Review on Remote Magnetic Navigation in Congenital Heart Disease
In patients with congenital heart disease, challenges to catheter‐based arrhythmia interventions are unique and numerous given the ...complexity of the underlying defects, anatomic and surgical intervention variants including baffles, conduits, patches, and/or shunts. Remote magnetic navigation offers significant advantages in these cases that may present with limited vascular access or difficult access to the target cardiac chambers implicated by the previous surgical interventions. We reviewed the data available on the safety, feasibility, and effectiveness of magnetic navigation for the treatment of arrhythmia in congenital heart disease and discussed the specific challenges related to various congenital defects and repair with the potential advantages offered by magnetic navigation in these circumstances.
Summary Background Dolutegravir (S/GSK1349572) is a once-daily HIV integrase inhibitor with potent antiviral activity and a favourable safety profile. We compared dolutegravir with HIV integrase ...inhibitor raltegravir, as initial treatment for adults with HIV-1. Methods SPRING-2 is a 96 week, phase 3, randomised, double-blind, active-controlled, non-inferiority study that began on Oct 19, 2010, at 100 sites in Canada, USA, Australia, and Europe. Treatment-naive adults (aged ≥18 years) with HIV-1 infection and HIV-1 RNA concentrations of 1000 copies per mL or greater were randomly assigned (1:1) via a computer-generated randomisation sequence to receive either dolutegravir (50 mg once daily) or raltegravir (400 mg twice daily). Study drugs were given with coformulated tenofovir/emtricitabine or abacavir/lamivudine. Randomisation was stratified by screening HIV-1 RNA (≤100 000 copies per mL or >100 000 copies per mL) and nucleoside reverse transcriptase inhibitor backbone. Investigators were not masked to HIV-1 RNA results before randomisation. The primary endpoint was the proportion of participants with HIV-1 RNA less than 50 copies per mL at 48 weeks, with a 10% non-inferiority margin. Main secondary endpoints were changes from baseline in CD4 cell counts, incidence and severity of adverse events, changes in laboratory parameters, and genotypic or phenotypic evidence of resistance. Our primary analysis was by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT01227824. Findings 411 patients were randomly allocated to receive dolutegravir and 411 to receive raltegravir and received at least one dose of study drug. At 48 weeks, 361 (88%) patients in the dolutegravir group achieved an HIV-1 RNA value of less than 50 copies per mL compared with 351 (85%) in the raltegravir group (adjusted difference 2·5%; 95% CI −2·2 to 7·1). Adverse events were similar between treatment groups. The most common events were nausea (59 14% patients in the dolutegravir group vs 53 13% in the raltegravir group), headache (51 12% vs 48 12%), nasopharyngitis (46 11% vs 48 12%), and diarrhoea (47 11% in each group). Few patients had drug-related serious adverse events (three <1% vs five 1%), and few had adverse events leading to discontinuation (ten 2% vs seven 2% in each group). CD4 cell counts increased from baseline to week 48 in both treatment groups by a median of 230 cells per μL. Rates of graded laboratory toxic effects were similar. We noted no evidence of treatment-emergent resistance in patients with virological failure on dolutegravir, whereas of the patients with virologic failure who received raltegravir, one (6%) had integrase treatment-emergent resistance and four (21%) had nucleoside reverse transcriptase inhibitors treatment-emergent resistance. Interpretation The non-inferior efficacy and similar safety profile of dolutegravir compared with raltegravir means that if approved, combination treatment with once-daily dolutegravir and fixed-dose nucleoside reverse transcriptase inhibitors would be an effective new option for treatment of HIV-1 in treatment-naive patients. Funding ViiV Healthcare.
Challenges with adherence to daily oral antiretroviral therapy (ART) among people living with HIV (PLHIV) have stimulated development of injectable long-acting (LA) regimens. We conducted 39 in-depth ...interviews with participants and providers in a Phase IIb study (LATTE-2) evaluating an injectable LA regimen in the U.S. and Spain. Interviews exploring participant and provider attitudes and experiences with LA versus oral ART were audiotaped, transcribed and analyzed using thematic content analysis. Participants described the convenience of LA injections versus daily pills and emotional benefits such as minimized potential for HIV disclosure and eliminating the "daily reminder of living with HIV." Providers recognized benefits but cautioned that LA candidates still need to adhere to clinic visits for injections and raised questions around ongoing clinical management. LA was seen as preferable to daily oral ART among PLHIV. Further research is needed regarding appropriate candidates, including with women and "non-adherent" populations across settings.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
LA Sphericity and Stroke Prediction
Background
Left atrial (LA) sphericity (LASP) is a new remodeling parameter based on LA shape analysis, with independent predictive value for recurrence after ...atrial fibrillation (AF) ablation.
Objectives
To evaluate the association between LASP and thromboembolic events (TE) in patients with AF.
Methods
Twenty‐nine AF patients and prior TE and 29 age‐ and gender‐matched controls were included. LASP was calculated using a 3D‐LA reconstruction. The LA appendage (LAA) volume and morphology were assessed. ROC curve analysis was performed for LASP, LA volume, LAA volume, and CHAD/CHA2D–VASc scores (Stroke2—the grouping variable—was excluded).
Results
Mean age of the study population was 61 ± 11 years (79.3% males, 53.4% hypertension, 8.6% diabetes). Patients with prior TE had higher LASP than those without (82.5 ± 3.3% vs. 80.2 ± 3.1%, P = 0.008); there were no differences in CHAD or CHA2D–VASc scores, LA volume, LAA volume, or LAA morphology. The C‐statistic was higher for LASP (0.71) than for other tested variables (CHAD score = 0.58, CHA2D–VASc score = 0.59, LA volume = 0.50, LAA volume = 0.46; P < 0.01 for all vs. LASP). The best cutoff value for LASP was 83.6% (sensitivity 0.52, specificity 0.90). Logistic regression analysis showed predictive value for LASP (OR 1.26 per each 1% increase 1.85–52.20, P = 0.013), but not for clinical risk scores. The addition of LASP to the CHAD and CHA2D–VASc scores increased the predictive value over the risk scores alone (P = 0.004), and reclassified 45.5% of patients with CHAD = 0 (no anticoagulation indicated) to moderate‐risk (anticoagulation indicated).
Conclusion
LA sphericity is associated with prior TE in AF patients and improves the performance of the CHAD and CHA2D–VASc scores alone.
We aim to investigate the infection rate, the clinical characteristics and outcomes of COVID-19-disease in a cohort of people living with HIV in Madrid (Spain), during the first year of pandemics.
...Observational single-center study, in which we included all HIV-infected patients (aged ≥ 18 years) with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as of February 28, 2021, at the Hospital Universitario 12 de Octubre.
Confirmed disease was defined as any patient with a positive antigen test, reverse transcriptase polymerase chain reaction, or serology for SARS-CoV-2. We compared the characteristics of patients with mild disease (asymptomatic included) with those with moderate or severe disease (requiring admission).
Of 2344 HIV-infected patients, 158 (82.9% male; median age, 46.5 years) were diagnosed with SARS-CoV-2 (infection rate, 6.74%; 95% confidence interval, 5.79 to 7.83). Thirty-nine individuals (24.7%) had moderate or severe disease, 43.7% had mild disease, and 31.6% were asymptomatic. Hypertension (23.4%) and obesity (15.8%) were the most prevalent comorbidities; 12.7% had at least 2 comorbidities. One hundred forty-five patients (97.3%) had RNA-HIV viral load of <50 copies per milliliter, and only 3 had CD4 cell count of <200 cells per cubic millimeter before infection. Of those admitted to hospital, 59% required oxygen support and 15.4%, invasive mechanical ventilation. Five patients died. None of the patient taking tenofovir-disoproxil-fumarate required admission. In the multivariate analysis, age remained as the only independent factor for moderate-severe disease (odds ratio, 1.09; 95% confidence interval 1.04 to 1.14; P < 0.001).
People living with HIV are at risk of severe SARS-CoV-2 infection. Age was the only variable with an independent association with moderate-severe disease, after adjusting by comorbidities and other factors.
The main international guidelines indicate DTG/3TC therapy as one of the preferred regimens for people living with HIV (PLWH), due to its observed efficacy in randomized clinical trials. However, ...information in real-life cohorts is relatively scarce for first-line use.
A retrospective multicenter study of adult PLWH starting DTG+3TC as a first-line regimen before January 31st, 2020. Virological failure (VF) was defined as 2 consecutive HIV RNA viral load (VL) >50 copies/mL.
135 participants were included. Treatment was started without knowing baseline drug resistance testing (bDRT) results in 71.9% of cases, with baseline resistance mutations being later confirmed in 17 patients (12.6%), two of them with presence of M184V mutation. Effectiveness at week 48 was 85.2% (CI95%: 78.1-90.7%) (ITT missing = failure M = F) and 96.6% (CI 95%: 91.6-99.1%) (per-protocol analysis). Six patients (4.4%) discontinued treatment. One developed not confirmed VF after discontinuing treatment due to poor adherence; no resistance-associated mutations emerged. Three discontinued treatments due to central nervous system side effects (2.2%), and two due to a medical decision after determining the M184V mutation in bDRT. Finally, 14 (10.4%) were lost to follow-up, most of them due to the COVID-19 pandemic.
In a real-life multicenter cohort of ART-naïve PLWH, treatment initiation with DTG + 3TC showed high effectiveness and favorable safety results, comparable to those of randomized clinical trials, without treatment-emergent resistance being observed through week 48. Starting treatment before receiving the results of baseline drug resistance testing did not have an impact on the regimen's effectiveness.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The unparalleled success of combination antiretroviral therapy (cART) is based on the combination of three drugs from two classes. There is insufficient evidence whether simplification to ritonavir ...boosted protease inhibitor (PI/r) monotherapy in virologically suppressed HIV-infected patients is effective and safe to reduce cART side effects and costs.
We systematically searched Medline, Embase, the Cochrane Library, conference proceedings and trial registries to identify all randomised controlled trials comparing PI/r monotherapy to cART in suppressed patients. We calculated in an intention to treat (loss-of follow-up, discontinuation of assigned drugs equals failure) and per-protocol analysis (exclusion of protocol violators following randomisation) and based on three different definitions for virological failure pooled risk ratios for remaining virologically suppressed.
We identified 10 trials comparing 3 different PIs with cART based on a PI/r plus 2 reverse transcriptase inhibitors in 1189 patients. With the most conservative approach (viral load <50 copies/ml on two consecutive measurements), the risk ratios for viral suppression at 48 weeks of PI/r monotherapy compared to cART were in the ITT analysis 0.94 8 (95% CI 0.89 to 1.00) p = 0.06; risk difference -0.06 (95%CI -0.11 to 0) p = 0.05, p for heterogeneity = 0.08, I(2) = 43.1%) and in the PP analysis 0.93 ((95%CI 0.90 to 0.97) p<0.001; risk difference -0.07 (95%CI -0.10 to -0.03) p<0.001, p for heterogeneity = 0.44, I(2) = 0%). Reintroduction of cART in 44 patients with virological failure led in 93% to de-novo viral suppression.
Virologically well suppressed HIV-infected patients have a lower chance to maintain viral suppression when switching from cART to PI/r monotherapy. Failing patients achieve high rates of de-novo viral suppression following reintroduction of reverse transcriptase inhibitors.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Background
The impact of contact force (CF) monitoring in pulmonary vein (PV) isolation after a circumferential anatomic ablation (CAA) is unknown. We analyze the usefulness of CF monitoring in acute ...PV isolation and procedure parameters using a CAA.
Methods
Fifty patients with paroxysmal atrial fibrillation were randomized into CF‐on (CF >10 grams; n = 25) or CF‐off (CF blinded; n = 25) groups. We performed a first round of CAA with a ThermoCool® SmartTouch® catheter blinded to the LASSO® catheter (Biosense Webster, Diamond Bar, CA, USA), with radiofrequency (RF) lesions tagged with the VisiTag™ Module. After the CAA, each PV was reviewed with the LASSO® catheter recording the segments with gaps.
Results
All the PVs were isolated with a CAA in 20 patients of the CF‐on versus eight of the CF‐off (P = 0.001). Of the 45 segments with gaps in the left PVs, 38 were from the CF‐off (P = 0.0001). Of the eight segments with gaps in the right PVs, seven were from the CF‐off (P = 0.06). The CF in the left PVs was higher in the CF‐on (16.3 ± 3.2 grams vs 10.5 ± 4.3 grams; P = 0.0001) and similar in the right PVs (17.6 ± 3.6 grams vs 15.2 ± 5.3 grams; P = 0.08). All of the gaps were closed with additional RF LASSO®‐guided touch‐up. Procedure and fluoroscopy times were shorter in the CF‐on (139 ± 24 minutes vs 157 ± 32 minutes and 20 ± 6 minutes vs 24 ± 7 minutes; both P = 0.039). At 12 months the AF recurrence was 84% CF‐on versus 75% CF‐off (log‐rank P = 0.4).
Conclusions
In paroxysmal atrial fibrillation, a CAA guided by CF reduces PV gaps and shortens the procedure parameters at the expense of the left PVs.
Este trabajo tiene como objetivo fundamental analizar los predictores de felicidad e inteligencia emocional, considerando edad, género, cultura y estatus, así como contemplar las relaciones entre las ...variables. Se contó con 811 participantes, de los cuales el 71.6% fueron musulmanes y el 28.4% cristianos, siendo el 46.1% varones y el 53.9% mujeres. Como instrumentos se han empleado un cuestionario para evaluar la felicidad y otro para valorar la inteligencia emocional. Los resultados reflejan que los predictores de la felicidad fueron edad, cultura, estatus y género, mientras que los de inteligencia emocional fueron edad, cultura y género. Se halló una relación estadísticamente significativa y directamente proporcional entre felicidad e inteligencia emocional.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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