Adherence to antihypertensive drug treatment in patients with apparently treatment-resistant hypertension in the INSPiRED pilot study.

PURPOSE: Drug adherence may be a major problem in the therapy of hypertension and in the diagnosis of therapy resistance. Adherence can be assessed by indirect methods or by direct methods like drug detection in urine with liquid chromatography-mass spectrometric methods. MATERIALS AND METHODS: The current analysis included patients with apparently treatment- resistant hypertension (TRH) referred for renal denervation (RDN) and included in the the INSPiRED pilot trial (NCT01505010). Adherence was repeatedly assessed by toxicological urine analysis over a time range of up to 17 months in a total of 18 patients. RESULTS: In the first urine samples of 18 patients the adherence rate (percentage of number of detected vs. prescribed medical drugs) ranged from 0 to 100% with a median of 73.2%. In further urine samples collected during the following up to 17 months every individual patient exhibited considerable changes in the adherence rate, neither a constancy nor a tendency could be deduced. CONCLUSIONS: Urine analysis results exhibit variation over time and an assessment at a certain time point cannot be regarded as representative or predictor for future behavior. Therefore, it appears necessary to perform drug adherence testing repeatedly over time.

Quality assessment in percutaneous coronary interventions: the QERMID Belgian PCI registry.

BACKGROUND: The recent increase in the number of interventional cathlabs that followed a moratorium of several years has resulted in an abrupt increase in the number of PCI and a dilution of the experience per centre and per operator. METHODS: Based on data extracted from the national "Quality Oriented Electronic Registration of Medical Implant Devices" (QERMID) database, we compared the characteristics and outcome of patients treated in 2015 in the 21 newly (<3 years) approved PCI centres with those of patients treated in the 28 historical PCI centres. RESULTS: The proportion of acute coronary syndromes was slightly higher in new than in historical centres (48% vs. 44%; p < 0.01) but few differences in co-morbidities were observed. Considering separately the patients treated for an acute coronary syndrome or for stable ischaemia, no significant difference in the overall in-hospital or 30-days mortality and in the proportion of same week bypass surgery was observed between newly approved and historical centres. In a substantial proportion (39%) of patients treated for stable angina or silent ischaemia, no test confirming the presence of ischaemia before PCI is reported, without significant difference between new and historical centres. CONCLUSIONS: Pending the limitations of the QERMID database, including a limited dataset and the absence of systematic on-site monitoring, no significant difference in the rate of major complications was identified between new and historical Belgian PCI centres.

Results of a randomized controlled pilot trial of intravascular renal denervation for management of treatment-resistant hypertension.

OBJECTIVE: Previous trials of catheter-based renal-artery denervation (RDN) as treatment modality in resistant hypertension (rHT) generated unconvincing results. In the Investigator-Steered Project on Intravascular Denervation for Management of Treatment-Resistant Hypertension (INSPiRED; NCT01505010), we optimized selection and management of rHT patients. METHODS: With ethical clearance to randomize 18 patients, three Belgian hypertension centers screened 29 rHT patients on treatment with ≥3 drugs, of whom 17 after optimization of treatment (age <70 years; systolic/diastolic office blood pressure (BP) ≥ 140/90 mm Hg; 24-h BP ≥130/80 mm Hg; glomerular filtration rate [eGFR] ≥ 45 mL/min/1.73 m2; body mass index <40kg/m2) were randomized and 15 were analyzed 6 months later, while medical treatment was continued (n = 9) or combined with RDN by the EnligHTN™ multi-electrode system (n = 6). RESULTS: The baseline-adjusted between-group differences amounted to 19.5/10.4 mm Hg (change in control vs. intervention group, +7.6/+2.2 vs. -11.9/-8.2 mm Hg; P = .088) for office BP, 22.4/13.1 mm Hg (+0.7/+0.3 vs. -21.7/-12.8; mm Hg; P ≤ .049) for 24-h BP, the primary efficacy endpoint, and 2.5 mL/min/1.73 m2 (+1.5 vs. -1.1 mL/min/1.73 m2; P = .86) for eGFR, the primary safety endpoint. At 6 month, ECG voltages and the number of prescribed drugs (P ≤ .036) were lower in RDN patients, but quality of life and adherence, captured by questionnaire and urine analysis were similar in both groups. Changes in BP and adherence were unrelated. No major complications occurred. CONCLUSIONS: The INSPiRED pilot suggests that RDN with the EnligHTN™ system is effective and safe and generated insights useful for the design of future RDN trials.

Impact of COVID-19-related public containment measures on the ST elevation myocardial infarction epidemic in Belgium: a nationwide, serial, cross-sectional study.

AIMS: The current study assessed the impact of COVID-19-related public containment measures (i.e. lockdown) on the ST elevation myocardial infarction (STEMI) epidemic in Belgium. METHODS AND RESULTS: Clinical characteristics, reperfusion therapy modalities, COVID-19 status and in-hospital mortality of consecutive STEMI patients who were admitted to Belgian hospitals for percutaneous coronary intervention (PCI) were recorded during a three-week period starting at the beginning of the lockdown period on 13 March 2020. Similar data were collected for the same time period for 2017-2019. An evaluation of air quality revealed a 32% decrease in ambient NO2 concentrations during lockdown (19.5 µg/m³ versus 13.2 µg/m³, p < .001). During the three-week period, there were 188 STEMI patients admitted for PCI during the lockdown versus an average 254 STEMI patients before the lockdown period (incidence rate ratio = 0.74, p = .001). Reperfusion strategy was predominantly primary PCI in both time periods (96% versus 95%). However, there was a significant delay in treatment during the lockdown period, with more late presentations (>12 h after onset of pain) (14% versus 7.6%, p = .04) and with longer door-to-balloon times (median of 45 versus 39 min, p = .02). Although the in-hospital mortality between the two periods was comparable (5.9% versus 6.7%), 5 of the 7 (71%) COVID-19-positive STEMI patients died. CONCLUSION: The present study revealed a 26% reduction in STEMI admissions and a delay in treatment of STEMI patients. Less exposure to external STEMI triggers (such as ambient air pollution) and/or reluctance to seek medical care are possible explanations of this observation.

Belgium: coronary and structural heart interventions from 2010 to 2015.

In a ranking of the gross domestic product per capita in 2015, Belgium ranked 19th in the world according to the International Monetary Fun1d and the World Bank. It has a Human Development Index of 0.890, in which it is preceded by only 20 other countries in the world. This is, at least in part, due to a well-developed social security system on which all citizens can rely. Over the last 5-10 years, however, this system has come under increasing pressure. This has resulted in insufficient, incomplete and late reimbursement of all technologies that were introduced over the last ten years in the cathlab: intracoronary imaging techniques are not reimbursed at all, and FFR only to a vastly insufficient degree. For several structural heart interventions, a system of limited and incomplete reimbursement has recently been set up, with a requirement to organise these procedures within the frames of hospital networks. Numbers of PCIs have risen by 15% over the last four years, coinciding with an increase in the number of cathlabs by 50%, aiming at better access to primary PCI for STEMI patients. This has also resulted in a decrease in the average procedure volume per centre. Two thirds of PCIs are performed via the radial access. DES penetration has increased to 74%, approaching 100% in some centres, while the uptake of BRS has been very limited so far.

Short-term effect of atorvastatin on ischaemic threshold in hypercholesterolaemic patients with stable ischaemic heart disease.

OBJECTIVE: Hypercholesterolaemia is associated with a loss of endothelium-dependent vasodilation, which may facilitate the occurrence of myocardial ischaemia in patients with coronary artery disease (CAD). The improvement of endothelial dilator function after 4 to 6 weeks of oral lipid-lowering therapy has been documented. Whether this early restoration of endothelial function by statins translates into anti-ischaemic effects is unknown. This study was designed to determine the effect of 4 weeks' treatment with 80 mg atorvastatin daily on exercise-induced ischaemia in patients with stable ischaemic heart disease (IHD) receiving standard anti-anginal drug therapy. METHODS AND RESULTS: A total of 41 patients with documented CAD, exercise-induced ischaemia and LDL-cholesterol > 130 mg/dl underwent exercise ECG, angina score and lipid level assessment at baseline, after 4 weeks of placebo treatment, and after 4 weeks of therapy with atorvastatin 80 mg. Primary endpoint was the change in time to 1 mm ST-segment depression (= ischaemic threshold) between placebo and treatment period. Atorvastatin treatment resulted in a 55% reduction of low-density lipoprotein (LDL) cholesterol (from mean of 162 (SD 32) to 72 (20) mg/dl). For a comparable rate-pressure product, the average time to 1 mm ST-segment depression was 295 (112) s at baseline, 314 (149) s after placebo and 301 (131) s after atorvastatin, indicating that the ischaemic threshold was not significantly modulated after 4 weeks of atorvastatin treatment. There was also no significant change in global angina score or in time to maximal ST-segment depression. CONCLUSIONS: High-dose atorvastatin treatment for 4 weeks drastically reduced LDL-cholesterol. However, the present study did not demonstrate a significant effect on the ischaemic threshold in patients with stable IHD already under treatment with anti-ischaemic agents.

Accidental closure of the left upper pulmonary vein with an Amplatzer atrial septal defect occluder.

We report the clinical outcome of a 46-year-old man referred for percutaneous closure of an atrial septal defect under transthoracic echocardiographic and fluoroscopic guidance, whose upper left pulmonary vein was erroneously obliterated using an Amplatzer atrial septal defect occluder. Various medical conditions have been associated with pulmonary vein stenosis including dyspnea on exertion or at rest, cough, and hemoptysis. However, there were no short- or long-term symptoms in this patient.

A prospective randomised comparison of titanium-nitride-oxide-coated bioactive stents with everolimus-eluting stents in acute coronary syndrome: the BASE-ACS trial.

AIMS: Titanium-nitride-oxide-coated bioactive stents (BAS) have demonstrated a favourable outcome when compared with paclitaxel-eluting stents in patients with acute myocardial infarction (MI). In a prospective randomised non-inferiority study design, we compared the safety and efficacy of BAS versus everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS). METHODS AND RESULTS: We randomised 827 patients with ACS (1:1) to either BAS (417) or EES (410). The primary endpoint was a composite of cardiac death, non-fatal MI or ischaemia-driven target lesion revascularisation (TLR) at 12-month follow-up. Analyses were performed by intention to treat. At 12-month follow-up, the primary composite endpoint occurred in 9.6% of patients in the BAS group and 9.0% of those in the EES group (HR [hazard ratio] 1.04, 95% CI [confidence interval] 0.81-1.32, p=0.81, p for non-inferiority =0.001). Non-fatal MI was significantly less frequent in the BAS as compared with the EES group (2.2% vs. 5.9%, p=0.007). However, the individual rates of cardiac death and ischaemia-driven TLR were similar between the two groups (1.9% vs. 1.0%, p=0.39, and 6.5% vs. 4.9%, p=0.37, respectively). CONCLUSIONS: In patients presenting with ACS, BAS achieved a clinical outcome that was non-inferior to EES at 12-month follow-up.