Long-term outcomes and cost effectiveness of high-dose dexamethasone for cardiac surgery: a randomised trial.

Prophylactic intra-operative administration of dexamethasone may improve short-term clinical outcomes in cardiac surgical patients. The purpose of this study was to evaluate long-term clinical outcomes and cost effectiveness of dexamethasone versus placebo. Patients included in the multicentre, randomised, double-blind, placebo-controlled DExamethasone for Cardiac Surgery (DECS) trial were followed up for 12 months after their cardiac surgical procedure. In the DECS trial, patients received a single intra-operative dose of dexamethasone 1 mg.kg-1 (n = 2239) or placebo (n = 2255). The effects on the incidence of major postoperative events were evaluated. Also, overall costs for the 12-month postoperative period, and cost effectiveness, were compared between groups. Of 4494 randomised patients, 4457 patients (99%) were followed up until 12 months after surgery. There was no difference in the incidence of major postoperative events, the relative risk (95%CI) being 0.86 (0.72-1.03); p = 0.1. Treatment with dexamethasone reduced costs per patient by £921 [€1084] (95%CI £-1672 to -137; p = 0.02), mainly through reduction of postoperative respiratory failure and duration of postoperative hospital stay. The probability of dexamethasone being cost effective compared with placebo was 97% at a threshold value of £17,000 [€20,000] per quality-adjusted life year. We conclude that intra-operative high-dose dexamethasone did not have an effect on major adverse events at 12 months after cardiac surgery, but was associated with a reduction in costs. Routine dexamethasone administration is expected to be cost effective at commonly accepted threshold levels for cost effectiveness.

The Dutch hospital standardised mortality ratio (HSMR) method and cardiac surgery: benchmarking in a national cohort using hospital administration data versus a clinical database.

OBJECTIVE: To compare the accuracy of data from hospital administration databases and a national clinical cardiac surgery database and to compare the performance of the Dutch hospital standardised mortality ratio (HSMR) method and the logistic European System for Cardiac Operative Risk Evaluation, for the purpose of benchmarking of mortality across hospitals. METHODS: Information on all patients undergoing cardiac surgery between 1 January 2007 and 31 December 2010 in 10 centres was extracted from The Netherlands Association for Cardio-Thoracic Surgery database and the Hospital Discharge Registry. The number of cardiac surgery interventions was compared between both databases. The European System for Cardiac Operative Risk Evaluation and hospital standardised mortality ratio models were updated in the study population and compared using the C-statistic, calibration plots and the Brier-score. RESULTS: The number of cardiac surgery interventions performed could not be assessed using the administrative database as the intervention code was incorrect in 1.4-26.3%, depending on the type of intervention. In 7.3% no intervention code was registered. The updated administrative model was inferior to the updated clinical model with respect to discrimination (c-statistic of 0.77 vs 0.85, p<0.001) and calibration (Brier Score of 2.8% vs 2.6%, p<0.001, maximum score 3.0%). Two average performing hospitals according to the clinical model became outliers when benchmarking was performed using the administrative model. CONCLUSIONS: In cardiac surgery, administrative data are less suitable than clinical data for the purpose of benchmarking. The use of either administrative or clinical risk-adjustment models can affect the outlier status of hospitals. Risk-adjustment models including procedure-specific clinical risk factors are recommended.

The role of exercise echocardiography in the management of mitral valve disease.

PURPOSE: Exercise echocardiography can assess the dynamic component of mitral valve (MV) disease and may therefore be helpful for the clinical decision-making by the heart team. The purpose of this study is to determine the role of exercise echocardiography in the management of disproportionately symptomatic or otherwise atypical patients with mitral regurgitation (MR) and stenosis (MS) in clinical practice. METHODS: Data of 14 MR and 14 MS patients, including echocardiograms at rest, were presented retrospectively to an experienced heart team to determine treatment strategy. Subsequently, exercise echo data were provided whereupon once again the treatment strategy was determined. This resulted in: value of exercise echo by means of 1) alteration or 2) confirmation of treatment strategy or 3) no additional value. RESULTS: During exercise the echocardiographic severity of MV disease increased in 9 (64 %) MR and 8 (57 %) MS patients. Based upon alteration or confirmation of the treatment strategy, the value of exercise echocardiography in the management of MR and MS was 86 % and 57 %, respectively. CONCLUSION: This study showed that physical exercise echo can have an important role in the clinical decision-making of challenging patients with MV disease. Exercise echocardiography had additional value to the treatment strategy in 71 % of these patients.

Early mitral valve repair versus watchful waiting in patients with severe asymptomatic organic mitral regurgitation; rationale and design of the Dutch AMR trial, a multicenter, randomised trial.

BACKGROUND: Asymptomatic severe mitral valve (MV) regurgitation with preserved left ventricular function is a challenging clinical entity as data on the recommended treatment strategy for these patients are scarce and conflicting. For asymptomatic patients, no randomised trial has been performed for objectivising the best treatment strategy. METHODS: The Dutch AMR (Asymptomatic Mitral Regurgitation) trial is a multicenter, prospective, randomised trial comparing early MV repair versus watchful waiting in asymptomatic patients with severe organic MV regurgitation. A total of 250 asymptomatic patients (18-70 years) with preserved left ventricular function will be included. Intervention will be either watchful waiting or MV surgery. Follow-up will be 5 years. Primary outcome measures are all-cause mortality and a composite endpoint of cardiovascular mortality, congestive heart failure, and hospitalisation for non-fatal cardiovascular and cerebrovascular events. Secondary outcome measures are total costs, cost-effectiveness, quality of life, echocardiographic and cardiac magnetic resonance parameters, exercise tests, asymptomatic atrial fibrillation and brain natriuretic peptide levels. Additionally, the complication rate in the surgery group and rate of surgery in the watchful waiting group will be determined. IMPLICATIONS: The Dutch AMR trial will be the first multicenter randomised trial on this topic. We anticipate that the results of this study are highly needed to elucidate the best treatment strategy and that this may prove to be an international landmark study.

The pathophysiological basis of pharmacological interventions in CAVD.

Calcific aortic valve disease (CAVD) results in aortic valve stenosis and is one of the most common cardiac diseases in both Western and developing countries. The burden of this disease is expected to increase rapidly in the future, but there are still no relevant pharmacological therapies available and aortic valve replacement remains the sole definite therapy. This review presents an overview of the most common causes of CAVD, followed by current debates and trials related to the onset and progression of this disease. Several differences and similarities between the different causes of CAVD are presented. Additionally, stages of CAVD are compared with stages in atherosclerosis. Finally, future directions for research on CAVD will be discussed.

Bicuspid stenotic aortic valves: clinical characteristics and morphological assessment using MRI and echocardiography.

BACKGROUND: Bicuspid aortic valve (BAV) is one of the most common congenital heart defects with a population prevalence of 0.5% to 1.3%. Identifying patients with BAV is clinically relevant because BAV is associated with aortic stenosis, endocarditis and ascending aorta pathology. METHODS AND RESULTS: Patients with severe aortic stenosis necessitating aortic valve replacement surgery were included in this study. All dissected aortic valves were stored in the biobank of the University Medical Centre Utrecht. Additionally to the morphological assessment of the aortic valve by the surgeon and pathologist, echocardiographic and magnetic resonance imaging (MRI) images were evaluated. A total of 80 patients were included of whom 32 (40%) were diagnosed with BAV by the surgeon (gold standard). Patients with BAV were significantly younger (55 vs 71 years) and were more frequently male. Notably, a significant difference was found between the surgeon and pathologist in determining valve morphology. MRI was performed in 33% of patients. MRI could assess valve morphology in 96% vs 73% with echocardiography. The sensitivity of MRI for BAV in a population of patients with severe aortic stenosis was higher than echocardiography (75% vs 55%), whereas specificity was better with the latter (91% vs 79%). Typically, the ascending aorta was larger in patients with BAV. CONCLUSION: Among unselected patients with severe aortic valve stenosis, a high percentage of patients with BAV were found. Imaging and assessment of the aortic valve morphology when stenotic is challenging.

Systemic embolisation as presentation and recurrence of cardiac myxoma two years after surgery.

Primary cardiac tumours are rare when compared with metastatic involvement. The majority of primary cardiac tumours are benign and in adults the majority of these masses are myxomas. The treatment is surgical removal because of the risk of embolisation and/or cardiovascular complications. We describe a female presenting with systemic embolisation and recurrence of cardiac myxoma after surgery. Recurrence of myxoma is rare after surgery in case of solitary tumours but more frequent in patients with familial myxomas in association with the Carney complex. Genetic analysis revealed a mutation in the PRKAR1A gene that has never been described before. (Neth Heart J 2010;18:499502.).

Cardiac surgery in patients irradiated for Hodgkin's lymphoma.

Background/Objectives. Therapy for Hodgkin's lymphoma is disease specific and cannot be compared with treatment for other diseases. It often includes more extensive radiotherapy on the mediastinum than for other malignancies. Cardiac morbidity is known to occur in patients previously irradiated. This study describes the postoperative course after cardiac surgery of patients previously irradiated for Hodgkin's lymphoma.Methods. From January 1990 until June 2008, 12 patients underwent cardiac surgery in the University Medical Center Utrecht after previous irradiation for Hodgkin's lymphoma. Data on radiotherapy, surgery and follow-up were collected retrospectively. The postoperative functional status was assessed by a telephone questionnaire.Results. Atrial fibrillation (33%) and pleural effusion (25%) were the most common postoperative complications. After a mean followup of 2.6+/-2.9 years four patients had died. The remaining patients were all in a favourable New York Heart Association and Canadian Cardiothoracic Society class. The estimated one-, two- and four-year survival rates were 83, 69 and 46% respectively.Conclusion. The early postoperative outcome of cardiac surgery in this population is reasonably good. The long-term results may prove to be disappointing, but the cohort is small. (Neth Heart J 2010;18:61-5.).

Infection after ICD implantation: operating room versus cardiac catheterisation laboratory.

BACKGROUND/OBJECTIVES: Since the insertion of an implantable cardioverter-defibrillator (ICD) has become technically comparable to pacemaker implantation, these procedures are increasingly being performed in a cardiac catheterisation laboratory (CCL) instead of the operating room (OR). This study aims to describe the relationship between incidence of ICD infection and procedure setting and to describe the characteristics of ICD infection. METHODS: A retrospective study was performed of first ICD implantation in 677 patients admitted to our hospital between 1996 and 2006. Implantations were performed in the OR until 2003, after 2003 they were carried out in the CCL. The follow-up was censored at one year after implantation. ICD infections were defined as pocket infection or ICD-related endocarditis and a descriptive analysis was performed. RESULTS: Cardiothoracic surgeons implanted 366 ICDs in the OR Electrophysiologists performed 301 implantations in the CCL. Pulse generators were inserted using a pectoral approach with transvenous lead systems. We identified seven ICD infections (incidence rate 1.2/100 person-years), three of which had been implanted in the OR and four in the CCL. CONCLUSION: In this single-centre study no difference in the incidence of ICD infection was observed between implantation in OR and CCL. However, a larger study will be necessary to rule out a relationship with certainty. (Neth Heart J 2009;17:95-100.).

Heart transplantation in the Netherlands: quo vadis?

Heart transplantation is limited by the lack of donor organs. Twenty years after the start of the Dutch transplant programmes in Rotterdam and Utrecht the situation has even worsened, despite efforts to increase the donor pool. The Dutch situation seems to be worse than in other surrounding countries, and several factors that may influence donor organ availability and organ utilisation are discussed. The indications and contraindications for heart transplantation are presented, which are rather restrictive in order to select optimal recipients for the scarce donor hearts. Detailed data on donor hearts, rejected for transplantation, are shown to give some insight into the difficult process of dealing with marginal donor organs. It is concluded that with the current low numbers of acceptable quality donor hearts, there is no lack of capacity in the two transplanting centres nor is the waiting list limiting the number of transplants. The influence of our current legal system on organ donation, which requires (prior) permission from donor and relatives, is probably limited. The most important determinants of donor organ availability are: 1. The potential donor pool, consisting of brain dead victims of (traffic) accidents and CVAs and 2. Lack of consent to a request for donation. The potential donor pool is remarkably small in the Netherlands, due to relatively low numbers of (traffic) accidents, with an almost equal number of CVA-related brain dead patients compared with neighbouring countries. Lack of consent can only be pushed back by improved public awareness of the importance of donation and improved skills of professionals in asking permission in case there is no previous consent.

A patient with four artificial heart valves after ergotamine therapy.

A 67-year-old female was evaluated in the out-patient clinic because of shortness of breath on exertion and regular spells of fever. She had been taking ergotamine tartrate to treat migraine for more than 30 years. The patient had undergone aortic-valve replacement for aortic insufficiency three years before. On echocardiographic evaluation, severe retraction and insufficiency of the remaining native heart valves was demonstrated. Endocarditis and carcinoid syndrome were excluded. The mitral, tricuspid and pulmonary valves were all replaced by a mechanical valvular prosthesis. Pathological-anatomical evaluation of the three replaced valves and the aortic valve replaced three years earlier disclosed identical findings, compatible with long-term ergotamine use. Nine months after surgery, a sick sinus syndrome developed necessitating implantation of a DDDR pacemaker with a right atrial and a coronary sinus lead. Functional class according to the New York Heart Association improved from class III to I. After stopping the ergotamine, the fever disappeared. However, the migraine spells reoccurred which are now being treated with paracetamol.

Recommended transoesophageal echocardiographic evaluation of mitral valve regurgitation.

Valve replacement in patients with mitral valve regurgitation is indicated when symptoms occur or left ventricular function becomes impaired. Using different surgical techniques, mitral valve reconstruction has lead to earlier interventions with good clinical results. In order to determine the possibility of a mitral valve reconstruction, echocardiographic parameters are necessary. With transoesophageal echocardiography a segmental analysis of the entire mitral valve can be performed; mitral valve motion abnormalities and severity and direction of the regurgitation jet can be judged. From this analysis clues for underlying pathology can be derived as well as the eligibility of a successful mitral valve reconstruction. This article focuses on transoesophageal examination with segmental analysis in patients with mitral valve regurgitation.

Comparison of outcomes after aortic valve replacement with a mechanical valve or a bioprosthesis using microsimulation.

BACKGROUND: Mechanical valves and bioprostheses are widely used for aortic valve replacement. Though previous randomised studies indicate that there is no important difference in outcome after implantation with either type of valve, knowledge of outcomes after aortic valve replacement is incomplete. OBJECTIVE: To predict age and sex specific outcomes of patients after aortic valve replacement with bileaflet mechanical valves and stented porcine bioprostheses, and to provide evidence based support for the choice of prosthesis. METHODS: Meta-analysis of published results of primary aortic valve replacement with bileaflet mechanical prostheses (nine reports, 4274 patients, and 25,726 patient-years) and stented porcine bioprostheses (13 reports, 9007 patients, and 54,151 patient-years) was used to estimate the annual risks of postoperative valve related events and their outcomes. These estimates were entered into a microsimulation model, which was employed to calculate age and sex specific outcomes after aortic valve replacement. RESULTS: Life expectancy (LE) and event-free life expectancy (EFLE) for a 65 year old man after implantation with a mechanical valve or a bioprosthesis were 10.4 and 10.7 years and 7.7 and 8.4 years, respectively. The lifetime risk of at least one valve related event for a mechanical valve was 48%, and for a bioprosthesis, 44%. For LE and EFLE, the age crossover point between the two valve types was 59 and 60 years, respectively. CONCLUSIONS: Meta-analysis based microsimulation provides insight into the long term outcome after aortic valve replacement and suggests that the currently recommended age threshold for implanting a bioprosthesis could be lowered further.

[The waiting time for heart interventions: trends for percutaneous coronary interventions and cardiothoracic interventions]. / De wachttijd voor hartinterventie: trends voor angioplastiek en operatie.

OBJECTIVE: (a) To describe trends in the number of heart interventions performed over time, (b) to determine the length of waiting lists for elective heart interventions in the Netherlands according to the monthly survey of the Supervisory Committee for Heart Interventions in the Netherlands [Begeleidingscommissie Hartinterventies Nederland (BHN)], (c) to compare the length of the waiting lists with existing standards, and (d) to determine the reliability of the waiting list survey. DESIGN: Prospective. METHOD: Data were obtained from the monthly waiting list survey of the 13 heart centres in the Netherlands (1 January 1999-30 November 2002) and from the intervention registry (1 January 1999-30 June 2001), which was complete for 10 centres. Both the survey and the maintenance of the registry are carried out by the Supervisory Committee for Heart Interventions in the Netherlands. RESULTS: (a) The number of percutaneous coronary interventions performed in the Netherlands has increased. The number of cardiothoracic interventions remained stable. (b) The number of patients waiting for a percutaneous coronary intervention is increasing by 16% per annum. In November 2002 there were 751 patients on the waiting list. The number of patients waiting for a cardiothoracic intervention increased by 20% per annum until August 2001 and since then there has been a decrease of 21% per annum. In November 2002, 1557 patients were on the waiting list. (c) The percentage of patients treated within existing standards has fallen to 78% for percutaneous coronary interventions and to 53% for cardiothoracic interventions. (d) The length of the waiting list and the waiting times obtained in the survey concurred with the data taken from the intervention registry. CONCLUSIONS: The length of the waiting list for heart interventions has increased and complies increasingly less with existing standards. The monthly waiting-list survey was a reliable method of determining the length of waiting lists for elective heart interventions.

Decision-making in aortic valve replacement: bileaflet mechanical valves versus stented bioprostheses.

BACKGROUND: Valve prosthesis selection for patients who require aortic valve replacement is dependent on several interrelated factors. Often, more than one valve type seems suitable for the individual patient and selection of a valve type may be difficult. METHODS: The application of an evidence-based microsimulation model as an objective tool to support the choice between a bileaflet mechanical prosthesis and a stented bioprosthesis in the individual patient is described. In addition, a pilot study investigating the effect of knowledge gained by this microsimulation model on prosthetic valve choice by cardiothoracic surgeons and cardiologists is presented for two hypothetical patients. RESULTS: After implantation of a mechanical valve, bleeding and thromboembolism are common, especially in the elderly. After implantation of a bioprosthesis, reoperation for structural failure is the most important valve-related complication, especially in younger patients. Life expectancy after aortic valve replacement is markedly reduced compared with the general Dutch age-matched population, regardless of the type of valve implanted. In the pilot study knowledge gained by the microsimulation model caused a shift in the preference towards a mechanical prosthesis in clinical experts. CONCLUSION: Microsimulation incorporating current epidemiological data provides an objective tool to estimate prognosis for individual patients after aortic valve replacement with different valve prostheses. It may develop towards a useful clinical decision support system for valve prosthesis selection.

[Coronary bypass surgery in 1971-80 and 1995-96: increased age and comorbidity, unchanged survival rates and fewer early reoperations 1 and 5 years postoperatively]. / Coronaire bypasschirurgie in 1971/'80 en in 1995/'96: toegenomen leeftijd en comorbiditeit, gelijke overlevingskans en minder vroege heringrepen I en 5 jaar na de operatie.

OBJECTIVE: To describe the characteristics of patients undergoing coronary bypass surgery (CABG) over the past 30 years and the outcome after 1 and 5 years. DESIGN: Retrospective. METHOD: All 1041 patients who had undergone a first CABG in the Thorax centre of the Erasmus Medical Centre in Rotterdam during the period from 1 July 1971 through 31 May 1980 (group I) were compared with all patients who had also undergone such a first operation during the period between 1 September 1995 and 31 December 1996 (group II). Data on the patients, the operations, any reoperations and the mortality were obtained from patient records, from general practitioners and from municipal archives. Cumulative percentages of survival and of not having reCABG or percutaneous transluminal coronary angioplasty (PTCA) were analysed by using the Kaplan-Meier-method. RESULTS: The patients in group I were 11 years younger on average than those in group II and there were more men (group I: 88%, group II: 76%). The patients in group II had more comorbidity than those in group I. The actuarial perioperative mortality was 1.2% in group I and 1.6% in group II. The overall 5-year mortality was significantly lower in group I than in group II (9.1% vs. 11.0%). After adjustment for the baseline characteristics, however, the patients in group II had a lower risk of mortality. Coronary revascularisation in the first 5 years was required more often in group I than in group II (7.4% vs. 4.2%). Independent predictors of a higher 5-year mortality were: a reduced ejection fraction (both groups), more extensive vascular disease (group I), chronic pulmonary disease, renal function disorders and diabetes mellitus (all group II), while treatment for hyperlipidaemia had a favourable effect on survival. CONCLUSION: The age and comorbidity of the operated patients had increased over the years, while the chance of survival was no less than before and there was less chance of an early reoperation.

Evolution of allograft aortic valve replacement over 13 years: results of 275 procedures.

OBJECTIVE: We describe our center's experience with the use of allografts for aortic valve or root replacement, illustrating the impact on outcome of the changes made in surgical and preservation techniques. METHODS: Between 4/1987 and 1/2001 275 allografts were used in 267 consecutive patients to replace the aortic valve or root. All patients were prospectively followed over time. Mean patient age was 46 years (SD 16; range 0.06-83), male/female ratio was 201/74. Prior cardiac operations took place in 73 patients; 49 patients presented with active endocarditis. Pre-operative NYHA-class was III in 51%. Initially, the subcoronary technique was used (SC; N=95) while in recent years root replacement (ARR; N=180) became the technique of choice. Seven fresh (two pulmonary and five aortic) and 268 cryopreserved (four pulmonary and 264 aortic; 35 glycerol and 233 DMSO) allografts were implanted. Concomitant procedures took place in 133 (48%). RESULTS: Operative mortality was 5.5% (N=15) and during follow-up (99% complete) 29 more patients died. Overall cumulative survival was 73% (95% CI 65-81%) at 9 years postoperative and significantly better for SC compared to ARR patients (P=0.005). Freedom from allograft-related reoperation (N=34) was 77% (95% CI 69-85) at 9 years, and worse in the SC compared to ARR group due to increased early technical failure (P=0.03). Freedom from reoperation for structural valve deterioration (SVD; N=22) was 81% (95% CI 73-89) at 9 years and did not differ between SC and ARR (P=0.51). Independent predictors of degenerative SVD were younger patient age (HR 0.93 with age as continuous variable; 95% CI 0.90-0.97), older donor age (HR 1.06 with age as a continuous variable; 95% CI 1.00-1.11), larger allograft diameter (HR 1.38; 95% CI 1.11-1.71) and the use of pulmonary allografts (HR 10.72; 95% CI 3.88-29.63). Calculated median time to reoperation for structural valve deterioration ranged from 23 years in a 65-year-old patient to 12 years in a 25-year-old. CONCLUSIONS: Aortic valve replacement with allografts yields adequate midterm results. Although important changes have been made over the years to improve durability, allografts still have a limited life span especially in young patients.

Short-term and 5-year outcome after primary isolated coronary artery bypass graft surgery: results of risk stratification in a bilocation center.

OBJECTIVE: We retrospectively investigated the short and mid-term outcome of non-emergent primary isolated coronary artery bypass graft (CABG) surgery in relation to risk stratification in the fully equipped university location (FE) and the low volume, limited facility location (LVLF) of our department. METHODS: Between September 1995 and December 1996, 832 patients were referred to our department to undergo a primary isolated CABG operation. The surgical team selected 482 patients (58%) as being at low-risk. These were treated in the LVLF hospital. The other 350 patients with mixed-risk were treated in the FE hospital. The selection consisted primarily of exclusion of patients with moderate or poor left ventricular function, severe COPD or renal impairment, from surgery in the LVLF location. Finally, the prognostic value of the EuroSCORE and the Parsonnet score was tested on our patient population. RESULTS: Overall in-hospital mortality was 1.6% (13 patients). One patient died in the LVLF group (0.2%) and 12 patients (3.4%) in the FE group. LVLF patients experienced less complications during the hospital period compared to the FE patients (5 versus 21%; P=0.0001). The Parsonnet risk model and the EuroSCORE risk model showed both a good relation with in-hospital mortality. After discharge, an increased risk of late mortality was observed up to 1 year postoperative in the FE group compared to the LVLF group (2.7 versus 0.5%; P=0.01). Risk factors for 5-year mortality were pre-operative renal impairment (blood creatinine >150 micromol/l) (hazard ratio (HR): 2.8; 95% confidence interval (CI): 1.4-5.5), diabetes (HR: 2.1; 95% CI: 1.3-3.5), impaired LVEF (HR: 1.9; 95% CI: 1.2-3.0), COPD (HR: 1.9; 95% CI: 1.1-3.5) and older age (HR: 1.07 per year; 95% CI: 1.01-1.10). Lipid-lowering therapy was a predictor of lower mortality at 5-years (HR: 0.5; 95% CI: 0.4-0.9). CONCLUSION: By careful decision making, selection of low-risk patients for a low volume and limited facility location resulted in excellent in-hospital survival with very low complication rates.