Data quality and auditing within the Netherlands Heart Registration: using the PCI registry as an example.

AIM: The aim of this article is to present the method and results of the data quality control system and audit within the Netherlands Heart Registration (NHR) using data of patients treated with percutaneous coronary intervention (PCI) in the Netherlands as an example. METHODS: The NHR is a Dutch nationwide registry of all cardiac interventions, comprising data from all 71 hospitals, of which 30 are cardiac intervention or heart centres. Each year, within the NHR, data validation and verification is performed by standard quality controls and monitoring visits (audits). For the audit in 2019, a sample of 50-100 medical records of patients treated with PCI in 2016 and 2017 were reviewed in each hospital by an independent auditor. The data received by the NHR were compared with the information in the hospitals' medical records. In total 12 patient characteristics, 5 intervention variables and 3 outcome variables were screened. The value of a variable was considered discrepant if more than 10% of the medical records reviewed regarding this variable were not consistent with the reported data received by the NHR. RESULTS: For all variables together, the consistency was high, 97.6%. All variables, except multivessel disease (9.3% discrepancy in the 2622 medical records reviewed), had an accuracy above 95%. CONCLUSION: The results of the audit of the PCI medical records show that the overall quality of the data is high. For variables such as multivessel disease it is important to improve knowledge of the definitions and to train all those involved in the registration process.

Report on outcomes of valve-in-valve transcatheter aortic valve implantation and redo surgical aortic valve replacement in the Netherlands.

OBJECTIVE: We sought to investigate real-world outcomes of patients with degenerated biological aortic valve prostheses who had undergone valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) or reoperative surgical aortic valve replacement (redo-SAVR) in the Netherlands. METHODS: Patients who had undergone ViV-TAVI or redo-SAVR for a degenerated biological aortic valve prosthesis in the Netherlands between January 2014 and December 2018 were eligible for this retrospective study. Patients with a prior homograft, active endocarditis or mechanical aortic valve prosthesis were excluded. Patients were matched using the propensity score. The primary endpoint was a composite of 30-day all-cause mortality and in-hospital postoperative stroke. Secondary endpoints were all-cause mortality at different time points, in-hospital postoperative stroke, pacemaker implantation and redo procedures within one year. Baseline characteristics and outcome data were collected from the Netherlands Heart Registration. RESULTS: From 16 cardiac centres, 653 patients were included in the study (374 ViV-TAVI and 279 redo-SAVR). European System for Cardiac Operative Risk Evaluation I (EuroSCORE I) was higher in ViV-TAVI patients (19.4, interquartile range (IQR) 13.3-27.9 vs 13.8, IQR 8.3-21.9, p < 0.01). After propensity score matching, 165 patients were matched with acceptable covariate balance. In the matched cohorts, the primary endpoint was not significantly different for ViV-TAVI and redo-SAVR patients (odds ratio 1.30, 95% confidence interval 0.57-3.02). Procedural, 30-day and 1­year all-cause mortality rates, incidence of in-hospital postoperative stroke, pacemaker implantation and redo procedures within one year were also similar between cohorts. CONCLUSION: Patients with degenerated aortic bioprostheses treated with ViV-TAVI or redo-SAVR have similar mortality and morbidity.

Better survival after transcatheter aortic valve replacement by process improvements.

OBJECTIVE: The aim of this study is to assess the effects on procedural, 30-day, and 1­year all-cause mortality by a newly introduced quality improvement strategy in patients after transcatheter aortic valve replacement (TAVR). METHODS: In October 2015, a coherent set of quality improving interventions with respect to patient geriatric screening, general diagnostic examination and safety of the procedure was implemented at a single centre in the Netherlands. Patients undergoing TAVR in 2013-2018 were included for retrospective analysis. Mortality was assessed in the pre-quality improvement strategy cohort (January 2013 to October 2015; cohort A) and in the post-quality improvement strategy cohort (November 2015 to December 2018; cohort B). Logistic regression analysis was used to estimate the influence of patient and procedural characteristics on the results of the quality improvement strategy in terms of procedural, 30-day, and 1­year all-cause mortality. RESULTS: In total, 806 patients were analysed with 274 patients in cohort A and 532 patients in cohort B. After introduction of the quality improvement strategy, procedural (4.4% to 1.3%, p < 0.01), 30-day (8.4% to 2.7%, p < 0.01) and 1­year (16.4% to 8.5%, p < 0.01) all-cause mortality significantly decreased. Multivariate regression analysis showed that the quality improvement strategy also significantly reduced 30-day (odds ratio [OR] 0.19, 95% confidence interval [CI] 0.09-0.42) and 1­year (OR 0.38, 95% CI 0.24-0.61) all-cause mortality if corrected for patient characteristics. CONCLUSION: Structural meetings on evaluation of outcomes highlight potential areas for improvement and subsequent outcome-based quality improvement initiatives can result in lower procedural, 30-day, and 1­year all-cause mortality.

IMPROV-ED trial: eHealth programme for faster recovery and reduced healthcare utilisation after CABG.

BACKGROUND: After coronary artery bypass grafting (CABG), healthcare utilisation is high and is partly unplanned. eHealth applications have been proposed to reduce healthcare consumption and to enable patients to get actively involved in their recovery. This way, healthcare expenses can be reduced and the quality of care can be improved. OBJECTIVES: We aim to evaluate whether the use of an eHealth programme can reduce unplanned healthcare utilisation and improve mental and physical health in the first 6 weeks after discharge in patients who underwent CABG. In addition, patient satisfaction and use of the eHealth programme will be evaluated. METHODS: For this single-centre randomised controlled trial, at least 280 patients referred for CABG will be included at the preoperative outpatient clinic and randomised to an intervention or control group. The intervention group will have access to an eHealth programme, which consists of online educational videos developed by the Dutch Heart Foundation and postoperative video consultations with a physician. The control group will receive standard care and will not have access to the eHealth programme. The primary endpoint is healthcare utilisation; other endpoints include anxiety, duration of recovery, quality of life and patient satisfaction. Participants will complete several questionnaires at 6 time points during the study. RESULTS: Patient enrolment started in February 2020 and completion of the follow-up period is expected in August 2021. CONCLUSION: This randomised trial was initiated to test the hypothesis that patients who are partaking in our eHealth programme use less unplanned care and experience a better quality of life, less anxiety and a faster recovery than controls.

Heart teams in the Netherlands: From teamwork to data­driven decision-making.

For all patients with cardiovascular disease requiring an intervention, this is a major life event. The heart team concept is one of the most exciting and effective team modalities to ensure cost-effective application of invasive cardiovascular care. It optimises patient selection in a complex decision-making process and identifies risk/benefit ratios of different interventions. Informed consent and patient safety should be at the centre of these decisions. To deal with increased load of medical data in the future, artificial intelligence could enable objective and effective interpretation of medical imaging and decision support. This technical support is indispensable to meet current patient and societal demands for informed consent, shared decision-making, outcome improvement and safety. The heart team should be restructured with clear leadership, accountability, and process and outcome measurement of interventions. In this way, the heart team concept in the Netherlands will be ready for the future.

Privacy of patient data in quality-of-care registries in cardiology and cardiothoracic surgery: the impact of the new general data protection regulation EU-law.

Quality-of-care registries have been shown to improve quality of healthcare and should be facilitated and encouraged. The data of these registries are also very valuable for medical data research. While fully acknowledging the importance of re-using already available data for research purposes, there are concerns about how the applicable privacy legislation is dealt with. These concerns are also articulated in the new European law on privacy, the 'General Data Protection Regulation' (GDPR) which has come into force on 25 May 2018. The aim of this review is to examine what the implications of the new European data protection rules are for quality-of-care registries in Europe while providing examples of three quality-of-care registries in the field of cardiology and cardiothoracic surgery in Europe. A general overview of the European and national legal framework (relevant data protection and privacy legislation) applying to quality-of-care registries is provided. One of the main rules is that non-anonymous patient data may, in principle, not be used for research without the patient's informed consent. When patient data are solely and strictly used for quality control and improvement, this rule does not apply. None of the described registries (NHR, SWEDEHEART, and NICOR) currently ask specific informed consent of patients before using their data in the registry, but they do carry out medical data research. Application of the GDPR implies that personal data may only be used for medical data research after informing patients and obtaining their explicit consent.