MEdical TReatment Optimization in cardiac rehabilitation (METRO study) : a French multicenter study.

BACKGROUND: Cardiac rehabilitation (CR) is the right place to optimize the medical treatment in coronary artery disease (CAD) patients. AIMS: To report the medical management in CAD patients during CR and evaluate the consequences. METHODS: CAD patients who attended a CR program within less than three months of an acute coronary syndrome (ACS), a percutaneous coronary intervention (PCI), or a coronary artery bypass graft (CABG) were included in a prospective multicenter study. Medical treatments were analyzed at the beginning and at discharge of the CR stay. Results of exercise tests were compared between 4 groups. G1: unchanged medication, n=443, G2: beta-blockers or bradycardic agents adaptation n=199, G3: renin-angiotensin system (RAS) inhibitors adaptation, n=194, G4: both medications adaptation, n=164. RESULTS: One thousand consecutive patients were included in 23 French CR centers (85.3% males; mean age 59.9 ± 11 years). The index event was ACS (68.5%), PCI (62.6%) and CABG (36.3%). During CR, we noted an adaptation for beta-blockers in 32.1%, in other bradycardic agents (ivabradine, verapamil, diltiazem, amiodarone) in 9.5%, and in RAS inhibitors in 36.3%. Patients of group 1 had an initial resting heart rate lower than in group 2 and 4, but at the final exercise testing, the range of the decrease was more important in group 2 and 4. The combination of physical training and therapeutic modifications resulted in similar exercise capacities in the four groups, from 5.2, 5.3, 5.4 and 5.2 MET (p=0.68), to 6.3, 6.5, 6.5 and 6.1 MET (p=0.44), respectively. CONCLUSION: The METRO study showed that significant alteration in medical treatment during cardiac rehabilitation programs could take part in improving physical capacity.

Early changes in local hemostasis activation following percutaneous coronary intervention in stable angina patients: a comparison between drug-eluting and bare metal stents.

BACKGROUND: Early change in local intracoronary hemostasis following drug-eluting (DES) and bare metal stent (BMS) implantation has never been assessed in stable angina patients. METHODS: Markers of local platelet activation (soluble glycoprotein V [sGPV] and P-Selectin [CD62P]), coagulation activation (tissue factor [TF], prothrombin fragments 1 + 2 [F1 + 2] and activated factor VII [FVIIa]) and fibrinolysis markers (D-dimers [DD], fibrinogen [FIB], tissue plasminogen activator [t-PA], and plasminogen activator inhibitor type-1 complexes [PAI-1]) were determined in 20 patients with stable angina who underwent percutaneous coronary intervention (PCI). All patients were pretreated with clopidogrel, aspirin, and enoxaparin. Systematic balloon predilation was performed before DES (9 patients) and BMS (11 patients) implantation. All blood samples were drawn 10-20 mm distal to the lesion site. RESULTS: No significant changes in levels of platelet activation markers occurred during PCI. There was a transient significant increase in TF (14%; P = 0.004), in F1 + 2 (40%; P = 0.001), and FVIIa (31%; P = 0.007) following angioplasty. Similarly, a significant 43% increase was observed in DD levels following balloon predilation, associated with an increase of 46%, 60%, and 70% in FIB, t-PA and PAI-1 levels, respectively (all P < 0.0001). All these markers returned to baseline values after stent implantation. No difference was observed between DES and BMS. CONCLUSIONS: Early changes in local hemostasis activation following PCI, were related to balloon predilation. Neither DES nor BMS increased markers of platelet activation, coagulation, or fibrinolysis, under dual antiplatelet and anticoagulant pretreatment.

Physical and Psychological Effectiveness of Cardiac Rehabilitation: Age Is Not a Limiting Factor!

BACKGROUND: There is little data regarding the impact of patient age on the physical and psychological effectiveness of cardiac rehabilitation (CR). The aim of the present study was therefore to compare the effects of an exercise-based CR program on physical and psychological parameters in young, old, and very old patients. We also aimed to identify the features that best predicted CR outcome. METHODS: A total of 733 patients were divided into 3 subgroups: YOUNG (< 65 years old), OLD (between 65 and 80 years old), and VERY OLD (≥ 80 years old). Physical variables such as peak workload and estimated peak VO2 as well as psychological variables such as scores of anxiety and depression were evaluated for all patients before and after CR. RESULTS: Performance in all tests and scores for all questionnaires were significantly improved in all patients (P < 0.05). Age was significantly correlated with all the initial values (P < 0.05) but not with post-CR values. In addition, lower initial values of peak workload were associated with larger post-CR improvements irrespective of age. However, higher pre-CR anxiety and depression scores were associated with greater post-CR increases in physical performance in YOUNG and OLD patients, respectively. CONCLUSIONS: CR induced significant improvements of physical and psychological parameters for all patient groups. More interestingly, our results suggest that patients with the greatest physical impairments at baseline would benefit the most from CR, whatever their age. However, the value of initial mental state as a predictor of post-CR improvement depends on the age of the patient.

Detection of glucose metabolism disorders in coronary patients enrolled in cardiac rehabilitation: Is glycated haemoglobin useful? Data from the prospective REHABDIAB study.

Introduction Diabetes and pre-diabetes are highly prevalent in patients with a history of acute coronary syndrome. This is why screening for glucose metabolism disorders is recommended in patients following an acute coronary syndrome. The aim of our study was to determine whether glycated haemoglobin alone compared with the oral glucose tolerance test could allow effective screening for glucose metabolism disorders in acute coronary syndrome patients undergoing cardiac rehabilitation. Patients and methods Among 347 patients with a recent history of acute coronary syndrome enrolled in our cardiac rehabilitation centre, 267 patients without previously known diabetes were recruited for this prospective study with performance of both oral glucose tolerance test and glycated haemoglobin measurement. The patients were divided into three groups: newly diagnosed diabetes mellitus, pre-diabetes and normoglycaemia according to the oral glucose tolerance test and glycated haemoglobin results. The results obtained with glycated haemoglobin were compared with those obtained with the oral glucose tolerance test, considered as the reference. Results For the diagnosis of diabetes, glycated haemoglobin had a sensitivity of 72% and a specificity of 100%. Positive and negative predictive values were high at 100% and 96%, respectively. However, for the diagnosis of pre-diabetes the sensitivity of glycated haemoglobin was low at 64% as were the specificity (53%) and the positive predictive values (37%). Glycated haemoglobin overdiagnosed pre-diabetes (52% vs 30%, p < 0.0001). For the diagnosis of normoglycaemia, the sensitivity of glycated haemoglobin was also low (48%). Conclusion According to our study, glycated haemoglobin has low sensitivity and specificity for the detection of pre-diabetes in patients with coronary disease enrolled in cardiac rehabilitation, and glycated haemoglobin over-diagnoses pre-diabetes in comparison with the oral glucose tolerance test.

Management of unsuccessful thrombolysis in acute massive pulmonary embolism.

BACKGROUND: The management of patients with acute massive pulmonary embolism (PE) who do not respond to fibrinolytic therapy remains unclear. We aimed to compare rescue surgical embolectomy and repeat thrombolysis in patients who did not respond to thrombolysis. METHODS: We conducted a prospective single-center registry of PE patients who underwent thrombolytic therapy. Lack of response to thrombolysis within the first 36 h was prospectively defined as both persistent clinical instability and residual echocardiographic right ventricular dysfunction. Patients underwent surgical embolectomy or repeat thrombolysis, at the discretion of the attending physician. The clinical end point was a combined end point including recurrent PE, bleeding complications, or PE-related death, which was defined as death from recurrent PE or cardiogenic shock. Long-term adverse outcomes included death, recurrent thromboembolic events, and congestive heart failure. RESULTS: From January 1995 to January 2005, 488 PE patients underwent thrombolysis, of whom 40 (8.2%) did not respond to thrombolysis. Fourteen patients were treated by rescue surgical embolectomy, and 26 were treated by repeat thrombolysis. There was no significant difference in baseline characteristics between the two groups. The in-hospital course was uneventful in 11 of the surgically treated patients (79%) and in 8 patients (31%) treated by repeat thrombolysis (p = 0.004). There was a trend for higher mortality in the medical group than in the surgical group (10 vs 1 deaths, respectively; p = 0.07). There were significantly more recurrent PEs (fatal and nonfatal) in the repeat-thrombolysis group (35% vs 0%, respectively; p = 0.015). While no significant difference was observed in number of major bleeding events, all bleeding events in the repeat-thrombolysis group were fatal. The rate of uneventful long-term evolution was the same in the two groups. CONCLUSION: Rescue surgical embolectomy led to a better in-hospital course when compared with repeat thrombolysis in patients with massive PE who have not responded to thrombolysis. The transfer of patients who have not responded to thrombolysis to tertiary cardiac surgery centers could be considered as an alternative option.

Characteristics of diabetic patients and diabetes care in cardiac rehabilitation.

BACKGROUND: Although diabetes is associated with a high cardiovascular risk, very little information is available about diabetic patients enrolled in cardiac rehabilitation (CR). AIMS: To analyse the characteristics of diabetic patients and diabetes care in CR. METHODS: From the database of 700 patients enrolled in CR during a 29-month period, we analysed data from all patients with glucose metabolism disorders (n=105) and 210 matched normoglycaemic patients. RESULTS: A total of 105 patients with glucose metabolism disorders (type 1 diabetes, n=5; type 2 diabetes, n=84; impaired fasting glucose, n=16) were enrolled in a CR programme (15% of whole population). Fifteen per cent of patients with type 2 diabetes and all patients with impaired fasting glucose were diagnosed during CR. These 105 patients were older and had a higher body mass index, a larger waist circumference, higher fasting blood glucose and triglyceride concentrations and lower low-density lipoprotein cholesterol concentrations than non-diabetic patients; they also had higher rates of hypertension (P=0.001) and dyslipidaemia (P=0.02). They were more frequently referred to CR for peripheral artery disease (P=0.001), coronary heart disease+peripheral artery disease (P=0.007) and primary prevention (P=0.009). The intervention of a diabetologist was needed for 42.6% of patients because of uncontrolled or newly diagnosed diabetes. CONCLUSION: In the present study, we showed that (1) the proportion of patients with diabetes in CR is lower than expected, (2) many glucose metabolism disorders are diagnosed during CR, (3) patients with glucose metabolism disorders show a more severe cardiovascular risk profile than normoglycemic patients, and (4) the intervention of a diabetologist is needed during CR for many patients with diabetes.

Impact of renal dysfunction and glucometabolic status on one month mortality after acute myocardial infarction.

Patients with impaired glucometabolic status or renal function have a higher mortality after acute myocardial infarction. It is unclear whether this higher risk is independent or related to the quality of care. In a prospective registry, stress hyperglycaemia (SH) was defined as glucose level>140 mg/dl. Renal function was assessed by the glomerular filtration rate (GFR): normal (>/=60), mild (30-60) and severe dysfunction (<30 ml/min/1.72 m(2)). The level of risk was assessed by the TIMI risk index and the quality of care by the rate of use of five guidelines-recommended treatments. Among the 1388 patients included, 23% had diabetes, 16% had SH, renal function was normal in 55%, mildly impaired in 35% and severely impaired in 9.5%. At one month, the mortality rate was higher in patients with SH (18%) as compared with diabetics (9%) or those with normal glucometabolic status (5%). Similarly, the mortality rate was higher in those with impaired renal function. Multivariable analysis identified SH, GFR group, TIMI risk index, ST segment elevation MI and quality of care as independent predictors of one-month mortality. In patients with acute MI, SH and GFR<30 ml/min/m(2) are independent predictors of mortality after adjustment for the level of risk and acute care.

One-year outcome of patients submitted to routine fractional flow reserve assessment to determine the need for angioplasty.

AIMS: In patients submitted to coronary angiography, fractional flow reserve (FFR) assessment by a pressure wire can be used to guide the decision for revascularization. Routine application of FFR assessment and 1-year outcome of patients are poorly documented. The aim of this study was to report a 4-year single-centre experience where the use of FFR for decision making in equivocal lesions is encouraged. METHODS AND RESULTS: A prospective registry was designed to collect clinical and angiographic characteristics, as well as 1-year clinical follow-up for all patients submitted to FFR assessment. The decisional cut-off point for revascularization was 0.80. Over a 4-year period, out of 6415 coronary angiographies, FFR was measured in 407 (6.3%) patients (469 lesions). FFR was assessed through 4 or 5 Fr diagnostic catheters in 330 (81%). Median FFR value was 0.87 (0.80; 0.93). On the basis of FFR results, 271 (67%) patients were treated with medical therapy alone. A subset of 71 (17%) patients were not treated in accordance with the results of FFR. All patients but four (i.e. 99%) had 1-year clinical follow-up. Three hundred and forty four (85%) were free from clinical event, six (1.5%) patients died, five (4%) had an acute coronary syndrome, and 20 (5%) underwent target-vessel revascularization. Event-free survival was comparable in patients with vs. without revascularization (0.94 +/- 0.02 and 0.93 +/- 0.01, respectively). Patients had significantly better 1-year outcome when treated in accordance with the results of the FFR assessment. CONCLUSION: In routine practice, FFR assessment during diagnostic angiography was performed in 6.3%. On the basis of FFR, two-thirds of patients with 'intermediate' lesions were left unrevascularized, with a favourable outcome, when FFR was above 0.80. These data suggest that routine use of FFR during diagnostic catheterization is feasible, safe, and provide help to guide decision making.