Transcatheter aortic valve implantation with the novel-generation Navitor device: Procedural and early outcomes.

Transcatheter aortic valve implantation (TAVI) has proved beneficial in patients with severe aortic stenosis, especially when second-generation devices are used. We aimed at reporting our experience with Navitor, a third-generation device characterized by intrannular, large cell, and cuffed design, as well as high deliverability and minimization of paravalvular leak. Between June and December 2021, a total of 39 patients underwent TAVI with Navitor, representing 20% of all TAVI cases. Mean age was 80.0 ± 6.7 years, and 14 (36.8%) women were included. Severe aortic stenosis was the most common indication to TAVI (37 [97.4%] cases), whereas 2 (5.3%) individuals were at low surgical risk. Device and procedural success was obtained in all patients, with a total hospital stay of 6.6 ± 4.5 days. One (2.9%) patient required permanent pacemaker implantation, but no other hospital events occurred. At 1-month follow-up, a cardiac death was adjudicated in an 87-year-old man who had been at high surgical risk. Echocardiographic follow-up showed no case of moderate or severe aortic regurgitation, with mild regurgitation in 18 (47%), and none or trace regurgitation in 20 (53%). The Navitor device, thanks to its unique features, is a very promising technology suitable to further expand indications and risk-benefit profile of TAVI.

Glycoprotein IIb/IIIa Inhibitors May Modulate the Clinical Benefit of Radial Access as Compared to Femoral Access in Primary Percutaneous Coronary Intervention: A Meta-Regression and Meta-Analysis of Randomized Trials.

OBJECTIVES: Several randomized controlled trials (RCTs) consistently reported better clinical outcomes with radial as compared to femoral access for primary percutaneous coronary intervention (PCI). Nevertheless, heterogeneous use of potent antiplatelet drugs, such as Gp IIb/IIIa inhibitors (GPI), across different studies could have biased the results in favor of radial access. We performed an updated meta-analysis and meta-regression of RCTs in order to appraise whether the use of GPI had an impact on pooled estimates of clinical outcomes according to vascular access. METHODS: We computed pooled estimates by the random-effects model for the following outcomes: mortality, major adverse cardiovascular events (death, myocardial infarction, stroke, and target vessel revascularization), and major bleedings. Additionally, we performed meta-regression analysis to investigate the impact of GPI use on pooled estimates of clinical outcomes. RESULTS: We analyzed 14 randomized controlled trials and 11090 patients who were treated by radial (5497) and femoral access (5593), respectively. Radial access was associated with better outcomes for mortality (risk difference 0.01 (0.00, 0.01), p=0.03), MACE (risk difference 0.01 (0.00, 0.02), p=0.003), and major bleedings (risk difference 0.01 (0.00, 0.02), p=0.02). At meta-regression, we observed a significant correlation of mortality with both GPI use (p=0.011) and year of publication (p=0.0073), whereas no correlation was observed with major bleedings. CONCLUSIONS: In this meta-analysis, the use of radial access for primary PCI was associated with better clinical outcomes as compared to femoral access. However, the effect size on mortality was modulated by GPI rate, with greater benefit of radial access in studies with larger use of these drugs.

Factors associated with suicide: Case-control study in South Tyrol.

BACKGROUND: As suicide is related to many factors in addition to psychiatric illness, broad and comprehensive risk-assessment for risk of suicide is required. This study aimed to differentiate nondiagnostic risk factors among suicides versus comparable psychiatric patients without suicidal behavior. METHODS: We carried out a pilot, case-control comparison of 131 cases of suicide in South Tyrol matched for age and sex with 131 psychiatric controls, using psychological autopsy methods to evaluate differences in clinically assessed demographic, social, and clinical factors, using bivariate conditional Odds Risk comparisons followed by conditional regression modeling controlled for ethnicity. RESULTS: Based on multivariable conditional regression modeling, suicides were significantly more likely to have experienced risk factors, ranking as: [a] family history of suicide or attempt≥[b] recent interpersonal stressors≥[c] childhood traumatic events≥[d] lack of recent clinician contacts≥[e] previous suicide attempt≥[f] non-Italian ethnicity, but did not differ in education, marital status, living situation, or employment, nor by psychiatric or substance-abuse diagnoses. CONCLUSIONS: Both recent and early factors were associated with suicide, including lack of recent clinical care, non-Italian cultural subgroup-membership, familial suicidal behavior, and recent interpersonal distress.

Transfemoral approach with systematic use of FemoSeal™ closure device compared to transradial approach in primary angioplasty.

OBJECTIVES: To compare the incidence of major adverse cardiac and cerebrovascular events (MACCE) and thrombolysis in myocardial infarction (TIMI) bleedings in primary percutaneous coronary intervention (pPCI) performed through transradial approach (TRA) or transfemoral approach (TFA) with systematic closure by FemoSeal™. BACKGROUND: Although the risk of bleeding can be reduced using vascular closure devices (VCD), there are few data comparing TRA and TFA with VCD, particularly in the setting of pPCI. METHODS: we included in this retrospective registry 777 patients who underwent pPCI at two centers from years 2010 to 2013. Exclusion criteria were implantation of intra-aortic balloon pump and achievement of femoral hemostasis by other means than FemoSeal™. We performed propensity-score matching and multivariate analysis to adjust for clinical and procedural confounders. RESULTS: We enrolled 511 patients in TRA group and 266 in TFA group. Both in the general population and in the propensity-matched population, the incidence of MACCE was comparable in TRA vs. TFA patients (3.5 vs. 3.4% and 4.4 vs. 2.6%, respectively; P = ns). On the contrary, we observed a higher incidence of TIMI bleedings in TFA vs. TRA patients (5.6 vs. 2.2% in the general population and 6.6 vs. 1.3% in the propensity-matched population; P < 0.05); this difference was mainly driven by TIMI major bleedings. TFA was an independent predictor of bleeding at multivariate analysis. CONCLUSIONS: In pPCI the rate of TIMI major bleedings was higher in TFA with closure by FemoSeal™ as compared to TRA, whereas the rates of minor bleedings and of MACCE were similar.

Future of left atrial appendage interventions.

Percutaneous left atrial appendage occlusion (LAAO), currently recognized as a procedure with relatively low risk, is increasingly being adopted in clinical practice. However, due to the preventive nature of the procedure and the necessity to compare it with newer and safer oral anticoagulants, further optimization is required to address remaining challenges. These latter include acquiring comprehensive data on safety and efficacy, establishing standardized pre-procedural planning, and simplifying procedural process. Consequently, we have provided an overview that encompasses future opportunities for enhancing procedural safety and efficacy, thereby establishing LAAO as the mainstream strategy for stroke and systemic embolism prevention in patients with atrial fibrillation and absolute contraindications to anticoagulant drugs.

Acute Kidney Injury in Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention: The Role of Vascular Access Site.

Background: in patients undergoing percutaneous coronary interventions (PCI), radial access should be favoured over femoral access as it reduces the risk of vascular complications and bleeding. Furthermore, a preventive role of radial access in the occurrence of acute kidney injury (AKI), mainly mediated by the reduction of bleeding and cholesterol crystal embolization into renal circulation, has been investigated in several studies, yielding conflicting results. Methods: we designed a retrospective study to appraise the effect of the use of a vascular access site on the occurrence of AKI in a cohort of 633 patients with acute myocardial infarction treated by PCI at our centre from 2018 to 2020. Results: after propensity score adjustment, radial access was associated with a reduced, albeit statistically not significant, incidence of AKI (14.7% vs. 21.0%; p = 0.06) and major bleeding (12.5% vs. 18.7%; p = 0.04) as compared to femoral access. At multivariate analysis, femoral access was an independent predictor of AKI, together with in-hospital occurrence of BARC 3-5 bleeding, Killip class >1 at presentation, female gender, baseline eGFR <60 mL/min, and baseline haemoglobin <12 g/dL. Conclusions: although limited by the observational design, our study supports the hypothesis that radial access may exert a protective role on the occurrence of AKI in patients with acute myocardial infarction undergoing PCI.

In-hospital outcomes of Portico transcatheter aortic valve replacement with the FlexNav as compared to the first-generation delivery system.

Introduction: Technological advancements in transcatheter heart valve platforms are essential in order to achieve high standards of efficacy and safety in transcatheter aortic valve replacement (TAVR). Aim: To evaluate the performance of the new version of the Portico valve delivery system (FlexNav) as compared to the first-generation device. Material and methods: In this single-center, observational study consecutive patients undergoing Portico valve implantation with the new FlexNav delivery system (DS) were compared with patients treated with the first-generation delivery system (1st gen DS). In-hospital outcomes were self-adjudicated according to the Valve Academic Research Consortium-3 definition. Results: Fifty patients were included in this study; 22 were treated with the FlexNav DS and the remaining patients with the 1st gen DS. Clinical characteristics were similar between groups, except for older age (82.6 ±3.6 vs. 80.7 ±3.8; p = 0.07) and higher prevalence of female gender (68.2% vs. 39.3%; p = 0.04) in the FlexNav DS group as compared to the 1st gen DS group, respectively. We observed similar rates of procedural success but higher rate of moderate-to-severe paravalvular leak in the 1st gen DS as compared to FlexNav DS group (28.6% vs. 4.6%; p = 0.03); major vascular complications were reduced, although not significantly, in the FlexNav DS as compared to the 1st gen DS group (4.5% vs. 10.7%; p = 0.64). Conclusions: Our data suggest that the FlexNav DS, thanks to its lower profile and enhanced stability during valve deployment, might be associated with reduced rates of vascular complications and moderate to severe paravalvular leak, thus improving procedural results.

Blood Pressure Levels at the Time of Percutaneous Coronary Revascularization and Risk of Coronary In-Stent Restenosis.

BACKGROUND: High blood pressure (BP) levels expose patients treated with percutaneous coronary interventions (PCI) to very high risk of 10-year cardiovascular morbidity and mortality. OBJECTIVE: To investigate the role of BP levels at the time of PCI on the risk of in-stent restenosis (ISR). METHODS: We retrospectively included 796 patients previously treated with PCI, who underwent repeated angiography for recurrent angina or reversible myocardial ischemia. Patients were stratified into either case (n = 354) and control (n = 442) groups in the presence or absence of ISR (defined as in-stent diameter stenosis ≥50%). BP levels were measured at the time of first and second procedures. Normal BP levels were defined for <140/90 mm Hg. RESULTS: Patients with normal BP showed significantly higher ISR-free survival (Log-rank: 5.937; P = 0.015). Both systolic (HR (95% CI): 0.731 (0.590-0.906)) and systolic/diastolic BP (HR (95% CI): 0.757 (0.611-0.939)) were significantly and independently associated with lower risk of ISR at Cox-regression analysis, adjusted for potential confounding factors, including stent type and concomitant medications. Patients with ISR showed lower rates of normal systolic/diastolic BP values (166 (47%) vs. 254 (57%); P = 0.003) compared to controls. They also received higher stent number (1.40±0.74 vs. 1.24±0.51; P < 0.001) with higher stent length (24.3±15.6 vs. 21.7±13.9 mm; P = 0.012), and lower rate of drug-eluting stents (DESs) (210 (48%) vs. 139 (40%); P = 0.025) compared to controls. CONCLUSIONS: Normal BP at the time of PCI is associated with nearly 24% risk reduction of ISR as evaluated in a new angiography in patients with coronary artery disease.

Comparison of risk of acute kidney injury after primary percutaneous coronary interventions with the transradial approach versus the transfemoral approach (from the PRIPITENA urban registry).

The risk of acute kidney injury (AKI) is a major issue after percutaneous coronary interventions (PCIs), especially in the setting of ST-elevation myocardial infarction. Preliminary data from large retrospective registries seem to show a reduction of AKI when a transradial (TR) approach for PCI is adopted. Little is known about the relation between vascular access and AKI after emergent PCI. We here report the results of the Primary PCI from Tevere to Navigli (PRIPITENA), a retrospective database of primary PCI performed at high-volume centers in the urban areas of Rome and Milan. Primary end point of this study was the occurrence of AKI in the TR and transfemoral (TF) access site groups. Secondary end points were major adverse cardiovascular events, stent thrombosis, and Thrombolysis in Myocardial Infarction major and minor bleedings. The database included 1,330 patients, 836 treated with a TR and 494 with a TF approach. After a propensity-matched analysis performed to exclude possible confounders, we identified 450 matched patients (225 TR and 225 TF). The incidence of AKI in the 2 matched groups was lower in patients treated with TR primary PCI (8.4% vs 16.9%, p = 0.007). Major adverse cardiovascular events and stent thrombosis were not different among study groups, whereas major bleedings were more often seen in the TF group. At multivariate analysis, femoral access was an independent predictor of AKI (odds ratio 1.654, 95% confidence interval 1.084 to 2.524, p = 0.042). In conclusion, in this database of primary PCI, the risk of AKI was lower with a TR approach, and the TF approach was an independent predictor for the occurrence of this complication.

Pulmonary Rehabilitation in COPD: A Reappraisal (2008-2012).

Chronic Obstructive Pulmonary Disease (COPD) is a complex pathological condition associated with an important reduction in physical activity and psychological problems that contribute to the patient's disability and poor health-related quality of life. Pulmonary rehabilitation is aimed to eliminate or at least attenuate these difficulties, mainly by promoting muscular reconditioning. The scope of this paper has been the analysis of the literature on pulmonary rehabilitation in COPD patients has appeared in the last five years, focusing on the principal outcomes obtained. The results demonstrate that pulmonary rehabilitation has a beneficial effect on dyspnoea relief, improving muscle strength and endurance. Moreover, pulmonary rehabilitation appears to be a highly effective and safe treatment for reducing hospital admissions mortality and improving health-related quality of life in COPD patients. It represents, therefore, a very important therapeutic option that, along with standard pharmachological therapy, can be used to obtain the best patient management. The favourable results obtained with pulmonary rehabilitation programs should stimulate researchers to improve our understanding of the mechanisms that form the basis of the beneficial effects of this therapeutic intervention. This would in turn increase the effectiveness of pulmonary rehabilitation in COPD patients.

Budesonide/formoterol dry powder in asthma: an option for control as maintenance and reliever therapy.

IMPORTANCE OF THE FIELD: Asthma is a heterogeneous disease with various components that may contribute to symptoms. Obtaining global control of is one of the fundamental parts of the management of this disease. AREAS COVERED IN THIS REVIEW: The Cochrane trial database, Medline and Embase, were searched systematically, and approximately 20 respiratory journals and conference abstracts were searched manually. The search was limited to publications in English language of last 20 years and which included the keywords 'budesonide', 'formoterol', 'asthma' and 'control'. WHAT THE READER WILL GAIN: The purposes of this review are: i) to discuss the rationale about possibility of using combination therapy administered with a single inhaler for both daily maintenance and relief as needed of breakthrough symptoms in asthma management; ii) to give readers the current status of clinical pharmacological treatment of asthma; iii) to discuss the evidence on the use of budesonide/formoterol dry powder in one inhaler. TAKE HOME MESSAGE: Among the various inhalatory drugs, budesonide and formoterol can be conveniently delivered in one dry powder inhaler and simplify treatment by providing immediate step-up when symptoms increase. Alongside the anti-inflammatory component, formoterol provides both short- and long-acting bronchodilator effects with maintenance and reliever properties. The option of using one inhaler simplifies treatment by simultaneously providing bronchodilator and anti-inflammatory activity, thus enhancing compliance. As indicated in guidelines, all these characteristics are essential for optimizing asthma treatment and control.

Close correlation between anxiety, depression, and asthma control.

BACKGROUND: We investigated the correlation between patients' characteristics, including anxiety and depression, and the level of asthma control evaluated by asthma control test (ACT), a self-administered validated questionnaire. METHODS: This is a cross-sectional study on asthmatic outpatients of three Italian hospitals. Demographic data, spirometry, anxiety and depression scores as well as the level of asthma control from 315 patients were collected. RESULTS: Patients with poorly controlled asthma were more frequently women, older, with a worse pulmonary function, obese, more anxious and/or more depressed. Four different independent factors associated with poor asthma control evaluated by ACT have been found: FEV(1)<60% (odds ratio, OR: 6.52), anxiety (OR: 3.76), age > or =65 years (OR: 2.69), and depression (OR: 2.45). The presence of anxiety and depression was associated with a higher healthcare utilization. Finally, we found a high level of agreement between ACT and multidimensional GINA approach in evaluating asthma control, with a concordance in 239 patients (81% of the population). CONCLUSION: There is a close correlation between anxiety and depression, and a poor asthma. A better understanding of this association may have major clinical implications, mainly in patients with poor controlled asthma in whom the presence of anxiety and depression should be investigated.