LittlEARS auditory questionnaire as an infant hearing screening in Germany after the newborn hearing screening.

Objective: To investigate the feasibility of using the LittlEARS® Auditory Questionnaire (LEAQ®) as part of the infant hearing screening programme in Germany. Design: LEAQ®s were distributed to 47 paediatric practices and were completed by the parents/guardians of the infants (aged between 9-14 months) involved in the study (= LEAQ® screening). The infants who failed the LEAQ® screening were invited to a LEAQ rescreening. Infants who failed the LEAQ® rescreening were sent to a paediatric ENT specialist. After 3 years, a follow-up was performed on two groups: the first group comprised infants who failed the LEAQ screening; the second group (control group) comprised 200 infants who passed the LEAQ screening. Study Sample: 5316 questionnaires were returned. Results: Six infants with permanent hearing loss were identified using the LEAQ® as a screening tool. Conclusions: An infant hearing screening using the LEAQ® is easily implementable in paediatric practices and may be a good alternative in countries where no objective screening instruments are available. The LEAQ® was suitable for monitoring hearing development in infants in general and could help to identify a late-onset or progressive hearing loss in infants.

C-reactive protein is elevated in heart failure patients with central sleep apnea and Cheyne-Stokes respiration.

BACKGROUND: Manifestation of central sleep apnea (CSA) with Cheyne-Stokes respiration is of major prognostic impact in chronic heart failure (CHF). Inflammatory processes have been linked to a progression of cardiovascular diseases, including heart failure. While an association of C-reactive protein (CRP) levels to obstructive sleep apnea has been documented before, there is a lack of information regarding variation of CRP levels in patients with CSA. OBJECTIVES: The objective of this study was to investigate a potential association of CRP levels to CSA severity in CHF patients. METHODS: High sensitivity CRP levels were analyzed in 966 patients with CHF (BMI 26.3 ± 4.6, New York Heart Association class 2.6 ± 0.5, left ventricular ejection fraction 29.4 ± 7.9%, N-terminal pro-brain natriuretic peptide, NT-proBNP, level 2,209 ± 3,315 pg/ml) without sleep-disordered breathing (SDB; Apnea-Hypopnea Index, AHI, <5/h) or various degrees of CSA, documented by in-hospital cardiorespiratory polygraphy or polysomnography. RESULTS: The CRP concentration in CHF patients was 0.550 ± 0.794 mg/dl in patients without SDB (AHI 0-4/h, n = 403) versus 0.488 ± 0.708 mg/dl in patients with mild CSA (AHI 5-14/h, n = 123, p = n.s.) and 0.660 ± 0.963 mg/dl in patients with moderate CSA (AHI 15-29/h, n = 160, p = n.s.). In patients with severe CSA (AHI ≥ 30/h, n = 280), significantly higher CRP concentrations were documented (0.893 ± 1.384 mg/dl, p < 0.05). Stepwise regression analysis revealed AHI, NT-proBNP and heart rate to be independently associated with elevated CRP levels. CONCLUSION: Severe CSA in CHF patients is associated with elevated levels of CRP, a systemic marker of inflammation and cardiovascular risk. This might explain in part the negative prognostic impact of CSA in these patients.

Immunogenicity and safety of the quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) in 2-10-year-old children: results of an open, randomised, controlled study.

UNLABELLED: In Europe, the introduction of monovalent meningococcal serogroup C (MenC) conjugate vaccines has resulted in a significant decline in MenC invasive disease. However, given the potential for strain evolution and increasing travel to areas of high endemicity, protection against additional serogroups is needed. In this study, the immunogenicity, measured by a serum bactericidal activity assay using rabbit complement (rSBA), and the safety of a quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) were compared to that of a licensed monovalent MenC conjugate vaccine (MenC-CRM197) in children 2-10 years of age. Children were randomised (3:1) to receive a single dose of either MenACWY-TT or MenC-CRM197. Non-inferiority of the immunogenicity of MenACWY-TT versus MenC-CRM197 in terms of rSBA-MenC vaccine response was demonstrated. Exploratory analyses suggested that rSBA-MenC geometric mean titres adjusted for pre-vaccination titres were lower in children vaccinated with MenACWY-TT compared to MenC-CRM197. Nevertheless, at 1 month post-vaccination, ≥99.3 % of the children who received MenACWY-TT had rSBA titres ≥1:128 for each of the four vaccine serogroups, which is the more conservative correlate of protection. The reactogenicity and safety profile of MenACWY-TT was clinically acceptable and no serious adverse events considered related to vaccination were reported throughout the study. CONCLUSION: When administered to European school-age children, MenACWY-TT has a clinically acceptable safety profile and, when compared with MenC-CRM197, the potential to broaden protection against meningococcal disease caused by serogroups A, W-135 and Y while maintaining protection against MenC. This study has been registered at www.clinicaltrials.gov NCT00674583.

Global Alliance for the Promotion of Physical Activity: the Hamburg Declaration.

Non-communicable diseases (NCDs), including coronary heart disease, stroke, hypertension, type 2 diabetes, dementia, depression and cancers, are on the rise worldwide and are often associated with a lack of physical activity (PA). Globally, the levels of PA among individuals are below WHO recommendations. A lack of PA can increase morbidity and mortality, worsen the quality of life and increase the economic burden on individuals and society. In response to this trend, numerous organisations came together under one umbrella in Hamburg, Germany, in April 2021 and signed the 'Hamburg Declaration'. This represented an international commitment to take all necessary actions to increase PA and improve the health of individuals to entire communities. Individuals and organisations are working together as the 'Global Alliance for the Promotion of Physical Activity' to drive long-term individual and population-wide behaviour change by collaborating with all stakeholders in the community: active hospitals, physical activity specialists, community services and healthcare providers, all achieving sustainable health goals for their patients/clients. The 'Hamburg Declaration' calls on national and international policymakers to take concrete action to promote daily PA and exercise at a population level and in healthcare settings.

Hypotensive effects of positive airway pressure ventilation in heart failure patients with sleep-disordered breathing.

INTRODUCTION: Obstructive sleep apnoea (OSA) as well as central sleep apnoea (CSA) are highly prevalent in heart failure (HF) patients. Positive airway pressure (PAP) therapy is usually intended to treat OSA and CSA. The aim of the present study was to investigate immediate hemodynamic effects of PAP therapy in these patients. MATERIALS AND METHODS: In 61 consecutive HF patients (NYHA ≥ II, EF ≤ 45%) with moderate to severe OSA or CSA (AHI ≥ 15/h) blood pressure (BP) and heart rate (HR) response to PAP therapy initiation was investigated during mask fitting with patients being awake and in supine position. While applying an endexspiratory pressure of 5.8 ± 0.9 cm H(2)O, there was a significant decrease in systolic (-8.9 ± 12.1 mmHg, p < 0.001) and diastolic BP (-5.1 ± 9.2 mmHg, p < 0.001) without a change in HR (p = n.s.). RESULTS: At least a transient drop in mean arterial pressure ≤70 mmHg was seen in 10% of these patients. Logistic regression analysis revealed a significant impact of baseline BP on potential BP drops: lower baseline BP was associated with BP drops. CONCLUSION: PAP therapy may cause unexpected hypotension especially in patients with low baseline BP as seen in HF patients treated according to current guidelines. Whether these hypotensive effects sustain, cause any harm to the patients and/or is responsible for non-acceptance or non-adherence of PAP therapy needs to be determined.

Pulse transit time: validation of blood pressure measurement under positive airway pressure ventilation.

PURPOSE: The objective of the present study was to validate noninvasive, continuous blood pressure (BP) measurement using pulse transit time (PTT) to represent absolute values and detect BP changes under continuous positive airway pressure (CPAP) treatment. METHODS: We applied CPAP to 78 patients of a cardiological sleep lab using 0 (baseline), 4, 8, and 12 cmH(2)O for 10 min at every level and measured BP simultaneous via PTT-based method and standard oscillometric method (OM). RESULTS: Quality of signal perception was acceptable to convert PTT into BP values in 64 patients (82%). When comparing both methods, we found a strong linear correlation of systolic and diastolic BP (baseline, r = 0.94 for systolic BP; r = 0.95 for diastolic BP, p < 0.001) while no significant differences between absolute values obtained with OM and PTT measurement. Mean bias at baseline was 4.1 ± 3.2 mmHg for systolic BP and 2.3 ± 2.2 mmHg for diastolic BP. With increasing CPAP levels, PTT and OM measurements differed continuously up to a systolic difference of 6.6 ± 4.9 mmHg and a diastolic difference of 4.4 ± 3.5 mmHg. There was no definite trend of PTT method to either over- or underestimate BP. CONCLUSIONS: We found that PTT- and OM-based BP results are closely correlated while applying CPAP over a period of 40 min. With higher CPAP level, bias between both methods increased.

[Alice in the digital wonderland-pediatric teaching during the COVID-19 pandemic]. / Alice im digitalen Wunderland: pädiatrische Lehre in der COVID-19-Pandemie: Eine Umfrage und Stellungnahme der AG Lehre der Deutschen Gesellschaft für Kinder- und Jugendmedizin (DGKJ).

The COVID-19 pandemic led to a rapid switch from undergraduate classroom teaching to online-teaching; a challenging process for teachers and students. Based on a recent online survey among German pediatric university hospitals the "AG Lehre der DGKJ" (teaching working group of the German Society of Pediatrics and Adolescent Medicine) summarizes latest experiences with e­learning during the summer term of 2020. The survey participants from 17 pediatric university hospitals report that the large spectrum of e­learning formats could sufficiently replace classical lectures and seminars but could not fully replace teaching involving direct contact to patients. The introduction of new digital teaching formats is time-consuming, needs high-quality IT infrastructure, should be embedded in a continuous curriculum and provide the possibility of regular exchange between students and teachers. Teachers should be provided with the opportunity for training in didactic methods and IT skills. These results correspond to the literature on e­learning in general and undergraduate medical education during the COVID-19 pandemic in particular. The experiences summarized here should not only facilitate the development of e­learning tools during the ongoing pandemic but also stimulate to establish e­learning as a valuable component of future pediatric medical education. New digital substitutes for teaching involving pediatric patients need to be developed.The statement was drafted by consensus by the German Society of Pediatrics and Adolescent Medicine Working Group on Teaching and approved by the DGKJ board.

[Corona in Children: the Co-Ki Study]. / Corona bei Kindern: Die Co-Ki Studie: Relevanz von SARS-CoV-2 in der ambulanten pädiatrischen Versorgung in Deutschland.

BACKGROUND: In Germany over 80% of children and adolescents are in the ambulatory care of registered pediatricians. These have a specific perspective on the COVID-19 pandemic. METHODS: For this reason, this professional group initiated a central recording of case numbers, individual case descriptions and observations on infections and illnesses with SARS-CoV­2 (www.co-ki.de). RESULTS: So far 557 pediatricians have participated. Together they care for ca. 670,000 children. They reported 9803 children who presented as suspected cases. The pediatricians themselves had a clinical suspicion of SARS-CoV­2 infections in 3654 children. In 7707 children PCR tests were carried out using nose/throat swabs of which 198 (2.6%) were positive. In addition, 731 children were tested for SARS-CoV­2 antibodies with detection in 82 cases (11.2%). Despite initially positive PCR tests, 47 children had a negative antibody test at least 2 weeks later. Our query as to infections of adults by children yielded only one case, which a telephone enquiry revealed as unlikely. DISCUSSION: From an outpatient pediatric perspective COVID-19 is rare. There was no convincing evidence that children are a relevant source of infection for SARS-CoV­2 nor that they are relevantly at risk.

[Use of masks by children to prevent infection with SARS-CoV-2]. / Verwendung von Masken bei Kindern zur Verhinderung der Infektion mit SARS-CoV-2: Stellungnahme der Deutschen Gesellschaft für Pädiatrische Infektiologie (DGPI), des Berufsverbandes der Kinder- und Jugendärzte (bvkj e. V.), der Deutschen Gesellschaft für Kinder- und Jugendmedizin (DGKJ), der Gesellschaft für Pädiatrische Pneumologie (GPP), der Deutschen Gesellschaft für Sozialpädiatrie und Jugendmedizin (DGSPJ), der Süddeutschen Gesellschaft für Kinder- und Jugendmedizin (SGKJ) und der Deutschen Gesellschaft für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie (DGKJP).

After initial reluctance masks have emerged as an important means of restricting the spread of SARS-CoV­2, the new coronavirus causing COVID-19. Other simple measures are keeping a distance of at least 1 ½â€¯m from other persons and observing hygiene recommendations, including washing or even disinfecting the hands, coughing into the crook of the arm and remaining at home when sick. Combining the initial letters of the German words for the three measures (Abstand-Hygiene-Alltagsmaske, distance-hygiene-face mask) the acronym AHA was formed, a colloquial German word meaning that the speaker understood the information presented. This acronym was later extended by the letter "L", initial letter of "Lüften" meaning air ventilation for indoor rooms and arriving at AHA­L, recommended by the federal German Health Institute the Robert Koch Institute. In fact, masks including surgical masks and face coverings can form an effective barrier against the spread of the virus: protecting other people from droplets expelled from the throat of the speaker wearing a mask and even in part protecting the wearer from inhaling droplets emanating from other peoples' throats. Studies to find out if wearing masks might impose risks did not find essential problems: alterations of respiratory parameters due to an increased airway resistance remained within normal limits in healthy adults and even in asthmatics whose disease was well controlled; however, many adults expressed their unease with masks describing them as cumbersome and inconvenient. Emotional resistance against masks made it increasingly more difficult for them to use a mask. Efficient application of masks requires, in addition to a logical explanation of its effect, the evocation of empathy for vulnerable people who can be protected from catching a possibly deadly disease. In children there are very few data on adverse effects of wearing a mask although there is ample experience in children with serious diseases compromising defense against infectious agents acquired via respiratory mucus membranes; however, when using masks appropriately in children relevant adverse effects have not been reported and are not to be expected. Masks should only be used in children when they are healthy and awake and can remove the masks themselves anytime they like. Children 10 years or older can use masks efficiently when they have been informed beforehand appropriate to their age. Under these conditions they can also be obliged to wear masks in certain situations, for example while walking through the school building to their desk in class. To limit the period of wearing a mask normally they will be allowed to remove the mask when sitting in class and keeping their distance. Children in primary schools may use masks, but they should not be obliged to wear them and children in kindergartens should not use masks. This exemption of younger children does not expose school and kindergarten teachers to additional risks since the infectivity with SARS-CoV­2 is age-dependent and increases with age reaching adult values only after 12 years of age.

Paediatric palliative home care by general paediatricians: a multimethod study on perceived barriers and incentives.

BACKGROUND: Non-specialist palliative care, as it is delivered by general practitioners, is a basic component of a comprehensive palliative care infrastructure for adult patients with progressive and far advanced disease. Currently palliative care for children and adolescents is recognized as a distinct entity of care, requiring networks of service providers across different settings, including paediatricians working in general practice. In Germany, the medical home care for children and adolescents is to a large extent delivered by general paediatricians working in their own practice. However, these are rarely confronted with children suffering from life-limiting diseases. The aim of this study was therefore to examine potential barriers, incentives, and the professional self-image of general paediatricians with regard to paediatric palliative care. METHODS: Based on qualitative expert interviews, a questionnaire was designed and a survey among general paediatricians in their own practice (n = 293) was undertaken. The survey has been developed and performed in close cooperation with the regional professional association of paediatricians. RESULTS: The results showed a high disposition on part of the paediatricians to engage in palliative care, and the majority of respondents regarded palliative care as part of their profile. Main barriers for the implementation were time restrictions (40.7%) and financial burden (31.6%), sole responsibility without team support (31.1%), as well as formal requirements such as forms and prescriptions (26.6%). Major facilitations were support by local specialist services such as home care nursing service (83.0%), access to a specialist paediatric palliative care consultation team (82.4%), as well as an option of exchange with colleagues (60.1%). CONCLUSIONS: Altogether, the high commitment to this survey reflects the relevance of the issue for paediatricians working in general practice. Education in basic palliative care competence and communication skills was seen as an important prerequisite for the engagement in paediatric palliative home care. A local network of specialist support on site and a 24/7 on-call service are necessary in order to facilitate the implementation of basic palliative care by paediatricians in their own practice.

Children and adolescents in the CoVid-19 pandemic: Schools and daycare centers are to be opened again without restrictions. The protection of teachers, educators, carers and parents and the general hygiene rules do not conflict with this.

In the opinion of the medical societies of hygiene and pediatrics undersigning the present statement, the analyses published to date regarding transmission of SARS-CoV-2 and the course of CoVid-19 show that children play a much less significant role in the spread of the virus than do adults. According to the findings available to date, not only do children and adolescents less frequently fall ill with CoVid-19, they also generally become less severely ill than do adults. The vast majority of infections in children and adolescents are asymptomatic or oligosymptomatic. Even the first analyses from China demonstrated that children and adolescents play a subordinate role in the transmission of the virus - not only to other children and adolescents, but also to adults. Taking into account regional infection rates and available resources, daycare centers, kindergartens and elementary schools promptly should be reopened. For children, this should be possible without excessive restrictions, such as clustering into very small groups, implementation of barrier precautions, maintaining appropriate distance from others or wearing masks. A factor more decisive than individual group size is the issue of sustaining the constancy of respective group members and the avoidance of intermixing. Children can be taught basic rules of hygiene such as handwashing and careful hygiene behavior when coming into contact with others during mealtimes and/or when using sanitary facilities. Independent of the prevention measures implemented for children and adolescents, the protection of teachers, educators and caregivers is crucial, (e.g., the maintenance of appropriate distance from others, use of medical masks, situation-dependent hand disinfection, when necessary, supported by regular pool testing). Children over the age of 10 and adolescents up to school graduation age are more capable of actively understanding and conforming to specific hygiene rules. For this group, maintaining appropriate distance from others (1.5 meters), wearing a mouth-and-nose protection (whenever they are not sitting in their assigned classroom seats) and consistent education regarding the basic rules of infection prevention may provide increased options for normalizing teaching activities. Children and adolescents suspected of infection with SARS-CoV-2 should be tested immediately in order to either confirm or rule out such an infection. Evidence of individual infections in children or students must not automatically lead to the closure of the entire daycare center or school. A detailed analysis of the chain of infection is a prerequisite for a balanced approach to infection control. The opening of schools and children's facilities should be accompanied by specifically structured, model surveillance studies that further clarify outstanding questions about infectious disease events and hygiene control. These prospective, concomitant examinations will be essential for the purpose of evaluating and verifying the effectiveness of the required hygiene measures.

Long-term development of radiation exposure, fluoroscopy time and contrast media use in daily routine in cryoballoon ablations after implementation of intracardiac echocardiography and other radioprotective measures: experiences from a large single-centre cohort.

PURPOSE: The concern of higher radiation exposure during cryoballoon ablation (CBA) compared with radiofrequency ablation for atrial fibrillation (AF) was raised before. Previously, we compared CBA plus intracardiac echocardiography (ICE) to our former standard approach without ICE. A substantial reduction of radiation exposure without compromising safety or outcome was observed. We now investigate if at all and possibly to which amount radiation reduction can be achieved with growing experience. METHODS: We retrospectively analysed procedure time, dose area product (DAP), fluoroscopy time (FT) and contrast media (CM) use for all patients receiving CBA between 2013 and 2017 for AF. RESULTS: In 1131 procedures, procedure time decreased significantly between 2013 and 2017 (2013 111 ± 26 min, 2017 99 ± 25 min, p = 0.005). DAP halved between 2013 and 2014 without further significant decline (2013 1428 ± 1276 cGycm2, 2014 725 ± 551 cGycm2, p < 0.001). FT demonstrated a constant decrease from 2013 to 2017 (2013 11.7 ± 5.5 min, 2017 5.1 ± 3.5 min, p < 0.001). CM use did not show a significant reduction comparing 2013 to 2017 (2013 62 ± 19 ml, 2017 59 ± 18 ml, 2013/2017 p = 0.584). CONCLUSION: Given the imminent negative effects of radiation, every effort should be undertaken for its reduction. Feasible protocols can be kept simple by technical changes as reducing frame rates and basic radiation reduction strategies such as collimation, but ICE might add additional benefit. With growing experience and awareness of radioprotection, DAP and FT as low as or lower than in radiofrequency ablations seem possible.

Pulmonary vein isolation and beyond: Predictive value of vagal reactions in second-generation cryoballoon ablation for the outcome of persistent atrial fibrillation.

BACKGROUND: Cryoballoon ablation (CBA) is gaining increasing acceptance in the treatment of persistent (per) atrial fibrillation (AF). The cardiac autonomic nervous system plays a pivotal role in the regulation of AF. OBJECTIVE: We evaluated the impact of vagal reactions (VRs), as a surrogate marker for autonomic nervous system modulation, on the outcome of CBA in patients (pts) with perAF. METHODS: A total of 250 consecutive pts (mean age 63.9 ± 10.0 years; 175 pts, 70% male) undergoing primary second-generation CBA for perAF were studied. VRs were defined as bradycardia <40 beats/min, asystole, or higher-degree atrioventricular block. Follow-up visits at 3, 6, and 12 months included 7-day Holter electrocardiograms. RESULTS: VRs were recorded in 61 pts (24%). These pts showed a significantly reduced recurrence rate of AF (5%) than did those without VRs (log-rank, P < .01). Univariate Cox regression analyses confirmed VRs as a strong predictor of AF-free survival (hazard ratio [HR] 0.10; P < .01). Female sex (HR 1.71; P = .02), preprocedural tachycardia (HR 1.01; P = .01), and AF (HR 1.75; P = .01) before CBA at admission were revealed as predictors of AF recurrence. Multivariate regression model calculation solely identified VRs (HR 0.11; 95% confidence interval 0.03-0.34; P < .01) and male sex (HR 0.57; 95% confidence interval 0.36-0.89; P = .01) as independent predictors of AF-free survival. CONCLUSION: VR is an independent predictor of AF-free survival after CBA for perAF.

Hemoptysis as a side effect of cryoballoon pulmonary vein isolation in atrial fibrillation: a retrospective case-control study.

PURPOSE: Hemoptysis and pulmonary hemorrhage are rarely described as complications of cryoballoon ablation for pulmonary vein isolation (CB PVI). This study evaluated a large cohort to determine the frequency and risk factors for manifestation of these complications and assess the clinical relevance of hemoptysis after CB PVI. METHODS: Seven hundred fifteen consecutive patients (351 female) from a single-center database were evaluated to identify those who developed hemoptysis after CB PVI. RESULTS: A total of 31 patients with hemoptysis (4.3%; 2 female, age 60.5 ± 11.5 years) were matched with a control group (n = 31). Hemoptysis developed within 72 h after CB PVI. Cases versus controls had significantly lower ablation temperatures in the right inferior pulmonary vein (PV) (- 56.2 ± 26.6 vs - 49.1 ± 13.2 °C; p = 0.004) and left inferior PV (- 56.4 ± 11.9 vs - 47.2 ± 7.6 °C; p = 0.001). A trend to lower temperatures not reaching the level of significance was also found for the superior PV. All other procedural parameters were not significantly different between cases and controls. Although pre-procedural hemoglobin levels were comparable, post-procedural hemoglobin was lower in cases versus controls (12.9 ± 1.6 vs 13.7 ± 1.5 g/dL; p < 0.05). Twenty-six patients presenting with hemoptysis underwent chest CT scan, which showed perivenous infiltration at either the right (n = 23) or left inferior PV (n = 2) or no infiltrate (n = 1). No negative long-term effects were reported after 3, 6, and 12 months' follow-up. CONCLUSIONS: Post-procedural hemoptysis after CB PVI is a relatively frequent finding and was associated with low freezing temperatures and pulmonary tissue infiltration predominantly located at the right inferior PV. Hemoptysis resolved without long-term sequelae.

Second generation cryoballoon ablation for persistent atrial fibrillation: an updated meta-analysis.

BACKGROUND: Catheter ablation is an established treatment option for patients with symptomatic atrial fibrillation (AF). The cornerstone of AF ablation is pulmonary vein isolation (PVI). The second-generation cryoballoon (2G-CB) has shown non-inferiority to radiofrequency (RF) ablation in paroxysmal AF in several trials. Growing evidence suggests that 2G-CB is also effective in patients with persistent AF (perAF). The aim of this study was to summarize and analyze available data on safety and mid-term (≥ 12 months) efficacy of PVI using 2G-CB in patients with perAF. METHODS: We did a search in PubMed, Web of Science, Cochrane Library, and clinicaltrials.gov in December 2016 for studies of 2G-CB ablation for perAF. Studies reporting clinical success rates at a follow-up (FU) of ≥ 12 months were included. Success was defined as freedom from any atrial arrhythmia lasting > 30 s after an initial blanking period of 3 months. Acute success and complication rates were also assessed. Data were analyzed applying random-effects model. RESULTS: A total of 917 patients from 11 studies meeting study inclusion criteria were analyzed. After a mean FU of 16.7 ± 3.0 months, 68.9% were free from recurrences [95% confidence interval (CI) 63.4-74.7%]. Overall acute success rate was 99.7% (95% CI 99.2-100%). Complications occurred in 5.5% (95% CI 2.4-9.6%). Vascular access complications were the most frequent 3.3% (95% CI 1.5-5.6%). The rate of phrenic nerve palsy/injury was 2.09% (95% CI 0.8-3.9%). No death, stroke or myocardial infarction was reported. CONCLUSION: The 2G-CB seems to be safe and effective in the treatment of perAF in the mid-term.

Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib and PHiD-CV When Coadministered With MenACWY-TT in Infants: Results of an Open, Randomized Trial.

BACKGROUND: This study evaluated the immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus virus-Haemophilus influenzae type b vaccine (DTPa-HBV-IPV/Hib) and a 10-valent pneumococcal conjugate vaccine (PHiD-CV) coadministered with a quadrivalent meningococcal conjugate vaccine (MenACWY-TT) in infants/toddlers. METHODS: In this open, controlled, phase III study (NCT01144663), 2095 healthy infants were randomized (1:1:1:1) into 4 groups to receive MenACWY-TT at 2, 3, 4 and 12 months of age or MenACWY-TT, MenC-CRM197, or MenC-TT at 2, 4 and 12 months of age. All participants received PHiD-CV and DTPa-HBV-IPV/Hib at 2, 3, 4 and 12 months of age. Immunogenicity of DTPa-HBV-IPV/Hib was evaluated in exclusive randomized subsets of 25% of participants from each group postprimary, prebooster and postbooster vaccination, whereas immunogenicity of PHiD-CV was evaluated at all time points. Reactogenicity was evaluated on the total vaccinated cohorts during 8 days after each vaccination. RESULTS: For each DTPa-HBV-IPV/Hib antigen, ≥97.2%, ≥76.5% and ≥97.9% of participants had seropositive/seroprotective levels 1 month postprimary vaccination, before the booster dose and 1 month postbooster, respectively. For each vaccine pneumococcal serotype, ≥74.0% of infants had antibody concentrations ≥0.35 µg/mL at 1 month postprimary vaccination, and robust increases in antibody geometric mean concentrations were observed from prebooster to postbooster. Redness was the most frequent solicited local symptom at the DTPa-HBV-IPV/Hib and PHiD-CV injection sites, reported after up to 47.7% and 57.0% of doses postprimary and postbooster vaccination, respectively. CONCLUSIONS: Primary and booster vaccinations of infants/toddlers with DTPa-HBV-IPV/Hib and PHiD-CV coadministered with MenACWY-TT were immunogenic with clinically acceptable reactogenicity profiles. These results support the coadministration of MenACWY-TT with routine childhood vaccines.

Left ventricular adaptation after TAVI evaluated by conventional and speckle-tracking echocardiography.

OBJECTIVE: Our study aimed to evaluate myocardial adaption and outcome after transfemoral aortic valve implantation (TAVI TF) for severe aortic stenosis by LV ejection fraction (LVEF) and speckle tracking analysis. METHODS AND RESULTS: From 168 patients who underwent TAVI TF between 2010 and 2013 in our institution, n=95 with a follow-up period ≥3months were included and grouped (G) according to baseline left ventricular ejection fraction (LVEF; G1: LVEF<40%, G2: 40%-55%, G3: >55%). LV function was evaluated using conventional and speckle-tracking based parameters. Mortality was tracked up to 60months. Aortic valve orifice diameter and mean aortic gradient improved significantly after TAVI. LV dimensions and LVEF remained largely unchanged. Systolic function significantly improved in G1 (LVEF, p<0.001, global longitudinal strain [GLS], p=0.02) but deteriorated in G3 (LVEF, p=0.004, GLS, p=0.03). It did not change in G2. Diastolic function parameters improved significantly only in G3. Changes of LVEF and GLS were also statistically significant between G1 and G3 (LVEF p<0.0001, GLS p=0.004). Patients exhibited a higher survival rate with an LVEF increase >8% than with LVEF deterioration >8% (p=0.04). GLS changes had no significant impact on mortality. CONCLUSION: In patient with aortic stenosis and LVEF impairment at baseline, TAVI results in an improved LVEF, while patients with a high LVEF at baseline experience a normalization of LVEF after TAVI. Independent of the baseline value, a deterioration of LVEF leads to a significant increase in mortality.

Safety and Immunogenicity of the Quadrivalent Meningococcal Serogroups A, C, W and Y Tetanus Toxoid Conjugate Vaccine Coadministered With Routine Childhood Vaccines in European Infants: An Open, Randomized Trial.

BACKGROUND: This was the first study evaluating the immunogenicity and safety of the quadrivalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) coadministered with routine childhood vaccines in young infants. METHODS: In this open, randomized, controlled, phase III study (NCT01144663), 2095 infants (ages 6-12 weeks) were randomized (1:1:1:1) into 4 groups to receive MenACWY-TT at 2, 3, 4 and 12 months of age, or MenACWY-TT, MenC-cross-reactive material (CRM197) or MenC-TT at 2, 4 and 12 months of age. All participants received PHiD-CV and DTPa-HBV-IPV/Hib at 2, 3, 4 and 12 months of age. Immune responses were measured by serum bactericidal activity assays using rabbit (rSBA) and human (hSBA) complement. Solicited and unsolicited symptoms were recorded during 8 and 31 days post-vaccination, respectively, and serious adverse events throughout the study. RESULTS: Noninferiority of immune responses to MenC induced by 2 or 3 doses of MenACWY-TT versus 2 doses of MenC-TT or MenC-CRM197 was demonstrated. Predefined criteria for the immunogenicity of MenACWY-TT to MenA, MenW and MenY were met. One month after 2 or 3 primary MenACWY-TT doses, ≥93.1% and ≥88.5% of infants had rSBA and hSBA titers ≥1:8 for all serogroups. The robust increases in rSBA and hSBA titers observed for all vaccine serogroups postbooster vaccination suggested that MenACWY-TT induced immune memory. MenACWY-TT coadministered with childhood vaccines had a clinically acceptable safety profile. CONCLUSIONS: This study supports the coadministration of MenACWY-TT with routine childhood vaccines as 2 or 3 primary doses during infancy followed by a booster dose in the second year of life.