bluuebunny/crossref_metadata_2025_split huggingface dataset:
Reporting quality of randomized controlled trials of percutaneous patent foramen ovale closure for the treatment of migraine based on the CONSORT statement
Authors: Beneki E , Dimitriadis K , Tsiachris D , Aznaouridis K , Sakalidis A , Mantzouranis M , Soulaidopoulos S , Papanikolaou A , Tsioufis P , Aggeli K , Tsiamis E , Tsioufis K 
Published: November 2023

Abstract

Background
Although several retrospective and non-randomized studies support reduction of migraine frequency and severity after patent foramen ovale (PFO) closure, three randomized controlled trials (RCTs) in this setting have not met their primary efficacy endpoints. In addition, currently there are is no analysis of the quality of RCTs of percutaneous PFO closure for the treatment of migraine.

Purpose
The present study aims to determine the reporting quality of RCTs focusing on the PFO closure for the treatment of migraine according to the revised CONsolidated Standards Of Reporting Trials (CONSORT) 2010 checklist.

Methods
Systematic searches of 2 databases (MEDLINE/PubMed and Cochrane library) were conducted. The search strategy identified reports on RCTs involving patients with migraine and PFO who were randomized to transcatheter device closure of PFO or medical treatment in order to investigate the effect of PFO closure for migraine. The primary objective was to establish the mean CONSORT compliance of RCTs of PFO closure for the treatment of migraine and secondary objectives were the calculation of compliance per CONSORT item and effect of CONSORT statement in high-ranked medical journals. Quality of reporting was assessed using a 37-item questionnaire based on the revised CONSORT 2010 checklist. Reporting above 75% of the items was defined as adequate compliance to the CONSORT statement.

Results
The search identified 3 eligible articles for analysis. The mean compliance was 69.66% ± 4.49%. Among the studies, only 1 RCT (PRIMA Trial) registered a good reporting quality (75% of the CONSORT items), whereas there were no RCTs with a CONSORT compliance less than 50% (Figure 1). Among assessed items, 19 items (51.4%) were reported in all (100%) of the articles. Also, 26 of the 37 items of the checklist (70.3%) were reported in more than half of the studies. The majority of the Results items registered an adequate reporting whereas randomization items were not so sufficiently reported overall (Figure 2). Each one of the RCTs used in the analysis were published in high-ranked medical journals (IF&gt;30). However, none of the studies reported all 37 items achieving 100% CONSORT compliance score.

Conclusions
Based on the present results, quality of reporting in RCTs focusing on the PFO closure for the treatment of migraine remains suboptimal according to the CONSORT analysis. In this sense, better designed RCTs on the management of migraine by PFO closure are currently needed to guide future clinical practice.Figure 1.Figure 2.
Microtransesophageal echocardiographic guidance of patent foramen ovale percutaneous closure
Authors: Bouziri N , Guedeney P , Malvy J , Zeitouni M , Mertens E , Ceccaldi A , Wallet T , Djebbar R , Silvain J , Montalescot G , Hammoudi N 
Published: November 2023

Abstract

Introduction
The important growth in the number of percutaneous patent foramen ovale (PFO) closure procedures requires to find alternatives to conventional guidance by transesophageal echocardiography (TEE) with general anesthesia (GA). The micro-TEE monitoring, with local anesthesia, could allow a reliable guidance with a reduced procedural length, without the need for GA.
The objective of this study is to evaluate the effectiveness and safety of PFO closure guided by micro-TEE compared to conventional TEE under GA.

Methods
This retrospective single-center observational study included all consecutive patients admitted to our hospital, from January 2019 to June 2021 for PFO closure. The type of guidance was based on PFO’s morphological characteristics and patient’s choice.
The primary endpoint was the successful implantation of at least one prosthesis without significant residual shunting (≤ grade 1). Key secondary endpoints were the procedure duration and periprocedural complications.

Results
A total of 237 patients (44% of female, mean age: 50 ± 14 years) were included, with TEE and micro-TEE guidance in 174 (73%) and 63 (27%) cases, respectively. Smaller devices were more frequently implanted among patients with micro-TEE compared to TEE guidance, with 59% vs. 44% respectively (p=0.04), reflecting cases selection on the basis of prior TEE.
Overall, there was no case of procedural failure and the primary endpoint was obtained in 158 (91%) and 60 (95%) patients with TEE and micro-TEE guidance, respectively (p=0.27). Procedural duration was shorter with micro-TEE guidance (median time 8 (7-11)min versus 21 (16-27)min, p=0.01). The rate of peri-procedural complications was low (1.3% overall) and limited to periprocedural atrial arrhythmia, without significant differences in both groups (p&gt;0.99).

Conclusions
Micro-TEE guidance may result in safe and shorter PFO percutaneous closure compared to TEE guidance with GA.These results obtained on selected patients must be confirmed on larger cohorts.
Long term follow-up of patent foramen closure due to embolic infarction in elderly patients
Authors: Hamm C H , Hamm C , Doerr O , Gruen D 
Published: November 2023

Abstract

Background
In patients &lt; 60 years (yrs) with crytogenic embolism associated with a patent foramen ovale (PFO) guidelines recommend interventional closure based on several randomized studies. There is no recommendation for elderly patients, although they seem to carry a similar risk for recurrent events. There are only scarce data on early and particularly late outcome.

Methods
We therefore retrospectively analyzed the up to 10 years outcome (median 4,2 yrs) in 444 consecutive patients (female, male) according to age at PFO closure.

Results
From 444 patients in our study population, 155 were &gt;60 years of age (mean age 66,7 (IQR 63,1-71,74), 45% females. Older patients had higher prevalence of cardiovascular risk factors like hypertension, hyperlipidemia and diabetes (p&lt; 0,01 for all vs. younger patients) while smoking was more prevalent in younger patients (p&lt;0,01). No difference in procedural success and periinterventional complications was observed between the two age groups. During follow up of median 4,2 years (5 patients lost to FU) event rate of recurrent stroke, atrial fibrillation and acute myocardial infarction did not differ between older and younger patients.

Conclusions
Long term outcome was independent of age despite higher CV risk factors burden and supports PFO closure in elderly patients.
Outcomes following permanent pacemaker implantation in patients undergoing tricuspid valve surgery
Authors: Kassab J , Harb S C , Desai M Y , El Dahdah J , Chedid El Helou M , Nakhla S , Elgharably H , Kapadia S , Cremer P C , Mentias A 
Published: November 2023

Abstract

Background
PPM implantation are commonly described after cardiac surgeries and notably after tricuspid valve surgery (TVS).

Purpose
Our study aimed to compare outcomes in patients who underwent PPM placement versus patients who did not following TVS.

Methods
We included 13 294 patients from the Medicare database who underwent isolated TV repair (N=1319 (10%)), isolated TV replacement (N=2123 (16%)), or concomitant TV repair or replacement with different combinations of surgical aortic valve replacement (SAVR), mitral valve repair or replacement (MVR), and coronary artery bypass graft (CABG). Patients who underwent TV surgery for endocarditis were excluded. The primary exposure of interest for the study was new pacemaker placement after TV surgery and before discharge, or within 30 days from discharge date. Each patient from the pacemaker group was matched to up to 3 controls from the no pacemaker group. The primary study outcome was all-cause mortality in follow-up in patients who underwent pacemaker placement after TV surgery versus patients who did not. The study’s secondary outcomes included 1-year mortality and the risk of hospital readmission with a diagnosis of endocarditis or heart failure (HF) in follow-up.

Results
Among the included patients, 2518 (18.9%) required a PPM placement after surgery. PPM placement was associated with a longer length of hospital stay (median 12 days (IQR 8-19 days) vs. 10 (7-17 days), P&lt;0.001). It was not associated with a difference in risk of 1-year mortality (18.9% vs. 20.7%, OR 0.90, 95% CI 0.79-1.03, P=0.1). After a median follow-up of 3.1 years (IQR 1-5.5 years), PPM placement was also not associated with a significant increase in the risk of mortality in comparison to patients who did not require PPM (HR 1.02, 95% CI 0.93-1.12, P=0.7) (Figure 1). However, it was associated with a higher risk of HF readmission in follow-up (HR 1.28, 95% CI 1.14-1.43, P&lt;0.001) when compared to no PPM (Figure 2). Finally, PPM was not associated with any difference in risk of endocarditis in follow-up (HR 1.03, 95% CI 0.74-1.45, P=0.8).

Conclusion
Post-procedural PPM implantation is a frequent complication of TVS. While mortality is not increased, PPM placement leads to higher HF hospitalization rates. Adequate risk stratification and counseling of patients before surgery decision is essential.Survival after TVSHeart Failure after TVS
The anemia conundrum in contemporary redo cardiac surgery
Authors: Montella A P , Rubino A S , Golini Petrarcone C , Palmieri L , De Feo M , De Santo L S 
Published: November 2023

Abstract

Aims
Preoperative anemia has been associated with increased morbidity and mortality after cardiac surgery, but little is known on its prognostic value in the setting of redo procedure. This study aimed to investigate whether preoperative anemia is an independent determinant of adverse events in this augmented risk patients subset.

Methods
A retrospective, observational, cohort study of prospectively collected data was undertaken on 409 consecutive patients referred for redo cardiac procedures between January 2011 and December 2020 (mean age of 62 ± 12.7 years, octogenarians 5.6%, female sex 52.8%, diabetes 19.5%, chronic kidney disease 30%, urgent/emergent status 34.8%, third-time sternotomy 9.8%). The EuroSCORE II calculated an average mortality risk of 25.7 ± 15.4%. The prevalence of preoperative anemia (according to World Health Organization definition) and its relationships with postoperative morbidity were obtained. Selection bias was assessed with propensity-adjustment method.

Results
The prevalence of preoperative anemia was 41%. In unmatched analysis, significant differences between the anemic and non-anemic group emerged in the risk of postoperative stroke (0.6% vs 4.4%, p = 0.023), postoperative renal dysfunction (29,7% vs 15.6%, p = 0.001), need for prolonged ventilation (18.1% vs 7.2%, p = 0.002), high dosage inotropes (53.1% vs 32.9%, p &lt; 0.001) along with both length of ICU and hospital stay (8.2±15.9 vs 4.3±5.4 days, p=0.003 and 18.8±17.4 vs 14.9±11.1, p=0.012 ). After propensity matching (143 pairs), preoperative anemia was still significantly associated with postoperative renal dysfunction, stroke and need for high dosage inotropes cardiac morbidity. Anemia proved also a significant predictor of acute kidney injury at univariate analysis.

Conclusions
Preoperative anemia is significantly associated with acute kidney injury, stroke and need for high dosage inotropes in patients referred for redo procedures. Further studies are warranted to determine whether preoperative low hemoglobin concentration is a marker of severity of illness or a modifiable risk factor.
Ten-year mortality after percutaneous coronary intervention, off-pump and on-pump surgery for complex coronary artery disease - who is the winner?
Authors: Kageyama S , Serruys P W , Ninomiya K , Colombo A , Van Genus R J , Milojevic M , Mack M J , Soo A , Onuma Y , Davierwala P 
Published: November 2023

Abstract

Aim
The very long-term mortality of off-pump and on-pump CABG versus PCI in a randomized complex coronary artery disease (CAD) population is unknown. This study aims to investigate the impact of on-pump and off-pump coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) on 10-year all-cause mortality.

Methods and results
The SYNTAXES trial randomized 1800 patients with three-vessel and/or left main CAD to PCI or CABG and assessed their survival at 10 years. In this sub-study, the hazard of mortality over 10 years was compared according to the technique of revascularization: on-pump CABG (n=725), off-pump CABG (n=128), and PCI (n=903). There was substantial inter-site variation in the use of off-pump CABG despite baseline characteristics being largely homogeneous amongst the three groups. The crude rate of mortality was significantly lower following on-pump CABG versus PCI (25.6% vs 28.4%, Hazard Ratio [HR] 0.79, 95% Confidence Interval [CI] 0.65-0.96), whilst it was comparable between off-pump CABG and PCI (28.5% vs 28.4%, HR 0.98, 95%CI 0.69-1.40). After adjusting for the nine variables included in the SYNTAX score II 2020, 10-year mortality remained significantly lower with on-pump CABG than PCI (HR 0.75 against PCI, p=0.009) (central figure).

Conclusion
In the SYNTAXES trial, 10-year mortality adjusted for major confounders was significantly lower following on-pump CABG compared to PCI, whilst off-pump CABG offered no prognostic survival benefit over PCI. Site heterogeneity in the technique used in bypass surgery has had measurable effects on treatment performance. Given its impact on outcomes, it should be pre-stratified in future studies.Central figure
Associations of long-term visit-to-visit blood pressure variability with subclinical kidney damage and albuminuria in adulthood: a 30-year prospective cohort study
Authors: Wang Y , Zhao P , Chu C , Du M F , Zhang X Y , Zou T , Hu G L , Jia H , Liao Y Y , Ma Q , Wang D , Chen F Y , Mu J J 
Published: November 2023

Abstract

Background
Recent evidence indicates that long-term visit-to-visit blood pressure variability (BPV) may be associated with the risk of cardiovascular disease. We therefore aimed to determine the potential associations of long-term BPV from childhood to middle age with subclinical kidney damage (SKD) and albuminuria in adulthood.

Methods
Using data from the ongoing cohort of Hanzhong Adolescent Hypertension study, which recruited children and adolescents aged 6 to 18 years at baseline, we assessed BP variability by standard deviation (SD) and average real variability (ARV) for 30 years (6 visits). Presence of SKD was defined as estimated glomerular filtration rate (eGFR) between 30 and 60 ml/min/ 1.73 m2 or elevated urinary albumin-to creatinine ratio (uACR) at least 30 mg/g. Albuminuria was defined as uACR ≥ 30 mg/g.

Results
During a follow-up of 30 years, of the 1771 participants, 204 SKD events occurred. After adjustment for demographic, clinical characteristics and mean BP during 30 years, higher SDSBP, ARVSBP, SDDBP, ARVDBP, SDMAP, ARVMAP and ARVPP were significantly associated with higher risk of SKD [ORs (95% CIs) were 1.14(1.06-1.23), 1.15(1.08-1.21), 1.12(1.06-1.17), 1.16(1.08-1.25), 1.12(1.07-1.17), 1.18(1.10-1.27) and 1.11(1.03-1.21), respectively]. When we used cumulative exposure to BP from childhood to adulthood instead of mean BP as adjustment factors, results were similar. In addition, greater long-term BPV was also associated with the risk of albuminuria [ORs (95% CIs) were 1.07(1.03-1.10) for SDSBP, 1.13(1.06-1.20) for ARVSBP, 1.11(1.06-1.17) for SDDBP, 1.14(1.06-1.23) for ARVDBP, 1.18(1.09-1.27) for ARVMAP and 1.08(1.01-1.17) for ARVPP]. Long-term BP variability for 30 years from childhood to middle age was associated with higher risk of SKD and albuminuria in adulthood, independent of mean BP or cumulative exposure to BP during follow-up.The example of SBP across 6 visits
Profile of miRNAs expression on serum of hypertensive patients with chronic kidney disease
Authors: Nadruz W , Minin E O Z , Schreiber R , Lopes E C P , Paim L R , Carvalho-Romano L F R S , Marques E R , Vegian C F L , Pio-Magalhaes J A , Velloso L A , Coelho-Filho O R , Sposito A C 
Published: November 2023

Abstract

Background/Introduction
Arterial hypertension is a major risk factor for chronic kidney disease (CKD). MicroRNAs (miRNAs) are a group of small non-coding RNA molecules that pair with messenger RNA sequences of target genes, causing transcriptional repression for protein synthesis. Several studies suggest that the aberrant expression of miRNAs may be involved in the development of cardiovascular diseases, however little is known about the role of miRNA expression in the development of CKD in hypertensive patients.

Purpose
The present study evaluated the differential expression of miRNAs in the serum of hypertensive patients comparing individuals with CKD with those without CKD.

Methods
We evaluated the clinical and laboratory characteristics of 42 hypertensive patients followed at a tertiary university hospital and determined the serum expression of 754 miRNAs using an Array system. Patients were divided into two groups based on estimated glomerular filtration rate (eGFR): group 1 (normal eGFR [≥60 mL/min/m2]) and group 2 (altered eGFR [&lt;60 mL/min/m2]). Differences in miRNAs expression between individuals with and without CKD were assessed by Student's t test and adjusted logistic regression analysis. P value&lt;0.05 was considered statistically significant.

Results
There were 33 patients in group 1and 9 patients in group 2. The groups had statistically similar prevalence of women and mean values of age and body mass index (BMI) (age=57±10 years, 66% women, BMI=27.1±4.1 kg/m2 in group 1; age=58±8 years, 42% Women, BMI=30.1±4.6 kg/m2). Among the studied miRNAs, 9 showed differential expression (Figure 1), 8 of which were upregulated (miR-125a, miR-215, miR-146b, miR-127, miR-339-5p, miR-18a, miR-30b and miR-199a) and one was downregulated (miR-451) in hypertensive patients with low eGFR when compared to hypertensive patients with normal eGFR. Logistic regression analysis adjusted for systolic blood pressure, diabetes mellitus and antihypertensive medications use showed that miR-125a, miR-146b and miR-451 remained differently expressed between the studied groups.

Conclusions
Our analysis showed that CKD is accompanied by distinct expression of circulating miRNAs in individuals with hypertension, especially miR-125a, miR-146b and miR-451, suggesting that these miRNAs might play a role in CKD and could be potential biomarkers of development of this disease in hypertensive patients.Figure 1
Severity of obstructive sleep apnea is associated with left ventricular abnormality in patients with hypertension in the young
Authors: Silaruks S , Wongwattanakij S , Khamsai S , Sawanyawisuth K 
Published: November 2023

Abstract

Background
Hypertension in the young is defined as the presence of hypertension in individuals with an age of onset before 35 years. A previous study found that obstructive sleep apnea (OSA) may be a contributing factor of hypertension in the young up to 90% if other causes of secondary hypertension were excluded. Left ventricular (LV) abnormality is a marker of future cardiovascular consequences. There is limited data on risk factors of LV abnormality in patients with hypertension in the young with OSA.

Objectives
We aim to evaluate risk factors of LV abnormality in patients with hypertension in the young.

Methods
This study was a retrospective study. The eligible patients were adult patients who diagnosed as hypertension at age before 35 years and evaluated for echocardiogram. Those with causes of secondary hypertension or pregnant women were excluded. The study period was between October 2017 and January 2021. OSA was categorized as mild, moderate, and severe by an apnea-hypopnea index of 5-14.9, 15-29.9, and 30 or over times/hour. LV abnormality defined by relative wall thickness (RWT) over 0.42 mm. by a Doppler echocardiography. Other echocardiographic findings were also reported including left ventricular mass (LVM), left ventricular mass index (LVMI), and ejection fraction (EF). Differences of variables among severities of OSA were computed by a one-way ANOVA, while differences of proportions between groups were calculated by Chi square test. Multivariable analyses, linear and logistic regressions were performed to find the association between OSA and LV abnormality.

Results
There were 52 patients who met the study criteria. Mild OSA group had lower LVM, LVMI, and RWT than moderate OSA and severe OSA group (172.98 vs 232.16 vs 177.78 g; p 0.036 for LVMI; 83.03 vs 107.87 vs 84.99 g/m2; p 0.013 for LVMI; and 0.38 vs 0.45 vs 0.47 mm; p 0.010 for RWT). There was no significant difference in EF among the three groups. Severe OSA was found have an increased association with the presence of LV abnormality compared to patients with mild to moderate OSA (OR 3.28, 95% CI 0.96-12.5), however this was not statistically significant (p-value 0.07) Patients with severe OSA was found to have a correlation with RWT measurements of greater than 0.42 (correlation co-efficient 0.2, 95% CI 0.01-0.39, p-value 0.04).

Conclusion
Hypertensive patients under the age of 35 with severe OSA have a higher proportion of LV abnormality compared to mild and moderate OSA. Severe OSA was found to be correlated to RWT measurements of greater than 0.42. This finding might be one of prognostic indicators of the future adverse cardiovascular events and be required proper management. However, this relationship should be needed further study.
Association of hydrochlorothiazide treatment compared to alternative diuretics with overall and skin cancer risk: a propensity-matched cohort study
Authors: Goetzinger F , Wilke T , Hardtstock F , Krieger J , Maywald U , Kunz M , Lauder L , Schulz M , Mahfoud F , Boehm M 
Published: November 2023

Abstract

Introduction
Hydrochlorothiazide (HCT) has been suggested to induce photosensitivity, thereby increasing the incidence of skin cancers. After a pharmacovigilance alert, HCT was frequently withdrawn or substituted by other diuretics. The aim of this study was to compare the association of exposure to HCT with cancer risk versus alternative diuretics.

Methods
A retrospective cohort study was conducted based on data from the AOK PLUS, a large German statutory health insurance fund. Patients with HCT treatment were propensity score matched (PSM) to patients using non-HCT diuretics. Incidence of cancer of any kind and, specifically, skin cancer was assessed in both groups. Time to incident cancer diagnosis was evaluated and compared between the groups.

Results
A total of 199,708 patients were included in the final analysis (n=76,855 in the HCT-group; n=122,853 in the non-HCT-diuretics group). After PSM, 122,554 patients remained in the sample (n=61,277 for both groups, of which &gt;96% had hypertension, mean age 73 years, 61% female). HCT treatment was associated with a lower incidence of cancer of any kind, compared with non-HCT diuretics (Incidence rate ratio (IRR) per 100 patient years 0.84 95% Confidence interval (CI): 0.82-0.87). HCT treatment was associated with a small albeit significantly higher IRR of skin cancer (1.14 95% CI: 1.06-1.24) with significant variances over time. Although numerically higher, the difference accounts to only 0.05 more skin cancer diagnoses in 100 patient years.

Conclusions
HCT treatment compared to alternative diuretics was associated with a lower all-cancer risk and was not associated with a meaningful increase in skin cancer risk in a large German population. Nevertheless, advice for skin protection is warranted in all patients taking thiazide or thiazide-like diuretics.HR of overall and skin cancerTime to cancer diagnosis - time to event