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Abstract Background Transcatheter aortic valve implantation (TAVI) can either be conducted as an elective (scheduled in advance) or a non-elective procedure performed during an unplanned hospital admission. The objective of this study was to compare the outcomes of elective and non-elective TAVI patients. Methods This single-centre study included 512 patients undergoing transfemoral TAVI between October 2018 and December 2020; 378 (73.8%) were admitted for elective TAVI, 134 (26.2%) underwent a non-elective procedure. Our TAVI programme entails an optimized fast-track concept aimed at minimizing the total length of stay to ≤ 5 days for elective patients which in the German healthcare system is currently defined as the minimal time period to safely perform TAVI. Clinical characteristics and survival rates at 30 days and 1 year were analysed. Results Patients who underwent non-elective TAVI had a significantly higher comorbidity burden. Median duration from admission to discharge was 6 days (elective group 6 days versus non-elective group 15 days; p

Abstract Background Mitral valve (MV) surgery has traditionally been performed by conventional sternotomy (CS), but more recently minimally invasive surgery (MIS) has become another treatment option. The aim of this study is to compare short- and long-term results of MV surgery after CS and MIS. Methods This study was a retrospective propensity-matched analysis of MV operations between January 2005 and December 2015. Results Among 1357 patients, 496 underwent CS and 861 MIS. Matching resulted in 422 patients per group. The procedure time was longer with MIS than CS (192 vs. 185 min; p = 0.002) as was cardiopulmonary bypass time (133 vs. 101 min; p

Abstract Background To evaluate the outcomes of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) in a real-world setting through a patient-level meta-analysis. Methods The meta-analysis included patients of three European multicenter, prospective, observational registry studies that compared outcomes after Edwards SAPIEN 3 or XT TAVI with (n = 339) or without (n = 355) BAV. Unadjusted and adjusted pooled odds ratios (with 95% confidence intervals) were calculated for procedural and 30-day outcomes. Results Median procedural time was shorter in the non-BAV group than in the BAV group (73 versus 93 min, p = 0.001), as was median fluoroscopy time (7 versus 11 min, p = 0.001). Post-delivery balloon dilation (15.5% versus 22.4%, p = 0.02) and catecholamine use (9.0% vs. 17.9%; p = 0.016) was required less often in the non-BAV group than in the BAV group with the difference becoming insignificant after multiple adjustment. There was a reduced risk for periprocedural atrioventricular block during the intervention (1.4% versus 4.1%, p = 0.035) which was non-significant after adjustment. The rate of moderate/severe paravalvular regurgitation post-TAVI was 0.6% in the no-BAV group versus 2.7% in the BAV group. There were no between-group differences in the risk of death, stroke or other adverse clinical outcomes at day 30. Conclusions This patient-level meta-analysis of real-world data indicates that TAVI performed without BAV is advantageous as it has an adequate device success rate, reduced procedure time and no adverse effects on short-term clinical outcomes.

Abstract Background Coronary artery disease (CAD) is associated with poorer outcomes after aortic valve replacement (AVR). For high-risk patients with complex CAD, combined transcatheter aortic valve replacement (TAVR) plus off-pump/minimally-invasive coronary artery bypass (OPCAB/MIDCAB) has been proposed. Methods A prospective registry analysis was performed to compare the characteristics and outcomes of patients undergoing TAVR+OP/MIDCAB with those undergoing TAVR plus percutaneous coronary intervention (PCI) and surgical AVR plus coronary artery bypass grafting (CABG) between 2008 and 2015 at a single site in Germany. Results 464 patients underwent SAVR+CABG, 50 underwent TAVR+OP/MIDCAB, and 112 underwent TAVR+PCI. The mean ages (p

Abstract Background In heart failure (HF) patients with implantable cardioverter defibrillators (ICD) or cardiac resynchronisation therapy defibrillators (CRT-D), remote monitoring has been shown to result in at least non-inferior outcomes relative to in-clinic visits. We aimed to provide further evidence for this effect, and to assess whether adding telephone follow-ups to remote follow-ups influenced outcomes. Methods InContact was a prospective, randomised, multicentre study. Subjects receiving quarterly automated follow-up only (telemetry group) were compared to those receiving personal physician contact. Personal contact patients were further divided into those receiving automated follow-up plus a telephone call (remote+phone subgroup) or in-clinic visits only. Results Two hundred and ten patients underwent randomisation (telemetry n = 102; personal contact n = 108 [remote+phone: n = 53; visit: n = 55]). Baseline characteristics were comparable between groups and subgroups. Over 12 months, 34.8% of patients experienced deterioration of their Packer Clinical Composite Response, with no significant difference between the telemetry group and personal care (p > 0.999), remote+phone (p = 0.937) or visit (p = 0.940) patients; predefined non-inferiority criteria were met. Mortality rates (5.2% overall) were comparable between groups and subgroups (p = 0.832/p = 0.645), as were HF-hospitalisation rates (11.0% overall; p = 0.605/p = 0.851). The proportion of patients requiring ≥1 unscheduled follow-up was nominally higher in telemetry and remote+phone groups (42.2 and 45.3%) compared to the visit group (29.1%). Overall, ≥ 1 ICD therapy was delivered to 15.2% of patients. Conclusion In HF patients with ICDs/CRT-Ds, quarterly remote follow-up only over 12 months was non-inferior to regular personal contact. Addition of quarterly telephone follow-ups to remote monitoring does not appear to offer any clinical advantage. Trial registration clinicaltrials.gov: NCT01200381 (retrospectively registered on September 13th 2010).

Abstract 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.

Abstract Background In older patients with aortic stenosis (AS) undergoing TAVI, the potential role of prior CGA is not well established. To explore the value of comprehensive geriatric assessment (CGA) for predicting mortality and/or hospitalisation within the first 3 months after transcatheter aortic valve implantation (TAVI). Methods An international, multi-centre, prospective registry (CGA-TAVI) was established to gather data on CGA results and medium-term outcomes in geriatric patients undergoing TAVI. Logistic regression was used to evaluate the predictive value of a multidimensional prognostic index (MPI); a short physical performance battery (SPPB); and the Silver Code, which was based on administrative data, for predicting death and/or hospitalisation in the first 3 months after TAVI (primary endpoint). Results A total of 71 TAVI patients (mean age 85.4 years; mean log EuroSCORE I 22.5%) were enrolled. Device success according to VARC criteria was 100%. After adjustment for selected baseline characteristics, a higher (poorer) MPI score (OR: 3.34; 95% CI: 1.39–8.02; p = 0.0068) and a lower (poorer) SPPB score (OR: 1.15; 95% CI: 1.01–1.54; p = 0.0380) were found to be associated with an increased likelihood of the primary endpoint. The Silver Code did not show any predictive ability in this population. Conclusions Several aspects of the CGA have shown promise for being of use to physicians when predicting TAVI outcomes. While the MPI may be useful in clinical practice, the SPPB may be of particular value, being simple and quick to perform. Validation of these findings in a larger sample is warranted. Trial registration The trial was registered in ClinicalTrials.gov on November 7, 2013 ( NCT01991444 ).

Abstract Background There is an increasing trend towards shorter hospital stays after transcatheter aortic valve implantation (TAVI), in particular for patients undergoing the procedure via transfemoral (TF) access. Preliminary data suggest that there exists a population of patients that can be discharged safely very early after TF-TAVI. However, current evidence is limited to few retrospective studies, encompassing relatively small sample sizes. Methods The Feasibility And Safety of early discharge after Transfemoral TAVI (FAST-TAVI) registry is a prospective observational registry that will be conducted at 10 sites across Italy, the Netherlands and the UK. Patients will be included if they have been scheduled to undergo TF-TAVI with the balloon-expandable SAPIEN 3 transcatheter heart valve (THV; Edwards Lifesciences, Irvine, CA). The primary endpoint is a composite of all-cause mortality, vascular-access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding, occurring during the first 30 days after hospital discharge. Patients will be stratified according to whether they were high or low risk for early discharge (≤3 days) (following pre-specified criteria), and according to whether or not they were discharged early. Secondary endpoints will include time-to-event (Kaplan–Meier) analysis for the primary outcome and its individual components, analysis of the relative costs of early and late discharge, and changes in short- and long-term quality of life. Multivariate logistic regression will be used to identify factors that indicate that a patient may be suitable for early discharge. Discussion The data gathered in the FAST-TAVI registry should help to clarify the safety of early discharge after TF-TAVI and to identify patient and procedural characteristics that make early discharge from hospital a safe and cost-effective strategy. Trial registration ClinicalTrials.gov Identifier: NCT02404467 (registration first received March 23rd 2015).

Abstract Background Effective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure. Cryoballoon (CB) ablation has been developed as an alternative to the use of radiofrequency (RF) energy for electrical isolation of the pulmonary veins. Herein, we provide long-term data regarding the efficacy of CB ablation in comparison to RF. Methods FreezeAF was a randomised non-inferiority study comparing CB ablation with RF ablation for the treatment of patients with drug-refractory paroxysmal AF. Procedural success for the long-term follow-up (30 months) was defined as freedom from AF with an absence of persistent complications. Results Of the 315 patients that were randomised and received catheter ablation, 292 (92.7%) completed the 30-month follow-up (147 in the RF group and 145 in the CB group). The baseline characteristics of the RF and CB groups were similar. Single-procedure success was achieved by 40% of patients in the RF group and 42% of the CB group (p

Abstract Background The reduction of blood pressure alone does not eliminate the increased risk of arterial hypertension. Whilst concomitant metabolic risk factors have been shown to be responsible, the available pharmacotherapy has differential effects on these metabolic risk factors. For example, diuretics and betablockers worsen glucose metabolism, hence the starting point of the current subanalysis of the CHILI (Candesartan in patients with HIgher cardiovascuLar rIsk) study was the assumption that an angiotensin receptor blocker may counterbalance the metabolic effects of a low dose diuretic in patients with several metabolic risk factors. Methods The present study was performed as a non-interventional observational study in Germany. Patients with previously uncontrolled hypertension with at least one further risk factor in which physicians deemed a treatment with 16 mg Candesartan/12.5 mg HCTZ to be necessary were included. The risk factors were calculated in patient subgroups with diabetes, the metabolic syndrome (MetSyn) and neither condition (control). The risk of cardiovascular mortality within the next 10 years was calculated using the SCORE algorithm of the ESC. Results Between August 2006 and February 2007 a total of 3,787 patients were included into the non-interventional trial. Patients were 62.2 ± 11.3 years old, 48.1% were female, 97.5% had at least one additional risk factor. Blood pressure was reduced by -27.2/-13.4 mmHg with only minor non significant variations between patient groups. Waist circumference was reduced (P < 0.0001) and HDL-C elevated (P < 0.05) in every subgroup except the control subgroup. Fasting blood glucose was reduced by -5.6 ± 21.6% (P < 0.0001 vs. baseline and vs. control) as well as triglycerides (-4.9 ± 29.4%; P < 0.0001 vs. baseline and vs. control). The SCORE value was reduced substantially (-8.7, -3.2 and -2.7% in patients with diabetes, the metabolic syndrome or neither). Conclusion The present study demonstrates that a 16 mg candesartan/12.5 mg HCTZ based treatment results in a pronounced blood pressure reduction and was associated with a favourable change in metabolic risk factors such as HDL cholesterol, triglycerides and blood glucose. These data indicate that metabolic effects observed in clinical trials like ALPINE, SCOPE or CHARM can also be observed in an unselected patient population in primary care.

Background: The reduction of blood pressure alone does not eliminate the increased risk of arterial hypertension. Whilst concomitant metabolic risk factors have been shown to be responsible, the available pharmacotherapy has differential effects on these metabolic risk factors. For example, diuretics and betablockers worsen glucose metabolism, hence the starting point of the current subanalysis of the CHILI (Candesartan in patients with HIgher cardiovascuLar rIsk) study was the assumption that an angiotensin receptor blocker may counterbalance the metabolic effects of a low dose diuretic in patients with several metabolic risk factors.Methods: The present study was performed as a non-interventional observational study in Germany. Patients with previously uncontrolled hypertension with at least one further risk factor in which physicians deemed a treatment with 16 mg Candesartan/12.5 mg HCTZ to be necessary were included. The risk factors were calculated in patient subgroups with diabetes, the metabolic syndrome (MetSyn) and neither condition (control). The risk of cardiovascular mortality within the next 10 years was calculated using the SCORE algorithm of the ESC.Results: Between August 2006 and February 2007 a total of 3,787 patients were included into the non-interventional trial. Patients were 62.2 +/- 11.3 years old, 48.1% were female, 97.5% had at least one additional risk factor. Blood pressure was reduced by -27.2/-13.4 mmHg with only minor non significant variations between patient groups. Waist circumference was reduced (P < 0.0001) and HDL-C elevated (P < 0.05) in every subgroup except the control subgroup. Fasting blood glucose was reduced by -5.6 +/- 21.6% (P < 0.0001 vs. baseline and vs. control) as well as triglycerides (-4.9 +/- 29.4%; P < 0.0001 vs. baseline and vs. control). The SCORE value was reduced substantially (-8.7, -3.2 and -2.7% in patients with diabetes, the metabolic syndrome or neither).Conclusion: The present study demonstrates that a 16 mg candesartan/12.5 mg HCTZ based treatment results in a pronounced blood pressure reduction and was associated with a favourable change in metabolic risk factors such as HDL cholesterol, triglycerides and blood glucose. These data indicate that metabolic effects observed in clinical trials like ALPINE, SCOPE or CHARM can also be observed in an unselected patient population in primary care. [ABSTRACT FROM AUTHOR]

Background: Coronary artery disease (CAD) is associated with poorer outcomes after aortic valve replacement (AVR). For high-risk patients with complex CAD, combined transcatheter aortic valve replacement (TAVR) plus off-pump/minimally-invasive coronary artery bypass (OPCAB/MIDCAB) has been proposed., Methods: A prospective registry analysis was performed to compare the characteristics and outcomes of patients undergoing TAVR+OP/MIDCAB with those undergoing TAVR plus percutaneous coronary intervention (PCI) and surgical AVR plus coronary artery bypass grafting (CABG) between 2008 and 2015 at a single site in Germany., Results: 464 patients underwent SAVR+CABG, 50 underwent TAVR+OP/MIDCAB, and 112 underwent TAVR+PCI. The mean ages (p < 0.001) and logistic EuroSCOREs (p < 0.001) were similarly higher in TAVR+OP/MIDCAB and TAVR+PCI patients compared to SAVR+CABG patients. Prior cardiac surgery was more common in TAVR+PCI than in TAVR+OP/MIDCAB and SAVR+CABG patients (p < 0.001). Procedural times were shortest (p < 0.001), creatine kinase (muscle brain) levels least elevated (p < 0.001), pericardial tamponade least common (p = 0.027), and length of hospital stay shortest (p = 0.011) in TAVR+PCI, followed by TAVR+OP/MIDCAB and SAVR+CABG patients. In-hospital mortality was highest for TAVR+OP/MIDCAB patients (18.0%) with comparable rates for TAVR+PCI and SAVR+CABG groups (9.0 and 6.9%; p = 0.009). Mortality by 12 months was more probable after TAVR+OP/MIDCAB (HR: 2.17, p = 0.002) and TAVR/PCI (HR: 1.63, p = 0.010) than after SAVR+CABG, with the same true of rehospitalisation (HR: 2.39, p = 0.003 and HR: 1.63, p = 0.033)., Conclusions: TAVR+OP/MIDCAB patients share many characteristics with TAVR+PCI patients, with only slightly poorer long-term outcomes. In patients ineligible for SAVR+CABG and TAVR+PCI, hybrid interventions are reasonable second-line options.

Background: In older patients with aortic stenosis (AS) undergoing TAVI, the potential role of prior CGA is not well established. To explore the value of comprehensive geriatric assessment (CGA) for predicting mortality and/or hospitalisation within the first 3 months after transcatheter aortic valve implantation (TAVI)., Methods: An international, multi-centre, prospective registry (CGA-TAVI) was established to gather data on CGA results and medium-term outcomes in geriatric patients undergoing TAVI. Logistic regression was used to evaluate the predictive value of a multidimensional prognostic index (MPI); a short physical performance battery (SPPB); and the Silver Code, which was based on administrative data, for predicting death and/or hospitalisation in the first 3 months after TAVI (primary endpoint)., Results: A total of 71 TAVI patients (mean age 85.4 years; mean log EuroSCORE I 22.5%) were enrolled. Device success according to VARC criteria was 100%. After adjustment for selected baseline characteristics, a higher (poorer) MPI score (OR: 3.34; 95% CI: 1.39-8.02; p = 0.0068) and a lower (poorer) SPPB score (OR: 1.15; 95% CI: 1.01-1.54; p = 0.0380) were found to be associated with an increased likelihood of the primary endpoint. The Silver Code did not show any predictive ability in this population., Conclusions: Several aspects of the CGA have shown promise for being of use to physicians when predicting TAVI outcomes. While the MPI may be useful in clinical practice, the SPPB may be of particular value, being simple and quick to perform. Validation of these findings in a larger sample is warranted., Trial Registration: The trial was registered in ClinicalTrials.gov on November 7, 2013 ( NCT01991444 ).

Background: There is an increasing trend towards shorter hospital stays after transcatheter aortic valve implantation (TAVI), in particular for patients undergoing the procedure via transfemoral (TF) access. Preliminary data suggest that there exists a population of patients that can be discharged safely very early after TF-TAVI. However, current evidence is limited to few retrospective studies, encompassing relatively small sample sizes., Methods: The Feasibility And Safety of early discharge after Transfemoral TAVI (FAST-TAVI) registry is a prospective observational registry that will be conducted at 10 sites across Italy, the Netherlands and the UK. Patients will be included if they have been scheduled to undergo TF-TAVI with the balloon-expandable SAPIEN 3 transcatheter heart valve (THV; Edwards Lifesciences, Irvine, CA). The primary endpoint is a composite of all-cause mortality, vascular-access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding, occurring during the first 30 days after hospital discharge. Patients will be stratified according to whether they were high or low risk for early discharge (≤3 days) (following pre-specified criteria), and according to whether or not they were discharged early. Secondary endpoints will include time-to-event (Kaplan-Meier) analysis for the primary outcome and its individual components, analysis of the relative costs of early and late discharge, and changes in short- and long-term quality of life. Multivariate logistic regression will be used to identify factors that indicate that a patient may be suitable for early discharge., Discussion: The data gathered in the FAST-TAVI registry should help to clarify the safety of early discharge after TF-TAVI and to identify patient and procedural characteristics that make early discharge from hospital a safe and cost-effective strategy., Trial Registration: ClinicalTrials.gov Identifier: NCT02404467 (registration first received March 23rd 2015).

Background: Effective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure. Cryoballoon (CB) ablation has been developed as an alternative to the use of radiofrequency (RF) energy for electrical isolation of the pulmonary veins. Herein, we provide long-term data regarding the efficacy of CB ablation in comparison to RF., Methods: FreezeAF was a randomised non-inferiority study comparing CB ablation with RF ablation for the treatment of patients with drug-refractory paroxysmal AF. Procedural success for the long-term follow-up (30 months) was defined as freedom from AF with an absence of persistent complications., Results: Of the 315 patients that were randomised and received catheter ablation, 292 (92.7%) completed the 30-month follow-up (147 in the RF group and 145 in the CB group). The baseline characteristics of the RF and CB groups were similar. Single-procedure success was achieved by 40% of patients in the RF group and 42% of the CB group (p < 0.001 for non-inferiority). When including re-do procedures in the analysis, the multiple procedure success rate was 72% in the RF group and 76% in the CB group., Conclusion: The data provide long-term evidence that CB ablation is non-inferior to RF ablation, with high proportions of patients reporting freedom from AF 30 months after the index procedure., Trial Registration: ClinicalTrials.gov Identifier: NCT00774566 ; first registered October 16, 2008; first patient included October 20, 2008.

Background: Severe aortic stenosis (AS) is a common, serious valve disease in which no effective medical therapy is available and, if not treated by intervention, has a 5-year survival of only 40-60%. Despite the availability of guidelines supporting the effective use of surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) to treat the majority of these patients, adherence to these guidelines in clinical practice is still unsatisfactory. Several recent studies have emphasised the necessity for improved communication between multidisciplinary teams, with the aim to ensure that severe AS patients receive appropriate treatment., Methods/design: IMPULSE is a prospective, multicentre, European registry designed to gather data over 12 months on the treatment decisions made by referring physicians for patients newly diagnosed with severe AS. Each patient has a follow-up of 3 months. The study will consist of two observational phases to assess the appropriateness and rate of referral based on current guidelines prior to and after an interventional phase aiming to determine whether a simple quality of care intervention improves patient management., Discussion: Data will be analysed firstly, to determine the appropriateness of treatment decisions for the management of severe AS in current European clinical practice, and secondly, to evaluate the effectiveness of facilitated data relay from a designated echocardiography department nurse to the referring physician early after diagnosis in improving quality of care. Additionally, variables will be identified that are associated with inappropriate decision-making. Collectively, the aim will be to design a clinical pathway that will improve the timely management of patients with newly diagnosed severe AS.

Background: Transcatheter aortic valve implantation via the transfemoral route (TF-TAVI) is commonly performed as a treatment for severe aortic stenosis (AS) in patients at high surgical risk. Pre-deployment balloon aortic valvuloplasty (BAV) has generally been considered an essential step for preparing the valve landing zone for receipt of the prosthesis. However, there is little evidence supporting the clinical value of BAV, while several associated complications have been documented. This has provoked several groups to evaluate the feasibility and safety of omitting BAV form the TF-TAVI procedure (direct TF-TAVI), with encouraging results. However, studies comparing the clinical outcomes of direct TF-TAVI to standard TF-TAVI are lacking., Methods: EASE-IT TF is a prospective, observational, two-armed, multicentre registry designed to gather data on procedural aspects, adverse events and survival rates associated with direct TF-TAVI using the Edwards SAPIEN 3 balloon-expandable prosthesis., Discussion: EASE-IT-TF data will be analysed firstly to determine the risks and benefits associated with direct TF-TAVI vs. standard TF-TAVI, and secondly to identify associations between patient variables and specific outcomes. This may assist identification of patients who stand to benefit from direct TF-TAVI, therefore contributing to clinical reductions in TF-TAVI-associated morbidity and mortality rates in high-risk AS patients., Trial Registrations: Clinictrials.gov: NCT02760771.

Background: Azilsartan medoxomil (AZL-M), has been demonstrated to be more effective than the other sartans currently in use; however, there is insufficient information available comparing it with ACE-inhibitors. Therefore, we aimed to compare the efficacy, safety, and tolerability of AZL-M with that of ACE-inhibitors in a real life clinical setting., Methods: The EARLY registry is a prospective, observational, national, multicentre registry with a follow-up period of 12 months. There were two principal objectives: 1) documentation of the achievement of target BP values set according to recent national and international guidelines, and 2) description of the safety profile of AZL-M., Results: A total of 3 849 patients with essential arterial hypertension were recruited from primary care offices in Germany. Patients who initiated monotherapy at baseline comprising either AZL-M or an ACE-inhibitor were included at a ratio of seven to three. Results demonstrated that a blood pressure target of <140/90 mmHg was achieved by a significantly greater proportion of patients in the AZL-M group (61.1 %) compared with the ACE-inhibitor group (56.4 %; p < 0.05; OR, 1.21; 95 % CI, 1.03-1.42), with this finding maintained after adjusting for differences in baseline characteristics. AZL-M appeared to have an equivalent safety profile to the ACE-inhibitors, with a similar incidence of adverse events in the two patient groups (p = 0.73)., Conclusions: These data add to the results of previous randomized controlled clinical trials suggesting that, compared with other agents that target the renin-angiotensin system, AZL-M provides statistically significant albeit small improvements in blood pressure control.

Background: In cases where antidiabetic monotherapy is unable to sufficiently control glucose levels in patients with type-2 diabetes, treatment needs to be intensified. Determining factors that may be predictors for the occurrence of comorbidities in these patients is essential for improving the efficacy of clinical diabetes care., Methods: The DiaRegis prospective cohort study included 3,810 type-2 diabetics for whom the treating physician aimed to intensify and optimise antidiabetic treatment due to insufficient glucose control. Treatment intensification was defined as increasing the dose of the originally prescribed drug, and/or selecting an alternative drug, and/or prescribing an additional drug. The aims were to monitor the co-morbidity burden of type-2 diabetic patients over a follow-up of two years, and to identify multivariable adjusted predictors for the development of comorbidity and cardiovascular events., Results: A total of 3,058 patients completed the 2 year follow-up. A substantial proportion of these patients had co-morbidities such as vascular disease, neuropathy, and heart failure at baseline. After treatment intensification, there was an increased use of DPP-4 inhibitors, insulin, and GLP-1 analogues, achieving reductions in HbA1c, fasting plasma glucose, and postprandial glucose. During the 2 year period 2.5% of patients (n = 75) died, 3.2% experienced non-fatal macrovascular events, 11.9% experienced microvascular events, and 4.3% suffered onset of heart failure. Predictors for combined macro-/microvascular complications/heart failure/death were found to be age (OR 1.36; 95% CI 1.10-1.68), prior vascular disease (1.73; 1.39-2.16), and history of heart failure (2.78; 2.10-3.68)., Conclusions: Determining the factors that contribute to co-morbidities during intensive glucose-lowering treatment is essential for improving the efficacy of diabetes care. Our results indicate that age, prior vascular disease, and heart failure constitute important predictors of poor cardiovascular outcomes in patients receiving such therapy.

Background: In patients with severe calcific aortic stenosis, balloon aortic valvuloplasty (BAV) is routinely performed in order to pre-dilate the stenosed aortic valve prior to transcatheter aortic valve implantation (TAVI). Although pre-dilation is considered to be essential for the preparation of the valve landing zone, there is no clear evidence to support its clinical value. In contrast, BAV has been suggested to be linked to several complications. Notably, while preliminary evidence has supported the feasibility and safety of TAVI without pre-dilation, larger studies directly comparing the benefit/risk profile of TAVI in the presence and absence of pre-dilation are required., Methods/design: Therefore, a prospective, two-armed, multicenter registry (EASE-IT) was designed to obtain essential data concerning procedural success rates, adverse events, and mortality in a large cohort of patients undergoing transapical (TA)-TAVI using the Edwards SAPIEN 3 balloon expandable heart valves with and without pre-ballooning., Discussion: Data provided by EASE-IT will be used to assess the relevance of BAV during the TAVI procedure and to investigate associations between patient characteristics and outcomes. Therefore, results obtained from the EASE-IT registry could contribute to reduced rates of TAVI-associated morbidity and mortality in patients with severe, calcific aortic stenosis., Trial Registration: ClinicalTrials.gov Identifier: NCT02127580.

Background: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed approach that provides an alternative delivery route for valve replacement in patients with vascular abnormalities or existing comorbidities. While initial studies have shown the principal efficacy and safety, the real world effectiveness and safety of this approach remains to be fully assessed., Methods/design: In this regard, the Registry Of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) represents the first multicenter, multinational prospective documentation of the course and outcome of patients with severe calcific aortic stenosis (AS) undergoing TAo-TAVI. ROUTE commenced in February 2013 with the goal of consecutively enrolling 300 patients at up to 22 sites across Europe. The primary objective of ROUTE is to determine the 30-day mortality associated with TAo-TAVI using the Edwards SAPIEN THV (Edwards Lifesciences, Irvine, CA). In addition, ROUTE aims to quantify complications, predictors of patient outcome and the value of CT guided valve sizing., Discussion: Findings from this landmark registry will provide important information regarding procedural success rates and early mortality in patients undergoing TAo-TAVI., Trial Registration: Identifier: NCT01991431.

Background: Arterial hypertension is highly prevalent but poorly controlled. Blood pressure (BP) reduction substantially reduces cardiovascular morbidity and mortality. Recent randomized, double-blind clinical trials demonstrated that azilsartan medoxomil (AZM) is more effective in reducing BP than the ubiquitary ACE inhibitor ramipril. Therefore, we aimed to test whether these can be verified under clinical practice conditions., Methods/design: The "Treatment with Azilsartan Compared to ACE-Inhibitors in Anti-Hypertensive Therapy" (EARLY) registry is a prospective, observational, national, multicenter registry with a follow-up of up to 12 months. It will include up to 5000 patients on AZM or ACE-inhibitor monotherapy in a ratio of 7 to 3. A subgroup of patients will undergo 24-hour BP monitoring. EARLY has two co-primary objectives: 1) Description of the safety profile of azilsartan and 2) achievement of BP targets based on recent national and international guidelines for patients treated with azilsartan in comparison to those treated with ACE-inhibitors. The most important secondary endpoints are the determination of persistence with treatment and the documentation of cardiovascular and renal events. Recruitment commenced in January 2012 and will be completed by February 2013., Conclusions: The data obtained will supplement previous results from randomized controlled trials to document the potential value of utilizing azilsartan medoxomil in comparison to ACE-inhibitor treatment for target BP achievement in clinical practice.