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Background In 2019, a multidisciplinary panel of experts from eight Italian scientific paediatric societies developed a consensus document for the use of inhaled corticosteroids in the management and prevention of the most common paediatric airways disorders. The aim is to provide healthcare providers with a multidisciplinary document including indications useful in the clinical practice. The consensus document was intended to be addressed to paediatricians who work in the Paediatric Divisions, the Primary Care Services and the Emergency Departments, as well as to Residents or PhD students, paediatric nurses and specialists or consultants in paediatric pulmonology, allergy, infectious diseases, and ear, nose, and throat medicine. Methods Clinical questions identifying Population, Intervention(s), Comparison and Outcome(s) were addressed by methodologists and a general agreement on the topics and the strength of the recommendations (according to the GRADE system) was obtained following the Delphi method. The literature selection included secondary sources such as evidence-based guidelines and systematic reviews and was integrated with primary studies subsequently published. Results The expert panel provided a number of recommendations on the use of inhaled corticosteroids in preschool wheezing, bronchial asthma, allergic and non-allergic rhinitis, acute and chronic rhinosinusitis, adenoid hypertrophy, laryngitis and laryngospasm. Conclusions We provided a multidisciplinary update on the current recommendations for the management and prevention of the most common paediatric airways disorders requiring inhaled corticosteroids, in order to share useful indications, identify gaps in knowledge and drive future research.

Chronic rhinosinusitis (CRS) is a chronic and recurrent disease that negatively affects patients' quality of life. CRS has two main phenotypes: CRS with nasal polyps (CRSwNP) and CRS without polyps (CRSsNP). Minimal research has been conducted to study the variability in patients' characteristics. Therefore, we conducted this study to examine these differences.A retrospective cohort study included patients with both CRSwNP and CRSsNP. Outcomes included symptom severity, radiographic severity, and number of sinus surgeries. Symptom severity was assessed using the Sino-nasal Outcome Test and the Lund-Mackay CT score was used to determine radiographic severity. Further subgroup analysis was done based on the presence or absence of comorbid asthma.A total of 110 and 106 patients were included in the CRSwNP and CRSsNP groups, respectively. The mean age in the CRSwNP and CRSsNP groups was 50.2 and 48.7, and the proportion of female patients was 40.9% and 58.5%, respectively. No significant difference in symptom severity was noted between CRSwNP and CRSsNP group (68.1±18.6 vs. 73.2±21.27; P=0.097), while the Lund-Mackay score was significantly lower in the CRSsNP group (7.4±2.3 vs. 11.9±3.6; P=0.016). Also, the number of surgeries was significantly lower in the CRSsNP group as compared to the CRSwNP group (P=0.023). Subgroup analysis revealed statistically significant differences between those with and without asthma in patients with CRSwNP in terms of Lund-Mackay scores and number of surgeries (P=0.038 and 0.043), respectively. However, no significant differences were noted in the CRSsNP group (P0.05).There is a clear variability in the characteristics of patients with CRSsNP and CRSwNP. A similar difference was noted in the CRSwNP group when patients were stratified based on the presence of absence of asthma. This warrants further investigation of potential correlation with the prognosis and optimum treatment strategies of this patient population.

Recurrent respiratory infections (RRIs) are a common clinical condition in children, in fact about 25% of children under 1 year and 6% of children during the first 6 years of life have RRIs. In most cases, infections occur with mild clinical manifestations and the frequency of episodes tends to decrease over time with a complete resolution by 12 years of age. However, RRIs significantly reduce child and family quality of life and lead to significant medical and social costs. Despite the importance of this condition, there is currently no agreed definition of the term RRIs in the literature, especially concerning the frequency and type of infectious episodes to be considered. The aim of this consensus document is to propose an updated definition and provide recommendations with the intent of guiding the physician in the complex process of diagnosis, management and prevention of RRIs. Supplementary Information The online version contains supplementary material available at 10.1186/s13052-021-01150-0.

The upper airways (UA) should be considered as a functional unit. Current functional anatomy divides URT in three, mutually dependent, “junction boxes”: i) the ostio-meatal complex (OMC), ii) the spheno-ethmoidal recess (SER), and iii) the rhinopharynx (RP). Correct ventilation and effective mucociliary clearance of these sites significantly affect the healthy physiology of the entire respiratory system. The OMC, SER, and RP obstruction is the first pathogenic step in the inflammatory/infectious cascade of UA disorders. The inflammation of the respiratory mucosa is the main pathogenic factor for airway obstruction. Moreover, bacterial biofilm (a strategy modality of bacterial survival) is an important local cause of systemic antibiotic ineffectiveness, recurrent infections, and antibiotic resistance. Health microbiota guarantees UA wellness; on the contrary, dysbiosis promotes and worsens UA infections. Allergy, namely type 2 inflammation, is a common cause of UA obstruction such as promoting in turn infections. Fiberoptic endoscopy is a mandatory diagnostic tool in clinical practice. Nasal cytology, mainly concerning flow cytometry, allows defining rhinitis phenotypes so allowing a precision medicine approach. Several conventional therapeutic approaches are available, but efficacy and safety should be ever properly considered before the prescription. Also, complementary medicine plays a fruitful role in the management of UA diseases. National and real-world studies are reported and discussed as they may be useful in daily clinical practice.

Aim To compare the long-term outcomes of patients implanted with Absorb bioresorbable scaffold (BRS) with optimal versus suboptimal technique. Methods and results All patients who received an Absorb between March 2012 and January 2016 were selected from 19 Italian centers databases to assess the impact of an optimal implantation technique (CIAO criteria) on long-term device-oriented composite end-point (DOCE) - including cardiac death (CD), target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) - on its single components and on scaffold thrombosis (ScT). CIAO criteria consist of predilation (balloon/vessel ratio 1:1), correct sizing (BRS/proximal reference vessel diameter -RVD- ratio 0.8–1.2) and high-pressure postdilation with non-compliant (NC) balloon (≥20 atm for balloon/BRS ratio 1:1 or ≥16 atm for a 0.25–0.5 mm oversized balloon). Among the 1.434 patients analyzed, 464 (32.4%) fulfilled all CIAO criteria for every BRS implanted (CIAO 3 group), while 970 (67.6%) did not in at least one of the received BRS (CIAO 0-1-2 group). At 31.0 (interquartile range -IQR- 24.8–38.5) months follow-up, CIAO criteria did not impact on DOCE (8.2% vs. 8.0%, p = 0.92), ID-TLR (6.9% vs. 7.1%, p = 0.72) or ScT (1.9% vs. 1.8%, p = 0.80) in the overall population. At multivariate analysis overall BRS length ( p = 0.001), severely calcified lesions (p = 0.03) and absence of CIAO criteria (CIAO 0, p = 0.005) were independent predictors of DOCE in long-term follow-up. Conclusion Our data suggest that strict application of an optimal Absorb implantation technique doesn't improve long-term DOCE or ScT but may mitigate the worse outcome of patients with calcific lesions.

BACKGROUND Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non-SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern. OBJECTIVE We aimed to compare outcomes of Absorb BVS versus a 2nd-generation metallic everolimus-eluting stents (EES) in the SVD setting, by pooling patients from three large, prospective studies. METHODS Patients with SVD (reference vessel diameter ≤2.75 mm by QCA) and treated with Absorb BVS were identified in the Italian RAI and the MAASSTAD-Absorb registries. EES controls were identified in the COMPARE II Trial. We performed a propensity-score matching using several clinical and angiographic variables. Implantation technique was not object of matching, being device-specific. RESULTS Out of 4635 enrolled subjects, 1147 belonged to the SVD population. After matching, we obtained 337 pairs of patients. High clinical and angiographic complexity was found in both groups. Predilation and postdilation rates were significantly higher in BVS patients. No differences were found in terms of the device-oriented composite end-point at 1-year (HR = 1.08, 95%CI 0.5-2.3, P = .8) and 2-years (HR = 1.28, 95% CI: 0.68-2.43, P = .5). Notwithstanding, higher incidence of definite/probable stent thrombosis was observed in the BVS group at 1 year (HR 4.7, 95%CI 0.8-31.4, P = .08) and 2-years (HR = 8.34 95%CI 1.1-60.2, P = .04). CONCLUSION In this propensity-matched analysis pooling SVD patients of three large prospective studies, incidence of composite device-related events was comparable between BVS and EES up to 2 years follow-up. However, higher rates of stent thrombosis were found in the BVS group.

Objectives: To report 1-year clinical outcomes of bioresorbable vascular scaffold (BVS) in acute coronary syndromes (ACS) population. Background: BVS use has rapidly extended to high-risk patients as those presenting with ACS. To date limited data have been reported on BVS performance in ACS patients. Methods: RAI is a multicenter, prospective registry that included 1,505 patients treated with at least 1 successful BVS implantation. A subgroup analysis on ACS patients was performed and the 1-year outcomes of this cohort compared to the remaining stable coronary artery disease (SCAD) population are reported here. Coprimary endpoints were target-lesion revascularization (TLR) and scaffold thrombosis (ScT) at 1-year follow-up. Results: Fifty-nine percent of the patients presented with ACS, of whom 36.5% with ST-elevation myocardial infarctions. ACS patients were significantly younger, with a better cardiovascular risk profile, a lower rate of multivessel disease, chronic total occlusion or in-stent restenosis and a lower Syntax score. Predilation and postdilation were performed in 97.4% and in 96.5% of cases, respectively. No differences were noted in terms of TIMI 3 final flow, but acute gain was greater in ACS compared to SCAD group (P < 0.001). At one-year follow-up no differences were found in terms of TLR (3.3% vs. 3.3%, P = 0.98), and device-oriented composite end-point (4.3% vs. 3.4%, P = 0.4) between ACS and SCAD groups. The rate of definite/probable ScT was numerically higher in ACS vs. stable CAD patients (1.3% vs. 0.8%, P = 0.2). Conclusions: Our data suggest that the use of BVS in ACS patients is associated with a numerically higher rate of ScT compared to SCAD population numerically higher, but without statistical significance.

Aims The aim of the study was to evaluate the impact of bioresorbable vascular scaffold (BRS) implantation technique on post-procedural quantitative coronary angiography (QCA) parameters in ST-elevation myocardial infarction (STEMI). Methods and results We assessed 442 STEMI patients who underwent BRS implantation in the BVS STEMI STRATEGY-IT study. Optimal BRS implantation was assessed using the PSP score, developed and validated in the GHOST-EU registry. We analysed post-implantation QCA parameters, including minimum lumen diameter (MLD) and maximum footprint, in patients with and without optimal BRS implantation, coded as maximum PSP score. Patients with optimal BRS implantation had higher post-procedural MLD and lower maximum footprint than those without. Multivariate analysis demonstrated that optimal BRS implantation was an independent predictor of high post-procedural MLD, defined as ≥2.4 mm for 2.5 or 3.0 mm BRS and ≥2.8 mm for 3.5 mm BRS. Thrombectomy before optimal BRS implantation showed a trend towards higher post-procedural MLD and lower maximum footprint. There was no relationship between optimal BRS implantation and device-oriented composite events at one year. Conclusions Optimal BRS implantation, as assessed by PSP score, was associated with better post-procedural QCA parameters in STEMI. Thrombectomy before optimal BRS implantation might improve angiographic results in STEMI. Long-term follow-up is needed to analyse the relationship between QCA parameters and clinical outcomes after BRS implantation in STEMI patients.

Acute coronary syndromes (ACS) may represent an intriguing clinical scenario for implantation of bioresorbable vascular scaffold (BRS). Nevertheless, the knowledge about the performance of these devices in patients with ACS is limited. Therefore, we performed a meta-analysis of clinical studies aiming to assess the safety and efficacy of everolimus-eluting-BRS versus everolimus-eluting-metallic stents (EES) in ACS patients undergoing percutaneous coronary intervention. Six studies enrolling 2,318 patients were included and analyzed for the risk of primary safety outcome (stent or scaffold thrombosis [ST/ScT]), primary efficacy outcome (target lesion revascularisation [TLR]), and secondary outcomes (myocardial infarction, cardiac death, all-cause death). Median follow-up was 9.5 (6 to 19.5) months. Patients treated with BRS had a significantly higher risk of definite ST/ScT compared with those receiving EES (2.3% vs 1.08%, odds ratio [OR] 2.22, 95% confidence interval [CI] 1.10 to 4.45, p = 0.03, I2 = 0%). Similarly, the risk of TLR was significantly higher in the BRS compared with EES group (3.5% vs 2.5%, OR 1.79, 95% CI 1.02 to 3.16, p = 0.04, I2 = 0%). When TLRs due to thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR 1.19, 95% CI 0.48 to 2.98, p = 0.71, I2 = 25%). Risk for secondary endpoints did not differ between the 2 groups. Results were confirmed when clinical and procedural variables were tested as potential effect modifiers in the meta-regression analysis for both primary endpoints. In conclusion, compared with those receiving EES, patients with ACS treated with BRS had increased risk of definite device thrombosis and TLR at mid-term follow-up.

We read with great interest the study of Alfonso et al. [(1)][1] assessing the value of bioresorbable vascular scaffold (BVS) for in-stent restenosis (ISR) treatment. The authors prospectively included patients treated with BVS for both bare-metal and drug-eluting stent (DES) ISR. Results were than

Objectives to compare the 1-year outcome between bioresorbable vascular scaffold (BVS), everolimus-eluting stent (EES), and drug-eluting balloon (DEB) for in-stent restenosis (ISR) treatment. Background BVS has been proposed as alternative for ISR treatment. To date a direct comparison between BVS and DES or DEB for ISR treatment is lacking. Methods We retrospectively analyzed all ISR lesions treated with BVS, DEB, and EES from January 2012 to December 2014. A total of 548 lesions (498 patients) were included. By applying two propensity-score matching, 93 lesions treated with BVS were compared with 93 lesions treated with DEB, and 100 lesions treated with BVS were compared to 100 lesions treated with EES. Results At 1-year follow-up the incidence of device-oriented cardiovascular events (DOCE) and its components did not significantly differ between BVS and DEB (DOCE: 10.9 vs. 11.8%, HR, 0.91; 95% CI, 0.33-2.52; P = 0.86; Cardiac death: 2.2 vs. 1.2%, HR, 1.74, 95% CI 0.16-18.80, P = 0.65; ID-TLR: 8.9 vs. 10.7%, HR, 0.81, 95% CI 0.27-2.48, P = 0.71; TV-MI: 3.3 vs. 1.2%, HR, 2.39, 95% CI 0.27-21.32, P = 0.43) and BVS vs. EES (DOCE: 10.1 vs. 5.2% HR, 1.81, 95% CI, 0.63-5.25; P = 0.27; Cardiac death: 3.0 vs. 1.1%; HR, 2.83, 95% CI 0.29-27.4, P = 0.37; ID-TLR: 7.2 vs. 4.2%, HR, 1.57, 95% CI 0.47-5.23, P = 0.46; TV-MI: 3.1 vs. 0%). Conclusion At 1-year follow-up the use of BVS as ISR treatment is associated with a higher, even if not significant, DOCE rate compared with EES while a similar rate compared to DEB.

Background The bioresorbable vascular scaffold (BVS) technology may be an appealing option in ST-segment elevation myocardial infarction (STEMI) patients. However, the available evidence on its use in this challenging subset is limited. Methods Registro Absorb Italiano (RAI) is a multicenter, prospective registry that aims to assess BVS performance through a 5-year follow-up of all consecutive patients who undergone at least 1 successful BVS implantation. As a part of it, a subgroup analysis in STEMI patients was performed and the outcomes of this cohort compared to the remaining population (defined as "non-STEMI") are reported here. Results Among the 1505 patients enrolled, 317 (21.1%) had STEMI on admission. Among those, 232 (73.2%) underwent primary percutaneous coronary intervention (PCI) within 12 h from symptom onset; 64 (20.2%) were late-comers (>12 h); 16 (5%) underwent PCI after successful thrombolysis while 5 (1.6%) underwent rescue-PCI. At a median follow-up time of 12 months (IQR 6–20 months) no differences were noticed between STEMI and "non-STEMI" groups in terms of device-oriented composite endpoint (4.1% vs. 5.6%; p = 0.3) and its singular components: ischemia-driven target lesion revascularization (3.2% vs. 3.6%; p = 0.7), target-vessel myocardial infarction (3.2% vs. 2.8%; p = 0.7) and cardiac death (0.6% vs. 0.6%; p = 0.9). The rate of definite/probable scaffold thrombosis (ScT) was numerically higher but not significant in the STEMI group (2.5% vs. 1.3%; p = 0.1). Conclusions BVS implantation in an unrestricted cohort of STEMI patients is associated with a numerically higher rate of ScT compared to the non-STEMI group. Further studies exploring the potential clinical impact of a pre-specified BVS implantation strategy in this high-risk clinical setting are needed.

Objectives The objective of this study was to investigate mid-term clinical outcomes of patients treated with ‘full-plastic jacket’ (FPJ) everolimus-eluting Absorb bioresorbable vascular scaffold (BRS) implantation. Background FPJ with BRS may represent an interesting option for patient with diffuse coronary artery disease (CAD), but data on the clinical impact of FPJ using the Absorb BRS are scant. Methods FPJ was defined as the implantation of >56 mm of overlapping BRS in at least one vessel. We compared outcomes of patients receiving Absorb FPJ vs. non-FPJ within the multicenter prospective RAI Registry. Results Out of 1505 consecutive patients enrolled in the RAI registry, 1384 were eligible for this analysis. Of these, 143 (10.3%) were treated with BRS FPJ. At a median follow-up of 649 days, no differences were observed between FPJ and non-FPJ groups in terms of the device-oriented composite endpoint (DoCE) (5.6% vs. 4.4%, p = 0.675) or the patient-related composite endpoint (PoCE) (20.9% vs. 15.9%, p = 0.149). Patients receiving FPJ had higher rates of target vessel repeat revascularization (TVR) (11.2% vs. 6.3%, p = 0.042). In the FPJ group, there was no cardiac death and only one (very late) stent thrombosis (ST) (0.7%). Conclusions Mid-term outcomes of a FPJ PCI strategy in the setting of diffuse CAD did not show a significant increase in composite device- and patient-related events, with rates of cardiac death and ST comparable to non-FPJ Absorb BRS implantation. However, these findings are hypothesis generating and requiring further validation.

ObjectivesTo compare clinical outcomes of patients treated with overlapping versus non-overlapping Absorb BVS. Background: Limited data are available on the clinical impact of stent overlap with the Absorb BVS bioresorbable stent. Methods: We compared outcomes of patients receiving overlapping or non-overlapping Absorb BVS in the multicenter prospective RAI Registry. Results: Out of 1,505 consecutive patients treated with Absorb BVS, 1,384 were eligible for this analysis. Of these, 377 (27%) were in the overlap group, and 1,007 (73%) in the non-overlap group. The most frequent overlap configuration was the marker-to-marker type (48%), followed by marker-over-marker (46%) and marker-inside-marker (6%) types. Patients of the overlap group had higher prevalence of multivessel disease and higher SYNTAX score, and required more frequently the use of intravascular imaging. At a median follow-up of 368 days, no difference was observed between overlap and non-overlap groups in terms of a device-related composite endpoint (cardiac death, TV-MI, ID-TLR) (5.8% vs. 4.1%, P=0.20) or of a patient-related composite endpoint (any death, any MI, any revascularization) (15.4% vs. 12.5%, P=0.18). Cardiac death (1.0% vs. 1.3%, P=0.54), MI (4.5% vs. 3.6%, P=0.51), TVR (4.5% vs. 3.6%, P=0.51) and stent thrombosis (1.1 vs. 1.5%, P=1.00) were also comparable between groups. When assessing outcomes of the overlap population according to overlap configurations used, no difference was observed in terms of the device- or patient-related composite endpoints. Conclusions: Outcomes of patients with or without overlapping BVS were comparable at mid-term follow-up despite higher angiographic complexity of the overlap subset. (c) 2017 Wiley Periodicals, Inc.

This multicenter experience sought to investigate the feasibility and safety of BVS for the treatment of ISR. From April 2012 to June 2014, a total of 315 patients (334 lesions) underwent PCI for ISR at the participating centers. Of those, 83 patients (90 lesions) received BVS. Procedural success was achieved in all patients. At a median of 7 (IQR 3–18) months follow-up, MACCE rate was 12%, TLR 7.7%, while one (1.1%) definite BVS-in-stent thrombosis was reported. The results of this multicenter experience suggest that BVS implantation for the treatment of coronary ISR is technically feasible and associated with favorable mid-term clinical results. These data could be considered hypothesis generating for a future randomized clinical trial.

Background/purpose Coronary in-stent restenosis (ISR) is a clinical problem for which a satisfactory solution has not been found yet. Bioabsorbable drug eluting vascular scaffolds (BVSs) provide transient vessel scaffolding combined with prolonged drug delivery capability. The aim of this study was to investigate the safety of BVS for the treatment of coronary ISR. Methods/materials Between January 2013 and June 2013, 27 patients (31 lesions), presenting with either stable or unstable angina due to coronary ISR, were enrolled in a single arm, prospective, open label registry. Primary end point was the occurrence of target vessel revascularization (TVR) at 12 months. Secondary end point was the composite of death, myocardial infarction and TVR at 12 months. Results A diffuse ISR pattern was present in 70% of the lesions; mean lesion length was 34.6 ± 15. BVS was successfully implanted in all patients with no in hospital MACE. At twelve months of follow up, MACE rate was 18.5%. One patient died for non-cardiac reason, one patient died due to a possible stent thrombosis and TVR was necessary in 3 patients (11.1%). Conclusions Our data suggest that BVS is safe and technically feasible for treatment of long and diffuse coronary ISR. These data could be considered hypothesis generator for a randomized clinical trial.

Objective of this study was to assess the clinical performance of bioresorbable vascular scaffold (BVS) compared to everolimus-eluting stent (EES) in subjects with ST-segment elevation myocardial infarction (STEMI). We included all consecutive patients with STEMI who underwent percutaneous coronary intervention (PCI) with BVS implantation in centers participating to the Italian ABSORB Prospective Registry (BVS-RAI) and PCI with EES in the same centers during the same period. The 2 groups were compared. The primary end point was patient-oriented composite end point (POCE) including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at the longest available follow-up. BVS or EES thrombosis at follow-up was also evaluated. Of the 563 patients with STEMI included, 122 received BVS and 441 EES. Procedural success was obtained in 549 (97.5%) cases without significant differences between the 2 groups (BVS 99.3% vs EES 97.0%, p = 0.2). At a median of 220-day (interquartile range 178 to 369) follow-up, no significant differences were observed in terms of POCE (BVS 4.9% vs EES 7.0%, p = 0.4); death (BVS 0.8%, EES 2.0%, p = 0.4), MI (BVS 4.1%, EES 2.0%, p = 0.2), TLR (BVS 4.1%, EES 4.5%, p = 0.8), device thrombosis (BVS 2.5%, EES 1.4%, p = 0.4). All TLR cases were successfully managed with re-PCI in both groups. A propensity matching of the study populations showed no significant differences regarding POCE at the longest available follow-up (odds ratio 0.53, 0.1 to 4.3). In conclusion, in this direct prospective comparison, BVS was associated with similar clinical results compared to EES in the STEMI setting. Larger and adequately powered randomized trials are needed to fully assess the potential clinical benefit of BVS versus the current standard of care in patients with STEMI.

Aims: In this multicentre prospective registry we sought to evaluate the immediate and midterm clinical out-comes following single or multiple overlapping bioresorbable vascular scaffold (BVS) implantation in the STEMI setting. Methods and results: A prospective cohort analysis was performed on all STEMI patients who underwent primary PCI with BVS implantation. Between December 2012 and February 2014, 1,232 STEMI patients underwent primary PCI at the participating centres. Of these, 74 (6.0%) received a BVS, 18 (24.3%) of them were multiple and overlapping. Procedural success was obtained in 72 (97.3%) cases without differences between the groups (overlapping BVS 100% vs. single BVS 96.4%, p=0.5). One patient experienced a rein-farction due to subacute BVS thrombosis which was successfully managed with balloon-only PCI while the other patient had a slow-flow phenomenon (final TIMI flow 2). At six-month follow-up, two non-fatal MI (2.7%), three target lesion revascularisations (4.1%), and one subacute BVS thrombosis were reported in three patients (one [5.6%] overlapping BVS and two [3.6%] in the single BVS group, p=0.5). All the events were successfully managed with re-PCI. Conclusions: BVS implantation in STEMI patients can be successfully performed with a high procedural success rate and encouraging midterm outcomes. Larger randomised trials and longer follow-up are needed to assess the potential clinical benefit of BVS versus new-generation DES in this setting.

Aims To compare the efficacy and safety of drug-eluting stents vs. bare-metal stents in patients with acute ST-segment elevation myocardial infarction. Methods and results We performed a meta-analysis of eight randomized trials comparing drug-eluting stents (sirolimus-eluting or paclitaxel-eluting stents) with bare-metal stents in 2786 patients with acute ST-segment elevation myocardial infarction. All patients were followed up for a mean of 12.0–24.2 months. Individual data were available for seven trials with 2476 patients. The primary efficacy endpoint was the need for reintervention (target lesion revascularization). The primary safety endpoint was stent thrombosis. Other outcomes of interest were death and recurrent myocardial infarction. Drug-eluting stents significantly reduced the risk of reintervention, hazard ratio of 0.38 (95% CI, 0.29–0.50), P < 0.001. The overall risk of stent thrombosis: hazard ratio of 0.80 (95% CI, 0.46–1.39), P = 0.43; death: hazard ratio of 0.76 (95% CI, 0.53–1.10), P = 0.14; and recurrent myocardial infarction: hazard ratio of 0.72 (95% CI, 0.48–1.08, P = 0.11) was not significantly different for patients receiving drug-eluting stents vs. bare-metal stents. Conclusion The use of drug-eluting stents in patients with acute ST-segment elevation myocardial infarction is safe and improves clinical outcomes by reducing the risk of reintervention compared with bare-metal stents.

The aim of this study was to assess the feasibility and clinical results following a pre-specified bioresorbable scaffold (Absorb BVS) implantation strategy in patients with ST-segment elevation myocardial infarction (STEMI).Concerns were raised about the safety of Absorb because a non-negligible rate of thrombosis was reported within 30 days and at midterm follow-up after primary percutaneous coronary intervention.This was a prospective, multicenter study of patients with STEMI (75 years of age with symptom onset12 h) undergoing primary percutaneous coronary intervention with Absorb following a dedicated implantation protocol. The primary endpoint was a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization within 30 days.During the study period, 505 patients with STEMI (16.9% of the overall STEMI population) were treated with the Absorb BVS. The mean age was 56.6 ± 9.4 years, and 487 patients (96.4%) were in Killip class I or II at admission. According to the study protocol, direct Absorb implantation was feasible in 47 patients (9.3%), whereas post-dilatation was performed in 468 cases (92.7%). Procedural success was attained in 94.8% of the cases. Dual antiplatelet therapy with ticagrelor or prasugrel was administered at discharge in 481 patients (95.1%). At 30-day follow-up, the hierarchical device-oriented composite endpoint rate was 0.6% (0.4% cardiac death, 0.2% target vessel myocardial infarction and ischemia-driven target lesion revascularization). One episode (0.2%) of probable scaffold thrombosis was reported.A pre-specified Absorb implantation strategy in real-world patients with STEMI undergoing primary percutaneous coronary intervention was feasible and associated with a low 30-day device-oriented composite endpoint rate. Mid- and long-term follow-up is strongly needed to eventually confirm these early results. (Use of BVS in ST-Segment Elevation Myocardial Infarction [STEMI]: The BVS STEMI STRATEGY-IT Prospective Registry [STRATEGY-IT]; NCT02601781).

The Absorb biovascular scaffold (BVS) is a bioresorbable, everolimus-eluting scaffold whose data on real-world patients with complex lesions are limited. Short-term follow-up from recent studies point to a higher rate of 30-day thrombosis than observed with drug-eluting stents. We aimed to understand the short-term safety and efficacy of BVS. Registro Absorb Italiano (RAI, ClinicalTrials.gov:NCT02298413) is an Italian, prospective, multicenter registry not funded, whose aim is to investigate BVS performance through a 5-year follow-up of all consecutive patients who have undergone successful implantation of >= 1 BVS in different clinical/lesion subsets. Co-primary end points were target lesion revascularization and definite/probable thrombosis. Secondary end point was the occurrence of device oriented cardiac events. The registry involved 23 centers, with patient enrollment from October 2012 to December 2015. We here report the 30-day outcomes of the whole population of the registry. We enrolled 1,505 consecutive patients, of which 82% were men and 22.4% diabetic. At presentation, 59.6% of the patients had an acute coronary syndrome, including 21% ST-elevation myocardial infarction. All lesions were pre-dilated and in 96.8% of the cases BVS was post-dilated. At 30 days, the co-primary study end point target lesion revascularization occurred in 0.6% of patients and definite/probable BVS thrombosis in 0.8%. There were 2 cases of cardiac and overall death (0.13%). Device-oriented cardiac events occurred in 1% of the patients. In conclusion, our data of consecutive patients suggest that current use of BVS in a wide spectrum of coronary narrowings and clinical settings is associated with good outcome at 30 days. (C) 2017 Elsevier Inc. All rights reserved.

Aims The aim of this study was to assess outcomes following Absorb bioresorbable scaffold (BVS) implantation in an unrestricted clinical practice according to an "on-label" versus "off-label" indication. Methods and results RAI is a prospective registry, investigating BVS performance in different lesion subsets. No specific exclusion criteria were applied. Co-primary endpoints were target lesion revascularisation (TLR) and definite/probable scaffold thrombosis (ScT) at one year. A total of 1,505 patients (1,969 lesions) were enrolled. In 58% of patients, BVS was implanted in at least one off-label subset according to the manufacturer's instructions for use. Predilatation was performed in 98.5% of the cases, and post-dilatation in 96.8%. At one-year follow-up, TLR and ScT rates were 3.3% and 1.3%, respectively. TLR was significantly higher in the off-label group (4.0% vs. 2.2%, HR 1.8, 95% CI: 1.0-3.4; p=0.05) while a trend towards a higher ScT rate was observed in the off-label group (1.7% vs. 0.6%, HR 2.7, 95% CI: 0.9-8.2; p=0.06). At multivariate analysis, treatment of in-stent restenosis, chronic total occlusion and BVS diameter were independent predictors of TLR. Conclusions Our data from a real-world population suggest that BVS could be associated with acceptable one-year clinical outcomes when meticulously implanted. However, a higher rate of adverse events was observed when this device was used in off-label lesions.

Recurrent respiratory infections (RRI) represent a social problem for both the pharmaco-economic impact and the burden on the family. Thermal water is popularly well accepted. However, there is no scientific evidence of its preventive activity on recurrent respiratory tract infections (RRI). Therefore, the purpose of this study was to evaluate the effects of Agnano thermal water nasal irrigation on RRI prevention in children. A total of 107 children (70 males, mean age 4.5±1.2 years) with RRI were enrolled in the study. At baseline, children were randomly assigned to the treatment with: A) inhaled crenotherapy with salso-sulphide water or B) isotonic saline (NaCl 0.9%). Inhaled therapy was performed using nasal washing by Rino-jet (ASEMA srl, Milan, Italy) b.i.d. for 12 days. Nasal washing lasted 2 minutes per nostril. Immediately before washing, children inhaled 1 l of water by stream inhalation per 2 minutes. Crenotherapy was capable of significantly reducing: the number of respiratory infections, nasal symptoms, neutrophil and bacteria count, turbinate and adenoidal hypertrophy, presence of biofilm, and blockage of ostiomeatal complex (OCM). In conclusion, this study provides the first evidence that Agnano crenotherapy may be capable of preventing RRI in children as it exerts some positive effects, such as reduction of nasal obstruction, OCM blockage, biofilm, and inflammatory events.

To assess the feasibility and the clinical results following a prespecified bioresorbable vascular scaffold (Absorb BVS) implantation strategy in ST-elevation myocardial infarction (STEMI) patients.Concerns raised about the BVS safety in STEMI setting because a not negligible thrombosis rate was reported within 30 days and 12 months after implantation. Technical procedural issues related to the structural BVS features were advocated as probable causes for the thrombotic events.This is an investigators-owned and -directed, prospective, nonrandomized, single-arm multicenter registry intended to obtain data from 500 consecutive STEMI patients undergoing primary PCI with BVS (1.1 or GT1) following a prespecified implantation protocol. The study is recorded in ClinicalTrials.gov with the identifier: NCT02601781.The primary endpoint is a device-oriented composite end-point (DOCE) of cardiac death, any myocardial infarction clearly attributable to the intervention culprit vessel and ischemic-driven target lesion revascularization within 30 days after the index procedure. The DOCE will be assessed even at 6-month, 1-, 3-, and 5-year follow-up.This will be the first study investigating the feasibility and the early- and long-term clinical impact of a prespecified BVS implantation protocol in thrombotic lesions causing STEMI. Here, we describe the rationale and the design of the study. © 2016 Wiley Periodicals, Inc.

Background— Treatment of in-stent restenosis (ISR) is still challenging. In this setting, the use of bioresorbable vascular scaffold (BVS) seems attractive because it allows drug delivery combined with transient vessel scaffolding. We aimed to investigate the long-term results after BVS use in ISR lesions. Methods and Results— A prospective analysis was performed on all patients who underwent percutaneous coronary intervention with BVS implantation for ISR at 7 Italian Centers. Primary end point was the device-oriented composite end point (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) at the longest follow-up available. From April 2012 to June 2014, 116 patients (127 lesions) underwent percutaneous coronary intervention for ISR with BVS implantation. Among the ISR lesions, the majority were drug-eluting stent ISR (78, 61.6%), de novo ISR (92, 72.4%), and diffuse ISR (81, 63.8%). Procedural success was achieved for all (100%) patients. No in-hospital death, myocardial infarction, or revascularization occurred. At 15 months of follow-up, the incidence of the device-oriented composite end point estimated with the Kaplan–Meier method was 9.1%. No significant differences were reported between drug-eluting stent and bare-metal stent ISR groups in terms of device-oriented composite end point (10.9% versus 6.4%; hazard ratio, 1.7; 95% confidence interval, 0.5–6.5; P =0.425) and its singular components (cardiac death: 2.8% versus 2.0%, hazard ratio, 1.3; 95% confidence interval, 0.1–14.1, P =0.843; target vessel myocardial infarction: 1.5% versus 0%, P =0.421; ischemia-driven target lesion revascularization: 9.6% versus 4.4%, hazard ratio, 2.3; 95% confidence interval, 0.5–10.8, P =0.309). Conclusions— Our registry suggests that the use of BVS implantation for the treatment of complex drug-eluting stent and bare-metal stent ISR lesions might be associated with acceptable long-term clinical outcomes.

To cite this article: Capasso M, Varricchio A, Ciprandi G. Impact of allergic rhinitis on asthma in children: effects on bronchodilation test. Allergy 2010; 65: 264–268 DOI: 10.1111/j.1398-9995.2009.02168.x. Abstract Background: Relevant relationship exists between upper and lower airways. Bronchial obstruction is a paramount feature of asthma and its reversibility is considered a diagnostic step for asthma diagnosis. Objective: This study aimed at evaluating a large group of children with allergic rhinitis alone for investigating the degree of brochodilation and possible factors related to it. Methods: Two hundred patients with allergic rhinitis and 150 normal subjects were consecutively evaluated. Clinical examination, skin prick test, spirometry, and bronchodilation test were performed in all patients. Results: Rhinitics showed a significant FEV1 increase after bronchodilation test (P

Objectives The aim of this study was to evaluate the benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) as compared with bare-metal stents (BMS) in patients undergoing primary angioplasty. Background Recent concerns have emerged on the potential higher risk of stent thrombosis after drug-eluting stent implantation, especially among ST-segment elevation myocardial infarction (STEMI) patients. Methods We randomly assigned STEMI patients admitted within 12 h of symptom onset undergoing primary angioplasty and stent implantation to BMS, PES, or SES. The primary study end point was target lesion revascularization at 1-year follow-up. All patients were reviewed at our outpatient clinic or by telephone interview at 6, 12, and 24 months. Results From October 2003 to December 2005, 270 STEMI patients undergoing primary angioplasty were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90). No patient was lost to follow-up. As compared with BMS (14.4%), both PES (4.4%, p = 0.023) and SES (3.3%, p = 0.016) were associated with a significant reduction in target lesion revascularization at 1-year follow-up. At 2-year follow-up no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared with BMS, both PES and SES were associated with significant benefits in major adverse cardiac events (PES: 16.7%, p = 0.015; SES: 15.6%, p = 0.009, respectively). Conclusions This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of target lesion revascularization up to the 2-year follow-up. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered for STEMI patients undergoing primary angioplasty. (PaclitAxel or Sirolimus-Eluting Stent versus Bare Metal Stent in Primary Angioplasty [PASEO] Randomized Trial; NCT00759850)

In this study, we investigated long-term results following bioresorbable vascular scaffold (BVS) implantation in small coronary arteries.Management of small coronary vessel disease with percutaneous coronary interventions (PCI) is often associated with high recurrencies and an increased risk of late or very late adverse events. Currently, little is known about BVS behavior in this setting.A retrospective cohort analysis in a consecutive all-comer population was performed in patients that had a BVS implanted for coronary artery disease (CAD) in vessels with reference diameter2.75 mm. Primary end-point was the occurrence of BVS failure (any event between target lesion revascularization (TLR) and definite/probable thrombosis) at the longest available follow-up. Secondary end-points were device-oriented clinical outcome (DOCE, a composite of cardiac death, target-vessel non-fatal myocardial infarction (MI) and TLR) and its single components at 12-month follow-up.A total of 121 patients (133 lesions) were treated between March 2013 and December 2014 at three high volume Italian centers. From baseline clinical and angiographic characteristics emerges a highly complex patient population. Procedural success was obtained in 120 (99.2%) patients. In-hospital events included one cardiac death. At the longest available clinical follow-up (average 12 ± 6, median 11.4 months, interquartile ranges (IQR) 8, primary end-point occurred in 12 patients (9.0%), including 12 (9.0%) TLR and 2 (1.5%) BVS thrombosis. DOCE occurred in 9.0% of cases. The use of overlapping BVS in this setting did not increase the risk of adverse events.BVS implantation in a highly complex clinical and angiographic setting of small coronary vessels was technically feasible and effective in maintaining vessel patency after 12 months. © 2016 Wiley Periodicals, Inc.

Background The Absorb™ BVS is a bioresorbable, everolimus-eluting scaffold approved and marketed for coronary use. Published data on long-term results after treatment are limited to a small number of patients, most of them with elective PCI of simple lesions. The importance of scaffold resorption is variably appreciated among cardiologists, and indications for use from health technology assessment bodies or guidelines are missing. Instruments are needed to collect, share and assess the experience being accumulated with this new device in several centres. Methods/Design The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists in cooperation with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri" Institute, and is not recipient of funding or benefits originating from the BVS manufacturer. It is a prospective registry with 5-year follow-up of all consecutive patients who have undergone successful implantation of 1 or more coronary BVS following the indications, techniques and protocols used in each of the participating institutions. Outcome measures are BVS target lesion failure within one year and device-oriented major adverse cardiac events within 5years. The registry started in October 2012 and will extend enrolment throughout 2015, with the aim to include about 1000 patients. ClinicalTrials.gov identifier is CT02298413. Conclusions The BVS-RAI Registry will contribute observational knowledge on the long-term safety and efficacy of the Absorb™ BVS as used in a number of Italian interventional centres in a broad spectrum of settings. Unrewarded and undirected consecutive patient enrolments are key-features of this observation, which is therefore likely to reflect common clinical practice in those centres.

Allergic rhinitis (AR) is a very common childhood disease that is associated with a significant reduction in the patients' quality of life. Its treatment combines educating the patients and their parents, immunotherapy and drug administration. However, even the best approach does not relieve the symptoms of a number of patients. Alternative therapies are particularly needed for children because the fear of adverse events frequently reduces parental compliance to the prescribed drugs, and immunotherapy is less easy to administer than in adults. In this prospective investigator-blinded study we evaluated whether children, with a documented history of seasonal grass pollen-related AR, benefit from nasal irrigation by assessing the effects on nasal signs and symptoms, on middle ear effusion and on adenoidal hypertrophy. We randomized children aged 5 to 9 years (median age 82 months) to normal saline or hypertonic saline (a 2.7% sodium chloride solution), administered twice-daily using a disposable 20 ml syringe, or no treatment. Nasal symptoms (rhinorrhea, itching, sneezing, nasal obstruction), swelling of turbinates, adenoid hypertrophy or middle ear effusion were assessed at baseline and after 4 weeks of treatment. Two hundred and twenty children (normal saline: 80; hypertonic saline: 80; no treatment: 60) completed the study. After four weeks, all the considered items were significantly reduced in the group receiving hypertonic saline (P

Diabetes has been shown to be associated with worse survival and repeat revascularization (TVR) after primary angioplasty. Drug-eluting stent (DES) may offer benefits in terms of TVR, that may be counterbalanced by an higher risk of stent thrombosis, especially among STEMI patients. Aim of the current study was to evaluate the impact of diabetes on 5-year outcome in patients undergoing primary angioplasty with glycoprotein IIb-IIIa inhibitors in the era of DES. Our population is represented by STEMI patients undergoing primary angioplasty and stent implantation at a tertiary center with 24-h primary PCI capability within 12 h of symptom onset. All patients received glycoprotein IIb-IIIa inhibitors. No patient was lost to follow up. From 2003 to 2005, 270 STEMI patients were treated with DES (n = 180), or BMS (n = 90). A total of 69 patients had history of diabetes at admission (25.5%). At a follow-up of 1510 +/- 406 days, diabetes was associated with a higher rate of death (29.5 vs. 5.1%, P < 0.0001), reinfarction (24.1 vs. 9.1%, P < 0.0001), TVR (19.1 vs. 13.1%, P = 0.052), IST (17.2 vs. 6.8%, P < 0.001) and MACE (51.9 vs. 25.1%, P < 0.001). These results were confirmed in both patients receiving BMS or DES, except for TVR, where no difference was observed between diabetic and non-diabetic patients. This study shows that among STEMI patients undergoing primary angioplasty with Gp IIb-IIIa inhibitors, diabetes is associated with worse long-term mortality, reinfarction, and IST, even with DES implantation, that, however, were able to equalize the outcome in terms of TVR as compared to non diabetic patients.

Drug-eluting stents may offer benefits in terms of repeat revascularization that may be counterbalanced by a potential higher risk of stent thrombosis, especially among ST-segment elevation myocardial infarction (STEMI) patients. No data have been reported so far on the long-term benefits and safety of drug-eluting stents in STEMI. Thus, the aim of the present study was to evaluate the short- and long-term benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) compared with bare metal stents (BMS) in patients undergoing primary angioplasty.Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary percutaneous coronary intervention capability were randomly assigned to BMS, PES, or SES. All patients received upstream glycoprotein IIb/IIIa inhibitors. The primary end point was target lesion revascularization at the 1-year follow-up. Secondary end points were death and/or reinfarction, in-stent thrombosis, and major adverse cardiac events (combined death and/or reinfarction and/or target lesion revascularization) at long-term follow-up (up to 4 to 6 years). Cumulative incidence of end points was investigated. No patient was lost to follow-up. From October 1, 2003, to December 31, 2005, 270 patients with STEMI were randomized to BMS (n=90), PES (n=90), or SES (n=90). Procedural success was obtained in 93% to 95% of patients. Follow-up data were available for all patients. Compared with BMS (14.4%), both PES (4.4%; hazard ratio, 0.29; 95% confidence interval, 0.095 to 0.89; P=0.023) and SES (3.3%; hazard ratio, 0.21; 95% confidence interval, 0.06 to 0.75; P=0.016) were associated with a significant reduction in target lesion revascularization at the 1-year follow-up (primary study end point). At the long-term follow-up (4.3 years; 25th to 75th percentile, 3.7 to 5 years), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but compared with BMS (22.2%), both PES (6.7%; hazard ratio, 0.27; 95% confidence interval, 0.11 to 0.68; P=0.005) and SES (5.6%; hazard ratio, 0.22; 95% confidence interval, 0.083 to 0.59; P=0.003) were associated with a significant reduction in target lesion revascularization.This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are associated with significant benefits in terms of target lesion revascularization at the long-term follow-up compared with BMS with no excess risk of thrombotic complications. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered among STEMI patients undergoing primary angioplasty.

Background Drug-eluting stent (DES) may offer benefits in terms of repeat revascularization, which may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with STEMI. No data have been reported so far on the long-term benefits and safety of DES in STEMI. The aim of the current study was to evaluate the short- and long-term benefits of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) as compared to bare-metal stent (BMS) in patients undergoing primary angioplasty. Methods Consecutive patients with STEMI admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary percutaneous coronary intervention capability were randomly assigned to BMS, PES, and SES. All patients received upstream glycoprotein IIb-IIIa inhibitors. Primary end point was target-lesion revascularization at 1-year follow-up. Secondary end points were (1) cumulative combined incidence of death and/or reinfarction; (2) cumulative incidence of in-stent thrombosis; and (3) major adverse cardiac events (MACE) (combined death and/or reinfarction and/or target lesion revascularization [TLR]) at long-term follow-up (up to 4 years). No patient was lost to follow-up. Results From October 1, 2003, to December 2005, 270 patients with STEMI were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90). Procedural success was obtained in 93% to 95% of patients. Follow-up data were available for all patients. As compared to BMS (14.4%), both PES (4.4%, hazard ratio [HR] 0.29, 95% CI 0.095-0.89, P = .023) and SES (3.3%, HR 0.21, 95% CI 0.06-0.75, P = .016) were associated with a significant reduction in TLR at 1-year follow-up (primary study end point). At long-term follow-up (1,233 ± 215 days), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared to BMS (21.1%), both PES (6.7%, HR 0.29, 95% CI 0.12-0.73, P = .008) and SES (5.6%, HR 0.24, 95% CI 0.09-0.63, P = .002), respectively, were associated with a significant reduction in TLR. Conclusions This study shows that among patients with STEMI undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of TLR up to 4 years' follow-up, as compared to BMS. Thus, until the results of further large randomized trials with long-term follow-up become available, DES may be considered among patients with STEMI undergoing primary angioplasty.

The aim of the present study was to evaluate the efficacy of the immunostimulating therapy with a new vaccine Ismigen in preventing recurrent infections of the upper respiratory tract in subjects belonging to a community of cloistered nuns. This product is a lysate obtained by mechanical lysis of bacteria (MLBL) usually responsible of respiratory tract infections. A randomized, double-blind, parallel groups, placebo controlled clinical trial was carried out in 47 nuns (age range 25-80 years) living in a cloistered religious community, suffering from recurrent infections of the upper respiratory tract. The 47 patients were allocated by randomization to two groups: Group A--The 24 patients (mean age SD: 48.12 +/- 14.25 years) of this group received one sublingual tablet of MLBL per day, for 10 consecutive days per month for 3 consecutive months (October, November and December 2001). Group B--The 23 patients (mean age +/- SD: 49.04 +/- 14.73 years) of this group received daily one sublingual tablet of taste masked placebo, for 10 consecutive days per month for 3 consecutive months (October, November and December 2001). At the end of the treatment period patients of both groups were followed up for further three months without any immunostimulating treatment.During and at the end of the treatment phase the number of respiratory infections (primary end-point) and their duration were statistically significantly lower in the MLBL group than in the placebo group. Moreover the administration of MLBL induced a marked reduction in the number of patients showing symptoms of infection in comparison to baseline and approximately 79 % of the patients showed an improvement of one or more of the evaluated symptoms. In the MLBL group a statistically significant increase of serum immunoglobulins (IgG +35%; IgM +86%; IgA +80 %) and salivary IgA (+110%) was found, in comparison to baseline; on the contrary no significant differences were observed in the placebo group. The beneficial effects of MLBL found in the treatment period were maintained also in the three-month follow-up. No adverse events associated with the treatment were found in both group. The results of this study demonstrate that MLBL is an efficacious and safe therapeutic option for the treatment and prevention of recurrent upper respiratory tract infections and that its use is recommended in subjects with a possible immune deficit.

A rare case of chondroid chordoma of the lateral skull base with laterocervical extension is reported. Clinical, radiological and pathological features of the tumor are described. This unusual location of chondroid chordoma enabled total resection of the neoplastic tissue through a combined laterocervical and far lateral transjugular approach. Copyright © 2001 S. Karger AG, Basel.

Objectives: The aim of this study was (1) to visualize internal mammary artery grafts (IMAG) on coronary artery by transthoracic echocardiography and (2) to assess the patency of the grafts. Methods: Twenty-three patients (21 men, 56 ± 6 years) with previous coronary artery bypass grafting were studied at baseline and after they underwent low-dose dipyridamole infusion. The parameters obtained were systolic (SPV) and diastolic (DPV) peak velocities and their ratio (DPV/SPV); the dipyridamole infusion to baseline ratio of DPV was an index of IMAG blood flow reserve (FR). Two groups of patients were selected at baseline: group A, (n = 12) with a DPV/SPV >1, and group B (n = 11), with a DPV/SPV Results: The IMAG was identified in all patients. Intraluminal flow signals obtained with pulsed wave Doppler showed a biphasic pattern (1 systolic and 1 diastolic wave). After dipyridamole infusion was administered, flow velocities increased in 11 of 12 patients in group A and in 5 of 11 patients in group B. In group A the DPV/SPV increased from 1.79 ± 0.47 to 1.8 ± 0.43 ( P = not significant), and the FR was 1.8 ± 0.4. In group B the DPV/SPV increased from 0.46 ± 0.05 to 0.5 ± 0.09 ( P = not significant), and the FR was 1.3 ± 0.41. Coronary angiography showed the graft patency in all patients in group A and in 5 patients in group B with increased flow velocity after dipyridamole infusion. In the identification of graft stenosis at baseline, DPV/SPV showed 100% sensibility and 58% specificity, and FR showed 92% sensibility and 84% specificity. Conclusion: Doppler echocardiographic evaluation of the IMAG is a simple noninvasive method to assess the functional impairment of the vessel. (J Am Soc Echocardiogr 1999;12:841-9.)

Antibiotic abuse for treating rhinopharyngitis induces the occurrence of resistant bacteria. As topical drugs might reduce this phenomenon, the aims of our study were to evaluate inhaled tobramycin in children with acute bacterial rhinopharyngitis and to compare it with oral amoxicillin/clavulanate. The trial was conducted as randomized, parallel group and double blind. Children, aged 3–6 years, with acute bacterial rhinopharyngitis were treated with 15 mg of aerosolized tobramycin (Group A) or 50 mg/Kg of amoxicillin/clavulanate (Group B) twice daily for 10 days. The following parameters were assessed: nasal obstruction, mucopurulent rhinorrhea, post-nasal drip, adenoidal hypertrophy, tympanic inflammation, tympanogramm, rhinomanometry and cultures. Of 416 patients screened, 311 children (178 females and 133 males), median age 4.5 years, completed the study: 156 in Group A and 155 in Group B. Both treatments improved all parameters (p