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.

Outpatient treatment of worsening heart failure with intravenous and subcutaneous diuretics: a systematic review of the literature.

AIMS: In the coming decade, heart failure (HF) represents a major global healthcare challenge due to an ageing population and rising prevalence combined with scarcity of medical resources and increasing healthcare costs. A transitional care strategy within the period of clinical worsening of HF before hospitalization may offer a solution to prevent hospitalization. The outpatient treatment of worsening HF with intravenous or subcutaneous diuretics as an alternative strategy for hospitalization has been described in the literature. METHODS AND RESULTS: In this systematic review, the available evidence for the efficacy and safety of outpatient treatment with intravenous or subcutaneous diuretics of patients with worsening HF is analysed. A search was performed in the electronic databases MEDLINE and EMBASE. Of the 11 included studies 10 were single-centre, using non-randomized, observational registries of treatment with intravenous or subcutaneous diuretics for patients with worsening HF with highly variable selection criteria, baseline characteristics, and treatment design. One study was a randomized study comparing subcutaneous furosemide with intravenous furosemide. In a total of 984 unique individual patients treated in the reviewed studies, only a few adverse events were reported. Re-hospitalization rates for HF at 30 and 180 days were 28 and 46%, respectively. All-cause re-hospitalization rates at 30 and 60 days were 18-37 and 22%, respectively. The highest HF re-hospitalization was 52% in 30 days in the subcutaneous diuretic group and 42% in 30 days in the intravenous diuretic group. CONCLUSIONS: The reviewed studies present practice-based results of treatment of patients with worsening HF with intravenous or subcutaneous diuretics in an outpatient HF care unit and report that it is effective by relieving symptoms with a low risk of adverse events. The studies do not provide satisfactory evidence for reduction in rates of re-hospitalization or improvement in mortality or quality of life. The conclusions drawn from these studies are limited by the quality of the individual studies. Prospective randomized studies are needed to determine the safety and effectiveness of outpatient intravenous or subcutaneous diuretic treatment for patient with worsening HF.

Value of machine learning in predicting TAVI outcomes.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become a commonly applied procedure for high-risk aortic valve stenosis patients. However, for some patients, this procedure does not result in the expected benefits. Previous studies indicated that it is difficult to predict the beneficial effects for specific patients. We aim to study the accuracy of various traditional machine learning (ML) algorithms in the prediction of TAVI outcomes. METHODS AND RESULTS: Clinical and laboratory data from 1,478 TAVI patients from a single centre were collected. The outcome measures were improvement of dyspnoea and mortality. Three experiments were performed using (1) screening data, (2) laboratory data, and (3) the combination of both. Five well-established ML techniques were implemented, and the models were evaluated based on the area under the curve (AUC). Random forest classifier achieved the highest AUC (0.70) for predicting mortality. Logistic regression had the highest AUC (0.56) in predicting improvement of dyspnoea. CONCLUSIONS: In our single-centre TAVI population, the tree-based models were slightly more accurate than others in predicting mortality. However, ML models performed poorly in predicting improvement of dyspnoea.

Transcatheter aortic valve replacement alters ascending aortic blood flow and wall shear stress patterns: A 4D flow MRI comparison with age-matched, elderly controls.

BACKGROUND: With the implementation of transcatheter aortic valve replacement (TAVR) in lower-risk patients, evaluation of blood flow characteristics and the effect of TAVR on aortic dilatation becomes of considerable interest. We employed 4D flow MRI in the ascending aorta of patients after TAVR to assess wall shear stress (WSS) and compare blood flow patterns with surgical aortic valve replacement (SAVR) and age- and gender-matched controls. METHODS: Fourteen post-TAVR patients and ten age- and gender-matched controls underwent kt-PCA accelerated 4D flow MRI of the thoracic aorta at 3.0 Tesla. Velocity and wall shear stress was compared between the two groups. In addition, aortic flow eccentricity and displacement was assessed and compared between TAVR patients, controls and 14 SAVR patients recruited as part of an earlier study. RESULTS: Compared to controls, abnormally elevated WSS was present in 30±10% of the ascending aortic wall in TAVR patients. Increased WSS was present along the posterior mid-ascending aorta and the anterior distal-ascending aorta in all TAVR patients. TAVR results in eccentric and displaced flow in the mid- and distal-ascending aorta, whereas blood flow displacement in SAVR patients occurs only in the distal-ascending aorta. CONCLUSION: This study shows that TAVR results in increased blood flow velocity and WSS in the ascending aorta compared to age- and gender-matched elderly controls. This finding warrants longitudinal assessment of aortic dilatation after TAVR in the era of potential TAVR in lower-risk patients. Additionally, TAVR results in altered blood flow eccentricity and displacement in the mid- and distal-ascending aorta, whereas SAVR only results in altered blood flow eccentricity and displacement in the distal-ascending aorta. KEY POINTS: • TAVR results in increased blood flow velocity and WSS in the ascending aorta. • Longitudinal assessment of aortic dilatation after TAVR is warranted in the era of potential TAVR in lower-risk patients. • Both TAVR and SAVR result in altered blood flow patterns in the ascending aorta when compared to age-matched controls.

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.

[Support of damaged heart with the Impella pump]. / Ondersteuning van beschadigd hart met Impella-pomp.

Temporary mechanical circulatory support is increasingly used, particularly in patients with cardiogenic shock or during high-risk percutaneous coronary interventions. In the last five years there have been numerous developments in this field. Experience has been gained from usage of temporary heart pumps, and new pumps have arrived on the market. Until recently, the intra-aortal balloon pump was the standard treatment for patients with cardiogenic shock; however, results from the latest research into the effectiveness of this pump have rendered it less popular. An alternative modality is the Impella system. Since 2012, usage of a heart pump in cardiogenic shock treatment is reimbursed by healthcare insurers in the Netherlands. Recently, the FDA approved the Impella system for said indication.

Cerebral oxygenation during changes in vascular resistance and flow in patients on cardiopulmonary bypass - a physiological proof of concept study.

Despite a rise in blood pressure, cerebral oxygenation decreases following phenylephrine administration, and we hypothesised that phenylephrine reduces cerebral oxygenation by activating cerebral α1 receptors. We studied patients on cardiopulmonary bypass during constant flow. Phenylephrine raised mean arterial pressure (α1 -mediated) from mean (SD) 69 (8) mmHg to 79 (8) mmHg; p = 0.001, and vasopressin raised mean arterial pressure (V1 mediated) from 69 (8) mmHg to 83 (6) mmHg; p = 0.001. Both drugs elicited a comparable decrease in cerebral oxygenation from 61 (7)% to 60 (7)%; p = 0.023 and 61 (8)% to 59 (8)%; p = 0.022, respectively. This implies that after phenylephrine or vasopressin administration, cerebral oxygenation declines as a result of cerebral vasoconstriction, due to either both cerebral α1 and V1 receptors being equipotentially activated or to an intrinsic myogenic mechanism of cerebral vasculature in reaction to blood pressure elevation.

The year of transparency: measuring quality of cardiac care.

The assessment of quality of care is becoming increasingly important in healthcare, both globally and in the Netherlands. The Dutch Minister of Health declared 2015 to be the year of transparency, thereby aiming to improve quality of care by transparent reporting of outcome data. With the increasing importance of transparency, knowledge on quality measurement will be essential for a cardiologist in daily clinical care. To that end, this paper provides a comprehensive overview of the Dutch healthcare structure, quality indicators and the current and future assessment of quality of cardiac care in the Netherlands.

Imaging for approach selection of TAVI: assessment of the aorto-iliac tract diameter by computed tomography-angiography versus projection angiography.

The choice of preferred access route for transcatheter aortic valve implantation (TAVI) is mainly guided by the minimal aorto-femoral tract diameter. Currently, projection angiography (XA) and CT-angiography (CTA) are used interchangeably to assess this diameter in the TAVI work-up. We aimed to assess the agreement of XA and CTA diameter measurements in TAVI candidates. Diameters of 700 aorta-iliac segments of 102 TAVI candidates were analyzed on both XA and CTA. The diameters on XA were measured manually, for the CTA-based analysis semi-automated segmentation software was used. Paired sample T test was used to evaluate differences in diameter measurements between the modalities. Disagreement on the suitability for a transfemoral (TF)-TAVI approach was identified. The interobserver agreement for both measurements was assessed by calculating the intraclass correlation coefficient (ICC). The average diameters were 10.1 ± 1.8 mm and 8.4 ± 1.7 for XA and CTA respectively. The mean paired difference was 1.73 mm (p < 0.001). For 18 patients (17.6 %) diameters measured on CTA images, were bilaterally less than 6 mm, whilst XA indicated a minimum diameter exceeding 6 mm. For both modalities, the interobserver agreement was excellent (ICC 0.95). Diameters measured semi-automatically on CTA were statistically significantly smaller compared to XA. This should be acknowledged in the work-up for selecting the most appropriate approach for TAVI. In our population 17.6 % of patients would have been denied a transfemoral TAVI based on CTA measurements, whilst XA suggested diameters sufficient for a TF approach.

Mechanical circulatory support with the Impella 5.0 device for postcardiotomy cardiogenic shock: a three-center experience.

AIM: Postcardiotomy cardiogenic shock (PCCS) is associated with high mortality rates, despite full conventional treatment. Although the results of treatment with surgically implantable ventricular assist devices have been encouraging, the invasiveness of this treatment limits its applicability. Several less invasive devices have been developed, including the Impella system. The objective of this study was to describe our three-center experience with the Impella 5.0 device in the setting of PCCS. METHODS: From January 2004 through December 2010, a total of 46 patients were diagnosed with treatment-refractory PCCS and treated with the Impella 5.0 percutaneous left ventricular assist device at three european heart centers. Baseline and follow-up characteristics were collected retrospectively and entered into a dedicated database. RESULTS: Within the study cohort of 46 patients, mean logistic and additive EuroSCORES were 24 ± 19 and 10 ± 4. The majority of patients underwent coronary artery bypass grafting (48%) or combined surgery (33%). Half of all patients had been treated with an intra-aortic balloon pump before 5.0-implantation, 1 patient had been treated with an Impella 2.5 device. All patients were on mechanical ventilation and intravenous inotropes. The Kaplan-Meier estimate of overall 30-day survival was 39.5%. CONCLUSION: Thirty-day survival rates for patients with PCCS, refractory to aggressive conventional treatment and treated with the Impella 5.0 device, are comparable to those reported in studies evaluating surgically implantable VADs, whereas the Impella system is much less invasive. Therefore, mechanical circulatory support with the Impella 5.0 device is a suitable treatment modality for patients with severe PCCS.

Sarcopenic obesity is associated with adverse clinical outcome after cardiac surgery.

BACKGROUND & AIMS: Both undernutrition - low fat free mass (FFM) - and obesity - high fat mass (FM) - have been associated with adverse outcome in cardiac surgical patients. However, whether there is an additional effect on outcome of these risk factors present at the same time, that is sarcopenic obesity (SO), is unknown. Furthermore, the association between SO and muscle function is unidentified. METHODS AND RESULTS: In 325 cardiac surgical patients, we prospectively analysed the association between preoperative FFM and FM, measured by bioelectrical impedance spectroscopy, and postoperative adverse outcomes, and their correlation with muscle function - handgrip strength (HGS). SO was associated with postoperative infections (28.2% vs. 5.3%, adj. odds ratio (OR): 7.9; 95% confidence interval (CI): 1.2-54.1; p=0.04). Further, a low FFM index (FFMI; kgm(-2)) was associated with postoperative infections (18.5% vs. 4.7%, adj. OR: 6.6; 95% CI: 1.7-25.2; p=0.01) while a high FM index (FMI; kgm(-2)) was not. Both components of SO, FFMI and FMI, correlated with HGS (FFMI: r=0.570; p<0.001, FMI: r=-0.263; p<0.001). CONCLUSION: SO is associated with an increased occurrence of adverse outcome after cardiac surgery. Our results suggest an additional risk of a low FFMI and high FMI present at the same time. Furthermore, SO is characterised by less muscle function. We advocate determining body composition in cardiac surgical patients to classify and treat undernourished patients, in particular those who are also obese.

Prognosis and prognostic factors of patients with mesothelioma: a population-based study.

BACKGROUND: It is important to regularly update survival estimates of patients with malignant mesothelioma as prognosis may vary according to epidemiologic factors and diagnostic and therapeutic management. METHODS: We assessed overall (baseline) survival as well as related prognostic variables in a large cohort of 1353 patients with a confirmed diagnosis of malignant mesothelioma between 2005 and 2008. RESULTS: About 50% of the patients were 70 years or older at diagnosis and the median latency time since start of asbestos exposure was 49 years. One year after diagnosis, 47% of the patients were alive, 20% after 2 years and 15% after 3 years. Prognostic variables independently associated with worse survival were: older age (HR=1.04 per year 95% CI (1.03-1.06)), sarcomatoid subtype (HR=2.45 95% CI (2.06-2.90)) and non-pleural localisation (HR=1.67 95% CI (1.26-2.22)). CONCLUSION: Survival of patients with malignant mesothelioma is still limited and depends highly on patient age, mesothelioma subtype and localisation. In addition, a substantial part of the patients had a long latency time between asbestos exposure and diagnosis.

Aortic root pathology in Marfan syndrome increases the risk of migraine with aura.

AIM: To assess the lifetime prevalence of migraine in patients with Marfan syndrome (MFS) and to investigate a history of aortic root replacement (AR) as a possible risk factor. METHODS: In a multicentre study 123 MFS patients (n = 52 with AR, n = 71 without AR), 82 age- and sex-matched controls and 51 patients with AR but without MFS, were interviewed using a semi-structured headache questionnaire. A multinomial logistic regression model was used to investigate risk factors for migraine with and without aura, adjusting for age and gender. RESULTS: Lifetime migraine prevalence was increased in female MFS patients (51%) compared to healthy female controls (29%), p = 0.017. In males lifetime migraine prevalence among MFS patients was only numerically increased. Lifetime prevalence of migraine with aura was increased among MFS patients compared to healthy controls both in males (19% vs. 3%, p = 0.048) and females (30% vs. 14%, p = 0.049). A history of AR, independently from MFS, gender and age, increased the lifetime prevalence of migraine with aura (OR 3.1 [1.2-8.0]). In all but one patient migraine started before the AR. CONCLUSIONS: The lifetime prevalence of migraine with aura, but not migraine without aura, is increased in patients with MFS. This association is driven by a history of AR. The replacement procedure itself is unlikely to be causally associated with migraine as in nearly all subjects, migraine started before the procedure. However this study adds to the evidence that underlying vessel wall pathology may be involved in migraine with aura.

Markers for the non-invasive diagnosis of mesothelioma: a systematic review.

BACKGROUND: Numerous markers have been evaluated to facilitate the non-invasive diagnostic work-up of mesothelioma. The purpose of this study was to conduct a structured review of the diagnostic performance of non-invasive marker tests for the detection of mesothelioma in patients with suspected mesothelioma. METHODS: Studies on the diagnostic accuracy of serum and cytological markers published till 31 December 2009, available in either PUBMED or Embase, to detect or exclude the presence of mesothelioma were extracted. Study quality was assessed with use of the Quadas criteria. RESULTS: In total, 82 articles were included in this systemic review. Overall, quality of the incorporated studies to address our objective was poor. The most frequently studied immunohistochemical markers for cytological analysis were EMA, Ber-Ep4, CEA, and calretinin. The most frequently investigated serum marker was soluble mesothelin-related protein (SMRP). The markers CEA, Ber-EP4, and calretinin were most valuable in discriminating mesothelioma from other malignant diseases. Markers EMA and SMRP were most valuable in discriminating mesothelioma from non-malignant diseases. No marker performed well in discriminating between mesothelioma and all other diseases. CONCLUSION: Currently, there is only limited evidence to properly assess the value of non-invasive marker tests in the diagnosis of mesothelioma. Studies were of limited value to address our objective and results showed considerable unexplained study heterogeneity.

Pulse contour cardiac output derived from non-invasive arterial pressure in cardiovascular disease.

Pulse contour methods determine cardiac output semi-invasively using standard arterial access. This study assessed whether cardiac output can be determined non-invasively by replacing the intra-arterial pressure input with a non-invasive finger arterial pressure input in two methods, Nexfin CO-trek and Modelflow , in 25 awake patients after coronary artery bypass surgery. Pulmonary artery thermodilution cardiac output served as a reference. In the supine position, the mean (SD) differences between thermodilution cardiac output and Nexfin CO-trek were 0.22 (0.77) and 0.44 (0.81) l.min(-1) , for intra-arterial and non-invasive pressures, respectively. For Modelflow, these differences were 0.70 (1.08) and 1.80 (1.59) l.min(-1) , respectively. Similarly, in the sitting position, differences between thermodilution cardiac output and Nexfin CO-trek were 0.16 (0.78) and 0.34 (0.83), for intra-arterial and non-invasive arterial pressure, respectively. For Modelflow, these differences were 0.58 (1.11) and 1.52 (1.54) l.min(-1) , respectively. Thus, Nexfin CO-trek readings were not different from thermodilution cardiac output, for both invasive and non-invasive inputs. However, Modelflow readings differed greatly from thermodilution when using non-invasive arterial pressure input.

Percutaneous implantation of the CoreValve aortic valve prosthesis in patients at high risk or rejected for surgical valve replacement: Clinical evaluation and feasibility of the procedure in the first 30 patients in the AMC-UvA.

Objective. To report the feasibility, safety and efficacy of percutaneous aortic valve implantation (PAVI) with the CoreValve self-expanding aortic valve bioprosthesis in elderly patients with aortic valve stenosis who are rejected for surgery or have a high surgical risk.Methods. PAVI using the CoreValve ReValving System was performed under general anaesthesia in 30 high-risk (surgical) patients with a symptomatic severe aortic valve stenosis.Results. The patients had a mean age of 80.5+/-7.7 years, a mean aortic valve area of 0.71+/-0.19 cm(2), a peak transvalvular aortic gradient of 79+/-25 mmHg, as measured with echo Doppler, a logistic EuroSCORE of 15+/-10% and a Society of Thoracic Surgeons (STS) score of 5.2+/-2.9%. Device success was achieved in all patients and acute procedural success in 27 patients (90%). In the surviving patients, there was in a reduction of the peak aortic pressure gradient from 76+/-24 mmHg to 22+/-7 mmHg (n=24, p<0.00001) 30 days after successful device implantation. At 30 days, major adverse cardiovascular and cerebral events had occurred in seven patients (23%). This included mortality in six patients (20%), of which one death was cardiovascular. The other five non-cardiovascular deaths involved two patients who died of an exacerbation of severe pre-existent pulmonary disease and three of infectious complications.Conclusions. Percutaneous aortic valve implantation was successfully performed in our centre in highrisk patients, with a 30-day mortality of 20%. When successful, marked haemodynamic improvement and relief of symptoms was achieved. (Neth Heart J 2010;18:18-24.).

Influence of dilated cardiomyopathy and a left ventricular assist device on vortex dynamics in the left ventricle.

Together with new developments in mechanical cardiac support, the analysis of vortex dynamics in the left ventricle has become an increasingly important topic in literature. The aim of this study was to develop a method to investigate the influence of a left ventricular assist device (LVAD) on vortex dynamics in a failing ventricle. An axisymmetric fluid dynamics model of the left ventricle was developed and coupled to a lumped parameter model of the complete circulation. Simulations were performed for healthy conditions and dilated cardiomyopathy (DCM). Vortex structures in these simulations were analysed by means of automated detection. Results show that the strength of the leading vortex ring is lower in a DCM ventricle than in a healthy ventricle. The LVAD further influences the maximum strength of the vortex and also causes the vortex to disappear earlier in time with increasing LVAD flows. Understanding these phenomena by means of the method proposed in this study will contribute to enhanced diagnostics and monitoring during cardiac support.

Understanding post-operative temperature drop in cardiac surgery: a mathematical model.

A mathematical model is presented to understand heat transfer processes during the cooling and re-warming of patients during cardiac surgery. Our compartmental model is able to account for many of the qualitative features observed in the cooling of various regions of the body including the central core containing the majority of organs, the rectal region containing the intestines and the outer peripheral region of skin and muscle. In particular, we focus on the issue of afterdrop: a drop in core temperature following patient re-warming, which can lead to serious post-operative complications. Model results for a typical cooling and re-warming procedure during surgery are in qualitative agreement with experimental data in producing the afterdrop effect and the observed dynamical variation in temperature between the core, rectal and peripheral regions. The influence of heat transfer processes and the volume of each compartmental region on the afterdrop effect is discussed. We find that excess fat on the peripheral and rectal regions leads to an increase in the afterdrop effect. Our model predicts that, by allowing constant re-warming after the core temperature has been raised, the afterdrop effect will be reduced.

['State of the nation's healthcare 2008' annual report: technology is useful, but training comes first]. / 'Staat van de gezondheidszorg 2008': techniek helpt, maar eerst komt oefening.

The Netherlands Health Care Inspectorate's annual report on the state of the nation's healthcare in 2008 is dedicated to the use of medical technology. The subtitle of the report is 'Risks of medical technology underestimated'. Lack of education and training expose patients to an unacceptable risk of injury within both the care and the cure setting. The Inspectorate urgently recommends applying a certification system to physicians to guarantee safe and appropriate use of devices and equipment. The administration of an institution has the primary responsibility for the visible implementation of risk and safety management. Also, the medical professional must become familiar with the principles of engineering and be trained in applying a systematic approach to safety and reliability within medical technology. This annual report provides recommendations on how to incorporate biomedical engineering into medical education.