Evaluation of the Retinopathy of Prematurity Activity Scale (ROP-ActS) in a randomised controlled trial aiming for prevention of severe ROP : A substudy of the Mega Donna Mega trial

Objective The current grading of retinopathy of prematurity (ROP) does not sufficiently discriminate disease severity for evaluation of trial interventions. The published ROP Activity Scales (original: ROP-ActS and modified: mROP-ActS), describing increasing severity of ROP, versus the categorical variables severe ROP, stage, zone and plus disease were evaluated as discriminators of the effect of an ROP preventive treatment. Methods and analysis The Mega Donna Mega trial investigated ROP in infants born <28-week gestational age (GA), randomised to arachidonic acid (AA) and docosahexaenoic acid (DHA) supplementation or no supplementation. Of 207 infants, 86% with finalised ROP screening were included in this substudy. ROP-ActS versus standard variables were evaluated using Fisher’s non-parametric permutation test, multivariable logistic and linear regression and marginal fractional response models. Results The AA:DHA group (n=84) and the control group (n=93) were well balanced. The maximum ROP-ActS measurement was numerically but not significantly lower in the AA:DHA group (mean: 4.0 (95% CI 2.9 to 5.0)) versus the control group (mean: 5.3 (95% CI 4.1 to 6.4)), p=0.11. In infants with any ROP, the corresponding scale measurements were 6.8 (95% CI 5.4 to 8.2) and 8.7 (95% CI 7.5 to 10.0), p=0.039. Longitudinal profiles of the scale were visually distinguished for the categories of sex and GA for the intervention versus control. Conclusions The preventive effect of AA:DHA supplementation versus no supplementation was better discriminated by the trial’s primary outcome, severe ROP, than by ROP-ActS. The sensitivity and the linear qualities of ROP-ActS require further validations on large data sets and perhaps modifications. Trial registration number NCT03201588

Effects of Sex on Early Outcome following Repair of Acute Type A Aortic Dissection:Results from The Nordic Consortium for Acute Type A Aortic Dissection (NORCAAD)

Background Female sex is known to have increased perioperative mortality in cardiac surgery. Studies reporting effects of sex on outcome following surgical repair for acute Type A aortic dissection (ATAAD) have been limited by small cohorts of heterogeneous patient populations and have shown diverging results. This study aimed to compare perioperative characteristics, operative management, and postoperative outcome between sexes in a large and well-defined cohort of patients operated for ATAAD. Methods The Nordic Consortium for Acute Type A Aortic Dissection study included patients with surgical repair of ATAAD at eight Nordic centers between January 2005 and December 2014. Independent predictors of 30-day mortality were identified using multivariable logistic regression. Results Females represented 373 (32%) out of 1,154 patients and were significantly older (65 ± 11 vs. 60 ± 12 years, p < 0.001), had lower body mass index (25.8 ± 5.4 vs. 27.2 ± 4.3 kg/m 2, p < 0.001), and had more often a history of hypertension (59% vs. 48%, p = 0.001) and chronic obstructive pulmonary disease (8% vs. 4%, p = 0.033) compared with males. More females presented with DeBakey class II as compared with males with dissection of the ascending aorta alone (33.4% vs. 23.1%, p = 0.003). Hypothermic cardiac arrest time (28 ± 16 vs. 31 ± 19 minutes, p = 0.026) and operation time (345 ± 133 vs. 374 ± 135 minutes, p < 0.001) were shorter among females. There was no difference between the sexes in unadjusted intraoperative death (9.1% vs. 6.7%, p = 0.17) or 30-day mortality (17.7% vs. 17.4%, p = 0.99). In a multivariable analysis including perioperative factors influencing mortality, no difference was found between females and males in 30-day mortality (odds ratio: 0.92, 95% confidence interval: 0.62-1.38, p = 0.69). Conclusions This study found no association between sex and early mortality following surgery for ATAAD, despite females being older and having more comorbidities, yet also presenting with a less widespread dissection than males

The Association between HbA1c, Fasting Glucose, 1-Hour Glucose and 2-Hour Glucose during an Oral Glucose Tolerance Test and Cardiovascular Disease in Individuals with Elevated Risk for Diabetes

Peer reviewe

Sodium‐glucose cotransporter 2 inhibitors are associated with reduced risk of mortality and readmissions in heart failure

Abstract Aims Compelling evidence from randomized trials has shown that sodium‐glucose cotransporter 2 inhibitors (SGLT2is) are effective in heart failure (HF) across the spectrum of left ventricular ejection fractions. However, there are very few studies with real‐world data. Methods and results A retrospective cohort analysis was performed based on patient‐level data from the Swedish Heart Failure Registry (SwedeHF) linked with three other national registers. Patients included had an index registration between 3 September 2013 and 31 December 2020 in SwedeHF and were on treatment with guideline‐recommended therapy without or with SGLT2i 3 months before or 6 months after their index registration. Endpoints were mortality or readmissions. Association between the use of SGLT2i and endpoints was studied using adjusted Cox models. In the overall cohort, 796/22 405 patients were included with/without SGLT2i. In patients with SGLT2i, 93.5% had diabetes mellitus. In the overall cohort, SGLT2i was statistically significantly associated with all‐cause mortality {hazard ratio [HR]: 0.61 [95% confidence interval (CI) 0.48–0.79], P < 0.0001}, cardiovascular mortality [HR: 0.29 (95% CI 0.17–0.50), P < 0.0001], cardiovascular mortality or HF readmission [HR: 0.89 (95% CI 0.80–1.00), P = 0.046], and all‐cause readmissions [HR: 0.90 (95% CI 0.81–0.99), P = 0.038]. Similar results were obtained for the diabetes cohort. However, no association with cause‐specific readmissions was observed. Conclusions This nationwide real‐world study indicates that patients with HF, in which majority coexisted with diabetes mellitus, who received SGLT2i were statistically significantly associated with lower risk for all‐cause mortality, cardiovascular mortality, cardiovascular mortality or HF readmissions, and all‐cause readmissions, in line with the randomized trials assessing SGLT2i

Complications, patient-reported outcomes, and aesthetic results in immediate breast reconstruction with a dermal sling : A systematic review and meta-analysis

An inferior dermal flap (“sling”) can be used to cover an implant with two layers of tissue following Wise pattern skin-reducing mastectomies. Here, we performed a systematic review of the risks and benefits of this technique, specifically regarding complications, patient-reported outcomes, and aesthetic outcomes. PubMed and other relevant databases were searched using specific key words, with inclusion criteria comprising studies of dermal sling use involving ≥ 5 patients and performance according to the PICO framework. A meta-analysis was performed using a random-effects model involving a binomial distribution with logit-link function. For each study, the 95% confidence interval (CI) was obtained based on exact limits from a binomial distribution, and heterogeneity testing was performed using a chi-squared test. A total of 428 abstracts were retrieved, with 24 studies meeting the inclusion criteria and including a total of 879 patients and 1184 reconstructed breasts. The mean complication rate was 21.6% (95% CI: 16.9–27.2%), with the most common complication involving wound-healing problems (mean, 11.4%; 95% CI: 8.5–15.2%), and the frequency of implant loss (< 3 months) varied from 0% to 14% (mean, 2.2%; 95% CI: 1.1–4.4%). Seven articles reported patient-reported outcomes, and four reported aesthetic outcomes, with the quality of evidence classified as low for complications and very low for patient-reported outcomes and aesthetic outcomes. Our findings showed that although implant-based reconstruction with a dermal sling is widely used, there is little scientific evidence supporting the method

Prognosis and outcome determinants after heart failure diagnosis in patients who underwent aortic valvular intervention

Aims To study clinical phenotype, prognosis for all-cause and cardiovascular (CV) mortality and predictive factors in patients with incident heart failure (HF) after aortic valvular intervention (AVI) for aortic stenosis (AS). Methods and results In this retrospective, observational study we included patients from the Swedish Heart Failure Registry (SwedeHF) recorded 2003-2016, with AS diagnosis and AVI before HF diagnosis. The AS diagnosis was established according to International Classification of Diseases 10th revision (ICD-10) codes, thus without information concerning clinical or echocardiographical data on the aortic valve disease. The patients were divided into two subgroups: left ventricular ejection fraction (LVEF) &amp;gt;= 50% (AS-HFpEF) and &amp;lt;50% (AS-HFrEF). We individually matched three controls with HF from the SwedeHF without AS (control group) for each patient. Baseline characteristics, co-morbidities, survival status and outcomes were obtained by linking the SwedeHF with two other Swedish registries. We used Kaplan-Meier curves to present time to all-cause mortality, cumulative incidence function for time to CV mortality and Cox proportional hazards model to evaluate the relative difference between AS-HFrEF and AS-HFpEF and AS-HF and controls. The crude all-cause mortality was 49.0%, CV mortality 27.9% in AS-HF patients, respectively 44.7% and 26.6% in matched controls. The adjusted risk for all-cause mortality and CV mortality was similar in HF, regardless of LVEF vs. controls. No significant difference in factors predicting higher all-cause mortality was observed in AS-HFrEF vs. AS-HFpEF, except for diabetes (only in AS-HFrEF), with statistically significant interaction predicting death between the two groups. Conclusions In this nationwide SwedeHF study, we characterized incident HF population after AVI. We found no significant differences in all-cause and CV mortality compared with general HF population. They had virtually the same predictors for mortality, regardless of LVEF.Funding Agencies|Swedish government [ALFGBG-72900, 73400]; Swedish County Councils, the ALF agreement [ALFGBG-72900, 73400]; Regional Development Fund, Vastra Gotaland County, Sweden [VGFOUREG-931060, VGFOUREG-849081]; Gothenburg Society of Medicine [20/935037]</p

Prognosis and outcome determinants after heart failure diagnosis in patients who underwent aortic valvular intervention

Abstract Aims To study clinical phenotype, prognosis for all‐cause and cardiovascular (CV) mortality and predictive factors in patients with incident heart failure (HF) after aortic valvular intervention (AVI) for aortic stenosis (AS). Methods and results In this retrospective, observational study we included patients from the Swedish Heart Failure Registry (SwedeHF) recorded 2003–2016, with AS diagnosis and AVI before HF diagnosis. The AS diagnosis was established according to International Classification of Diseases 10th revision (ICD‐10) codes, thus without information concerning clinical or echocardiographical data on the aortic valve disease. The patients were divided into two subgroups: left ventricular ejection fraction (LVEF) ≥ 50% (AS‐HFpEF) and <50% (AS‐HFrEF). We individually matched three controls with HF from the SwedeHF without AS (control group) for each patient. Baseline characteristics, co‐morbidities, survival status and outcomes were obtained by linking the SwedeHF with two other Swedish registries. We used Kaplan–Meier curves to present time to all‐cause mortality, cumulative incidence function for time to CV mortality and Cox proportional hazards model to evaluate the relative difference between AS‐HFrEF and AS‐HFpEF and AS‐HF and controls. The crude all‐cause mortality was 49.0%, CV mortality 27.9% in AS‐HF patients, respectively 44.7% and 26.6% in matched controls. The adjusted risk for all‐cause mortality and CV mortality was similar in HF, regardless of LVEF vs. controls. No significant difference in factors predicting higher all‐cause mortality was observed in AS‐HFrEF vs. AS‐HFpEF, except for diabetes (only in AS‐HFrEF), with statistically significant interaction predicting death between the two groups. Conclusions In this nationwide SwedeHF study, we characterized incident HF population after AVI. We found no significant differences in all‐cause and CV mortality compared with general HF population. They had virtually the same predictors for mortality, regardless of LVEF

Non-cardiac comorbidities and mortality in patients with heart failure with reduced vs. preserved ejection fraction: a study using the Swedish Heart Failure Registry

Background Heart failure (HF) and non-cardiac comorbidities often coexist and are known to have an adverse effect on outcome. However, the prevalence and prognostic impact of non-cardiac comorbidities in patients with HF with reduced ejection fraction (HFrEF) vs. those with preserved (HFpEF) remain inadequately studied. Methods and results We used data from the Swedish Heart Failure Registry from 2000 to 2012. HFrEF was defined as EF amp;lt; 50% and HFpEF as EF amp;gt;= 50%. Of 31 344 patients available for analysis, 79.3% (n = 24 856) had HFrEF and 20.7% (n = 6 488) HFpEF. The outcome was all-cause mortality. We examined the association between ten non-cardiac comorbidities and mortality and its interaction with EF using adjusted hazard ratio (HR). Stroke, anemia, gout and cancer had a similar impact on mortality in both phenotypes, whereas diabetes (HR 1.57, 95% confidence interval [CI] [1.50-1.65] vs. HR 1.39 95% CI [1.27-1.51], p = 0.0002), renal failure (HR 1.65, 95% CI [1.57-1.73] vs. HR 1.44, 95% CI [1.32-1.57], p = 0.003) and liver disease (HR 2.13, 95% CI [1.83-2.47] vs. HR 1.42, 95% CI [1.09-1.85] p = 0.02) had a higher impact in the HFrEF patients. Moreover, pulmonary disease (HR 1.46, 95% CI [1.40-1.53] vs. HR 1.66 95% CI [1.54-1.80], p = 0.007) was more prominent in the HFpEF patients. Sleep apnea was not associated with worse prognosis in either group. No significant variation was found in the impact over the 12-year study period. Conclusions Non-cardiac comorbidities contribute significantly but differently to mortality, both in HFrEF and HFpEF. No significant variation was found in the impact over the 12-year study period. These results emphasize the importance of including the management of comorbidities as a part of a standardized heart failure care in both HF phenotypes.Funding Agencies|Swedish Heart-Lung Foundation [20170453]; Vastra Gotalands region [ALFGBG-721961]; University of Gothenburg [ALFGBG-721961]</p

Temporal trends in outcome and patient characteristics in dilated cardiomyopathy, data from the Swedish Heart Failure Registry 2003–2015

Abstract Background Temporal trends in clinical composition and outcome in dilated cardiomyopathy (DCM) are largely unknown, despite considerable advances in heart failure management. We set out to study clinical characteristics and prognosis over time in DCM in Sweden during 2003–2015. Methods DCM patients (n = 7873) from the Swedish Heart Failure Registry were divided into three calendar periods of inclusion, 2003–2007 (Period 1, n = 2029), 2008–2011 (Period 2, n = 3363), 2012–2015 (Period 3, n = 2481). The primary outcome was the composite of all-cause death, transplantation and hospitalization during 1 year after inclusion into the registry. Results Over the three calendar periods patients were older (p = 0.022), the proportion of females increased (mean 22.5%, 26.4%, 27.6%, p = 0.0001), left ventricular ejection fraction was higher (p = 0.0014), and symptoms by New York Heart Association less severe (p < 0.0001). Device (implantable cardioverter defibrillator and/or cardiac resynchronization) therapy increased by 30% over time (mean 11.6%, 12.3%, 15.1%, p < 0.0001). The event rates for mortality, and hospitalization were consistently decreasing over calendar periods (p < 0.0001 for all), whereas transplantation rate was stable. More advanced physical symptoms correlated with an increased risk of a composite outcome over time (p = 0.0043). Conclusions From 2003 until 2015, we observed declining mortality and hospitalizations in DCM, paralleled by a continuous change in both demographic profile and therapy in the DCM population in Sweden, towards a less affected phenotype