Clinical and demographic characteristics, management of patients with type 2 diabetes mellitus and vascular complications: analysis of the Ukrainian cohort of the DISCOVER Global Registry

The aim – to describe baseline data of the Ukraine cohort of DISCOVER Global Registry (DGR) with real-world insights on current treatment practices, complications, and associated clinical outcomes in people with type 2 diabetes mellitus (T2DM).Materials and methods. This healthcare provider-led prospective registry involves non‑interventional data collection from adults (aged ≥ 18 years) with T2DM receiving standard medical care as part of routine clinical practice per their treating physician’s discretion.Results and discussion. The initial data of 353 people with T2DM, who were included in the Ukrainian cohort of the DGR Register, were analyzed. The mean (±standard deviation) age of the study population was 58.85±10.02 years with female predominance (64 % [n=226]). The mean T2DM duration was 10.27±12.15 years with a mean glycated hemoglobin (HbA1c) level of 8.62±1.89 %. Only one-fifth (20.5 %, n=59) of the patients had glycemic control (HbA1c < 7.0 %). Among those with any complication, 73.8 % had microvascular and 79.3 % had cardiovascular complications. Retinopathy and heart failure were the most common microvascular and cardiovascular complications, respectively. Overall, 88 % of the patients were taking any antidiabetic therapy; of these, 27.3 % received insulin (monotherapy: n=28; combination therapy: n=57). As oral antidiabetic drugs (OAD), 32.2 % and 12.9 % received metformin and sulphonylurea monotherapies, respectively; minor proportions received newer OAD monotherapy (sodium-glucose co-transporter-2 inhibitors [4.8 %] and dipeptidyl peptidase-4 inhibitor [1 %]).Conclusions. Baseline data from the Ukraine cohort of DGR reveals poor glycemic control, with a higher mean HbA1c and proportion of patients with micro- and cardiovascular complications than that of the global cohort. The landscape of therapeutic agents displayed marked diversities in the management strategies. Robust real-world data from the DGR can help understand the gaps in care of T2DM patients and lights the need of the formulation of region-specific holistic therapeutic strategies to optimize glycemic control and improving clinical patients’ outcomes.

Differences in Mid-Term Outcomes Between Patients Undergoing Thoracic Endovascular Aortic Repair for Aneurysm or Acute Aortic Syndromes: Report From the Global Registry for Endovascular Aortic Treatment

Purpose: To analyze differences in baseline characteristics, overall mortality, device-related mortality, and re-intervention rates in patients who underwent thoracic endovascular aortic repair (TEVAR) for descending thoracic aortic aneurysm (DTAA) with atherosclerotic/degenerative cause or acute aortic syndrome (AAS), using the Global Registry For Endovascular Aortic Treatment (GREAT). Materials and Methods: Patients submitted to TEVAR for AAS or DTAA, included in GREAT, were eligible for this analysis. Primary outcome was 30-day all-cause mortality rate. Secondary outcomes were 30-day aorta-related mortality and re-intervention rate, 1-year and 3-year all-cause mortality, aorta-related mortality and re-intervention rate. Results: Five-hundred and seventy-five patients were analyzed (305 DTAA and 270 AAS). Thirty-day mortality rate was 1.3% and 1.8% for DTAA and AAS, respectively (p=0.741). One-year and 3-year mortality rates were 6.2% versus 9.3 and 17.3% versus 15.9% for DTAA and AAS, respectively (p=0.209 and p=0.655, respectively). Aorta-related mortality rates at 30 days, 1 year and 3 years were 1.3%, 1.3%, and 2.6% for DTAA, 1.8%, 4.2%, and 4.2% for AAS (p=ns). Re-intervention rates at 30 days, 1 year, and 3 years were 1.3%, 4.3%, and 7.5% for DTAA, 3.3%, 8.1%, and 10.7% for AAS (p=ns). Furthermore, a specific analysis with similar outcomes was performed dividing follow-up in 3 periods (1-30 days, 31-365 days, 366-1096 days) and describing mutual differences between 2 groups and temporal trends in each group. Conclusion Patients who underwent TEVAR for DTAA or AAS experienced different mortality and re-intervention rates among years during mid-term follow-up. Although all-cause related deaths within 30 days were TEVAR-related, aorta-related deaths were more common for AAS patients within 1 year. A greater re-intervention rate was described for AAS patients, although only 1 year after TEVAR.

Cryoballoon Ablation for the Treatment of Atrial Fibrillation in Patients With Concomitant Heart Failure and Either Reduced or Preserved Left Ventricular Ejection Fraction: Results From the Cryo AF Global Registry

Background Heart failure (HF) and atrial fibrillation (AF) often coexist; yet, outcomes of ablation in patients with AF and concomitant HF are limited. This analysis assessed outcomes of cryoablation in patients with AF and HF. Methods and Results The Cryo AF Global Registry is a prospective, multicenter registry of patients with AF who were treated with cryoballoon ablation according to routine practice at 56 sites in 26 countries. Patients with baseline New York Heart Association class I to III (HF cohort) were compared with patients without HF. Freedom from atrial arrhythmia recurrence ≥30 seconds, safety, and health care utilization over 12‐month follow‐up were analyzed. A total of 1303 patients (318 HF) were included. Patients with HF commonly had preserved left ventricular ejection fraction (81.6%), were more often women (45.6% versus 33.6%) with persistent AF (25.8% versus 14.3%), and had a larger left atrial diameter (4.4±0.9 versus 4.0±0.7 cm). Serious procedure‐related complications occurred in 4.1% of patients with HF and 2.6% of patients without HF ( P =0.188). Freedom from atrial arrhythmia recurrence was not different between cohorts with either paroxysmal AF (84.2% [95% CI, 78.6–88.4] versus 86.8% [95% CI, 84.2–89.0]) or persistent AF (69.6% [95% CI, 58.1–78.5] versus 71.8% [95% CI, 63.2–78.7]) ( P =0.319). After ablation, a reduction in AF‐related symptoms and antiarrhythmic drug use was observed in both cohorts (HF and no‐HF), and freedom from repeat ablation was not different between cohorts. Persistent AF and HF predicted a post‐ablation cardiovascular rehospitalization ( P =0.032 and P =0.001, respectively). Conclusions Cryoablation to treat patients with AF is similarly effective at 12 months in patients with and without HF. Registration URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT02752737.

Another Perspective on Huntington’s Disease: Disease Burden in Family Members and Pre-Manifest HD When Compared to Genotype-Negative Participants from ENROLL-HD

Background: In addition to the effects on patients suffering from motor-manifest Huntington’s disease (HD), this fatal disease is devasting to people who are at risk, premanifest mutation-carriers, and especially to whole families. There is a huge burden on people in the environment of affected HD patients, and a need for further research to identify at-risk caregivers. The aim of our research was to investigate a large cohort of family members, in comparison with genotype negative and premanifest HD in order to evaluate particular cohorts more closely. Methods: We used the ENROLL-HD global registry study to compare motoric, cognitive, functional, and psychiatric manifestation in family members, premanifest HD, and genotype negative participant as controls. Cross-sectional data were analyzed using ANCOVA-analyses in IBM SPSS Statistics V.28. Results: Of N = 21,116 participants from the global registry study, n = 5174 participants had a premanifest motor-phenotype, n = 2358 were identified as family controls, and n = 2640 with a negative HD genotype. Analysis of variance revealed more motoric, cognitive, and psychiatric impairments in premanifest HD (all p < 0.001). Self-reported psychiatric assessments revealed a significantly higher score for depression in family controls (p < 0.001) when compared to genotype negative (p < 0.001) and premanifest HD patients (p < 0.05). Family controls had significantly less cognitive capacities within the cognitive test battery when compared to genotype negative participants. Conclusions: Within the largest cohort of HD patients and families, several impairments of motoric, functional, cognitive, and psychiatric components can be confirmed in a large cohort of premanifest HD, potentially due to prodromal HD pathology. HD family controls suffered from higher self-reported depression and less cognitive capacities, which were potentially due to loaded or stressful situations. This research aims to sensitize investigators to be aware of caregiver burdens caused by HD and encourage support with socio-medical care and targeted psychological interventions. In particular, further surveys and variables are necessary in order to implement them within the database so as to identify at-risk caregivers.

Bronchial Thermoplasty Global Registry (BTGR): 2-year results

ObjectivesBronchial thermoplasty (BT) is a device-based treatment for subjects ≥18 years with severe asthma not well controlled with inhaled corticosteroids and long-acting beta-agonists. The Bronchial Thermoplasty Global Registry (BTGR) collected real-world data on subjects undergoing this procedure.DesignThe BTGR is an all-comer, prospective, open-label, multicentre study enrolling adult subjects indicated for and treated with BT.SettingEighteen centres in Spain, Italy, Germany, the UK, the Netherlands, the Czech Republic, South Africa and AustraliaParticipantsOne hundred fifty-seven subjects aged 18 years and older who were scheduled to undergo BT treatment for asthma. Subjects diagnosed with other medical conditions which, in the investigator’s opinion, made them inappropriate for BT treatment were excluded.Primary and secondary outcome measuresBaseline characteristics collected included demographics, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Test (ACT), medication usage, forced expiratory volume in one second and forced vital capacity, medical history, comorbidities and 12-month baseline recall data (severe exacerbations (SE) and healthcare utilisation). SE incidence and healthcare utilisation were summarised at 1 and 2 years post-BT.ResultsSubjects’ baseline characteristics were representative of persons with severe asthma. A comparison of the proportion of subjects experiencing events during the 12 months prior to BT to the 2-year follow-up showed a reduction in SE (90.3% vs 56.1%, p<0.0001), emergency room visits (53.8% vs 25.5%, p<0.0001) and hospitalisations (42.9% vs 23.5 %, p=0.0019). Reductions in asthma maintenance medication dosage were also observed. AQLQ and ACT scores improved from 3.26 and 11.18 at baseline to 4.39 and 15.54 at 2 years, respectively (p<0.0001 for both AQLQ and ACT).ConclusionsThe BTGR demonstrates sustained improvement in clinical outcomes and reduction in asthma medication usage 2 years after BT in a real-world population. This is consistent with results from other BT randomised controlled trials and registries and further supports improvement in asthma control after BT.Trial registration numberNCT02104856.

Laparoscopic Sleeve Gastrectomy for the Surgical Treatment of Obesity: Is It an Easy Procedure?

Laparoscopic sleeve gastrectomy (LSG) is currently the most performed bariatric procedure in the world. The 4th International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Global registry report (2014-18) estimates 87,015 procedures, equal to 45.9% of all bariatric procedures. Initially performed as the first step of the duodenals witch (biliopancreatic diversion with duodenal switch (BPD-DS)), a very complex malabsorptive procedure invented by a Canadian Surgeon P. Marceau as an evolution of the BPD, invented by N. Scopinaro, an Italian surgeon, LSG established itself in the early 2000s as a stand alone procedure, especially following the observations of Michael Gagner, pioneer of bariatric surgery. Over the years LSG has grown rapidly. The reasons for this popularity are the relative technical simplicity compared to other procedures, efficacy, good quality. For these reasons there has been a real explosion of bariatric surgery: many surgeons, driven by the relative simplicity of the procedure (longitudinal gastrectomy on the guide of a probe), begun to propose this procedure. So is LSG really an effective simple procedure that is good for all patients? Absolutely not. Performing a longitudinal gastrectomy can be simple; performing a good LSG is not.