The COORDINATE Pilot Study: Impact of a Transcatheter Aortic Valve Coordinator Program on Hospital and Patient Outcomes.

The transcatheter aortic valve implantation (TAVI) treatment pathway is complex, leading to procedure-related delays. Dedicated TAVI coordinators can improve pathway efficiency. COORDINATE was a pilot observational prospective registry at three German centers that enrolled consecutive elective patients with severe aortic stenosis undergoing TAVI to investigate the impact a TAVI coordinator program. Pathway parameters and clinical outcomes were assessed before (control group) and after TAVI coordinator program implementation (intervention phase). The number of repeated diagnostics remained unchanged after implementation. Patients with separate hospitalizations for screening and TAVI had long delays, which increased after implementation (65 days pre- vs. 103 days post-implementation); hospitalizations combining these were more efficient. The mean time between TAVI and hospital discharge remained constant. Nurse (p = 0.001) and medical technician (p = 0.008) working hours decreased. Patient satisfaction increased, and more consistent/intensive contact between patients and staff was reported. TAVI coordinators provided more post-TAVI support, including discharge management. No adverse effects on post-procedure or 30-day outcomes were seen. This pilot suggests that TAVI coordinator programs may improve aspects of the TAVI pathway, including post-TAVI care and patient satisfaction, without compromising safety. These findings will be further investigated in the BENCHMARK registry.

DIVE/DPV registries: benefits and risks of analog insulin use in individuals 75 years and older with type 2 diabetes mellitus.

INTRODUCTION: The aims of this study were to characterize insulin-treated individuals aged ≥75 years with type 2 diabetes using basal insulin analogs (BIA) or regular insulins (human insulin (HI)/neutral protamine Hagedorn (NPH)) and to compare the benefits and risks. RESEARCH DESIGN AND METHODS: The analysis was based on data from the DPV (Diabetes-Patienten-Verlaufsdokumentation) and DIVE (DIabetes Versorgungs-Evaluation) registries. To balance for confounders, propensity score matching for age, sex, diabetes duration, body mass index and hemoglobin A1c (HbA1c) as covariates was performed. RESULTS: Among 167 300 patients aged ≥75 years with type 2 diabetes (mean age, 80.3 years), 9601 subjects used insulin regimens with basal insulin (HI/NPH or BIA). Of these 8022 propensity score-matched subjects were identified. The mean diabetes duration was ~12 years and half of the patients were male. At the time of switch, patients provided with BIA experienced more dyslipidemia (89.3% vs 85.9%; p=0.002) and took a greater number of medications (4.3 vs 3.7; p<0.001) and depression was more prevalent (8.4% vs 6.5%; p=0.01). Aggregated to the most actual treatment year, BIA was associated with a higher percentage of patients using basal-supported oral therapy (42.6% vs 14.4%) and intensified conventional insulin therapy (44.3% vs 29.4%) and lower total daily insulin doses (0.24 IU/kg/day vs 0.30 IU/kg/day; p<0.001). The study did not reveal significant differences in efficacy (HbA1c 7.4% vs 7.3%; p=0.06), hospitalizations (0.7 vs 0.8 per patient-year (PY); p=0.15), length of stay (16.3 vs 16.1 days per PY; p=0.53), or rates of severe hypoglycemia (4.07 vs 4.40 per 100 PY; p=0.88), hypoglycemia with coma (3.64 vs 3.26 per 100 PY; p=0.88) and diabetic ketoacidosis (0.01 vs 0.03 per 100 PY; p=0.36). CONCLUSION: BIA were used in more individually and patient-centered therapy regimens compared with HI/NPH in patients with a mean age of 80 years. Both groups were slightly overtreated with mean HbA1c <7.5%. The risk of severe hypoglycemia was low and independent of insulin type. Further analyses of elderly patients with type 2 diabetes are needed to provide evidence for best practice approaches in this age group.

Validation of the Microlife BP B3 AFIB upper arm blood pressure monitor in adults and adolescents according to the ANSI/AAMI/ISO 81060-2:2019 protocol.

OBJECTIVE: Aim of this study was to validate the Microlife BP B3 AFIB/enterprise resource planning (ERP) No: BP3KT1-3 N blood pressure (BP) monitor according to the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization (ISO) 81060-2:2019 in adolescents and adults from a general population. METHODS: BP measurements on the upper arm were performed in 85 subjects (age range 12-88 years), using the Microlife BP B3 AFIB and a standard mercury reference sphygmomanometer. RESULTS: A total of 255 valid BP comparisons were performed for the present validation analysis. The mean ± SD difference between the test and the reference device was 0.70 ± 7.05 mmHg for SBP (pass criterion ≤5 mmHg) and -0.85 ± 4.70 mmHg for DBP (pass criterion ≤5 mmHg) with the SD below the required value of ≤8 mmHg. The mean ± SD of the intraindividual differences between the test and the reference device was 0.70 ± 5.87 mmHg for SBP (pass criterion for the SD ≤6.90 mmHg) and -0.85 ± 4.19 mmHg for DBP (pass criterion for the SD ≤6.88 mmHg). CONCLUSION: The Microlife BP B3 AFIB/ERP No: BP3KT1-3 N has passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 protocol and can be recommended for home BP measurements in adolescents and adults.

Type 2 diabetes in older patients: an analysis of the DPV and DIVE databases.

BACKGROUND: The clinical profile differs between old and young patients with type 2 diabetes mellitus (T2DM). We explored, based on a large real-world database, patient and disease characteristics and actual treatment patterns by age. METHODS: The analysis was based on the DIVE and DPV registries of patients with T2DM. Patients were analyzed by age groups 50-59 (middle-young), 60-69 (young-old), 70-79 (middle-old), 80-89 (old), and 90 years or more (oldest-old). RESULTS: A total of 396,719 patients were analyzed, of which 17.7% were 50-59 years, 27.7% 60-69 years, 34.3% 70-79 years, 18.3% 80-89 years and 2.0% at least 90 years. We found that (a) T2DM in old and oldest-old patients was characterized much less by the presence of metabolic risk factors such as hypertension, obesity, dyslipidemia and smoking than in younger patients; (b) the HbA1c was much lower in oldest-old than in middle-young patients (7.2 ± 1.6% versus 8.0 ± 2.2%; p < 0.001), but it was associated with higher proportions of patients with severe hypoglycemia (7.0 versus 1.6%; p < 0.001); (c) this was potentially associated with the higher and increasing rates of insulin use in older patients (from 17.6% to 37.6%, p < 0.001) and the particular comorbidity profile of these patients, for example, chronic kidney disease (CKD); (d) patients with late diabetes onset had lower HbA1c values, lower bodyweight and less cardiovascular risk factors; (e) patients with a longer diabetes duration had a considerable increase in macrovascular and even more microvascular complications. CONCLUSION: In very old patients there is a need for frequent careful routine assessment and a tailored pharmacotherapy in which patient safety is much more important than blood-glucose-lowering efficacy.

Treatment intensification strategies after initial metformin therapy in adult patients with type-2 diabetes: results of the DPV and DIVE registries.

AIMS: Our study aimed to analyse treatment strategies after failure of initial metformin mono-therapy in adult patients with type-2 diabetes (T2DM). METHODS: The DIVE and DPV databases were combined and 16,681 adult patients with T2DM and metformin mono-therapy identified. Patients were analysed depending on whether metformin was continued (MET), or whether it was combined with other oral antidiabetics (OAD), with GLP-1 antagonists (GLP-1) or with basal insulin (BOT/BOT plus). Metabolic control, body weight and hypoglycaemia, micro- and macro-vascular events were compared within 1 year. RESULTS: A total of 11,911 (71%) participants continued MET until the end of the observation period, 3334 (20.0%) were intensified using OAD, 579 (3%) started on GLP-1, and 857 (5%) were initiated on BOT/BOTplus. Predictors of OAD and BOT/BOTplus therapy were elevated HbA1c, longer diabetes duration and the presence of micro- and macro-vascular diseases, while GLP-1 therapy was predicted by younger age, female sex, higher body weight and shorter diabetes duration. Micro- and macro-vascular diseases were negative predictors of GLP-1 therapy. Effects on HbA1c were highest in the BOT/BOTplus and OAD group, while GLP-1 treatment had the best effect on body weight. CONCLUSIONS: BOT/BOTplus and OAD show good HbA1c reduction even in patients with longer diabetes duration and in older patients. GLP-1 therapy is effective concerning weight loss in overweight patients and is more often used in females and patients with shorter diabetes duration. Interestingly, despite several studies showing positive effects on micro- and macro-vascular outcomes, prevalent macro-vascular diseases are no predictors of GLP-1 use.

Characteristics of Patients with Type-1 or Type-2 Diabetes Receiving Insulin Glargine U300: An Analysis of 7268 Patients Based on the DPV and DIVE Registries.

INTRODUCTION: Insulin glargine 300 U/ml (U300) was registered based on the EDITION clinical trial program. The aim of this database analysis was to describe the profile of adult U300 recipients with type-1 (T1DM) or type-2 diabetes (T2DM). METHODS: The analysis was based on data from the German DIVE/DPV registries. Patients were sampled in May (DIVE) and in March 2018 (DPV) and divided into those who commenced U300 within the 1st year (early adopters) or 2nd year (late adopters). Patients were further compared to patients receiving U100 during the same time period. RESULTS: Among 581,519 adult patients contained in the databases, 7268 with either T1 or T2DM received U300 and 22,050 U100. Baseline characteristics of U300 and U100 recipients did not differ substantially in both types of diabetes. Patients with T2DM had many risk factors and comorbidities. The median HbA1c (both T1DM and T2DM, 8.1% for U300 and 7.9 and 8.3% for U100) and fasting blood glucose values were similar at baseline. Severe hypoglycemia was less prevalent in T2DM and among recipients of U300 (3.1 vs. 3.9%), whereas in T1DM the rate was higher (10.6 vs. 10.1%). There were minor, but clinically probably irrelevant, differences in age and BMI for T1DM and T2DM between the first and second years. Patients with T2DM being initiated in the second year had a higher HbA1c value (8.6 vs. 8.3%) than those initiated during the first year. Patients in clinical practice showed substantially higher HbA1c values in both T1DM and T2DM, and doses used were lower than those reported from the EDITION trial program. U300 patients had a longer diabetes duration (T1 and T2DM), a higher BMI and received higher basal insulin doses (T1 and T2DM) compared to U100. While HbA1c was comparable, the rate of severe hypoglycemia under U300 was reduced in T2DM but not T1DM with or without adjustment for differences in baseline characteristics in T2DM. CONCLUSION: The data confirm the clinical profile documented for U300 in the EDITION studies during the first years of its registration. In an unselected patient population, there was a lesser rate of severe hypoglycemia but at a comparable HbA1c. FUNDING: German Centre for Diabetes Research (DZD) (01GI1106), the European Foundation for the Study of Diabetes (EFSD) and the German Diabetes Society (DDG). The DIVE registry (organized as Diabetes Agenda 2010 GmbH, Berlin, Germany) received funding from Sanofi, AstraZeneca, Bayer, and Abbott and was conducted under the auspices of diabetesDE.

Patient and disease characteristics of adult patients with type 1 diabetes in Germany: an analysis of the DPV and DIVE databases.

BACKGROUND: An understanding of the current status of patients with type 1 diabetes mellitus (T1DM) can help to provide appropriate treatment. METHODS: This was a retrospective analysis of the DIabetes Versorgungs-Evaluation (DIVE) and the Diabetes-Patienten-Verlaufsdokumentation (DPV) databases for Germany. RESULTS: The analysis included 56,250 people with T1DM (54.2% male), a median age of 36.8 years, and a median diabetes duration of 12.4 years. 15.3% were obese (body mass index ≥ 30kg/m2). Long-acting insulin analogs were used by 53.3%, short-acting analogs by 72.1%, and oral antidiabetic drugs by 4.7%. Patients had a median glycosylated hemoglobin (HbA1c) of 7.8%. There was a drop in HbA1c and an increase in the rate of hypertension, oral antidiabetic drug use, and in the rate of severe hypoglycemia (all p < 0.01) with age. Flash glucose monitoring (FGM) showed the best glucose values with fewer complications compared to other monitoring systems. HbA1c and FBG were lower in patients using a pump versus multiple daily injections (MDIs; 7.7 versus 7.9% and 7.8 versus 8.7 mmol/l; all adjusted p < 0.01). Patients had a lower risk of at least one severe hypoglycemic or DKA episode during the most recent treatment year with pump treatment compared to MDI (9.4% versus 10.5% and 4.7% versus 6.1%, both adjusted p < 0.01). CONCLUSION: The data demonstrated less-than-optimal glycemic control in the young, an increasing metabolic pattern in T1DM with increasing age, a benefit of FGM to improve HbA1c control and adverse effects, as well as benefits of pump treatment over MDIs.

Patient and disease characteristics of type-2 diabetes patients with or without chronic kidney disease: an analysis of the German DPV and DIVE databases.

BACKGROUND: To evaluate the characteristics of type 2 diabetes (T2DM) patients with or without chronic kidney disease (CKD) in Germany. METHODS: Using combined DPV/DIVE registry data, the analysis included patients with T2DM at least ≥ 18 years old who had an estimated glomerular filtration rate (eGFR) value available. CKD was defined as an eGFR < 60 mL/min/1.73 m2 or eGFR ≥ 60 mL/min/1.73 m2 and albuminuria (≥ 30 mg/g). Median values of the most recent treatment year per patient are reported. RESULTS: Among 343,675 patients with T2DM 171,930 had CKD. Patients with CKD had a median eGFR of 48.9 mL/min/1.73 m2 and 51.2% had a urinary albumin level ≥ 30 mg/g. They were older, had a longer diabetes duration and a higher proportion was females compared to patients without CKD (all p < 0.001). More than half of CKD patients (53.5%) were receiving long-acting insulin-based therapy versus around 39.1% of those without (p < 0.001). CKD patients also had a higher rate of hypertension (79.4% vs 72.0%; p < 0.001). The most common antihypertensive drugs among CKD patients were renin-angiotensin-aldosteron system inhibitors (angiotensin converting enzyme inhibitors 33.8%, angiotensin receptor blockers 14.2%) and diuretics (40.2%). CKD patients had a higher rate of dyslipidemia (88.4% vs 86.3%) with higher triglyceride levels (157.9 vs 151.0 mg/dL) and lower HDL-C levels (men: 40.0 vs 42.0 mg/dL; women: 46.4 vs 50.0 mg/dL) (all p < 0.001) and a higher rate of hyperkalemia (> 5.5 mmol/L: 3.7% vs. 1.0%). Comorbidities were more common among CKD patients (p < 0.001). CONCLUSION: The results illustrate the prevalence and morbidity burden associated with diabetic kidney disease in patients with T2DM in Germany. The data call for more attention to the presence of chronic kidney disease in patients with diabetes, should trigger intensified risk factor control up and beyond the control of blood glucose and HbA1c in these patients. They may also serve as a trigger for future investigations into this patient population asking for new treatment options to be developed.

Periprocedural anticoagulation during left atrial ablation: interrupted and uninterrupted vitamin K-antagonists or uninterrupted novel anticoagulants.

BACKGROUND: There is a lack of data on anticoagulation requirements during ablation of atrial fibrillation (AF). This study compares different oral anticoagulation (OAC) strategies to evaluate risk of bleeding and thromboembolic complications. METHODS: We conducted a single-centre study in patients undergoing left atrial ablation of AF. Three groups were defined: 1) bridging: interrupted vitamin-K-antagonists (VKA), INR ≤2, and bridging with heparin; 2) VKA: uninterrupted VKA and INR of > 2; 3) DOAC: uninterrupted direct oral anticoagulants. Bleeding complications, thromboembolic events and peri-procedural heparin doses were assessed. RESULTS: In total, 780 patients were documented. At 48 h, major complications were more common in the bridging group compared to uninterrupted VKA and DOAC groups (OR: 3.42, 95% CI: 1.29-9.10 and OR: 3.01, 95% CI: 1.19-7.61), largely driven by differences in major pericardial effusion (OR: 4.86, 95% CI: 1.56-15.99 and OR: 4.466, 95% CI, 1.52-13.67) and major vascular events (OR: 2.92, 95% CI: 0.58-14.67 and OR: 9.72, 95% CI: 1.00-94.43). Uninterrupted VKAs and DOACs resulted in similar odds of major complications (overall OR: 1.14, 95% CI: 0.44-2.92), including cerebrovascular events (OR: 1.21, 95% CI: 0.27-5.45). However, whereas only TIAs were observed in DOAC and bridging groups, strokes also occurred in the VKA group. Rates of minor complications (pericardial effusion, vascular complications, gastrointestinal hemorrhage) and major/minor groin hemorrhage were similar across groups. CONCLUSION: Our dataset illustrates that uninterrupted VKA and DOAC have a better risk-benefit profile than VKA bridging. Bridging was associated with a 4.5× increased risk of complications and should be avoided, if possible.