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Objectives Renal denervation (RDN) proved to significantly lower blood pressure (BP) at 2–6 months in patients on and off antihypertensive drugs. Given a lack of longer-term follow-up data, our aim was to assess the safety and efficacy of RDN up to five years taking into account antihypertensive drug regimen changes over time. Methods In the present single-center study, patients underwent RDN for (therapy resistant) hypertension. Patients underwent protocolized yearly follow-up out to five years. Data were collected on 24-h ambulatory BP and office BP monitoring, renal function, antihypertensive drug regimen, and safety events, including non-invasive renal artery imaging at 6/12 months. Efficacy analyses were performed using linear mixed-effects models. Results Seventy-two patients with mean age 63.3 ± 9.5 (SD) years (51% female) were included. Median follow-up time was 3.5 years and Clark’s Completeness Index was 72%. Baseline ambulatory daytime BP was 146.1/83.7 ± 17.4/12.2 mmHg under a mean number of 4.9 ± 2.7 defined daily doses (DDD). At five years, ambulatory daytime systolic BP as calculated from the mixed model was 120.8 (95% CI 114.2–127.5) mmHg and diastolic BP was 73.3 (95% CI 69.4–77.3) mmHg, implying a reduction of -20.9/-8.3 mmHg as compared to baseline estimates (p p = 0.87). No procedure-related major adverse events resulting in long-term consequences were observed. Conclusions The BP-lowering effect of RDN was safely maintained at least five years post-procedure as reflected by a significant decrease in ambulatory daytime BP in the absence of escalating antihypertensive drug therapy over time. Graphical abstract

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) are frequently used for primary and secondary prevention in patients with cardiomyopathies due to different etiologies. However, long-term outcome studies in patients with noncompaction cardiomyopathy (NCCM) are scarce.OBJECTIVES: This study summarizes the long-term outcome of ICD therapy in patients with NCCM compared with those with dilated cardiomyopathy (DCM) or hypertrophic cardiomyopathy (HCM).METHODS: Prospective data from our single-center ICD registry were used to analyze the ICD interventions and survival in patients with NCCM (n = 68) compared with patients with DCM (n = 458) and patients with HCM (n = 158) from January 2005 to January 2018.RESULTS: This NCCM population with an ICD for primary prevention comprised 56 (82%) patients with a median age of 43 years and 52% males, compared with 85% in patients with DCM and 79% in patients with HCM (P = 0.20). During a median follow-up of 5 years (IQR: 2.0-6.9 years), appropriate and inappropriate ICD interventions were not significantly different. Nonsustained ventricular tachycardia during Holter monitoring in patients with NCCM was the only significant risk factor for appropriate ICD therapy in patients with NCCM, with a HR of 5.29 (95% CI: 1.12-24.96). The long-term survival was significantly better in the univariable analysis in the NCCM group. However, there was no difference in multivariable Cox regression analyses between the cardiomyopathy groups.CONCLUSIONS: At 5 years of follow-up, the rate of appropriate and inappropriate ICD interventions in NCCM was comparable to that in DCM or HCM. In multivariable analysis, no differences in survival were found between the cardiomyopathy groups.

Aims Standard outcome sets enable the value-based evaluation of health care delivery. Whereas the attainment of expert opinion has been structured using methods such as the modified-Delphi process, standardized guidelines for extraction of candidate outcome measures from literature are lacking. As such, we aimed to describe a novel methodology to obtain a comprehensive list of candidate outcome measures for potential inclusion in standard outcome datasets. Methods We designed a three-key steps to develop a list of candidate outcome measures to evaluate healthcare and applied these steps for the development of the international consortium of health outcome measures Heart valve disease dataset to illustrate the method. Our methodological approach involves: 1) Benchmark review of relevant registries and Clinical Practice Guidelines; 2) Applying machine learning to screen (using frequent words in abstracts) the studies that have been extracted from a systematic search of the literature using only the disease term; and 3) Extracting the candidate outcome measures from randomly selected batches of the retrieved studies iteratively until saturation is reached. Batch cutoff choices were investigated using data of 1000 simulated cases. Results Simulation showed that on average 98% (range 92% to 100%) saturation is reached using a 100-article batch initially, with 25 articles in the subsequent batches. On average 1.7 repeating rounds (range 1-5) of 25 new articles were necessary to achieve saturation. Conclusion In this paper a standardized three-pillar approach is proposed to identify relevant outcome measures for a standard dataset. This approach creates a balance between comprehensiveness and feasibility in conducting literature reviews for the identification of candidate outcome measures.

OBJECTIVES The Berlin Heart EXCOR (BHE) offers circulatory support across all paediatric ages. Clinically, the necessary care and the outcomes differ in various age groups. The EUROMACS database was used to study age- and size-related outcomes for this specific device. METHODS All patients RESULTS In total, 303 patients were included [mean age: 2.0 years (interquartile range: 0.6–8.0, males: 48.5%)]. Age and BSA were not significantly associated with mortality (n = 74, P = 0.684, P = 0.679). Factors associated with a transplant (n = 175) were age (hazard ratio 1.07, P = 0.006) and aetiology other than congenital heart disease (hazard ratio 1.46, P = 0.020). Recovery rates (n = 42) were highest in patients with a BSA of CONCLUSIONS Mortality rates in Berlin Heart-supported patients cannot be predicted by age or BSA. Recovery rates are remarkably high in the smallest patient category (BSA

OBJECTIVES: Ventricular assist device support as a bridge to transplant or recovery is a well-established therapy in children on the cardiac transplant waiting list. The goal of this study was to investigate the incidence of and the associated factors for cerebrovascular accidents in paediatric patients supported by a Berlin Heart EXCOR. METHODS: All patients, European Association for Cardio-Thoracic Surgery, The European Association for Cardio-Thoracic Surgery supported this study and made resources available to execute this work. No funding was received for this work.

The Berlin Heart EXCOR offers circulatory support across all paediatric ages. Clinically, the necessary care as well as outcomes differ in various age groups. The EUROMACS database was used to study age and size-related outcomes for this specific device.All patients19 years of age from the EUROMACS database supported with a Berlin Heart EXCOR between 2000 and November 2021 were included. Maximally Selected Rank statistics were used to determine BSA cut-off values. Multivariable Cox Proportional-Hazard Regression using ridge penalization was performed to identify factors associated with outcomes.In total, 303 patients were included (mean age: 2.0 years (interquartile range: 0.6-8.0, males: 48.5%)). Age and BSA were not significantly associated with mortality (n = 74, p = 0.684, p = 0.679). Factors associated with transplantation (n = 175) were age (HR 1.07, p = 0.006) and aetiology other than congenital heart disease (HR 1.46, p = 0.020). Recovery rates (n = 42) were highest in patients with a BSA0.53 m2 (21.8% vs 4.3-7.6% at 1 year, p = 0.00534). Patients with a BSA ≥0.73 m2 had a lower risk of early pump thrombosis, but a higher risk of early bleedings compared to children with a BSA0.73 m2.Mortality rates in Berlin Heart supported patients cannot be predicted by age or BSA. Recovery rates are remarkably high in the smallest patient category (BSA0.53 m2). This underscores that the Berlin Heart EXCOR is a viable therapeutic option, even for the smallest and youngest patients.