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 exercise training feasibility after aortic valve repair: A multicentre prospective French survey on behalf of the Aortic Valve repair International Registry (AVIATOR).

BACKGROUND: Standardization of aortic valve repair by the external ring annuloplasty approach is an alternative to valve replacement to avoid prosthetic valve-related events. Although the benefit of exercise training to improve postoperative exercise tolerance has been demonstrated in many conditions after cardiac surgery, it has never been described after aortic valve repair. OBJECTIVES: To evaluate the feasibility of an early exercise training programme after aortic valve repair. METHODS: Consecutive patients were prospectively included in 13 postoperative centres. Patients underwent an exercise training programme for approximately 3-5 weeks. Transthoracic echocardiography and a cardiopulmonary exercise test were performed before and after the exercise training programme. RESULTS: Fifty patients (mean±standard deviation [SD] age: 50±13 years) were included a mean of 13.6±12.0 days after aortic valve repair. The preoperative degree of aortic insufficiency was moderate to severe in 35 patients (70%) and the aortic valve was bicuspid in 24 patients (48%). Valve-sparing root replacement and isolated aortic valve repair (including 10% supracoronary aorta replacement) were performed in 64% and 36% of patients, respectively. We found no aortic insufficiency occurrence or worsening and no adverse clinical events after the exercise training programme. Mean left ventricular ejection fraction increased significantly (from 54%±8% to 57%±9%; P=0.0007). Mean peak oxygen consumption and first ventilatory threshold increased from 17.0±5.3 to 22.5±7.8mL/kg/min (32% increase) and from 12.0±3.9 to 14.3±5.2mL/kg/min (19% increase), respectively (both P<0.05). CONCLUSION: Exercise training early after aortic valve repair is safe and seems to significantly improve exercise capacity.

Mitral Annular Calcium and Mitral Stenosis Determined by Multidetector Computed Tomography in Patients Referred for Aortic Stenosis.

Mitral annular calcium (MAC) is a common finding in older patients referred for transcatheter aortic valve implantation (TAVI). Multidetector computed tomography (MDCT) allows fine quantification of the calcific deposits. Our objective was to estimate the prevalence of MAC and associated mitral stenosis (MS) in patients referred for TAVI using MDCT. A cohort of 346 consecutive patients referred for TAVI evaluation was screened by MDCT for MAC: 174 had MAC (50%). Of these patients, 165 patients (95%) had mitral valve area (MVA) assessable by MDCT planimetry (age 83.8 ± 5.9 years). Median mitral calcium volume and MVA were 545 mm3 (193 to 1,253 mm3) and 234 mm2 (187 to 297 mm2), respectively. The MS was very severe, severe, and moderate in 2%, 22%, and 10% patients, respectively. By multivariate analysis, MVA was independently correlated to mitral calcium volume, aortic annular area, and some specific patterns of mitral leaflet calcium. Based on these findings, a formula was elaborated to predict the presence of a significant MS. In conclusion, MDCT allows detailed assessment of MAC in TAVI populations, demonstrating a high prevalence. Mitral analysis should become routine during MDCT screening before TAVI as it may alter therapeutic strategy.

Nonsteroidal anti-inflammatory drug treatment for postoperative pericardial effusion: a multicenter randomized, double-blind trial.

BACKGROUND: The incidence of asymptomatic pericardial effusion is high after cardiac surgery. Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed in this setting, but no study has assessed their efficacy. OBJECTIVE: To assess whether the NSAID diclofenac is effective in reducing postoperative pericardial effusion volume. DESIGN: Multicenter randomized, double-blind, placebo-controlled study. (Clinical trials.gov registration number: NCT00247052) SETTING: 5 postoperative cardiac rehabilitation centers. PATIENTS: 196 patients at high risk for tamponade because of moderate to large persistent pericardial effusion (grade 2, 3, or 4 on a scale of 0 to 4, as measured by echocardiography) more than 7 days after cardiac surgery. INTERVENTION: Random assignment at each site in blocks of 4 to diclofenac, 50 mg, or placebo twice daily for 14 days. MEASUREMENTS: The main end point was change in effusion grade after 14 days of treatment. Secondary end points included frequency of late cardiac tamponade. RESULTS: The initial mean pericardial effusion grade was 2.58 (SD, 0.73) for the placebo group and 2.75 (SD, 0.81) for the diclofenac group. The 2 groups showed similar mean decreases from baseline after treatment (-1.08 grades [SD, 1.20] for the placebo group vs. -1.36 (SD, 1.25) for the diclofenac group). The mean difference between groups was -0.28 grade (95% CI, -0.63 to 0.06 grade; P = 0.105). Eleven cases of late cardiac tamponade occurred in the placebo group and 9 in the diclofenac group (P = 0.64). These differences persisted after adjustment for grade of pericardial effusion at baseline, treatment site, and type of surgery. LIMITATION: The sample was not large enough to find small beneficial effects of diclofenac or assess the cardiovascular tolerance of diclofenac. CONCLUSION: In patients with pericardial effusion after cardiac surgery, diclofenac neither reduced the size of the effusions nor prevented late cardiac tamponade. PRIMARY FUNDING SOURCE: French Society of Cardiology.

Thromboembolic events early after mitral valve repair: incidence and predictive factors.

BACKGROUND AND OBJECTIVES: The incidence of thromboembolic events (TE) in the early period following mitral valve repair (MV repair) is poorly documented. The aim of this prospective study was to evaluate it, and to determine predictive factors. METHODS AND RESULTS: In this prospective multicenter non-randomized study, 350 consecutive patients were included after MV repair and monitored until post-operative day 44+/-6. 65.7% received Vitamin K antagonists (VKA), 18.8% aspirin (ASA), 5.4% ASA+VKA and 10% received no antithrombotic therapy (AT). All patients with AF received VKA or VKA+ASA. Twelve patients had a cerebral TE during follow-up:14.3% among untreated patients, 3.0% in the VKA group, and 0% in the ASA and in the ASA+VKA groups (p=0.03 for comparison no AT group versus the three other combined groups; p=NS for VKA versus ASA). In univariate analysis, only the absence of post-operative AT was related to the risk of TE (HR=6.7, CI 95%[2.1-21], p=0.0002). In a prespecified subgroup (n=185) of patients with sinus rhythm and without concomitant cardiac surgery (in which the choice of AT is not influenced by these associate conditions), only the absence of post-operative AT remained related to the risk of TE (HR=10.0, CI 95%[2.45-40], p=0.001). CONCLUSION: In the first six weeks following MV repair, the incidence of thromboembolic events is far from negligible (3.5%), even in patients with sinus rhythm. The main predictive factor for thromboembolic event determined in this study is the absence of an antithrombotic therapy.

Role of B-type natriuretic peptide and echocardiographic indices in predicting the development of acute heart failure following beta-blocker uptitration in chronic heart failure patients with left ventricular systolic dysfunction.

We evaluated the role of clinical, BNP and echocardiographic left ventricular (LV) indices in predicting the development of acute heart failure (HF) following beta-blocker initiation and uptitration in 50 stable CHF patients with LVEF < 40% and creatininemia < 250 micromol/l. Use of NYHA class alone predicted the development of acute HF decompensation in only 56% and the absence of this event in 93% of patients. Use of echocardiographic indices (systolic PAP < 40 mmHg or E/A ratio < 1.4 or EDT > 145 ms) predicted the absence of acute HF decompensation in 100% of patients. Use of NYHA > 3 combined with BNP > 398 pg/ml or with echocardiographic indices (i.e. systolic PAP > 40 mmHg or E/A > 1.4 or EDT < 145 ms) predicted the development of acute HF decompensation in 100% of patients. In conclusion use of BNP and echocardiographic LV filling pressure indices in combination with NYHA class may predict beta-blocker tolerance more accurately than clinical indices alone in patients with LV systolic dysfunction (LVEF < 40%).

Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation.

BACKGROUND: Cardiac rehabilitation is widely recognized as a medical management procedure that reduces mortality, but the cardiovascular safety of exercise training has not been clearly established. Published data are retrospective or outdated, as patient management has substantially progressed in recent years. The aim of this prospective registry was to determine the current complication rate during exercise performed in the course of cardiac rehabilitation. METHODS: This study was conducted by the Functional Evaluation and Cardiac Rehabilitation Working Group of the French Society of Cardiology. During a 1-year period, 65 cardiac rehabilitation centers reported that serious events had occurred during or 1 hour after an exercise stress test or a training session. Severe cardiovascular events were validated by a scientific committee. RESULTS: A total of 25,420 patients (78% men; mean age, 61.3 years) were included in the study. Initial indications for cardiac rehabilitation were post-cardiac surgery (coronary bypass, 34.3%; valvular surgery, 18.4%); recent percutaneous coronary intervention (21.6%); and other coronary (13.2%) and noncoronary (12.5%) conditions. The study population underwent 42,419 exercise stress tests and 743,471 patient-hours of exercise training. Twenty severe cardiac events were reported: 5 were related to exercise testing and 15 were related to exercise training. The event rate was 1 per 8484 exercise stress tests and 1 per 49,565 patient-hours of exercise training; the cardiac arrest rate was 1.3 per million patient-hours of exercise. Neither fatal complications nor emergency defibrillations were reported. CONCLUSION: The frequency of major cardiovascular complications during supervised exercise training in France is quite low.

Low-molecular-weight heparin as a bridging anticoagulant early after mechanical heart valve replacement.

BACKGROUND: After mechanical heart valve replacement (MHVR), long-term use of unfractionated heparin is sometimes required because vitamin K antagonists (VKA) are temporarily contraindicated or because the time to reach the target international normalized ratio is long. The aim of this study was to investigate the feasibility of low-molecular-weight heparin treatment in these patients. METHODS AND RESULTS: This work was conducted as a prospective study. We selected all patients (n=695) who underwent MHVR and were transferred to a postoperative cardiac rehabilitation center between January 2000 and January 2005. The study focused on patients who had not yet started VKA therapy or who had a below-target international normalized ratio despite VKA therapy. Unfractionated heparin was replaced by enoxaparin (100 IU/kg BID) until VKA treatment was fully effective. Two hundred fifty patients (60+/-11 years old) were enrolled 16+/-11 days after surgery (aortic valve replacement, n=190; mitral valve replacement, n=34; double valve replacement, n=26). Of these, 50% had permanent or transient atrial fibrillation, 40% had hypertension, 13% had diabetes, and 19% had a history of cardiac surgery. The mean duration of low-molecular-weight heparin treatment was 8.3+/-6.0 days. Patients were followed for 90 days, during which there were two major and three minor bleeding episodes and one transient ischemic attack. There were no cases of valve thrombosis and no deaths. CONCLUSIONS: After MHVR, one third of patients leave the cardiac surgery unit before VKA treatment is fully effective. Bridging anticoagulation therapy with enoxaparin appears to be feasible during this high-risk period for thromboembolism and could shorten the length of hospital stay.

Beta-blockade intolerance in anthracycline-induced cardiomyopathy.

Beta-blockade efficiency and safety in anthracycline induced cardiomyopathy (AIC) are poorly documented. Cardiac Heart Failure (CHF) due to an AIC has haemodynamic and histologic particularities: only mild ventricular dilatation, restriction pattern and myocardial and endocardial fibrous thickening. Therefore, beta blockade therapy initiation may cause heart failure decompensation by absence of the usual left ventricular adaptation (improvement of left ventricular compliance allowing maintenance of stroke volume). We describe an AIC patient in whom a first beta-blockade initial administration caused a global cardiac failure; after stabilisation, one month later, a second attempt caused a new cardiac failure. We raise the question of beta-blockade safety in restrictive cardiomyopathies.

Early exercise training after mitral valve repair: a multicentric prospective French study.

BACKGROUND: Surgical mitral valve (MV) repair is now the best technique to correct mitral regurgitation (MR). However, clinical studies have shown that without exercise training (ET), there is no significant postoperative exercise tolerance improvement. Moreover, healing duration of the MV wound is not well known; thus, the feasibility of an early ET program (ETP) may be discussed. OBJECTIVES: To evaluate safety and feasibility of an early ETP after MV repair. METHODS AND RESULTS: All patients hospitalized in 13 postoperative centers after MV repair from September 2002 to June 2003 were included in this prospective study. They underwent an ETP during 3 weeks on average. Transthoracic echocardiography and a cardiopulmonary exercise test were performed before and after the ETP. PATIENTS: Two hundred fifty-one consecutive patients (male gender, 70%; mean age, 59 +/- 14 years [+/- SD]) were included 16 +/- 10 days after MV repair. There was no MR occurrence or worsening after the ETP. Left ventricular ejection fraction slightly increased (53 +/- 10% vs 55 +/- 9%, p = 0.004). Peak oxygen consumption and anaerobic threshold increased from 16.3 +/- 4.5 to 20.0 +/- 6.0 mL/kg/min (22% increase) and from 12.2 +/- 3.8 to 14.2 +/- 4.3 mL/kg/min (16% increase) respectively, (p < 0.0001). CONCLUSION: ET after MV repair does not deteriorate the outcome of recent surgery and seems efficient.

Functional assessment of mitral regurgitation by transthoracic echocardiography using standardized imaging planes diagnostic accuracy and outcome implications.

OBJECTIVES: We sought to assess the value of transthoracic echocardiography (TTE) using standardized imaging planes for the functional analysis of mitral regurgitation (MR) as well as for postoperative outcome implications. BACKGROUND: The feasibility of mitral valve repair is based on functional assessment of MR, mainly by transesophageal echocardiography (TEE). Considering the recent advances in TTE imaging, the incremental value of TEE in this setting needs to be re-examined. METHODS: Consecutive patients (n = 279; 181 men; median age 68 years [quartiles, 61 to 74]) who underwent surgery for MR were enrolled prospectively in two tertiary care centers. The accuracy of TTE (harmonic imaging) versus TEE for functional assessment of MR was evaluated against surgical findings. RESULTS: Valve repair (n = 237 patients, 85%) or replacement (n = 42) was predicted accurately by TTE in 97% of cases; TEE added significant information for only two patients. In the subgroup of degenerative MR (n = 190), agreement with surgical findings for the localization of prolapsed segments was 91% for TTE (kappa, 0.81) and 93% for TEE (kappa, 0.85) without incremental value of TEE (p = 0.40). Patients with single prolapse of the middle posterior scallop (P2) had a better postoperative outcome as compared with patients who had non-P2 lesions (p = 0.008). Furthermore, mitral replacement predicted by TTE was an independent predictor for postoperative long-term mortality (odds ratio 5.7, 95% confidence interval 1.97 to 16.4, p = 0.001). CONCLUSIONS: In experienced hands, functional assessment of MR by TTE can predict accurately valve repairability and has a strong influence on postoperative outcome. Thus, in most cases preoperative TEE is not mandatory, provided intraoperative TEE is performed.

Evolution of the postoperative pericardial effusion after day 15: the problem of the late tamponade.

STUDY OBJECTIVES: To evaluate, through clinical and transthoracic echocardiography (TTE) follow-up, the natural history of persistent pericardial effusion (PE) after postoperative day 15 in patients who were given and were not given anticoagulant therapy. DESIGN AND PATIENTS: We retrospectively studied a cohort of 1,277 patients who were hospitalized between May 1997 and May 1999 in our center a mean (+/- SD) time period of 15 +/- 3 days after undergoing coronary artery bypass graft (CABG) surgery (856 patients) or valve replacement (VR) surgery (421 patients). MEASUREMENTS: TTE was performed on mean (+/- SD) postoperative day 20 +/- 1 (TTE(1)) and postoperative day 30 +/- 2 (TTE(2)). PE severity was classified on a scale from grade 1 to grade 4. RESULTS: On postoperative day 20 +/- 1, PE was present in 22% of the 1,277 patients and was more frequent after patients underwent CABG surgery than after undergoing VR surgery (25% vs 17%, respectively; p < 0.01). On postoperative day 30 +/- 2, the overall incidence of late tamponade in patients with PE was 4%. The incidence increased with the severity grade of PE at TTE(1) (p < 0.001). The negative predictive value of a severity grade < 2 at TTE(1) for late tamponade was 100%. Late tamponade incidence was higher after VR surgery than after CABG surgery (11% vs 2%, respectively; p < 0.01), and was higher in patients who had received anticoagulation therapy than in those who had not (8% vs 2%, respectively; p < 0.05). CONCLUSION: Persisting PE is common after postoperative day 15 and is more frequent after undergoing CABG surgery than after undergoing VR surgery. The incidence of late tamponade is usually underestimated, and it increases with the presence of VR, anticoagulation therapy, and/or higher postoperative TTE severity grade. Our data suggest that only patients with a PE severity grade of >/= 2 (< 10% of patients) require TTE follow-up after postoperative day 20.