sites between the lead and the superior vena cava (SVC) and/or right atrium (RA) wall (HR = 0.270; p = 0.040). (4) Conclusions: Non-modifiable factors may have a negative influence on long-term survival after TLE. Various forms of connective tissue overgrowth and abnormal course of the leads modifiable by TLE can be a factor of better prognosis after TLE.

Echocardiographic findings in patients with cardiac implantable electronic devices-analysis of factors predisposing to lead-associated changes.

BACKGROUND: The constant interaction between intracardiac leads and the heart and veins results in excessive accumulation of fibrous connective tissue around the leads. The extent of this pathological phenomenon, which is visible on transesophageal echocardiography (TEE), and predisposing factors are not well defined. METHODS: We examined 936 transesophageal echocardiograms prior to transvenous lead extraction (TLE) performed at a high-volume centre between 2015 and 2019. RESULTS: The most important echocardiographic findings were fibrous binding sites between leads and cardiovascular structures, lead-to-lead adhesions, excessive lead loops, lead-dependent tricuspid dysfunction (LDTD), asymptomatic masses on endocardial leads (AMEL) and vegetations. Fibrotic reaction within the walls of the heart and veins correlated with the presence of lead loops (OR = 1.771; p < .01) and lead dwell time (OR = 1.111; p < .001). Women were more likely to have excessive lead loops (OR = 1.639; p < .01), and the occurrence of loops increase with the number of implanted leads (OR = 2.557; p < .001). Heart failure (OR = 4.016; p < .001), lead looping (OR = 2.603; p < .01) and longer cumulative lead dwell time (OR = 1.017; p < .05) increased the likelihood of LDTD. A variety of AMEL were identified in this study, most commonly in patients with older leads (OR = 1.043; p < .001). CONCLUSIONS: Lead dwell time is the main factor predisposing to the occurrence of most lead-associated phenomena visualized by TEE in patients with cardiac implantable electronic devices (CIED). Excessive looping of the lead is an important cause of fibrous binding sites and LDTD. AMEL are frequently detected in CIED patients, and their various forms concurrent with vegetations could represent an evolutionary stage of lead-associated masses.

Transvenous Lead Extraction without Procedure-Related Deaths in 1000 Consecutive Patients: A Single-Center Experience.

BACKGROUND: Transvenous lead extraction (TLE) is now a first-line technique for the treatment of complications related to cardiac implantable electronic devices. The aim of the study was to demonstrate that it is possible to safely perform difficult TLE procedures with a maximum reduction of peri-procedural major complications. METHODS: A total of 1000 consecutive patients undergoing TLE in a single high-volume center from 2016 to 2019 were studied. All procedures were performed in a hybrid room or operating room by a specialized TLE team. TLE was performed under general anesthesia and monitored by transesophageal echocardiography, and the operating room was suitably equipped for immediate surgical intervention. The effectiveness and safety of the procedures were assessed, with particular emphasis on major complications. RESULTS: In all, 1952 leads with the mean implant duration of 111.7 ± 77.6 months had been extracted. Complete procedural success of patients was achieved in 95.9% and clinical success in 99.1%. Major complications, predominantly cardiac tamponade (63.3%), occurred in 22 patients (2.2%). Rapid diagnosis and immediate intervention were the key to a 100% survival in patients with this complication. CONCLUSION: Performing procedures in a hybrid operating room under general anesthesia in the presence of a cardiac surgeon and with the use of transesophageal echocardiography significantly improves the safety of transvenous lead extraction.

ANalgesic Efficacy and safety of MOrphiNe versus methoxyflurane in patients with acute myocardial infarction: the rationale and design of the ANEMON-SIRIO 3 study: a multicentre, open-label, phase II, randomised clinical trial.

INTRODUCTION: The unfavourable influence of morphine on the pharmacokinetics of ticagrelor resulting in weaker and retarded antiplatelet effect in patients with acute coronary syndrome (ACS) has been previously shown. Replacing morphine with methoxyflurane, a potent, non-opioid analgesic agent, that does not weaken or delay the effect of antiplatelet agents may improve the clinical efficacy of treatment of patients with ACS. METHODS: The ANEMON-SIRIO 3 study was designed as a multicentre, open-label, phase II, randomised clinical trial aimed to test the analgesic efficacy and safety of methoxyflurane in patients with ACS. The study population will comprise patients with ST-elevation myocardial infarction or non-ST-elevation ACS admitted to the study centres with typical chest pain requiring analgesic treatment. Before percutaneous coronary intervention (PCI) for the patients with index ACS will be randomly assigned in 1:1 ratio to receive methoxyflurane administered by inhalation, or to obtain morphine administered intravenously. Analgesic treatment will be followed by 300 mg loading dose of aspirin and 180 mg loading dose of ticagrelor. Patients will be assessed with regard to pain intensity according to the Numeric Pain Rating Scale at baseline, 3 min after study drug administration and immediately after PCI. Moreover, patients will be actively monitored with regard to the occurrence of side effects of evaluated therapies, as well as adverse events that may be related to insufficient platelet inhibition (no-reflow phenomenon assessed immediately after PCI, administration of GPIIb/IIIa inhibitors during PCI, acute stent thrombosis). ETHICS AND DISSEMINATION: The study will be conducted in six Polish clinical centres from the beginning of in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. TRIAL REGISTRATION DETAILS: ClinicalTrials.gov, NCT04476173.

A new approach to ticagrelor-based de-escalation of antiplatelet therapy after acute coronary syndrome. A rationale for a randomized, double-blind, placebo-controlled, investigator-initiated, multicenter clinical study.

The risk of ischemic events gradually decreases after acute coronary syndrome (ACS), reaching a stable level after 1 month, while the risk of bleeding remains steady during the whole period of dual antiplatelet treatment (DAPT). Several de-escalation strategies of antiplatelet treatment aiming to enhance safety of DAPT without depriving it of its efficacy have been evaluated so far. We hypothesized that reduction of the ticagrelor maintenance dose 1 month after ACS and its continuation until 12 months after ACS may improve adherence to antiplatelet treatment due to better tolerability compared with the standard dose of ticagrelor. Moreover, improved safety of treatment and preserved anti-ischemic benefit may also be expected with additional acetylsalicylic acid (ASA) withdrawal. To evaluate these hypotheses, we designed the Evaluating Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome - a randomized clinical trial (ELECTRA-SIRIO 2), to assess the influence of ticagrelor dose reduction with or without continuation of ASA versus DAPT with standard dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischemic efficacy in ACS patients. The study was designed as a phase III, randomized, multicenter, double-blind, investigator-initiated clinical study with a 12-month follow-up (ClinicalTrials.gov Identifier: NCT04718025; EudraCT number: 2020-005130-15).

Interrupted aortic arch in an adult female.

Interrupted aortic arch is a rare and usually lethal malformation, representing approximately 1% of congenital heart disease. This presents as a missing segment of the aortic arch and is divided into three types: A-called extreme form of coarctation, and is characterized by disruption of aorta's continuity distal to the left subclavian artery (30-40%), B-disruption between the left subclavian and the left carotid arteries (55-60%), and C-the most uncommon type, interruption proximal to the left common carotid artery. The suspicion of coarctation of the aorta can be made from a combination of physical findings including systolic ejection murmur, the murmurs of collateral blood vessels, diminished or absent femoral pulse, and difference in blood pressure between arms and legs. Interrupted aortic arch is an extremely rare anomaly in adult patients. To our knowledge, the world medical literature contains only about 13 reports of interrupted aortic arch diagnosed in adults.

Evaluation of safety and the success rate of cryoballoon ablation of the pulmonary vein ostia in patients with atrial fibrillation--a preliminary report.

BACKGROUND: Cryoballon isolation of the pulmonary veins has recently emerged as a promissing technique for ablation of atrial fibrillation (AF). AIM: To present our initial experience in cryoballon isolatin of the pulmonary veins in patients with AF. METHODS: Eight patients (5 males; age 59+/-2 years) with AF: 2 with persistent and 6 with paroxysmal (5 of them after unsuccessful RF ablation) with >or=6 month follow-up after the procedure were included. One patient after myocardial infarction was treated with primary angioplasty with stent implantation. Another one had biatrial pacemaker. The procedure was performed with cryobaloon with 28 mm diameter (Arctic Front--Cryocath). After transseptal puncture mapping of the pulmonary vein ostia was performed with Lasso catheter (Johnson and Johnson). At each pulmonary vein ostium with pulmonary vein potentials 2 cryoapplications of 300 s duration was performed. Correct balloon placement before cryoapplication was checked using contrast injection into the pulmonary veins. During cryoapplication in the right pulmonary vein ostia permanent pacing of the phrenic nerve 30 beats per minute was performed to prevent its paralysis. After cryoapplications in all veins remapping with Lasso catheters was performed. In the absence of pulmonary vein potentials the procedure was finished, otherwise next cryoapplications were performed. During follow-up ECG was performed if any palpitations occurred, and 24-hour Holter monitoring was performed 1, 2 ,4, 6, 8, 10 and 12 months after the procedure. A 2-month blanking period after the procedure was used. The lack of symptomatic AF and the absence of AF>30 s on Holter ECG monitoring were defined as successful procedure. An improvement was defined as reduction of frequency/duration of AF paroxysm and reduction of the EHRA index>or=1. RESULTS: During 8 procedures isolation of 31 pulmonary vein was performed. Procedure duration was 3.5+/-0.85 h, fluoroscopy time--33.55+/-15.44 min, and total cryoapplication time--38.33+/-4.1 min. There were no complications. After the follow-up of 8.5+/-0.99 months 6 (75%) patients were free from arrhythmia, including the patient after myocardial infarction and one patient with permanent AF prior ablation. In another patient an improvement was observed (EHRA score II/III to I) whereas in one patient with permanent AF the procedure was unsuccessful. CONCLUSION: Cryoballoon ablation of pulmonary vein ostia is effective and safe, and can be an alternative to RF ablation. Easier procedure technique make possible shortening of the learning curve and increase the number of treated patients.

Transesophageal echocardiography for the monitoring of transvenous lead extraction.

Transesophageal echocardiography (TEE) is regarded as the gold standard in diagnostic cardiology and has become an essential tool for monitoring the patient undergoing cardiac surgery and transcatheter procedures. Considering the increasing number of complications related to cardiac implantable electronic devices, TEE can also be used to detect these irregularities. Transvenous lead extraction (TLE) is the first--line treatment for cardiac implantable electronic device-related complications. The essence of TLE is the dissection of leads from connective tissue adhesions that attach them to the walls of the heart and vessels. Separation of strongly immobilized leads may cause injury to the veins or heart resulting in life--threatening bleeding. For this reason, the guidelines from the American and European cardiac societies recommend clinicians to use TEE for monitoring the patient undergoing TLE. The advantage of such an approach is immediate detection, localization, and evaluation of TLE complications and sequelae. Additionally, according to our experience, continuous monitoring of the TLE procedure enables the operator to be informed about the expected technical problems.