Abstract We report the case of a 56-year-old male with ischemic cardiomyopathy, severe left ventricular dysfunction and right bundle branch block (RBBB) with a wide QRS duration (180 ms) who received ...dual-chamber implantable cardioverter–defibrillator for primary prevention of sudden death. After having placed the right ventricular lead in the middle of the inter-ventricular septum, a significant narrowing of QRS duration was observed, thus obtaining “ de facto ” a cardiac resynchronization therapy (CRT). This type of cardiac pacing could be an alternative to conventional CRT with left ventricular pacing in patients with wide QRS due to RBBB. The long-term effects of this RV only pacing strategy with ICD in patients with heart failure yet remain to be determined.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Objectives
The aim of this study was to assess the incidence of being overweight and metabolic syndrome (MS) among people living with HIV (PHIV) in three different cross‐sectional studies conducted ...over three different periods: 2005, 2011 and 2015.
Methods
This was a multi‐centre, nationwide study. Data were collected in three studies from the CISAI group – SIMOne, HIV‐HY and STOPSHIV – and included a total of 3014 PHIV.
Logistic regression odds ratio (OR), 95% confidence interval (CI) was used to account for age and gender difference among three groups when comparing MS prevalence and being overweight; potential confounders were accounted for by including them in the regression equation.
Results
Overall, the mean age was 46.9 ± 10.2 years, and men comprised 73.3% of participants. Comparing 2005, 2011 and 2015, MS was present in 34.5%, 33.0% and 29.3% of PHIV, respectively. Adjusted OR for MS was 0.64 (95% CI: 0.52–0.78) in 2011 and 0.56 (95% CI: 0.46–0.69) in 2015 compared with 2005, while BMI (kg/m2) increased from 23.6 in 2005, 24.5 in 2011 and 24.5 in 2015, with a concomitant increase of being overweight from 29.4% to 39.5% to 39.6% (p < 0.0001).
Conclusions
In recent years, PHIV have had a significantly improved metabolic profile compared with previously, despite increasing weight and BMI.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, SIK, UILJ, UKNU, UL, UM, UPUK
Cetuximab plus chemotherapy is a first-line treatment option in metastatic KRAS and NRAS wild-type colorectal cancer (CRC) patients. No data are currently available on continuing anti-epidermal ...growth factor receptor (EGFR) therapy beyond progression.
We did this open-label, 1:1 randomized phase II trial at 25 hospitals in Italy to evaluate the efficacy of cetuximab plus 5-fluorouracil, folinic acid and oxaliplatin (FOLFOX) as second-line treatment of KRAS exon 2 wild-type metastatic CRC patients treated in first line with 5-fluorouracil, folinic acid and irinotecan (FOLFIRI) plus cetuximab. Patients received FOLFOX plus cetuximab (arm A) or FOLFOX (arm B). Primary end point was progression-free survival (PFS). Tumour tissues were assessed by next-generation sequencing (NGS). This report is the final analysis.
Between 1 February 2010 and 28 September 2014, 153 patients were randomized (74 in arm A and 79 in arm B). Median PFS was 6.4 95% confidence interval (CI) 4.7–8.0 versus 4.5 months (95% CI 3.3–5.7); hazard ratio (HR), 0.81; 95% CI 0.58–1.12; P = 0.19, respectively. NGS was performed in 117/153 (76.5%) cases; 66/117 patients (34 in arm A and 32 in arm B) had KRAS, NRAS, BRAF and PIK3CA wild-type tumours. For these patients, PFS was longer in the FOLFOX plus cetuximab arm median 6.9 (95% CI 5.5–8.2) versus 5.3 months (95% CI 3.7–6.9); HR, 0.56 (95% CI 0.33–0.94); P = 0.025. There was a trend in better overall survival: median 23.7 (95% CI 19.4–28.0) versus 19.8 months (95% CI 14.9–24.7); HR, 0.57 (95% CI 0.32–1.02); P = 0.056.
Continuing cetuximab treatment in combination with chemotherapy is of potential therapeutic efficacy in molecularly selected patients and should be validated in randomized phase III trials.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Rilpivirine is associated with a good efficacy and safety profile. However, data from real-life settings are scarce.
We investigated the durability, safety and efficacy of Rilpivirine-based ...antiretroviral therapy in a prospective, observational, multicenter study.
We enrolled 499 HIV-infected patients, 360 (72.1%) males, mean age 43.4 ± 10.5 years, mean CD4 600 ± 327 cell/μL, mean HIV-RNA 3.80 ± 1.15 log
cp/mL. After a median follow up of 16 months, 81 (16.2%) interruptions were reported, 36 (7.2%) of which for adverse events (16 of grade ≥3), most commonly neurological and gastrointestinal. We observed virological failures in only 8 (1.6%) patients. Naive patients showed a significant reduction in eGFR at week 24, 48 and 72 and in total cholesterol (TC)/HDL ratio at week 48 (
=0.007). In patients switching from PI we found a significant decrease at week 24 and 48 in TC and triglycerides at week 24, 48 and 72. eGFR showed a significant decrease at week 48 and 72. TC/HDL ratio showed a statistically significant decrease at week 24 (
=0.0008) and 72 (
=0.04). A significant increase at week 24 and 48 in AST and ALT values was observed. Patients switching from TDF/FTC/EFV showed a reduction in HDL, total cholesterol and triglycerides at week 24 and 48 and in eGFR at all follow up times. TC/HDL ratio showed a significant decrease at week 48 (
=0.01). CDC stage C and antiretroviral-experience (especially Protease Inhibitors) were associated with RPV discontinuation.
In conclusion, our data confirm Rilpivirine efficacy, safety and tolerability with improvement in lipid profile. Although hepatic and renal events rarely caused discontinuation, liver and kidney parameters should be monitored.
Abstract
Funding Acknowledgements
Type of funding sources: None.
Aim
The aim of this study was to determine the prevalence and prognostic implications of MR severity in patients with LFLG-AS ...undergoing TAVR, and to evaluate whether the improvement of MR after procedure could influence 1-year outcome.
Methods
All consecutive patients with severe LFLG-AS undergoing TAVR in two high-volume Italian centres from 2017 to 2022 were prospectively included. LFLG-AS was defined as indexed aortic valve area (AVAì) ≤0.6 cm2/m2; mean gradient <40 mmHg and stroke volume index <36 ml/m2. LFLG-AS was classified as classical if LVEF was <50%, and paradoxical if LVEF was >50%. Dobutamine stress-echo was systematically performed in patients with LVEF<50% in order or exclude pseudo-severe AS. The study population was divided into two groups according to the baseline MR severity: ≤2+ (moderate or less than moderate) and >2+ (moderately-severe or severe) and reassessed after TAVR. The primary outcome was the composite of all-cause death and hospitalization for HF up to 1 year. The secondary outcomes were the single components of the primary outcome.
Results
The study included 268 patients 81±6 years; 53% females; of them, 57 (21.3%) patients showed MR>2+ at hospital admission. Patients with MR>2+ showed a significantly higher NYHA class at admission (p = 0.001); higher EuroSCORE II (p<0.001); lower LVEF at baseline (p = 0.003); higher RV dysfunction (p = 0.003) compared with those with MR≤2+. Death was reported in 2 (0.7%) patients, vascular complications in 8 (3%), and permanent pacemaker implantation in 23 (8.5%).
The primary outcome was reported in 55 (20.5%) patients; all-cause death was reported in 29 (10.8%) patients, and HF hospitalization in 34 (12.7%). At one year, patients with MR>2+ showed a significantly higher percentage of the primary outcome (p <0.001) and of all-cause mortality (p<0.001), which was related to cardiovascular cause in the majority of cases, and of HF rehospitalization (p<0.001). The survival free from the primary and secondary outcome was significantly lower in patients with MR>2+ compared with those with MR≤2+ (Log-Rank <0.001; Figure 1). The absence of MR improvement after TAVR was associated with higher percentage of the primary outcome (p = 0.020), all-cause death (p = 0.044), and HF rehospitalization (p = 0.030) at one year. The one-year survival free from the primary and secondary outcome was significantly higher in patients with MR improvement than in those without (Log-Rank = 0.009; Figure 2).
Conclusion
MR>2+ was reported in about 20% of patients with LFLG-AS undergoing TAVR, portend a worse clinical outcome up to one year. TAVR may improve MR severity, resulting in a potential outcome benefit after discharge. Our study suggests that both, the presence and the persistence of moderately-severe or severe MR, are of utmost importance for patient prognostic stratification, and should be carefully and systematically assessed in the very high-risk clinical scenario of LFLG-AS undergoing TAVR.
The SARS-CoV-2 spread has impacted Healthcare systems. COVID-19 pandemic has had consequences for patients with cancer, being associated with delays in diagnosis, in treatment And follow-up care, ...increase in overall infection rates and higher mortality. A survey on COVID-19 and a vaccination-questionnaire were developed at different times of the outbreak, to evaluate cancer patient-reported experience measures (PREMs) on the policies implemented to reduce the infection from SARS-CoV-2 and on the timing and methods of COVID-19 vaccination.
The survey was distributed to all patients accessing the Institute during the "first-wave" Of the pandemic, evaluating patients' concerns about the pandemic, the pandemics' consequences on their cancer care, and their perception Of the measures adopted to limit the infection spread. The vaccination-questionnaire was proposed to 10% of the first 5297 cancer patients vaccinated with two doses of the Pfizer-BioNTechCOVID-19 vaccine. This questionnaire aimed at assessing the degree Of satisfaction with the Institutional vaccination campaign and vaccination-related adverse events.
From May 18th 2020 to June 15th 2020 the survey was completed by 3238 patients. Most of the responders expressed concern on the pandemic yet acknowledging their oncological disease as a priority. Measures implemented were appreciated by patients. Telemedicine was positively evaluated and the absence of the caregiver during the visit did not determine discomfort for two thirds of patients. From March 6th 2021 to May 8th 2021 the vaccination-questionnaire was completed by 357 patients. The 98.8% were satisfied with the vaccination campaign. No serious vaccination-correlated adverse events were reported. No patient had to delay/discontinue chemotherapy due to vaccination.
PREMs during COVID-19 pandemic and related vaccination can provide important information to help reorganization of the health care systems for cancer care. Patients' feedback on the organizational changes implemented in the emergency period are essential for healthcare improvement and to help informed choices that are consistent with patients' needs.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
The Computerized Interactive Remediation of Cognition - Training for Schizophrenia (CIRCuiTS) is a form of cognitive remediation therapy developed to target neurocognitive and metacognitive deficits ...of people with schizophrenia, which have a detrimental impact on real-life functioning. The English version of CIRCuiTS demonstrated good acceptability and feasibility. A recent randomized controlled trial provided evidence that the program improves memory and functioning, and that the impact on functional outcome is mediated by metacognition. The next steps in the development of CIRCuiTS include both: 1) the translation and adaptation of the program in different cultural settings; and 2) the demonstration of feasibility, acceptability and effectiveness of a standardized method to administer CIRCuiTS remotely.
To implement the CIRCuiTS Italian version and to assess acceptability, feasibility and efficacy of a standardized method to administer CIRCuiTS remotely.
Participants were assessed at baseline and received up to 40 CIRCuiTS therapy sessions, three times a week, for about 1 hr over a three-month period. Participants were reassessed post-treatment.
The program demonstrated good feasibility and high acceptability when assessed by the number of dropouts and evaluation of patients' satisfaction. Participants improved in learning, speed of processing, working memory and executive control. They showed a reduction in disorganization and improvement in self-esteem, functional capacity, and real-life functioning.
In this study, a standardized protocol for using CIRCuiTS from home was implemented. The first set of data showed in the paper is encouraging. The proposed procedure could lead to a dropout reduction while maintaining the efficacy of the program.
Metabolic disorders are common amongst HIV-infected patients. Data from real-life setting on the impact of DTG/ABC/3TC in virologically suppressed HIV-infected patients are scarce.
We investigated ...the modification of metabolic profile including fasting glucose, lipid profile and markers of insulin resistance (IR) in experienced patients switching from a boosted protease inhibitors (bPI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen to DTG/ABC/3TC in a prospective, observational, multicenter study.
We enrolled 131 HIV-infected patients, of whom 91 (69.5%) males, mean age was 50.5±10.6 years. CDC stage was A in 66 (50.4%) patients, of whom 91 (69.5%) had acquired HIV through sexual contacts. The previous regimen was bPI-based in 79 patients (60.3%) and NNRTI-based in 52 (39.7%). Patients switching from NNRTI showed a significant reduction at week 24 in total cholesterol (TC) and low-density lipoprotein cholesterol (LDL). Triglycerides/high-density lipoprotein cholesterol (TG/HDL) ratio, HDL, median TG and TG/HDL ratio did not show significant modification during follow-up times. Among patients switching from a bPI, we observed a significant reduction in TC and LDL at both follow-up times and a slight increase in HDL. Triglycerides/HDL ratio, median TG and TG/HDL ratio showed a decrease over time that became significant at weeks 24 and 48. Blood glucose levels did not significantly vary during the observation period in patients switching from both bPI and NNRTI-based regimens.
Our data suggest an improvement in lipid profile and TG/HDL ratio in pretreated HIV-1-infected patients who switched to DTG/ABC/3TC over 48 weeks, especially in those previously receiving a bPI-based regimen.
Few data exist about the effect of dolutegravir (DTG) on bone mineral density (BMD) in real life. The aim of this study was to determine rates of change in BMD over time in people living with HIV ...(PLWH) treated with DTG.
The SCOLTA project is a multicenter observational study enrolling HIV-infected people who start newly commercialized drugs prospectively, with the aim of identifying toxicities and adverse events (AE) in a real-life setting.
Dual-energy X-ray absorptiometry at the femoral neck (FN) and lumbar spine (LS) was performed at study entry (baseline, BL) and after 96 weeks. Percentage BMD change from BL was evaluated using a general linear model, including factors potentially associated with bone loss.
One hundred and sixty PLWH were enrolled (26.3% female, mean age 49.9 ± 11.2 years) from April 2015 to April 2017. Overall, we could calculate BMD change from baseline, for at least one site, in 133 subjects (83.1%). After a median of 102 weeks (IQR: 90-110), mean FN BMD increased, but not significantly, whereas LS BMD showed a significant mean increase of 13.1 (95% confidence interval, CI: 1.7-24.6) mg/cm
(+1.6%, 95% CI: 0.3%, 2.8%) after a median time of 102 weeks (IQR: 84-110). As regards LS BMD, patients with osteopenia/osteoporosis at study entry experienced a high increase from baseline (20.6, 95% CI: 3.1, 38.1 mg/cm
), as well as experienced subjects (16.9, 95% CI: 4.7, 29.2 mg/cm
) and those on vitamin D supplementation (26.8, 95% CI: 7.7, 45.9 mg/cm
).
Dolutegravir-containing regimens could reduce the negative impact of antiretroviral therapy on bone, especially in patients with low BMD.
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