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Item does not contain fulltext, OBJECTIVES: We aimed to develop a model to predict long-term mortality after percutaneous coronary intervention (PCI), to aid in selecting patients with sufficient life expectancy to benefit from bioabsorbable scaffolds. BACKGROUND: Clinical trials are currently designed to demonstrate superiority of bioabsorbable scaffolds over metal devices up to 5 years after implantation. METHODS: From 2000 to 2011, 19.532 consecutive patients underwent PCI in a tertiary referral hospital. Patients were randomly (2:1) divided into a training (N = 13,090) and validation (N = 6,442) set. Cox regression was used to identify determinants of long-term mortality in the training set and used to develop a risk model. Model performance was studied in the training and validation dataset. RESULTS: Median age was 63 years (IQR 54-72) and 72% were men. Median follow-up was 3.6 years (interquartile range [IQR] 2.4-6.8). The ratio elective vs. non-elective PCIs was 42/58. During 88,620 patient-years of follow-up, 3,156 deaths occurred, implying an incidence rate of 35.6 per 1,000. Estimated 5-year mortality was 12.9%.Regression analysis revealed age, body mass index, diabetes mellitus, renal insufficiency, prior myocardial infarction, PCI indication, lesion location, number of diseased vessels and cardiogenic shock at presentation as determinants of mortality. The long-term risk model showed good discrimination in the training and validation sets (c-indices 0.76 and 0.74), whereas calibration was appropriate. CONCLUSIONS: A simple risk model, containing 9 baseline clinical and angiographic variables effectively predicts long-term mortality after PCI and may possibly be used to select suitable patients for bioabsorbable scaffolds.

Item does not contain fulltext, Aims: Previous studies have reported the safety and feasibility of both time-domain optical coherence tomography (TD-OCT) and Fourier-domain OCT (FD-OCT) in highly selected patients and clinical settings. However, the generalizability of these data is limited, and data in unselected patient populations reflecting a routine cathlab practice are lacking. We compared safety of intracoronary FD-OCT imaging to intravascular ultrasound (IVUS) imaging in a large real-world series of consecutive patients who underwent invasive imaging during coronary catheterization in our centre. Methods and results: This is a prospective, single-centre registry of patients scheduled for coronary angiography or intervention undergoing intracoronary imaging with FD-OCT or IVUS between April 2008 and December 2013. Intra-procedural and major in-hospital adverse events that could be possibly related to invasive imaging were registered routinely by the operator as part of our clinical report and prospectively recorded in our database. These events were retrospectively individually adjudicated by an independent safety committee. Between April 2008 and December 2013, 13 418 diagnostic or interventional coronary catheterization procedures were performed. Of these, 1142 procedures used OCT and 2476 procedures used IVUS. Invasive imaging-related complications were rare, did not differ between the two imaging methods (OCT: n = 7, 0.6%; IVUS: n = 12, 0.5%; P = 0.6), and were self-limiting after retrieval of the imaging catheter or easily treatable in the catheterization laboratory. No major adverse events, prolongation of hospital stay, or permanent patient harm was observed. Conclusion: FD-OCT is safe in an unselected and heterogeneous group of patients with varying clinical settings.

Item does not contain fulltext, BACKGROUND: A new-generation everolimus eluting platinum-chromium stent (EePCS), offering improved radial strength, radiopacity and conformability compared to everolimus-eluting cobalt-chromium stents (EeCCS), was evaluated with regard to safety and efficacy in an all-comer cohort. METHODS: A total of 1000 consecutive all-comer patients (including acute coronary syndrome, multivessel disease, calcified lesions) treated with an EePCS (Promus Premier, Boston Scientific, Natick, Massachusetts) from May 2013 to October 2014 were compared to 1000 consecutive patients treated with an EeCCS (Xience Prime, Abbott Vascular, Santa Clara, California) from April 2012 to May 2013. Patients were clinically followed for 1year. RESULTS: Mean age was 66+/-12years with diabetes in 20.7%, previous infarction in 22.7%, and ACS as the indication in 71.2% of patients. The mean number of stents per patient was 1.8+/-1.13. Total stented length was 35+/-25mm. Lesion classification was B2/C in 73.9% of patients. At 1year the primary endpoint of major adverse cardiac events (all-cause mortality, myocardial infarction [MI], ischemia-driven target vessel revascularization [TVR]) was reached in 11.7% in the EePCS cohort and 10.9% in the EeCCS cohort (adjusted HR 1.01 [0.77-1.33]; p=0.95). No significant differences were noted in the individual clinical endpoints all-cause mortality (6.8% versus 6.4%), MI (2.2% versus 2.3%), and TVR (4.3% versus 3.7%) in the respective EePCS and EeCCS cohorts. Stent thrombosis occurred in 0.8% and 1.0% respectively. CONCLUSIONS: In all-comer patients undergoing percutaneous coronary intervention, the use of EePCS was associated with similar 1-year clinical outcome as compared to EeCCS.

Item does not contain fulltext, BACKGROUND: Some aspects of prognosis are not reflected by cumulative survival estimates. These aspects include information on the time already survived by the patient and the patient's survival compared with the general population. Conditional survival (ie, conditional on having survived a certain period of time already) and relative conditional survival (ie, compared with the general population) do incorporate these aspects. We investigated these measures of prognosis in patients undergoing percutaneous coronary intervention. METHODS AND RESULTS: We studied 17 903 consecutive patients undergoing percutaneous coronary intervention between 2000 and 2014. Cumulative survival was estimated for patients with ST-segment-elevation myocardial infarction (n=5996, 853 deaths), non-ST-segment-elevation myocardial infarction (n=5371, 901 deaths), and stable angina pectoris (n=6536, 965 deaths) in 4 age categories. One-year conditional and relative conditional survival up to 10 years post-percutaneous coronary intervention was calculated. The results demonstrated that 1-year cumulative survival for patients with ST-segment-elevation myocardial infarction aged >/=76 years was 83%. One-year conditional survival, conditional on surviving the first month, was 92% in this group, and relative conditional survival (relative to the general population) was 99%. In younger age categories and in patients with non-ST-segment-elevation myocardial infarction and stable angina pectoris , similar patterns were found albeit less pronounced. Five-year relative conditional rendered similar results. CONCLUSIONS: Relative conditional survival provides a comprehensive picture of patient prognosis, particularly for older patients with ST-segment-elevation myocardial infarction. Although, as expected, their cumulative survival is low, once they survive the first month after percutaneous coronary intervention, their prognosis is comparable to that of the general population. Therefore, relative conditi

Item does not contain fulltext, OBJECTIVES: To assess whether the RXi Navvus system compared to the use of standard Fractional Flow Reserve (FFR) wires reduces total contrast volume, radiation and overall study cost in a real world patient population referred for coronary angiography or percutaneous coronary intervention. BACKGROUND: FFR is the mainstay of functional hemodynamic assessment of coronary artery lesions. The RXi Navvus system (ACIST Medical Systems, Eden Prairie, MN) is a monorail microcatheter with FFR-measurement capability through optical pressure sensor technology. METHODS: This is an investigator-initiated, prospective, single-center, observational cohort study. A total of 238 patients were enrolled, 97 patients with Navvus and 141 with conventional pressure-wire based FFR (PW-FFR). Final analyses were performed on the cohort in which only 1 device was used (82 Navvus procedures vs. 136 PW-FFR procedures). RESULTS: No significant differences were found in the total amount of contrast used (150+/-77 vs 147+/-79ml; p=0.81), radiation use (6200+/-4601 vs. 5076+/-4655 centiG *cm(2); p=0.09) or costs (euro1994,- vs. euro1930,-; p=0.32) in the Navvus vs. PW-FFR groups respectively. CONCLUSIONS: No significant differences were found in the amount of contrast used, total procedural costs or radiation when the Navvus system was used as compared to conventional FFR wires. CONDENSED ABSTRACT: CONTRACT is an investigator-initiated, prospective, single-center, observational cohort study that evaluated whether the RXi Navvus system compared to the use of standard Fractional Flow Reserve (FFR) wires reduces total contrast volume, radiation and overall study cost in a real world patient population referred for coronary angiography or percutaneous coronary intervention. Use of the RXi Navvus system was associated with comparable procedural costs, amount of radiation and contrast used as compared to PW-FFR systems.

Contains fulltext : 153587.pdf (publisher's version ) (Closed access), To evaluate the moderating influence of parental variables on changes in health-related quality of life (HRQoL) in adolescents with Tetralogy of Fallot (ToF) or a Fontan circulation after participation in standardized exercise training. A multicenter randomized controlled trail in which 56 patients, aged 10-15, were randomly allocated (stratified by age, gender, and congenital heart disease) to a 12-week period with either: (a) 3 times per week standardized exercise training or (b) care-as-usual (randomization ratio 2:1). Adolescents and their parents filled in online questionnaires at baseline and at 12-week follow-up. In this randomized controlled trail, primary analyses involved influence of parental mental health and parental social support for exercise on changes in the TNO/AZL Child Quality of Life Questionnaire Child Form at follow-up. Secondary analyses concerned comparing levels of parental characteristics with normative data. Compared with controls, adolescents in the exercise group reported a decrease in social functioning when their parents had more anxiety/insomnia or severe depression themselves. Adolescents also reported a decrease in social functioning when their parents showed poorer overall mental health themselves. Parents reported comparable or even better mental health compared with normative data. The effect of a standardized exercise program on HRQoL changes in adolescents with ToF or a Fontan circulation is moderated by parental mental health, more specifically by parental anxiety/insomnia and severe depression. The trial registration number of this article is NTR2731 ( www.trialregister.nl ).

Contains fulltext : 138518.pdf (publisher's version ) (Closed access), PURPOSE: To evaluate effects of an exercise program on health-related quality of life (HRQoL) in children and adolescents with tetralogy of Fallot (ToF) or a Fontan circulation. METHODS: Stratified, randomized, controlled intervention study conducted in five participating centers of pediatric cardiology in The Netherlands. In total, 93 patients, aged 10-25 years, with surgical repair for tetralogy of Fallot or with a Fontan circulation for single-ventricle physiology were included. They were randomly allocated with a ratio of 2:1 to: (1) a 12-week period with an exercise program for 3 times per week or (2) to a control group. Randomization was stratified by age, gender, and cardiac diagnosis. At baseline and follow-up after 12 weeks, all participants completed Web-based age-appropriate HRQoL questionnaires. Primary analyses involved change in HRQoL during follow-up. Secondary analyses concerned influence of cardiac diagnosis and comparison with normative data. RESULTS: Forty-eight (86%) and 32 (86%) patients in the exercise-group and control-group respectively completed all questionnaires at baseline and follow-up. Compared with the control-group, children, aged 10-15 years, in the exercise-group improved significantly on self-reported cognitive functioning, p < .05, r = .30, and parent-reported social functioning, p < .05, r = .30. Youngsters aged 16-25 years did not change their HRQoL. Cardiac diagnosis had no influence on pre/post changes. Children and youngsters in this study reported comparable or better HRQoL than norm groups. CONCLUSIONS: Participation in an exercise program improved HRQoL of children with ToF or a Fontan circulation, especially in those with low baseline QoL.

Item does not contain fulltext, BACKGROUND: The fate of right ventricular dimensions after surgical closure of secundum-type atrial septal defects remains unclear. The objectives of this study were to assess ventricular dimensions, exercise capability, and arrhythmias of patients operated for secundum-type atrial septal defect and compare the results with those in healthy references. METHODS: A total of 78 consecutive patients underwent surgical closure for a secundum-type atrial septal defect between 1990 and 1995. In all, 42 patients were included and underwent a cross-sectional evaluation including echocardiography, magnetic resonance imaging, exercise testing, and 24-hour ambulatory electrocardiography. Patients were matched with healthy controls for gender, body surface area, and age. RESULTS: The mean age at surgery was 4.6 plus or minus 2.8 years, and the mean age at follow-up was 16 plus or minus 3 years. There were no residual intracardiac lesions. The mean right ventricular endsystolic volume was significantly larger in patients (142 +/- 26 millilitres) than in references (137 +/- 28 millilitres; p = 0.04). In 25% of the patients, right ventricular end-systolic volume was larger than the 95th percentile for references. No relevant arrhythmias were detected. Exercise testing did not reveal differences with healthy references: maximal power (169 +/- 43 Watt patients versus 172 +/- 53 controls; p = 0.8), maximal oxygen uptake (38 +/- 8 versus 41 +/- 13 millilitres per minute per kilogram; p = 0.1). COMMENT: After surgical closure of secundum-type atrial septal defect, right ventricular end-systolic volume is increased. These findings have no impact on rhythm status or exercise capacity at this stage of follow-up, but may have implications for the timing of surgery or the technique of closure if confirmed in longer follow-up.

Contains fulltext : 71166.pdf (publisher's version ) (Closed access), OBJECTIVE: The aim of the study was to assess the long-term results of a selective policy toward pulmonary valve replacement in adult patients with repaired tetralogy of Fallot and severe pulmonary regurgitation. METHODS: Sixty-seven patients with tetralogy of Fallot were followed up from 15 +/- 3 years until 27 +/- 3 years after surgery. RESULTS: Twenty-two patients had mild-to-moderate pulmonary regurgitation. No significant changes occurred in the follow-up period. Of 45 patients with severe pulmonary regurgitation and severe right ventricular dilatation, 28 (62%) remained free of symptoms and did not undergo pulmonary valve replacement. No changes in right ventricular size or exercise capacity were found. In 3 (11%) of 28 patients, QRS duration increased to more than 180 ms. Seventeen patients had symptoms and underwent pulmonary valve replacement: 9 (54%) of 17 patients improved clinically and echocardiographically, and QRS duration shortened postoperatively. Right ventricular dimensions did not regress despite pulmonary valve replacement in 8 patients. CONCLUSION: Refraining from pulmonary valve replacement in asymptomatic patients led to no measurable deterioration in 25 (89%) of 28 patients. Referring symptomatic patients for pulmonary valve replacement led to an improvement in 9 (53%) of 17 patients. In 11 (24%) of 45, a selective approach led to questionable or unsatisfactory results.

Contains fulltext : 47851.pdf (publisher's version ) (Closed access), OBJECTIVE: We examined the independent prognostic value of the four subscales of the Heart Patients Psychological Questionnaire (HPPQ) on mortality in acute myocardial infarction (AMI) survivors up to 8 years after the event. METHODS: The HPPQ, which measures well-being, feelings of being disabled, despondency and social inhibition, was administered to 567 AMI patients during hospitalisation and at 3 months follow-up. The patients were followed for 8 years. RESULTS: During follow-up, 157 patients (28%) died. Forty-one percent of the patients had a score indicating at least mild to moderate feelings of being disabled. Patients with feelings of being disabled were at increased risk of mortality compared with those having a low score, adjusted for other cardiac risk factors [hazard ratio (HR)=1.8, 95% confidence interval (CI)=1.3-2.5]. There was no interaction between feelings of being disabled and gender. None of the other HPPQ subscales were related to mortality or recurrent myocardial infarction (MI). When the study population was stratified by low and high clinical risk (43% vs. 57%, respectively), feelings of being disabled was the most prominent predictor of mortality in the low-risk group (HR=3.5, 95% CI=1.4-8.8). CONCLUSION: Feelings of being disabled measured at baseline and at 3 months was the most prominent predictor of mortality in low-risk patients 8 years post-MI. This finding adds to the existing knowledge that psychosocial variables influence morbidity and mortality in cardiac patients.