New developments in adult congenital heart disease.

Congenital heart disease (CHD) affects 0.8% of live births and over the past decades technical improvements and large-scale repair has led to increased survival into adulthood of over 95% of the new-born. A new group of patients, those who survived their congenital heart defect, has emerged but late complications including heart failure, pulmonary hypertension (PH), arrhythmias, aneurysms and endocarditis appeared numerous, with a huge impact on mortality and morbidity. However, innovations over the past years have changed the landscape of adult CHD dramatically. In the diagnostic process important improvements have been made in the use of MRI, biomarkers, e­health concepts and 3D visualisation of anatomy. Care is now concentrated in specialised centres, with a continuous emphasis on education and the introduction of weekly multidisciplinary consultations on diagnosis and intervention. Surgery and percutaneous intervention have been refined and new concepts applied, further reducing the burden of the congenital malformations. Research has matured from case series to global networks. Currently, adults with CHD are still facing high risks of early mortality and morbidity. By global collaboration and continuous education and development and innovation of our diagnostic and therapeutic arsenal, we will improve the perspectives of these young patients.

NT-proBNP and exercise capacity in adult patients with congenital heart disease and a prosthetic valve: a multicentre PROSTAVA study.

OBJECTIVES: N-terminal B­type natriuretic peptide (NT-proBNP) is an important biomarker for the detection of heart failure. Adults with congenital heart disease (ACHD) and a prosthetic heart valve are at risk for heart failure. This study aimed to determine the value of NT-proBNP in ACHD patients with a prosthetic valve and investigate its relationship with cardiac function and exercise capacity. METHODS: In this multi-centre cross-sectional observational study, data regarding medical history, echocardiography, exercise testing (VO2peak) and laboratory blood evaluation (including NT-proBNP) were collected in ACHD patients with a single prosthetic valve (either homografts, heterografts or mechanical valves). RESULTS: A total of 306 ACHD patients with pulmonary valve replacement (PVR, n = 139), aortic valve replacement (n = 141), mitral valve replacement (n = 21) or tricuspid valve replacement (n = 5) were investigated. The majority of patients (77 %) were in NYHA class I or II. Elevated NT-proBNP levels (cut-off ≥125 pg/ml) were found in 50 % of the patients, with the highest levels in patients with mitral valve replacements. In this study population, NT-proBNP levels were associated with gender (p = 0.029) and VO2max (p < 0.001). In PVR patients, NT-proBNP levels were associated with lower VO2peak, also after adjustment for age, gender and age at valve replacement in a multivariate model (p = 0.015). CONCLUSIONS: In patients with ACHD and a prosthetic valve, elevated NT-proBNP levels are frequently observed despite preserved NYHA class. In PVR patients, a higher NT-proBNP level was associated with a lower VO2peak. These results may be of importance in the ongoing discussion about the timing of valve replacement in patients with CHD.

Impact of introduction of 20-week ultrasound scan on prevalence and fetal and neonatal outcomes in cases of selected severe congenital heart defects in The Netherlands.

OBJECTIVES: To evaluate in a population-based cohort the effect of the introduction of the 20-week ultrasound scan in 2007 on the time of diagnosis, pregnancy outcome and total prevalence and liveborn prevalence of cases with selected congenital heart defects (CHDs) in The Netherlands. METHODS: We included children and fetuses diagnosed with selected severe CHD, born in the 11-year period from 2001 to 2011. Two groups of CHD were defined: those associated with an abnormal four-chamber view at ultrasound (Group 1), and those associated with a normal four-chamber view at ultrasound (Group 2). The time of diagnosis, pregnancy outcome and total liveborn prevalence were compared for both groups over two 5-year periods, before and after the introduction of the 20-week ultrasound scan. Trends in total and liveborn prevalence were examined over 2001 to 2011. RESULTS: Information was collected on 269 children and fetuses. After the introduction of the 20-week ultrasound scan, the prenatal detection rate of CHDs increased in both groups (Group 1, 34.6% in 2001-2005 vs 84.8% in 2007-2011 (P < 0.001); Group 2, 14.3% in 2001-2005 vs 29.6% in 2007-2011 (P = 0.037)). The rate of termination of pregnancy (TOP) increased significantly only for Group 1 (15.4% vs 51.5% (P < 0.001)). The total prevalence of CHD in Group 1 increased over time from 2.9 per 10 000 births in 2001 to 6.4 per 10 000 births in 2011 (P = 0.016). The liveborn prevalence did not show a trend over time. For Group 2, no trends in total or liveborn prevalence could be detected over time. CONCLUSIONS: Since the implementation of the routine 20-week ultrasound scan in The Netherlands, prenatal detection rate of selected severe CHDs increased significantly. Improved prenatal detection was accompanied by a more than three-fold increase in TOP, although only in those CHDs with an abnormal four-chamber view at prenatal ultrasound.

Postoperative renal dysfunction and preoperative left ventricular dysfunction predispose patients to increased long-term mortality after coronary artery bypass graft surgery.

BACKGROUND: Both preoperative left ventricular dysfunction and postoperative renal function deterioration are associated with increased long-term mortality after cardiac surgery. The influence of preoperative left ventricular dysfunction on postoperative renal dysfunction and long-term mortality is not defined. METHODS: We collected data from 641 consecutive patients undergoing coronary bypass surgery with cardiopulmonary bypass in 1991 at our institution. Prospective follow-up was through to July 2004. RESULTS: In-hospital mortality was 2.7% (17 of 641). During follow-up, 248 (40%) patients discharged alive died (5 and 10 yr survival 90% and 70%, respectively). On univariate analysis, preoperative left ventricular dysfunction (ejection fraction <50%) and an increase in serum creatinine > or =25% in the first postoperative week were associated with long-term mortality. The associated mortality risk was additive in predominantly non-overlapping patients groups: the hazard ratio (HR) for renal function deterioration only was 1.41 [95% confidence interval (CI) 0.95-2.32, P=0.083; n=64] and for left ventricular dysfunction only 1.71 (95% CI 1.26-2.95, P=0.0026; n=73). In patients in whom both were present, HR was 3.23 (95% CI 2.52-20.28, P<0.0001; n=20). Although postoperative renal dysfunction was associated with left ventricular dysfunction (P=0.008), both left ventricular dysfunction and postoperative renal function deterioration were independently associated with long-term mortality on multivariate analysis, as were age and the use of venous conduits. CONCLUSIONS: Both postoperative renal function deterioration and preoperative left ventricular dysfunction independently identify largely non-overlapping groups of patients with increased long-term mortality after coronary bypass surgery. In the group of patients with both factors present, the mortality risks appear additive.

Changes in glomerular filtration rate after cardiac surgery with cardiopulmonary bypass in patients with mild preoperative renal dysfunction.

BACKGROUND: Cardiac surgery with cardiopulmonary bypass (CPB) is commonly perceived as a risk factor for decline in renal function, especially in patients with preoperative renal dysfunction. There are few data on the effects of CPB on renal function in patients with mild preoperative renal dysfunction. The purpose of this study was to evaluate renal function in patients with pre-existing mild renal dysfunction undergoing cardiac surgery with CPB. METHODS: In a multicentre study cohort we measured prospectively the glomerular filtration rate (GFR) by radioactive markers both before operation and on the 7th postoperative day in cardiac surgical patients with preoperative serum creatinine >120 micromol l(-1) (n=56). In a subgroup of patients (n=14) in addition to the GFR, the effective renal plasma flow (ERPF) and the filtration fraction (FF) were measured. RESULTS: While preoperative GFR [77.9 (25.5) ml min(-1)] increased to 84.4 (23.7) ml min(-1) (P=0.005) 1 week after surgery, ERPF did not change [295.8 (75.2) ml min(-1) and 295.9 (75.9) ml min(-1), respectively; P=0.8]. In accordance, the FF increased from 0.27 (0.05) (before operation) to 0.30 (0.04) (Day 7, P=0.01). CONCLUSION: Our results oppose the view that cardiac surgery with CPB adversely affects renal function in patients with preoperative mild renal dysfunction and an uncomplicated clinical course.

Hybrid approach for complex coronary artery and valve disease: a clinical follow-up study.

BACKGROUND: For patients suffering from complex coronary artery disease (CAD) with or without concomitant valve disease, no evidence is available in the current guidelines to propose a predefined treatment regimen. We sought to assess the clinical impact of an unconventional or extended definition of the hybrid approach that combines percutaneous coronary intervention (PCI) and cardiac surgery in subjects suffering from severe solitary CAD or combined with valve disease. METHODS AND RESULTS: Between July 2002 and August 2004, 18 consecutive patients with complex CAD with or without significant valve disease who qualified for a hybrid approach were enrolled in a clinical follow-up study. Four patients eventually did not complete the proposed interventions. One patient refused treatment after inclusion, one patient died before treatment could be undertaken and two patients died after surgery but before PCI. In the other 14 cases combined treatment was technically successful. After a mean follow-up period of 15alpha5 months two patients had died, one due to sudden cardiac death and one of a noncardiac cause. No other major adverse clinical events were reported. A marked increase in quality of life was reported in those alive. CONCLUSION: Hybrid approach had a favourable long-term outcome in patients with complex cardiovascular disease undergoing successful treatment; however, this was observed at the expense of significant periprocedural mortality in these high-risk subjects. Therefore we believe that hybrid approaches may provide an alternative for selected cases. (Neth Heart J 2007;15:329-4.).

Non-cardiac complications during pregnancy in women with isolated congenital pulmonary valvar stenosis.

BACKGROUND: Information on the outcome of pregnancy in patients with pulmonary valvar stenosis is scarce, mostly limited to cardiac complications observed during pregnancy. OBJECTIVES: To investigate the magnitude and determinants of non-cardiac and fetal risks during pregnancy of women with isolated pulmonary valvar stenosis. METHODS: Using the nationwide registry (CONgenital CORvitia), 106 women with (un-)corrected pulmonary valvar stenosis receiving care in six tertiary medical centres in The Netherlands were included. A total of 51 women had 108 pregnancies, including 21 (19%) miscarriages and 6 elective abortions. RESULTS: In the 81 completed (>20 weeks of gestation) pregnancies, we observed a high number of hypertension-related disorders (n = 12, 15%, including pre-eclampsia (n = 4) and eclampsia (n = 2)), premature deliveries (n = 14, 17%, including one twin) and thromboembolic events (n = 3, 3.7%). Furthermore, recurrence of congenital heart defects in the offspring was detected in three children (3.7%, pulmonary valvar stenosis (n = 2) and complete transposition of the great arteries in combination with anencephaly). In addition to the intrauterine fetal demise of the transposition child, three other children died shortly after birth owing to immaturity, hydrocephalus combined with prematurity and meningitis (overall offspring mortality, 4.8%). CONCLUSION: In this largest report on pregnancy in women with (un-) corrected isolated pulmonary valvar stenosis, an excessive number of (serious) non-cardiac complications and mortality were observed in the offspring.

Pregnancy and delivery in women after Fontan palliation.

OBJECTIVES: To evaluate the outcome of pregnancy in women after Fontan palliation and to assess the occurrence of infertility and menstrual cycle disorders. DESIGN AND PATIENTS: Two congenital heart disease registries were used to investigate 38 female patients who had undergone Fontan palliation (aged 18-45 years): atriopulmonary anastomosis (n = 23), atrioventricular connection (n = 5) and total cavopulmonary connection (n = 10). RESULTS: Six women had 10 pregnancies, including five miscarriages (50%) and one aborted ectopic pregnancy. During the remaining four live-birth pregnancies clinically significant complications were encountered: New York Heart Association class deterioration; atrial fibrillation; gestational hypertension; premature rupture of membranes; premature delivery; fetal growth retardation and neonatal death. Four of seven women who had attempted to become pregnant reported female infertility: non-specified secondary infertility (n = 2), uterus bicornis (n = 1) and related to endometriosis (n = 1). Moreover, several important menstrual cycle disorders were documented. In particular, the incidence of primary amenorrhoea was high (n = 15, 40%), which resulted in a significant increase in age at menarche (14.6 (SD 2.1) years, p < 0.0001, compared with the general population). CONCLUSION: Women can successfully complete pregnancy after adequate Fontan palliation without important long-term sequelae, although it is often complicated by clinically significant (non-)cardiac events. In addition, subfertility or infertility and menstrual disorders were common.

Long-term outcome after heart transplantation performed in the University Medical Centre Groningen.

BACKGROUND: Ten years ago, there was a difference of opinion about the suitability of ventilated patients with end-stage cardiac failure for heart transplantation (HTX). Although guidelines at that time qualified mechanical ventilation as a contraindication, we thought those patients could be candidates for HTX. In the same period a number of other patients received a donor heart in our centre. In this article we describe the clinical course and survival after these procedures. METHODS: We performed a retrospective study using our post HTX database. All patients undergoing transplants in our hospital were selected. Patients underwent echocardiography, scintigraphy (MUGA), ergo-spirometry (VO2 peak), blood tests and completed a quality of life questionnaire (SF-36). All tests were completed in the 1st quarter of 2006. RESULTS: Eight patients were identified; three were mechanically ventilated at the time of HTX. All eight patients were treated according to the standard protocol. Repeated surveillance cardiac biopsies were taken. One patient died 3.5 years after HTX due to an acute myocardial infarction. Seven patients, including the three patients on a ventilator at the time of the HTX, are alive, resulting in a survival rate of 88%. The current median survival time is 126 months (range 55 to 184 months). All patients are in good cardiac condition. The SF-36 domains of social functioning and mental health show high scores, the average score of general health and vitality is moderate. CONCLUSION: Survival of our eight transplanted patients after a median period of ten years was 88%, which is at least comparable with data from larger series. This finding suggests that HTX can be performed effectively and safely in a low volume centre. The finding that all three patients on a ventilator prior to HTX are alive is remarkable. It appears that mechanical ventilation is not always an absolute contraindication for HTX.

Pregnancy, fertility, and recurrence risk in corrected tetralogy of Fallot.

OBJECTIVE: To determine in women with surgically corrected tetralogy of Fallot the risk of pregnancy for mother and fetus, whether fertility was compromised, and the recurrence risk of congenital heart disease. DESIGN: Data were collected from 83 patients through interviews and review of medical records. RESULTS: In 29 patients 63 pregnancies were observed, of which 13 ended in an abortion. Fifty successful pregnancies were observed in 26 patients. During six successful pregnancies (12%) complications (symptomatic right sided heart failure, arrhythmias, or both) occurred. Both patients who developed symptomatic heart failure had severe pulmonary regurgitation. No clear relation between offspring mortality, premature birth or being small for gestational age, and cardiac characteristics of the mother was identified. Fifty seven patients were childless (41 (72%) voluntarily). Recurrence risk for congenital heart disease was 2.2%. Infertility was uncommon. CONCLUSIONS: Although complications did occur in five of 26 (19%) of the patients with a corrected tetralogy of Fallot, pregnancy was generally well tolerated in this largest report so far. No obvious predictors for maternal events or child outcome were determined, except for a possible relation between severe pulmonary regurgitation and symptomatic heart failure.

Effect of dexamethasone on perioperative renal function impairment during cardiac surgery with cardiopulmonary bypass.

BACKGROUND: In cardiac surgery with cardiopulmonary bypass (CPB), corticosteroids are administered to attenuate the physiological changes caused by the systemic inflammatory response. The effects of corticosteroids on CPB-associated renal damage have not been documented. The purpose of this study was to evaluate the effects of dexamethasone on perioperative renal dysfunction in patients undergoing cardiac surgery with CPB. METHODS: Renal damage was prospectively studied in 20 patients without concomitant morbidity undergoing coronary artery surgery with CPB. Patients were randomized in a double-blind fashion to receive dexamethasone or placebo. Markers of glomerular function (creatinine clearance) and damage (microalbuminuria), and markers of tubular function (fractional excretion of sodium and free water clearance) and damage (N-acetyl-beta-D glucosaminidase (NAG)) were evaluated in addition to plasma and urinary glucose levels. Plasma and urinary specimens were obtained at the following time periods: (1) baseline, during the 12 h before surgery; (2) skin incision before heparinization; (3) from heparinization until the end of CPB; (4) during the 2 h following weaning from CPB; (5) in the intensive care unit from 2 to 6 h after weaning of CBP; (6) and from 36 to 60 h after weaning of CPB. RESULTS: CPB was associated with an increase in markers in the placebo group, which returned to baseline during the second postoperative day, demonstrating a transient impairment of glomerular and tubular renal function. Similar patterns were observed in patients treated with dexamethasone. While postoperative glycosuria was significantly higher in the dexamethasone-treated group, no other differences between groups were observed. CONCLUSION: Dexamethasone administration before CPB has no protective effect on perioperative renal dysfunction in low-risk cardiac surgical patients.

Evaluation of different paediatric venous cannulae using gravity drainage and VAVD: an in vitro study.

Six different commercially available paediatric venous cannulae, together with a specially constructed cannula, were tested in vitro for their pressure-flow relationship. With the cannulae placed in an open reservoir, flow increased with larger diameters and higher pressures. At a pressure of 30 cm H2O, flows were 219 +/- 20, 285 +/- 13, 422 +/- 11 and 728 +/- 4 ml/min for the 12, 13.2, 14 and 16 French, respectively. No differences were found between angled and straight cannulae. When the cannulae were tested in a latex model simulating the right atrium and vena cavae, the highest flow obtained by gravity was 164 ml/min using an angled 14-French cannula. When vacuum was applied to augment venous return, a maximum flow of 179 ml/min was measured using an angled 14-French cannula. Collapse can occur when the pressure difference becomes too high in the test system. This is important, since most children are selectively cannulated in both major veins. Monitoring of the intravascular pressure might help to prevent collapse. A larger-diameter venous cannula does not always produce the highest flow when placed in a vein. This is most obvious when augmenting venous return. The design of the cannula tip, in combination with VAVD, can affect the venous return.

Ventricular septal rupture caused by myocardial bridging.

A 70-year-old woman was referred to us with postinfarction angina. During cardiac catheterization the only coronary abnormality found was myocardial bridging in the mid and distal parts of the left anterior descending coronary artery, despite a large ventricular septal rupture. The pulmonary-to-systemic flow ratio was 2.5:1. Her operation was successful.

Mini-maze suffices as adjunct to mitral valve surgery in patients with preoperative atrial fibrillation.

INTRODUCTION: After mitral valve (MV) surgery, preoperative atrial fibrillation (AF) often recurs while cardioversion therapy generally fails. Additional Cox maze surgery improves postoperative arrhythmia outcome, but the extensive nature of such an approach limits general appliance. We investigated the clinical outcome of a simplified, less extensive Cox maze procedure ("mini-maze") as adjunct to MV surgery. METHODS AND RESULTS: Thirteen patients with MV disease and preoperative AF were treated with combined surgery (group 1). Nine control patients without previous AF underwent isolated MV surgery (group 2). We retrospectively compared the results to findings in 23 patients with preoperative AF who had undergone isolated MV surgery (group 3). In group 1, mini-maze took an additional 46 minutes of perfusion time. One 75-year-old patient died of postoperative multiple organ failure. Seven patients showed spontaneously converting (within 2 months) postoperative AF. After 1 year, 82% were in sinus rhythm (SR). No sinus node dysfunction was observed. In group 2, all patients were in SR after 1 year. In group 3, only 53% were in SR after 1 year, despite serial cardioversion and antiarrhythmic drug therapy. Exercise tolerance and heart rate were comparable for groups 1 and 2. Left atrial function was present in all but one patient in group 1 and in all patients in group 2 (after MV reconstruction). CONCLUSION: Adding a relatively simple mini-maze to MV surgery improves arrhythmia outcome in patients with preoperative AF without introducing sinus node dysfunction or persistent absence of left atrial function. The results of this type of combined surgery are encouraging and deserve further attention.

Phosphorylcholine coating of extracorporeal circuits provides natural protection against blood activation by the material surface.

OBJECTIVE: The aim of this study is to evaluate the use of a new coating, mimicking the outer cell membrane, in paediatric cardiac surgery. METHODS: Two groups of ten patients with a body weight below 8 kg, undergoing elective cardiac operations for different congenital anomalies, were prospectively enrolled in this study. In one group the whole extracorporeal circuit, including the cannulas, was coated with phosphorylcholine (PC). In the second group the same circuit was used without coating. Platelet activation (thromboxane B2 (TXB2), beta-thromboglobulin (betaTG)), activation of the coagulation system (F1+2), leukocyte activation (CD11b/CD18) and terminal complement activation (TCC) were analyzed pre-cardiopulmonary bypass (CPB), at 15, 60 min of CPB, at the end of CPB, 20 min post CPB and at postoperative day 1 and 6. RESULTS: No statistical differences were found for F1+2 and CD11b/CD18. After onset of CPB mean levels of TCC remained stable in the PC group whereas an increase was observed in the control group. During CPB betaTG values in both groups increased to a maximum at the end of CPB. Within groups the increase in betaTG levels during CPB was statistically significant (P<0.05) from baseline in the control group starting from 60 min of CPB whereas no statistical difference was observed in the PC group. After the start of CPB TXB2 mean levels increased to 405+/-249 pg/ml in the PC group vs. 535+/-224 pg/ml in the control group. After this initial increase there was a small decline in the PC group with further increase. This was in contrast to the control group were TXB2 levels further increased up to a mean of 718+/-333 pg/ml at the end of CPB (P=0.016). CONCLUSIONS: Phosphorylcholine coating had a favourable effect on blood platelets, which is most obvious after studying the changes during cardiopulmonary bypass. A steady increase of TXB2 and betaTG was observed in the control group, whereas plateau formation was observed in the phosphorylcholine group. Clinically, this effect may contribute to reduced blood loss and less thromboembolic complications. Complement activation is lower in the coated group.

Angiotensin II formation in human vasculature after chronic ACE inhibition: a prospective, randomized, placebo-controlled study. QUO VADIS Investigators.

The QUO VADIS (the effects of QUinapril On Vascular Ace and Determinants of ISchemia) study was a randomized, double-blind, placebo-controlled trial designed to evaluate the effects of long-term angiotensin-converting enzyme (ACE) inhibition on angiotensin II formation in human vasculature. Patients (n = 187) scheduled for coronary artery bypass surgery used study medication 27 +/- 1 days before surgery. Segments of internal mammary arteries were exposed to increasing doses (0.1 nM-1 microM) of angiotensin I and II in organ baths. The rate of local angiotensin II formation is a function of the reciprocal of the difference between the pEC50's of the dose response curves to angiotensin I and II (-log/mol) and of the area between the curves (units). Quinapril (40 mg) and captopril (3 x 50 mg) similarly and significantly reduced mean blood pressure compared with placebo (p = 0.04). Difference between pEC50's was 0.90 +/- 0.08 in quinapril patients compared with 0.60 +/- 0.08 for placebo (p = 0.01); the area between curves was 91 +/- 8 for quinapril patients compared with 67 +/- 8 for placebo (p = 0.03). Angiotensin II formation was decreased to a lesser extent with captopril and was not statistically different from placebo (p = 0.3); the difference between pEC50's was 0.83 +/- 0.15; the area between curves was 84 +/- 12. This is the first randomized study to demonstrate that long-term oral treatment with an ACE inhibitor reduces vascular angiotensin II formation in humans.

Procoagulant activity after off-pump coronary operation: is the current anticoagulation adequate?

BACKGROUND: Hemostasis is preserved after off-pump coronary operations compared with conventional coronary procedures. However, this preserved hemostasis may result in a procoagulant activity. METHODS: We prospectively studied coagulation in 22 patients who underwent off-pump coronary operation either through a midline sternotomy (n = 14) or with minimally invasive anterolateral thoracotomy (n = 8). RESULTS: Procoagulant activity, represented by prothrombin factor 1 and 2, remained at baseline levels during operation but increased significantly on postoperative day 1. Factor VII remained at baseline levels during the operation but decreased significantly on postoperative day 1. Fibrinolysis was increased as indicated by the fibrin degradation products on postoperative day 1. A promoted hemostasis attributable to endothelial activation was indicated by the increase in von Willebrand factor on postoperative day 1. Platelets counts and platelet activation (beta-thromboglobulin) remained at baseline levels after the operation. No adverse clinical events occurred. CONCLUSIONS: Patients undergoing off-pump coronary operation show an increased procoagulant activity in the first postoperative 24 hours regardless of the surgical approach (midline sternotomy or anterolateral thoracotomy). This procoagulant activity is not mediated by platelet-related factors. Therefore, a specific perioperative prophylactic pharmacologic regimen is advisable.

Aortic valve replacement via ministernotomy: early results of a two-center study.

BACKGROUND: The reversed T ministernotomy has been proposed by Gundry to perform different congenital and common acquired heart valve operations. In this study we assessed the technical aspects of this approach for aortic valve replacement before starting a prospective randomized study. We evaluated the results of a two-Center study on the technical feasibility of aortic valve replacement via the reversed T ministernotomy according to the Gundry's approach. METHODS: From January to October 1998 aortic valve replacement via ministernotomy was successfully accomplished in 16 patients at the Catholic University of the Sacred Heart of Rome (Italy) and the Academisch Ziekenhuis of Groningen (The Netherlands). RESULTS: No complications were reported, except for the damage to the internal mammary artery during the opening of the sternum. The mean postoperative stay was 5.1 days. The postoperative respiratory recovery was easy and fast. CONCLUSIONS: Prospective randomized studies are needed to evaluate the effectiveness of the minimally invasive approach compared to standard sternotomy.

Thromboembolism and mechanical heart valves: a randomized study revisited.

BACKGROUND: This study was designed to revise and substantiate previous inferences, based on short-term follow-up, about differences in the incidence of anticoagulant-related events after heart valve replacement among patients who had been randomly assigned to receive either a Björk-Shiley, Edwards-Duromedics, or Medtronic-Hall mechanical heart valve prosthesis. METHODS: Intermediate-term follow-up to January 1995 was completed in 418 of 419 patients randomized to receive one of three types of heart valve prostheses between January 1982 and January 1987. Median follow-up was 98.5 months. Multivariable analysis in the hazard function domain was performed to identify factors that influenced the incidence of time-related thromboembolism and bleeding. These findings were compared with those made previously after a median follow-up of 37.5 months. RESULTS: No differences were found among the three prostheses in rates of anticoagulant-related hemorrhage. However, the incidence of thromboembolism was higher after mitral valve replacement among patients who had received the Medtronic-Hall prosthesis (linearized rate, 5.4% per patient year; 70% confidence interval, 4.0% to 7.1%), compared with Edwards-Duromedics (1.3%; 70% confidence interval, 0.4% to 3.0%) and Björk-Shiley prostheses (1.2%; 70% confidence interval, 0.6% to 2.2%). CONCLUSIONS: At long-term follow-up, in contrast to the findings at short-term follow-up, patients with either Björk-Shiley or Edwards-Duromedics prostheses had low rates of thromboembolism, whereas higher rates occurred in patients with a Medtronic-Hall prosthesis in the mitral position.