Humanitas Mater Domini

Severe acute respiratory syndrome coronavirus (SARS-CoV)-2, a novel coronavirus from the same family as SARS-CoV and Middle East respiratory syndrome coronavirus, has spread worldwide leading the World Health Organization to declare a pandemic. The disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19), presents flu-like symptoms which can become serious in high-risk individuals. Here, we provide an overview of the known clinical features and treatment options for COVID-19. We carried out a systematic literature search using the main online databases (PubMed, Google Scholar, MEDLINE, UpToDate, Embase and Web of Science) with the following keywords: 'COVID-19', '2019-nCoV', 'coronavirus' and 'SARS-CoV-2'. We included publications from 1 January 2019 to 3 April 2020 which focused on clinical features and treatments. We found that infection is transmitted from human to human and through contact with contaminated environmental surfaces. Hand hygiene is fundamental to prevent contamination. Wearing personal protective equipment is recommended in specific environments. The main symptoms of COVID-19 are fever, cough, fatigue, slight dyspnoea, sore throat, headache, conjunctivitis and gastrointestinal issues. Real-time PCR is used as a diagnostic tool using nasal swab, tracheal aspirate or bronchoalveolar lavage samples. Computed tomography findings are important for both diagnosis and follow-up. To date, there is no evidence of any effective treatment for COVID-19. The main therapies being used to treat the disease are antiviral drugs, chloroquine/hydroxychloroquine and respiratory therapy. In conclusion, although many therapies have been proposed, quarantine is the only intervention that appears to be effective in decreasing the contagion rate. Specifically designed randomized clinical trials are needed to determine the most appropriate evidence-based treatment modality.

PURPOSE: The ability to accurately control and monitor internal training load is an important aspect of effective coaching. The aim of this study was to apply in soccer the RPE-based method proposed by Foster et al. to quantify internal training load (session-RPE) and to assess its correlations with various methods used to determine internal training load based on the HR response to exercise. METHODS: Nineteen young soccer players (mean +/- SD: age 17.6 +/- 0.7 yr, weight 70.2 +/- 4.7 kg, height 178.5 +/- 4.8 cm, body fat 7.5 +/- 2.2%, VO2max, 57.1 +/- 4.0 mL x kg x min) were involved in the study. All subjects performed an incremental treadmill test before and after the training period during which lactate threshold (1.5 mmol x L above baseline) and OBLA (4.0 mmol x L) were determined. The training loads completed during the seven training weeks were determined multiplying the session RPE (CR10-scale) by session duration in minutes. These session-RPE values were correlated with training load measures obtained from three different HR-based methods suggested by Edwards, Banister, and Lucia, respectively. RESULTS: Individual internal loads of 479 training sessions were collected. All individual correlations between various HR-based training load and session-RPE were statistically significant (from r = 0.50 to r = 0.85, P < 0.01). CONCLUSION: The results of this study show that the session-RPE can be considered a good indicator of global internal load of soccer training. This method does not require particular expensive equipment and can be very useful and practical for coaches and athletic trainer to monitor and control internal load, and to design periodization strategies.

ESGE recommends against routine preoperative biliary drainage in patients with malignant extrahepatic biliary obstruction; preoperative biliary drainage should be reserved for patients with cholangitis, severe symptomatic jaundice (e. g., intense pruritus), or delayed surgery, or for before neoadjuvant chemotherapy in jaundiced patients. Strong recommendation, moderate quality evidence. ESGE recommends the endoscopic placement of a 10-mm diameter self-expandable metal stent (SEMS) for preoperative biliary drainage of malignant extrahepatic biliary obstruction. Strong recommendation, moderate quality evidence.ESGE recommends SEMS insertion for palliative drainage of of extrahepatic malignant biliary obstruction. Strong recommendation, high quality evidence. ESGE recommends against the insertion of uncovered SEMS for the drainage of extrahepatic biliary obstruction of unconfirmed etiology. Strong recommendation, low quality evidence. ESGE suggests against routine preoperative biliary drainage in patients with malignant hilar obstruction. Weak recommendation, low quality evidence.ESGE recommends uncovered SEMSs for palliative drainage of malignant hilar obstruction. Strong recommendation, moderate quality evidence.ESGE recommends temporary insertion of multiple plastic stents or of a fully covered SEMS for treatment of benign biliary strictures. Strong recommendation, moderate quality evidence.ESGE recommends endoscopic placement of plastic stent(s) to treat bile duct leaks that are not due to transection of the common bile duct or common hepatic duct. Strong recommendation, moderate quality evidence.

Physiological assessment of soccer training usually refers to the measurement of anatomical, physiological, biochemical and functional changes specific to the sport discipline (training outcome). The quality, quantity and organization of physical exercises (training process) are, on the other hand, usually described by the external work imposed by the coach on his or her athletes. In this review, we demonstrate that this approach is not appropriate in soccer, as training is often based on group exercises. The physiological stress (internal load) induced by such training often differs between individuals. Here, we present some physiological laboratory-based tests and field tests used to evaluate training outcomes in soccer, together with methods based on heart rate and perceived exertion to quantify internal load imposed during training. The integrated physiological assessment of both training outcome and process allows researchers: (1) to improve interpretation of physical tests used to verify the effectiveness of training programmes; (2) to evaluate the organization of the training load in order to design periodization strategies; (3) to identify athletes who are poor responders; (4) to control the compliance of the training completed to that planned by the coach; and (5) to modify the training process before the assessment of its outcome, thus optimizing soccer performance.

The aim of this study was to compare the effects of specific (small-sided games) vs. generic (running) aerobic interval training on physical fitness and objective measures of match performance in soccer. Forty junior players were randomly assigned to either generic (n=20) or specific (n=20) interval training consisting of 4 bouts of 4 min at 90-95 % of maximum heart rate with 3 min active rest periods, completed twice a week. The following outcomes were measured at baseline (Pre), after 4 weeks of pre-season training (Mid), and after a further 8 weeks of training during the regular season (Post): maximum oxygen uptake, lactate threshold (Tlac), running economy at Tlac, a soccer-specific endurance test (Ekblom's circuit), and indices of physical performance during soccer matches (total distance and time spent standing, walking, and at low- and high-intensity running speed). Training load, as quantified by heart rate and rating of perceived exertion, was recorded during all training sessions and was similar between groups. There were significant improvements in aerobic fitness and match performance in both groups of soccer players, especially in response to the first 4 weeks of pre-season training. However, no significant differences between specific and generic aerobic interval training were found in any of the measured variables including soccer specific tests. The results of this study showed that both small-sided games and running are equally effective modes of aerobic interval training in junior soccer players.

BACKGROUND: There is controversy about the outcome of patients with acute myocarditis (AM), and data are lacking on how patients admitted with suspected AM are managed. We report characteristics, in-hospital management, and long-term outcome of patients with AM based on a retrospective multicenter registry from 19 Italian hospitals. METHODS: A total of 684 patients with suspected AM and recent onset of symptoms (<30 days) were screened between May 2001 and February 2017. Patients >70 years of age and those >50 years of age without coronary angiography were excluded. The final study population comprised 443 patients (median age, 34 years; 19.4% female) with AM diagnosed by either endomyocardial biopsy or increased troponin plus edema and late gadolinium enhancement at cardiac magnetic resonance. RESULTS: At presentation, 118 patients (26.6%) had left ventricular ejection fraction <50%, sustained ventricular arrhythmias, or a low cardiac output syndrome, whereas 325 (73.4%) had no such complications. Endomyocardial biopsy was performed in 56 of 443 (12.6%), and a baseline cardiac magnetic resonance was performed in 415 of 443 (93.7%). Cardiac mortality plus heart transplantation rates at 1 and 5 years were 3.0% and 4.1%. Cardiac mortality plus heart transplantation rates were 11.3% and 14.7% in patients with complicated presentation and 0% in uncomplicated cases (log-rank P<0.0001). Major AM-related cardiac events after the acute phase (postdischarge death and heart transplantation, sustained ventricular arrhythmias treated with electric shock or ablation, symptomatic heart failure needing device implantation) occurred in 2.8% at the 5-year follow-up, with a higher incidence in patients with complicated forms (10.8% versus 0% in uncomplicated AM; log-rank P<0.0001). β-Adrenoceptor blockers were the most frequently used medications both in complicated (61.9%) and in uncomplicated forms (53.8%; P=0.18). After a median time of 196 days, 200 patients had follow-up cardiac magnetic resonance, and 8 of 55 (14.5%) with complications at presentation had left ventricular ejection fraction <50% compared with 1 of 145 (0.7%) of those with uncomplicated presentation. CONCLUSIONS: In this contemporary study, overall serious adverse events after AM were lower than previously reported. However, patients with left ventricular ejection fraction <50%, ventricular arrhythmias, or low cardiac output syndrome at presentation were at higher risk compared with uncomplicated cases that had a benign prognosis and low risk of subsequent left ventricular systolic dysfunction.

PURPOSE: To establish the validity and reliability of a new vertical jump force test (VJFT) for the assessment of bilateral strength asymmetry in a total of 451 athletes. METHODS: The VJFT consists of countermovement jumps with both legs simultaneously: one on a single force platform, the other on a leveled wooden platform. Jumps with the right or the left leg on the force platform were alternated. Bilateral strength asymmetry was calculated as [(stronger leg - weaker leg)/stronger leg] x 100. A positive sign indicates a stronger right leg; a negative sign indicates a stronger left leg. Studies 1 (N = 59) and 2 (N = 41) examined the correlation between the VJFT and other tests of lower-limb bilateral strength asymmetry in male athletes. In study 3, VJFT reliability was assessed in 60 male athletes. In study 4, the effect of rehabilitation on bilateral strength asymmetry was examined in seven male and female athletes 8-12 wk after unilateral knee surgery. In study 5, normative data were determined in 313 male soccer players. RESULTS: Significant correlations were found between VJFT and both the isokinetic leg extension test (r = 0.48; 95% confidence interval, 0.26-0.66) and the isometric leg press test (r = 0.83; 0.70-0.91). VJFT test-retest intraclass correlation coefficient was 0.91 (0.85-0.94), and typical error was 2.4%. The change in mean [-0.40% (-1.25 to 0.46%)] was not substantial. Rehabilitation decreased bilateral strength asymmetry (mean +/- SD) of the athletes recovering from unilateral knee surgery from 23 +/- 3 to 10 +/- 4% (P < 0.01). The range of normal bilateral strength asymmetry (2.5th to 97.5th percentiles) was -15 to 15%. CONCLUSIONS: The assessment of bilateral strength asymmetry with the VJFT is valid and reliable, and it may be useful in sports medicine.

Three studies involving 108 football players were conducted to examine the reliability of a repeated- shuttle-sprint ability (RSSA) test and its ability to differentiate between players of various competitive levels and playing positions. Study 1: Short-term reliability was determined in 22 professional players completing the RSSA test (6 × 40-m sprints with 20 s of recovery between sprints) on two separate occasions. Study 2: Long-term reliability (seasonal changes) was examined in 31 professional players completing the RSSA test four times (during the preseason period, at the start, middle and end of the competitive season). Study 3: 108 players were divided and compared according to competitive level or playing position. Standard error of measurement values expressed as coefficient of variation for RSSA mean time and best time were 0.8 and 1.3% (short-term reliability) and 0.9 and 1.2% (long-term reliability), respectively. The smallest worthwhile changes were 0.5% for both mean and best time. Professional players showed better RSSA performance than amateur players, and defenders displayed the lowest RSSA performance. In conclusion, the RSSA test showed adequate construct validity but only RSSA mean time showed sufficient reliability to detect large training-induced changes but not small important differences.

Background: Acute myocarditis (AM) is thought to be a rare cardiovascular complication of COVID-19, although minimal data are available beyond case reports. We aim to report the prevalence, baseline characteristics, in-hospital management, and outcomes for patients with COVID-19–associated AM on the basis of a retrospective cohort from 23 hospitals in the United States and Europe. Methods: A total of 112 patients with suspected AM from 56 963 hospitalized patients with COVID-19 were evaluated between February 1, 2020, and April 30, 2021. Inclusion criteria were hospitalization for COVID-19 and a diagnosis of AM on the basis of endomyocardial biopsy or increased troponin level plus typical signs of AM on cardiac magnetic resonance imaging. We identified 97 patients with possible AM, and among them, 54 patients with definite/probable AM supported by endomyocardial biopsy in 17 (31.5%) patients or magnetic resonance imaging in 50 (92.6%). We analyzed patient characteristics, treatments, and outcomes among all COVID-19–associated AM. Results: AM prevalence among hospitalized patients with COVID-19 was 2.4 per 1000 hospitalizations considering definite/probable and 4.1 per 1000 considering also possible AM. The median age of definite/probable cases was 38 years, and 38.9% were female. On admission, chest pain and dyspnea were the most frequent symptoms (55.5% and 53.7%, respectively). Thirty-one cases (57.4%) occurred in the absence of COVID-19–associated pneumonia. Twenty-one (38.9%) had a fulminant presentation requiring inotropic support or temporary mechanical circulatory support. The composite of in-hospital mortality or temporary mechanical circulatory support occurred in 20.4%. At 120 days, estimated mortality was 6.6%, 15.1% in patients with associated pneumonia versus 0% in patients without pneumonia ( P =0.044). During hospitalization, left ventricular ejection fraction, assessed by echocardiography, improved from a median of 40% on admission to 55% at discharge (n=47; P &lt;0.0001) similarly in patients with or without pneumonia. Corticosteroids were frequently administered (55.5%). Conclusions: AM occurrence is estimated between 2.4 and 4.1 out of 1000 patients hospitalized for COVID-19. The majority of AM occurs in the absence of pneumonia and is often complicated by hemodynamic instability. AM is a rare complication in patients hospitalized for COVID-19, with an outcome that differs on the basis of the presence of concomitant pneumonia.

PURPOSE: To examine whether the fatigue accumulated during match play or determined by short bouts of high-intensity intermittent activities affect short-passing ability in junior soccer players. A further aim was to examine the influence of physical fitness as measured using the Yo-Yo Intermittent Recovery Test (YYIRT) on the changes in short-passing ability after a 5-min simulation of high-intensity activities (HIS). METHODS: Sixteen players (mean +/- SD: age 17.6 +/- 0.5 yr, height 174 +/- 7 cm, body mass 68 +/- 6 kg) participated in the study. A quasi-experimental control-period design was used for the study. Short-passing ability was measured using the Loughborough Soccer Passing Test (LSPT). Players completed the LSPT in two sessions during the 1-wk control period, followed by two unofficial matches during which the LSPT was performed during and after the first and the second halves of the game. Furthermore, the change in LSPT performance was determined after 5 min of HIS. RESULTS: A decline in LSPT performance was found during and after the game (P < 0.01). The accuracy of the LSPT decreased after the HIS. A significant correlation was found between the YYIRT scores and the decline in LSPT performance (accuracy, total time, total time with penalties) after HIS (r = -0.51 to -0.65; P < 0.05). CONCLUSIONS: This study showed that the fatigue developed during a match and after relatively short bouts of high-intensity intermittent activities has a detrimental effect on short-passing ability, and that the fatigue-related decline in technical proficiency for a given intensity is associated with the fitness level of the players.

Background: Optimal timing for catheter ablation of ventricular tachycardia is an important unresolved issue. There are no randomized trials evaluating the benefit of ablation after the first implantable cardioverter defibrillator (ICD) shock. Methods: We conducted a 2-phase, prospective, multicenter, randomized clinical trial. Patients with ischemic or nonischemic dilated cardiomyopathy and primary or secondary prevention indication for ICD were enrolled in an initial observational phase until first appropriate shock (phase A). After reconsenting, patients were randomly assigned 1:1 in phase B to immediate ablation (within 2 months from shock delivery) or continuation of standard therapy. The primary end point was a composite of death from any cause or hospitalization for worsening heart failure. Amiodarone intake was not allowed except for documented atrial tachyarrhythmias. On July 23, 2021, phase B of the trial was interrupted as a result of the first interim analysis on the basis of the Bayesian adaptive design. Results: Of the 517 patients enrolled in phase A, 154 (30%) had ventricular tachycardia, 56 (11%) received an appropriate shock over a median follow-up of 2.4 years (interquartile range, 1.4–4.4), and 47 of 56 (84%) agreed to participate in phase B. After 24.2 (8.5–24.4) months, the primary end point occurred in 1 of 23 (4%) patients in the ablation group and 10 of 24 (42%) patients in the control group (hazard ratio, 0.11 [95% CI, 0.01–0.85]; P =0.034). The results met the prespecified termination criterion of &gt;99% Bayesian posterior probability of superiority of treatment over standard therapy. No deaths were observed in the ablation group versus 8 deaths (33%) in the control group ( P =0.004); there was 1 worsening heart failure hospitalization in the ablation group (4%) versus 4 in the control group (17%; P =0.159). ICD shocks were less frequent in the ablation group (9%) than in the control group (42%; P =0.039). Conclusions: Ventricular tachycardia ablation after first appropriate shock was associated with a reduced risk of the combined death or worsening heart failure hospitalization end point, lower mortality, and fewer ICD shocks. These findings provide support for considering ventricular tachycardia ablation after the first ICD shock. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01547208.

Abstract Trastuzumab deruxtecan (T-DXd) intracranial activity has been observed in small or retrospective patient cohorts with human epidermal growth factor receptor 2–positive (HER2 + ) advanced/metastatic breast cancer (mBC) and stable or active (untreated/previously treated and progressing) brain metastases (BMs). The phase 3b/4 DESTINY-Breast12 study investigated T-DXd in patients with HER2 + mBC and is, to our knowledge, the largest prospective study of T-DXd in patients with BMs in this setting. Patients (stable/active BMs ( n = 263) and no BMs ( n = 241)) treated with one or more prior anti-HER2–based regimens received T-DXd (5.4 mg per kg). Primary endpoints were progression-free survival (PFS; BMs cohort) and objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (non-BMs cohort). Additional endpoints included central nervous system (CNS) PFS, ORR, time to second progression, CNS ORR (BMs cohort), incidence of new symptomatic CNS metastases (non-BMs cohort), time to progression, duration of response, overall survival and safety (both cohorts). No formal hypothesis testing was conducted for this single-arm, open-label study. In the BMs cohort, 12-month PFS was 61.6% (95% confidence interval (CI): 54.9–67.6), and 12-month CNS PFS was 58.9% (95% CI: 51.9–65.3). In the non-BMs cohort, ORR was 62.7% (95% CI: 56.5–68.8). Grade 3 or higher adverse events occurred in 51% (BMs cohort) and 49% (non-BMs cohort) of patients. Investigator-reported interstitial lung disease/pneumonitis occurred in 16% (grade ≥3: 3%) of patients with BMs and 13% (grade ≥3: 1%) of patients without BMs. These data show substantial and durable overall and intracranial activity for T-DXd, supporting its use in previously treated patients with HER2 + mBC irrespective of stable/active baseline BMs. ClinicalTrials.gov identifier: NCT04739761 .

INTRODUCTION: Currently, abdominal obesity has reached an epidemic stage and obesity represents an important challenge for worldwide health authorities. Epidemiologic studies have demonstrated that the stone risk incidence increases with Body Mass Index, through multiple pathways. Metabolic syndrome and diabetes are associated with an increased renal stones disease incidence. The aim of this systematic review was to investigate the prevalence, morbidity, risk factors involved in the association between obesity and urolithiasis. EVIDENCE ACQUISITION: The search involved finding relevant studies from MEDLINE, EMBASE, Ovid, the Cochrane Central Register of Controlled Trials, CINAHL, Google Scholar, and individual urological journals between January 2001 and May 2017. The inclusion criteria were for studies written in the English language, reporting on the association between obesity and urinary stones. EVIDENCE SYNTHESIS: The underlying pathophysiology of stone formation in obese patients is thought to be related to insulin resistance, dietary factors, and a lithogenic urinary profile. Uric acid stones and calcium oxalate stones are observed frequently in these patients. Insulin resistance is thought to alter the renal acid-base metabolism, resulting in a lower urine pH, and increasing the risk of uric acid stone disease. Obesity is also associated with excess nutritional intake of lithogenic substances and with an increase in urinary tract infection incidence. Recent studies highlighted that renal stone disease increases the risk of myocardial infarction, progression of chronic kidney disease, and diabetes. Contemporary, bariatric surgery has been shown to be associated with hyperoxaluria and oxalate nephropathy. Certainly, the many health risks of obesity, including nephrolithiasis, will add more burden on urologists and nephrologists. CONCLUSIONS: Obesity related nephrolithiasis seems to necessitate weight loss as primary treatment, but the recognition of the associated complications is necessary to prevent induction of new and equally severe medical problems. The optimal approach to obesity control that minimizes stone risk needs to be determined in order to manage obesity-induced renal stones disease.

INTRODUCTION: Better understanding of atrial propagation during sinus rhythm (SR) in normal hearts under the most normal physiologic conditions may be propaedeutic to pathophysiologic studies of complex atrial arrhythmias. In this study, qualitative and quantitative analyses of sinus impulse propagation in both atria were performed by electroanatomic mapping in patients with no organic heart disease who were undergoing an electrophysiologic procedure. METHODS AND RESULTS: Seven patients (5 men and 2 women; age 37 +/- 11 years) undergoing ablation of a left-sided accessory pathway were considered. Associated heart disease and coexisting atrial arrhythmias were excluded. After obtaining informed consent, electroanatomic mapping of both atria was performed during SR using a nonfluoroscopic system in the postablation phase. Mapping was accomplished in all patients with no complications. Qualitative analysis showed that sinus impulse propagation gives a reproducible activation pattern with minor individual variations. During interatrial propagation, two breakthroughs (anterior and posterior) in the left atrium are observed in the majority of cases. The anterior breakthrough, which reflects conduction over Bachmann's bundle, is predominant and shows a peculiar "preexcitation-like" endocardial activation pattern. Quantitative analysis showed minimal individual variations of propagation time intervals. Atria are activated simultaneously for 65% +/- 9% of the duration of the atrial systolic time interval. CONCLUSION: In normal humans, electroanatomic mapping of SR identifies a typical and reproducible propagation pattern during SR. Bachmann's bundle plays the most important role in interatrial propagation. Atria are activated simultaneously by sinus impulse for a relevant portion of the systolic time interval.

OBJECTIVES: The aim of the present study was to compare the incidence of genitourinary (GU) dysfunction after elective laparoscopic low anterior rectal resection and total mesorectal excision (LAR + TME) with high or low ligation (LL) of the inferior mesenteric artery (IMA). Secondary aims included the incidence of anastomotic leakage and oncological outcomes. BACKGROUND: The criterion standard surgical approach for rectal cancer is LAR + TME. The level of artery ligation remains an issue related to functional outcome, anastomotic leak rate, and oncological adequacy. Retrospective studies failed to provide strong evidence in favor of one particular vascular approach and the specific impact on GU function is poorly understood. METHODS: Between June 2014 and December 2016, patients who underwent elective laparoscopic LAR + TME in 6 Italian nonacademic hospitals were randomized to high ligation (HL) or LL of IMA after meeting the inclusion criteria. GU function was evaluated using a standardized survey and uroflowmetric examination. The trial was registered under the ClinicalTrials.gov Identifier NCT02153801. RESULTS: A total of 214 patients were randomized to HL (n = 111) or LL (n = 103). GU function was impaired in both groups after surgery. LL group reported better continence and less obstructive urinary symptoms and improved quality of life at 9 months postoperative. Sexual function was better in the LL group compared to HL group at 9 months. Urinated volume, maximum urinary flow, and flow time were significantly (P < 0.05) in favor of the LL group at 1 and 9 months from surgery. The ultrasound measured post void residual volume and average urinary flow were significantly (P < 0.05) better in the LL group at 9 months postoperatively. Time of flow worsened in both groups at 9 months compared to baseline. There was no difference in anastomotic leak rate (8.1% HL vs 6.7% LL). There were no differences in terms of blood loss, surgical times, postoperative complications, and initial oncological outcomes between groups. CONCLUSIONS: LL of the IMA in LAR + TME results in better GU function preservation without affecting initial oncological outcomes. HL does not seem to increase the anastomotic leak rate.

BACKGROUND: Patients who achieve significant target lobe volume reduction (TLVR) following endobronchial valve (EBV) treatment may experience substantial improvements in clinical outcome measures. However, in cases of rapid TLVR, the risk of pneumothorax increases due to parenchymal rupture of the adjacent untreated lobe. Target lobe collapse may be more likely in EBV-treated patients who have low collateral ventilation. OBJECTIVES: The aim of this study was to evaluate the impact of pneumothorax on outcome following EBV treatment. METHODS: Data from three prospective clinical trials (the US and European cohorts of VENT and the Multicenter Chartis study) were retrieved for the analysis. All patients had undergone chest X-ray within 24 h of EBV implantation to explore the presence of pneumothorax. TLVR was assessed at either 30 (Chartis study) or 180 days (VENT), and clinical outcome measures (forced expiratory volume in 1 s (FEV1), St. George's Respiratory Questionnaire (SGRQ) and 6-min-walk distance (6-MWD)) were assessed 180 days after implantation. RESULTS: The overall rate of pneumothorax following valve therapy was 5.9% (25/421). Among these patients, 68% had a prolonged air leak for >7 days. However, patients who experienced a pneumothorax benefitted from EBV therapy, with a mean TLVR of 65% (n = 20). The mean percent change in FEV1 was 15 ± 15%, and the mean change in SGRQ was -7 ± 12 points. CONCLUSIONS: Although pneumothorax is a complication of EBV placement, it does not appear to have a negative impact on clinical outcome in terms of FEV1 and health-related quality of life.

AIMS: Pulmonary vein (PV) isolation is a curative treatment for patients with atrial fibrillation. The aim of this study was to evaluate prospectively the effects of adenosine administration on the PV activity and atrio-venous conduction after PV isolation. METHODS AND RESULTS: Twenty-nine patients (21 m; age: 55+/-8 years) were submitted to ostial PV isolation guided by basket catheter recordings. After successful isolation, the effects of a 12 mg intravenous bolus of adenosine were tested in 62 PVs. In 22/62 PVs (35%), left atrium (LA)-to-PV conduction was transiently (16.6+/-7.1 s, range: 3.8-27.9 s) or permanently (3 PVs) restored in response to adenosine administration. The prevalence of this phenomenon was 39% in left superior PVs, 43% in right superior PVs, and 22% in left inferior PVs (p=0.365). It occurred more frequently in the presence of dissociated PV activity (11/15 PVs, 73% vs. 11/47 PVs, 23%; p=0.002), whereas it was not influenced by the median duration of the radiofrequency current (RFC) delivery for each PV [19 (IQR: 12-26) min vs. 16 (IQR: 11-24) min: p=0.636]. A lengthening or shortening of the LA-PV conduction time was observed at LA-PV conduction appearance and disappearance in 36% and 55% of the cases, respectively. Further RFC applications (median: 5.5 min, IQR: 4-11 min) at the residual conduction breakthrough(s) indicated by the basket catheter recordings definitively eliminated adenosine-induced recovery of LA-PV conduction in all cases. Finally, when present, intrinsic PV discharge was invariably depressed by adenosine administration. CONCLUSIONS: Adenosine may transiently or permanently re-establish LA-PV conduction after apparently successful PV isolation. This phenomenon is abolished by additional RFC delivery. However, its possible influence on the clinical results of PV ablation must be evaluated by properly designed, randomized studies.

Endoscopic papillectomy (EP) is a viable therapy in ampullary lesions (AL). Many series have reported low morbidity and acceptable outcomes. We performed a systematic review with pooled analysis to assess the safety and efficacy of EP for AL. Electronic databases (Medline, Scopus and EMBASE) were searched up to September 2018. Studies that included patients with endoscopically resected AL were eligible. The rate of adverse events (AEs; primary outcome) and the rates of both technical and clinical efficacy outcomes were pooled by means of a random- or fixed-effects model to obtain a proportion with a 95% confidence interval (CI). Twenty-nine studies were included (1751 patients). The overall AE rate was 24.9%. The post-procedural pancreatitis rate was 11.9%, with the only factor affecting this outcome being prophylactic pancreatic stenting. The complete resection rate was 94.2%, with a rate of oncologically curative resection of 87.1%. The recurrence rate was 11.8% (follow-up: 9.6-84.5 months). EP is a relatively safe and effective option for AL. Our study might definitively suggest the protective role of prophylactic pancreatic stenting against post-procedural pancreatitis.

BACKGROUND: Estimates of the prevalence of atrial fibrillation (AF) in heart failure (HF) originate from patients enrolled in clinical trials. AIMS: To assess the prevalence and clinical correlates of AF among HF patients in everyday clinical practice from HF patients screened for the T-wave ALternans in Patients with Heart fAilure (ALPHA) study; to investigate the correlation between AF and functional status. METHODS AND RESULTS: Consecutive patients (N=3513) seen at nine Heart Failure Clinics were studied; 21.4% were in AF. AF prevalence was greater with increasing age (OR 1.04/year, p<0.001) in non-ischaemic cardiomyopathy (OR 2.34, p<0.001) and with increasing NYHA class (p<0.0001). Multiple logistic regression predictors of AF were age >70 years (OR 2.35), NYHA class II III or IV vs class I (OR 1.8, 4.4 and 3.1) and non-ischaemic cardiomyopathy (OR 3.2). A logistic model indicated that AF was associated with a 2.5 OR of being in NYHA class III-IV vs I-II while accounting for age, gender, left ventricular ejection fraction (LVEF), and aetiology of HF. CONCLUSIONS: The prevalence of AF in HF patients exceeds 20%, and increases with age and functional class. The presence of AF leads to a more severe NYHA class, indicating that AF contributes to the severity of heart failure.

BACKGROUND: Due to its rarity, male breast cancer (mBC) remains an inadequately characterized disease, and current evidence for treatment derives from female breast cancer (FBC). METHODS: We retrospectively analyzed the clinicopathological characteristics, treatment patterns, and outcomes of mBCs treated from 2000 to 2013. RESULTS: From a total of 97 patients with mBC, 6 (6.2%) with ductal in situ carcinoma were excluded, and 91 patients with invasive carcinoma were analyzed. Median age was 65 years (range: 25-87 years). Estrogen receptors were positive in 88 patients (96.7%), and progesterone receptors were positive in 84 patients (92.3%). HER-2 was overexpressed in 13 of 85 patients (16%). Median follow-up was 51.5 months (range: 0.5-219.3 months). Five-year progression-free survival (PFS) was 50%, whereas overall survival (OS) was 68.1%. Patients with grades 1 and 2 presented 5-year PFS of 71% versus 22.5% for patients with grade 3 disease; 5-year OS was 85.7% for patients with grades 1 and 2 versus 53.3% of patients with grade 3. Ki-67 score >20% and adjuvant chemotherapy were also statistically significant for OS on univariate analyses. Twenty-six of 87 patients (29.8%) experienced recurrent disease and 16 of 91 patients (17.6%) developed a second neoplasia. CONCLUSION: Male breast cancer shows different biological patterns compared with FBC, with higher positive hormone-receptor status and lower HER-2 overexpression. Grade 3 and Ki-67 >20% were associated with shorter OS. IMPLICATIONS FOR PRACTICE: There is little evidence that prognostic features established in female breast cancer, such as grading and Ki-67 labeling index, could be applied to male breast cancer as well. This study found that grade 3 was associated with shorter overall survival and a trend for Ki-67 >20%; this could help in choosing the best treatment option in the adjuvant setting. Many questions remain regarding the impact of HER-2 positivity on survival and treatment with adjuvant anti-HER-2 therapy. Regarding metastatic male breast cancer, the results suggest that common regimens of chemo-, endocrine and immunotherapy used in female breast cancer are safe and effective for men. Male breast cancer patients show a higher incidence of second primary tumors, especially prostate and colon cancers and should therefore be carefully monitored.