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Aims: The aim of this study was to provide an up-to-date overview of gender differences or similarities in risk factor control and medical management in the Belgian CHD population., Methods: All analyses are based on the ESC EORP EUROASPIRE IV and EUROASPIRE V (European Survey Of Cardiovascular Disease Prevention And Diabetes) surveys. Patients between 18 and 80 years old, hospitalised for a first or recurrent coronary event, were included in the survey., Results: Data were available for 10,519 patients, of which 23.9% were women. Women had a worse risk factor profile compared to men. Women were more physical inactive (OR = 1.31, 95% CI = 1.19-1.44), had a higher prevalence of obesity (OR = 1.37, 95% CI = 1.25-1.50) and had a worse LDL-C control (OR = 1.52, 95% CI = 1.36-1.70). Moreover, women were less likely to use ACE-I/ARBs (OR = 0.84, 95% CI = 0.76-0.94) and statins (OR = 0.79, 95% CI = 0.70-0.90). In addition, little gender differences were found in patients' risk factor awareness, except on cholesterol awareness. Women were more aware about their total cholesterol levels (OR = 1.37, 95% CI = 1.21-1.56)., Conclusion: Despite little to no gender differences in the management of CHD patients, women still have a worse risk factor profile, both in Belgian and in other European high-income countries.

Objectives: This study aimed to assess discordance between results of instantaneous wave-free ratio (iFR), fractional flow reserve (FFR), and intravascular ultrasound (IVUS) in intermediate left main coronary (LM) lesions, and its impact on clinical decision making and outcome., Methods: We enrolled 250 patients with a 40%-80% LM stenosis in a prospective, multicenter registry. These patients underwent both iFR and FFR measurements. Of these, 86 underwent IVUS and assessment of the minimal lumen area (MLA), with a 6 mm2 cutoff for significance., Results: Isolated LM disease was recognized in 95 patients (38.0%), while 155 patients (62.0%) had both LM disease and downstream disease. In 53.2% of iFR+ and 56.7% of FFR+ LM lesions, the measurement was positive in only one daughter vessel. iFR/FFR discordance occurred in 25.0% of patients with isolated LM disease and 36.2% of patients with concomitant downstream disease (P=.049). In patients with isolated LM disease, discordance was significantly more common in the left anterior descending artery and younger age was an independent predictor of iFR-/FFR+ discordance. iFR/MLA and FFR/MLA discordance occurred in 37.0% and 29.4%, respectively. Within 1 year of follow-up, major cardiac adverse events (MACE) occurred in 8.5% and 9.7% (P=.763) of patients whose LM lesion was deferred or revascularized, respectively. Discordance was not an independent predictor of MACE., Conclusions: Current methods of estimating LM lesion significance often yield discrepant findings, complicating therapeutic decision-making.

Aim: Due to improved therapy in childhood, many patients with congenital heart disease reach adulthood and are termed adults with congenital heart disease (ACHD). ACHD often develop heart failure (HF) as a consequence of initial palliative surgery or complex anatomy and subsequently require advanced HF therapy. ACHD are usually excluded from trials evaluating heart failure therapies, and in this context, more data about heart failure trajectories in ACHD are needed to guide the management of ACHD suffering from HF., Methods and Results: The pAtients pResenTing with cOngenital heaRt dIseAse Register (ARTORIA-R) will collect data from ACHD evaluated or listed for heart or heart-combined organ transplantation from 16 countries in Europe and the Asia/Pacific region. We plan retrospective collection of data from 1989-2020 and will include patients prospectively. Additional organizations and hospitals in charge of transplantation of ACHD will be asked in the future to contribute data to the register. The primary outcome is the combined endpoint of delisting due to clinical worsening or death on the waiting list. The secondary outcome is delisting due to clinical improvement while on the waiting list. All-cause mortality following transplantation will also be assessed. The data will be entered into an electronic database with access to the investigators participating in the register. All variables of the register reflect key components important for listing of the patients or assessing current HF treatment., Conclusion: The ARTORIA-R will provide robust information on current management and outcomes of adults with congenital heart disease suffering from advanced heart failure., (© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Objectives: The study aimed to demonstrate through instant wave-free ratio (iFR) measurements that myocardium distal to a chronic total occlusion (CTO) is ischemic, that ischemia is reversible by PCI, and that iFR assessment after PCI can be used to optimize PCI results., Background: The greatest benefit of revascularization is found in patients with low fractional flow reserve. In patients with CTOs, iFR measurement may be more appropriate to evaluate ischemia as it does not require maximal microvascular vasodilation, which may be hampered by microvascular dysfunction., Methods: The iFR was measured in 81 CTO patients, both pre- and post-PCI in 63 patients, and only post-PCI in the following 18 patients. A pressure wire pullback was performed post-PCI if iFR ≤0.89., Results: The first 63 patients all had significant ischemia distal to the CTO with a median iFR of 0.33 [0.22; 0.44], improving significantly post-PCI to a median iFR of 0.93 [0.89;0.96] (p < .001). In the complete cohort, the median iFR post-PCI was 0.93 [0.86;0.96] but still ≤0.89 in 23 patients (30%). 12 of these patients had further PCI optimization because of a residual focal pressure gradient on pullback, after which only two had a final iFR ≤0.89., Conclusions: In CTO patients with an indication for PCI, iFR consistently demonstrated profound myocardial ischemia. Successful PCI immediately relieved ischemia in 70% of patients. In the remaining 30% of cases, a manual iFR pullback proved helpful in guiding further optimization of the PCI result., (© 2020 Wiley Periodicals LLC.)

Background: Granulomatosis with polyangiitis (GPA), formerly known as Wegener's granulomatosis, is a systemic inflammatory process predominantly affecting upper and lower respiratory tract and kidneys. Valvular heart disease is a rare manifestation of GPA., Case Summary: We report two cases of acute valvular heart disease mimicking acute endocarditis caused by GPA. Both patients were middle-aged females with acute aortic valve regurgitation suggestive of possible infective endocarditis. In their recent medical history, atypical otitis and sinusitis were noted. The first patient was admitted with heart failure and the second patient because of persisting fever. Echocardiogram revealed severe aortic regurgitation with an additional structure on two cusps, suggestive of infective endocarditis in both patients. Urgent surgical replacement was performed; however, intraoperative findings did not show infective endocarditis, but severe inflammatory changes of the valve and surrounding tissue. In both patients, the valve was replaced by a prosthetic valve. Microscopic examination of the valve/myocardial biopsy showed diffuse acute and chronic inflammation with necrosis and necrotizing granulomas, compatible with GPA after infectious causes were excluded. Disease remission was obtained in both patients, in one patient with Rituximab and in the other with Glucocorticoids and Cyclophosphamide. Both had an uneventful follow-up., Discussion: Granulomatosis with polyangiitis can be a rare cause of acute aortic valve regurgitation mimicking infective endocarditis with the need for surgical valve replacement. Atypical ear, nose, and throat symptoms can be a first sign of GPA. Symptom recognition is important for early diagnosis and appropriate treatment to prevent further progression of the disease., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Mechanical circulatory support with continuous-flow left ventricular assist devices (LVADs) has emerged as a viable treatment modality for patients with advanced heart failure. LVAD support results in unique haemodynamic and echocardiographic alterations that must be understood to provide optimal care for these patients. In this review, we propose essential echocardiographic and haemodynamic elements for the assessment of optimal LVAD function based on the literature and the use of simulation software. A key element of LVAD physiology remains the interaction between an unloaded left ventricle and a loaded right ventricle. The echocardiographic assessment and treatment of the pathophysiology of the right-sided part of the heart remains critical to maintaining optimal LVAD support., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Objectives: Interstitial lung disease (ILD) and pulmonary arterial hypertension (PAH) are the leading causes of death in systemic sclerosis (SSc). Although the six-minute walk test (6MWT) is used for evaluating ILD and PAH, no data are available on the evolution of the six-minute walk distance (6MWD) in SSc patients without ILD and PAH and whether the baseline 6MWD could serve as individual reference value for the management of those who will develop PAH or ILD., Methods: Prospectively collected data of the first 6MWT (at baseline or 6-month follow-up) and the 6MWTs at 18-, 30-, 42-, 54-, and 66-month visit of 165 consecutive SSc patients without ILD and PAH, included in the Ghent University SSc Cohort between May 2006 and December 2016 were analysed., Results: 96-100% of the included patients performed a 6MWT during the follow-up visits. The mean 6MWD during the baseline 6MWT of 165 SSc patients without ILD and PAH (35% limited, 56% limited cutaneous, 9% diffuse cutaneous SSc) was 484.20+/-92.65m with no significant difference in the 6MWD at different follow-up visits as compared to baseline. In 46 SSc patients without ILD and PAH who performed a 6MWT at baseline and at 66-month visit, the 6MWD walked at 66-month visit correlated with the baseline 6MWD (r=0.564, p<0.001)., Conclusions: In SSc without ILD and PAH, the 6MWT is feasible and the 6MWD is clinically stable over a 66 months period. Hence, the individual 6MWD might be used as individual reference value in management of those who will develop PAH or ILD.

Familial amyloid polyneuropathy (FAP) is a most often length-dependent axonal neuropathy, often part of a multisystem disorder also affecting other organs, such as cardiac, gastrointestinal, genitourinary, renal, meningeal and eye tissue. It is most frequently the result of a mutation in the TTR gene, most commonly a p.Val50Met mutation. TTR-FAP is a rare autosomal dominant heritable disabling, heterogeneous disease in which early diagnosis is of pivotal importance when attempting treatment. This paper discusses the course of four Belgian FAP patients with different TTR mutations (p.Val48Met; p.Val52Ala; p.Ala59Val; p.Val50Met). We also review the diagnosis and differential diagnosis of TTR-FAP, diagnostic studies, follow-up, its current treatment and those in development, prognosis and the importance of genetic counseling. At first, TTR-FAP is often misdiagnosed as a chronic inflammatory demyelinating polyneuropathy or chronic idiopathic axonal polyneuropathy. Genetic testing is obligatory to confirm the diagnosis of TTR-FAP, except in familial cases. Biopsy samples are an asset in diagnosing TTR-FAP but can be falsely negative. At the moment, tafamidis meglumine is considered as first-line treatment in stage I neurological disease. Patients eligible for liver transplantation should be carefully selected when first-line therapy fails.

Objectives: Interstitial lung disease (ILD) and pulmonary arterial hypertension (PAH) are the leading causes of death in systemic sclerosis (SSc) patients. Although the six-minute walk test (6MWT) is used for evaluating ILD and PAH in clinical practice, no data are available on six-minute walk distance (6MWD) and oxygen desaturation in SSc patients without ILD and PAH., Methods: Prospectively collected data of the 6MWTs at baseline and 6-month follow-up of 300 consecutive SSc patients, included in the Ghent University Hospital Systemic Sclerosis Unit between May 2006 and April 2015 were analysed., Results: The mean 6MWD of 165 SSc patients without ILD and PAH who performed a 6MWT at baseline or at the 6-month visit was 484±93m. Patients in the diffuse cutaneous (DcSSc) subgroup (435±94m) walked less than in the limited (LSSc) subgroup (499±91m, p=0.04) and tended to walk less than in the limited cutaneous (LcSSc) subgroup (483±92m, p=0.15). In 115 SSc patients without ILD and PAH who walked at both moments, there was no significant difference between the 6MWDs (mean difference -7.60m 95%CI [-19.93m; 4.73m], p=0.23) and the oxygen desaturation was not statistically different in 102 of them (mean difference 0.41% 95%CI [-0.49%; 1.31%], p=0.37)., Conclusions: In SSc without ILD and PAH, the 6MWD and oxygen desaturation is clinically stable over a 6 months period. The DcSSc subgroup walks less than the LSSc and the LcSSc subgroup.

Objectives: The European Scleroderma Study Group (EScSG) activity index meets nearly all the OMERACT-standards of truth, discrimination and feasibility. The sensitivity to change remains to be attested. This study assesses sensitivity to change of the EScSG activity index in patients with early and severe diffuse cutaneous Systemic Sclerosis (dcSSc) treated with rituximab., Methods: 12-month follow-up (open-label study) of 14 consecutive patients with early dcSSc. Patients received an infusion of two times 1000 mg rituximab at month 0 and 6, together with 100 mg methylprednisolone. Clinical read outs (modified Rodnan skin score [mRSS], lung function and echocardiography) and EScSG activity index were performed at month 0, 3, 6 and 12. Mixed models analyses (MMA) were used to evaluate changes in parameters over time., Results: There was a clinically significant change in skin score with a mean (SD) mRSS of 24.8 (4.44) at baseline and 10.4 (3.12) at month 12 (MMA p<0.001). Also the EScSG activity index decreased significantly, with a mean (SD) of 4.3 (1.79) at baseline and 0.7 (0.83) at month 12 (MMA p<0.001). The estimated mean change of the EScSG activity index was -3.6 (95%CI -4.9; -2.4) over 12 months. Indices of internal organ involvement remained stable throughout the study., Conclusions: A significant improvement of the EScSG activity index was observed, in line with the significant improvement of the mRSS and the stabilisation of internal organ involvement. To our knowledge, this is the first study to attest sensitivity to change of the EScSG activity index in the subset of 'early' dcSSc., Trial Registration: ClinicalTrials.gov Registration, http://clinicaltrials.gov, number NCT00379431.

Background: Pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD) are the leading causes of death in systemic sclerosis (SSc). Although the six-minute walk test (6MWT) is generally used for evaluating PAH and ILD, utility in SSc is undetermined. This study evaluates the role of 6MWT in SSc by systematic review and meta-analysis., Methods: A systematic literature search on PubMed, Web of Science and Cochrane Library Online was performed using the medical subject heading search terms for "systemic sclerosis", "CREST" and "six minute walk test", "six minute walk distance (6MWD)", "(cardiopulmonary) exercise test", "treadmill test" or "step test"., Results: Meta-analysis of 43 included studies (3185 SSc-all patients) revealed that the mean 6MWD was comparable between the SSc-PAH and SSc-ILD-PH subgroups (288m [95% CI: 259-317m] vs 286m [95% CI: 259-314m], p=0.93). The pooled mean of 725 SSc-PAH patients was significantly lower than the pooled mean of 413 SSc-noPAH patients (430m [95% CI: 402-458m], p<0.001). 95 SSc-ILD-PH patients walked significantly less than 328 SSc-ILD patients (388m [95% CI: 362-415m], p<0.001) and significantly less than 86 SSc-noILD patients (420m [95% CI: 325-515m], p=0.008). 81-98% of the SSc-PAH/ILD/ILD-PH patients performed a 6MWT., Conclusions: During a 6MWT, SSc-PAH patients walk less than SSc-noPAH patients and SSc-ILD-PH patients walk less than SSc-ILD and SSc-noILD patients., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Heart transplantation in patients with Marfan syndrome is challenging and raises concerns with regards to the haemodynamic and immunosuppressive-induced effects on the inherently fragile aorta. Most aortic events following transplantation reported so far in the literature occurred in patients with pre-existent distal aortic dissection. We report a case of successful orthotopic heart transplantation in a patient with Marfan syndrome that was complicated by late-onset type B dissection in pre-existing mild and stable distal aortic dilation. Serial aortic imaging revealed progressive growth at the level of the descending thoracic aorta. An open thoracoabdominal aortic repair procedure was successfully performed 6 months after the transplantation., (2015 BMJ Publishing Group Ltd.)

Pediatric heart allocation in Eurotransplant (ET) has evolved over the past decades to better serve patients and improve utilization. Pediatric heart transplants (HT) account for 6% of the annual transplant volume in ET. Death rates on the pediatric heart transplant waiting list have decreased over the years, from 25% in 1997 to 18% in 2011. Within the first year after listing, 32% of all infants (<12 months), 20% of all children aged 1-10 years, and 15% of all children aged 11-15 years died without having received a heart transplant. Survival after transplantation improved over the years, and in almost a decade, the 1-year survival went from 83% to 89%, and the 3-year rates increased from 81% to 85%. Improved medical management of heart failure patients and the availability of mechanical support for children have significantly improved the prospects for children on the heart transplant waiting list., (© 2014 Steunstichting ESOT.)

Objectives: To evaluate (1) changes in clinical, biochemical and echocardiographic parameters, (2) whether deterioration in exercise capacity and resting oxygen saturation (SatO2-rest) are related with adverse outcome and (3) its additional value in predicting outcome in Eisenmenger patients., Methods: Seventy-seven (36 ± 14 years, 30% male) patients were included and prospectively followed. Changes between baseline and final visit were evaluated. Clinical deterioration was defined as a deterioration in exercise capacity or SatO2-rest. Univariate and multivariate analyses were performed to evaluate predictors of outcome defined as the need for hospitalization due to right heart failure, transplantation, or all-cause mortality. Finally, the additional prognostic value of deterioration in exercise capacity and SatO2-rest was evaluated., Results: During a mean follow-up period of 4.0 ± 2.1 years, 27 (35%) events occurred. Patients in the event-group presented with an deterioration in NYHA class (P<0.0001), 6 minute walk distance (P=0.006) and SatO2-rest (P<0.0001). After adjustment for baseline variables, multivariate Cox regression analysis indicated that clinical deterioration was independently associated with adverse outcome., Conclusions: Clinical deterioration, defined as a deterioration in exercise capacity or SatO2-rest was associated with adverse outcome in Eisenmenger patients. Moreover, these parameters provided additional information on which patients would develop an event and may benefit from initiation or escalation of disease targeting therapy., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Background: Patients awaiting heart transplantation in Eurotransplant are prioritized by waiting time and medical urgency. To reduce mortality, the introduction of post-transplant survival in an allocation model based on the concept of survival benefit might be more appropriate. The aim of this study was to assess the prognostic accuracy of the heart failure survival score (HFSS), the Seattle heart failure model (SHFM), the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) model, and the index for mortality prediction after cardiac transplantation (IMPACT) score for predicting mortality., Methods: The HFSS, SHFM, the adapted SHFM, and the INTERMACS model were evaluated for predicting waiting list mortality among heart transplant candidates, and the IMPACT score was tested for predicting post-transplant mortality in separate Cox regression models. Included were the 448 adult heart transplant candidates listed for an urgent status between October 2010 and June 2011 in Eurotransplant. A cardiac allocation score (CAS) was calculated based on the estimated survival times as predicted by the scores. All analyses were performed for the total cohort and separately for ventricular assist device (VAD) and non-VAD patients., Results: Mortality on the waiting list could significantly be predicted in the non-VAD cohort by HFSS (p = 0.005) and SHFM (p < 0.0001) and after transplant by IMPACT (p < 0.0001). None of the tested scores could predict mortality among VAD-supported patients., Conclusions: In non-VAD patients, the HFSS, SHFM, and IMPACT provide accurate risk stratification. Further studies will reveal whether these models should be considered as the basis for a new heart allocation policy in Eurotransplant., (Copyright © 2013 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Portopulmonary hypertension (POPH), a complication of chronic liver disease, may be a contraindication to liver transplantation (LT) because of the elevated risk of peritransplant and posttransplant morbidity and mortality. Because POPH is frequently asymptomatic, screening with echocardiography is recommended. The only reliable technique, however, for diagnosing POPH is right heart catheterization (RHC). The aims of this study were to evaluate the current estimated systolic pulmonary artery pressure (sPAP) cutoff value of 30 mm Hg and to determine a better cutoff value. One hundred fifty-two patients underwent pretransplant echocardiography between January 2005 and December 2010. These echocardiographic results were compared with pulmonary artery pressures measured during the pretransplant workup or at the beginning of the transplantation procedure (both by catheterization). With a cutoff value of 30 mm Hg, 74 of the 152 patients met the criteria for POPH on echocardiography, although the diagnosis was confirmed in only 7 patients during catheterization; this resulted in a specificity of 54%. It would have been more accurate to use a cutoff value of 38 mm Hg, which had a maximal specificity of 82% and, at the same time, guaranteed a sensitivity and negative predictive value of 100%. With the incorporation of the presence or absence of right ventricular dilatation, the specificity even increased to 93% for this new cutoff value. In conclusion, the prevalence of POPH was 4.6% among LT candidates in this study. We can recommend that LT candidates with an sPAP > 38 mm Hg should be referred for RHC. With the cutoff value increased from 30 to 38 mm Hg, the number of patients undergoing invasive RHC during their evaluation could be safely reduced., (Copyright © 2013 American Association for the Study of Liver Diseases.)

To evaluate (1) whether right ventricular (RV) dysfunction, evaluated using tricuspid annular plane systolic excursion (TAPSE) is associated with a worse outcome in patients with the Eisenmenger syndrome, (2) which variables are related to RV dysfunction, and (3) whether differences exist among simple pretricuspid, simple post-tricuspid, and combined shunt lesions. Patients with Eisenmenger syndrome, aged >18 years, who underwent echocardiography, were selected from the Belgian Eisenmenger registry and prospectively followed up using a Web-based registry. Cox regression analysis was performed to evaluate the relation to outcomes, defined as all-cause mortality, transplantation, and hospitalization for cardiopulmonary causes. Comparative and bivariate analysis was performed, where applicable. A total of 58 patients (mean age 35.1 ± 13.2 years, 32.8% men) were included. During a mean follow-up of 3.2 years, 22 patients (37.9%) reached the predefined end point. Only TAPSE (hazard ratio 0.820, 95% confidence interval 0.708 to 0.950; p = 0.008) was related to the adverse outcomes on multivariate analysis. Patients with pretricuspid shunt lesions were older (p <0.0001) had greater left (p <0.0001) and right atrial (p <0.0001) dimensions, greater RV dimensions (p = 0.002), and more tricuspid regurgitation (p = 0.012) compared to patients with post-tricuspid lesions. Lower TAPSE was related to the presence of pulmonary artery thrombosis (R = -0.378; p = 0.006). In conclusion, in patients with Eisenmenger syndrome, RV dysfunction, evaluated using TAPSE, is related to worse outcomes. Patients with Eisenmenger syndrome with pretricuspid shunt lesions were older and had greater left atrial, right atrial, and RV dimensions compared to patients with post-tricuspid lesions, indicating a difference in the RV response. Lower TAPSE was associated with the presence of pulmonary artery thrombosis., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Aims: Iron deficiency is common in patients with Eisenmenger syndrome (ES). This study aimed at evaluating (i) whether iron deficiency is related with adverse outcome, (ii) the determinants of iron deficiency, and (iii) the relation between iron reserves and haemoglobin level in a contemporary cohort of ES patients., Methods and Results: All ES patients, older than 18 years, selected from the Belgian Eisenmenger registry, were prospectively followed using a web-based registry. Univariate Cox-regression analysis was performed to evaluate the relation with outcome, defined as all-cause mortality, transplantation, and hospitalisation due to cardiopulmonary causes. Bivariate analysis was performed where applicable. A total of 68 patients with a complete dataset (mean age 36.9 ± 14.2 years; 30.9% male) were included. During a median follow-up time of 3.1 years, 21 patients (30.9%) reached the predefined endpoint. New York Heart Association (NYHA) class ≥ III (HR 4.76; 95% CI 1.84-12.30; P = 0.001), iron deficiency (HR 5.29; 95% CI 2.04-13.76; P = 0.001), mean corpuscular volume (MCV) (HR 0.94; 95% CI 0.90-0.99; P = 0.021), and mean corpuscular haemoglobin (MCH) (HR 0.87; 95% CI 0.76-0.98; P = 0.027) were related with adverse outcome. The use of oral anticoagulation and frequent phlebotomies were independently related with iron deficiency (P = 0.005 and P = 0.008). In iron-deplete patients, MCV (R = -0.408; P= 0.014) and MCH (R = -0.437; P = 0.026) were inversely related with haematocrit. In patients with low oxygen saturation, iron reserves were related with haemoglobin levels (R = 0.587; P = 0.001)., Conclusions: Iron deficiency was associated with a higher risk of adverse outcome. Moreover, the use of oral anticoagulation OAC and frequent phlebotomies were related to iron deficiency. Patients under anticoagulation should be monitored rigorously for iron deficiency. However, in patients with low oxygen saturations, careful iron substitution to avoid too high haemoglobin levels is suggested.

Background and Aim of the Study: Since its introduction in May 1992, the bileaflet ATS Open Pivot valve has been implanted routinely at the authors' institution. The study aim was to analyze, retrospectively, the 15-year clinical results of these implanted ATS valves., Methods: Between May 1992 and December 2005, a total of 1,160 ATS valves (749 aortic, 381 mitral, 21 tricuspid, nine pulmonary) was implanted in 1,047 consecutive patients (655 males, 392 females; mean age 62.1 +/- 12.4 years). Preoperatively, 75% of the patients were in NYHA class III or higher (mean 3.1). The most frequent comorbidities included atrial fibrillation (n = 381), coronary disease (n = 288) and diabetes (n = 172)., Results: The mean follow up was 78 months (range: 24-183 months); the total follow up was 6,887 patient-years (pt-yr) and was 99.8% complete. In-hospital mortality was 4% (n = 43; three valve-related). Survival (Kaplan-Meier) at five and 10 years was significantly better for aortic than for mitral valve patients (84% and 65% versus 75% and 41%, respectively) (Mantel-Cox, p < 0.001). A log rank analysis detected no statistical difference in the incidence of thromboembolism (p = 0.182) or bleeding (p = 0.375) between both groups. The overall linearized incidences were: thromboembolism 1.08%/pt-yr; bleeding 0.91%/pt-yr; endocarditis 0.22%/pt-yr; paravalvular leakage 0.33%/pt-yr; and valve thrombosis 0.21%/pt-yr. Multivariate analysis (Cox regression) indicated age > 70 years (p < 0.0001), NYHA class > or = III (p < 0.0001), non-sinus rhythm (p = 0.001), concomitant CABG (p = 0.008) and higher INR values (p = 0.013) to be significant risk factors for death., Conclusion: This 15-year experience with the ATS bileaflet prosthesis showed excellent clinical outcomes for patients, with no structural failure and an acceptable incidence of adverse events.