Nicolas Boudou

Unprotected left main stenting with a second-generation drug-eluting stent: one-year outcomes of the LEMAX Pilot study

AIMS We sought to assess the efficacy and safety of everolimus-eluting stents for unprotected left main disease. METHODS AND RESULTS A total of 173 consecutive patients with de novo significant unprotected left main stenosis received an everolimus-eluting stent in four French centres. Among them, 140 (81 %) had involvement of the distal portion of left main, and 129/140 (92%) were treated with provisional side branch T-stenting, with a side branch stenting rate of 20%. Angiographic success was achieved in all cases. At 12 months, the cumulative rate of major adverse cardiac or cerebrovascular events (MACCE) was 26/173 (15%) including death from any cause (N=5, 2.9%), stroke (N=4, 2.3%), Q-wave myocardial infarction (MI) (N=2, 1.2%), non-Q-wave MI (N=6, 3.5%) and any repeat revascularisation (N=16, 9.3%). At one year, the rate of target-lesion revascularisation (TLR) was 5/173 (2.9%), target-vessel revascularisation was 12/173 (7 %) and the rate of definite or probable left main stent thrombosis 1/173 (0.6 %). CONCLUSIONS Unprotected left main stenting using everolimus-eluting stents and a strategy of provisional side branch T-stenting for distal lesions, is safe and effective in the midterm, with a relatively low rate of events and reintervention at one year.

Two-year outcomes of everolimus vs. paclitaxel-eluting stent for the treatment of unprotected left main lesions: a propensity score matching comparison of patients included in the French Left Main Taxus (FLM Taxus) and the LEft MAin Xience (LEMAX) registries.

AIMS With newer drug-eluting stents (DES), PCI has appeared as an acceptable alternative to cardiac surgery in the treatment of unprotected left main (ULM) lesions. Using data from the French Left Main Taxus and the LEft MAin Xience registries, we compared two-year outcomes in consecutive patients from 2003-2008 using everolimus-eluting stents (EES) vs. paclitaxel-eluting stents (PES). METHODS AND RESULTS We performed a matched comparison according to SYNTAX score, distal LM stenosis, provisional side-branch T-stenting and single stent use, focusing on the primary endpoints of target vessel MI (TVMI) and target vessel failure (TVF). After propensity score matching, there were 172 patients in each group. There was no difference in gender (76.5% male), age (69.5 ± 11.3 years), diabetes (26.2% vs. 24.4%, p=0.71), NSTEMI (40.7% vs. 40.7%, p=1), or LVEF <40% (11.0% vs. 6.7%, p=0.22). Patients with distal LM lesions (75.9%) were treated using provisional T-stenting in 91.1%. The side branch was stented in 22% of all patients (p=0.51). Cumulative two-year events showed significant differences in TVMI (9.9% vs. 4.1%, p=0.04) and TVF (16.3% vs. 7.6%, p=0.01) for PES and EES, respectively. CONCLUSIONS ULM stenting with EES is safer and more effective than PES with a reduction in TLF by 53% at two years.

Initial French experience of percutaneous mitral valve repair with the MitraClip: a multicentre national registry.

BACKGROUND Percutaneous mitral valve repair (MVR) using the MitraClip(®) is a new option for severe mitral regurgitation (MR). AIM To describe initial French experience regarding short-term and mid-term safety and efficacy. METHODS A multicentre cohort reported experience of percutaneous MVR using the MitraClip(®) in French centres from December 2010 to September 2012. All patients were judged inoperable or at high surgical risk. Short-term and mid-term safety and efficacy results are presented. RESULTS Sixty-two patients (72.7±11.4years; 71.7% men; 81.0% New York Heart Association [NYHA] class III or IV; logistic Euroscore 18.7±13.1%; 93.3% MR≥grade 3; 73.8% secondary MR) underwent percutaneous MVR using the MitraClip(®) under general anaesthesia. Procedural success was 95.2% (83.1% of patients received one clip; 16.9% received two clips). At discharge, 88.2% of implanted patients had a residual MR≤grade 2. Transthoracic echocardiography showed a significant decrease in ejection fraction (39.9±14.8% pre vs. 36.2±14.3% post), end-diastolic diameter (63.8±10.6mm vs. 61.4±12.3mm, respectively) and systolic pulmonary pressure (52.1±13.9mmHg vs. 44.7±10.9mmHg, respectively). The in-hospital mortality rate was 3.2%. The survival rate at 6-month follow-up was estimated at 83.1%, with 90.9% of patients in NYHA class I or II and residual MR≤grade 2 in 80% of cases. CONCLUSION This initial French experience, despite being in its learning phase, showed promising results in patients considered ineligible for surgery, as observed in more experienced centres. Randomized studies are mandatory to confirm these preliminary data.

A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions

Aims The clinical value of percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) is not established by randomized trials. This study should compare the benefit of PCI vs. optimal medical therapy (OMT) on the health status in patients with at least one CTO. Method and results Three hundred and ninety-six patients were enrolled in a prospective randomized, multicentre, open-label, and controlled clinical trial to compare the treatment by PCI with OMT with a 2:1 randomization ratio. The primary endpoint was the change in health status assessed by the Seattle angina questionnaire (SAQ) between baseline and 12 months follow-up. Fifty-two percent of patients have multi-vessel disease in whom all significant non-occlusive lesions were treated before randomization. An intention-to-treat analysis was performed including 13.4% failed procedures in the PCI group and 7.3% cross-overs in the OMT group. At 12 months, a greater improvement of SAQ subscales was observed with PCI as compared with OMT for angina frequency [5.23, 95% confidence interval (CI) 1.75; 8.71; P = 0.003], and quality of life (6.62, 95% CI 1.78-11.46; P = 0.007), reaching the prespecified significance level of 0.01 for the primary endpoint. Physical limitation (P = 0.02) was also improved in the PCI group. Complete freedom from angina was more frequent with PCI 71.6% than OMT 57.8% (P = 0.008). There was no periprocedural death or myocardial infarction. At 12 months, major adverse cardiac events were comparable between the two groups. Conclusion Percutaneous coronary intervention leads to a significant improvement of the health status in patients with stable angina and a CTO as compared with OMT alone. Trial registration NCT01760083.

Drug-eluting or bare-metal stents in subjects over 75 years of age: what is the best therapeutic strategy? Data from 460 consecutive patients with 1-year outcome

BACKGROUND The use of stents has become common in subjects over 75 years of age, but choosing the best type of stent still remains difficult. Our objective was to compare safety and clinical benefits of drug-eluting stent (DES) and bare-metal stent (BMS) at 1 year in this population. METHODS We included 460 consecutive patients aged 75 or over who had undergone angioplasty with DES (n=167) or BMS (n=293) between January 1 and December 31, 2005, and had 12-month clinical follow-up. RESULTS At 12 months, the cumulative percentages of all-cause deaths, cardiac deaths, and major adverse cardiac event (cardiac death, myocardial infarction, or repeat revascularization) were higher in the BMS group (15.7% vs. 7.2%; P=.008; 11.3% vs 3.0%; P=.002; 15.7% vs 8.4%; P=.025). Major hemorrhages were not significantly different between the two groups (3.7% with BMS vs 3.6% with DES; P=.930). In multivariate survival analysis, the relative risk (RR) of death in the BMS group as compared to the DES group was 2.20 (95% confidence interval, 1.16-4.19; P=.016). However, the difference disappeared after exclusion of deaths that occurred during the first month (RR=1.33; 95% confidence interval, 0.63-2.82; P=.456) or when analysis was performed on patients matched according to a propensity score to be treated with BMS (RR=1.46; 95% confidence interval, 0.54-3.92; P=.453). CONCLUSION Beyond the first month, DES implantation was associated in these patients over 75, with a 1-year risk of death that was not significantly different from the risk associated with the implantation of BMS. DES still should be preferred in indications currently recognized from a scientific standpoint.

In-hospital and long-term outcomes after percutaneous coronary intervention for chronic total occlusion in elderly patients: A consecutive, prospective, single-centre study

BACKGROUND Elderly patients are increasingly referred for complex percutaneous coronary interventions (PCI), including recanalization of chronic total occlusion (CTO). AIMS To assess the feasibility, safety and clinical benefits associated with CTO-PCI in elderly patients. METHODS Consecutive patients (n=356) who underwent CTO-PCI in our institution between January 2008 and December 2011 were prospectively included. The short-term outcomes of CTO-PCI were assessed by comparing the rates of successful recanalization and postoperative complications in patients aged ≥ 75 years and those < 75 years. The clinical effect of successful recanalization was evaluated in a 20-month follow-up analysis in patients ≥ 75 years. RESULTS Although patients ≥ 75 years (n = 93) had more complex coronary artery disease, the procedural success rate was similar to that in younger patients (78.2% vs. 74.3%, respectively; P = 0.41). Postoperative complications were more frequent in older patients (5.4% vs. 0.4%; P = 0.005). Major adverse cardiac event-free survival analysis at 20 months revealed that successful revascularization was indicative of a better prognosis in older patients (hazard ratio: 0.43, 95% confidence interval: 0.19-0.96; P = 0.039). CONCLUSION Elderly patients have more complex coronary disease and are at a higher risk of postoperative complications. Nevertheless, we observed a similar success rate for CTO-PCI in elderly patients as for younger patients. Successful CTO recanalization improved the event-free survival rate at 20 months. Thus, CTO-PCI constitutes an alternative strategy for treating selected elderly patients.

Gender disparity in 48-hour mortality is limited to emergency percutaneous coronary intervention for ST-elevation myocardial infarction

BACKGROUND Previous studies indicate that mortality from acute coronary syndromes is higher in women than in men, especially in case of interventional strategy. AIM To assess whether the in-hospital mortality rate differs between genders during the first 48h after emergency percutaneous coronary intervention for ST-elevation myocardial infarction (emergency PCI-STEMI) or after non-emergency PCI. METHODS All patients treated with PCI between January 2005 and June 2008 were included. The primary endpoint was frequency of death within 48h after the PCI procedure; secondary endpoints included frequency of recurrent myocardial infarction, new PCI or coronary artery bypass graft surgery, stroke, and major vascular or renal complications. Data were analysed via logistic regression with and without propensity-score matching. RESULTS More than 9000 patients underwent PCI. In the emergency PCI-STEMI group (n=1753), 48-hour mortality occurred in 2.2% of men and 4.9% of women (p=0.004). However, gender disparity occurred only in elderly patients; the rate was significantly (p=0.02) higher in women (8.1%) than in men (3.3%) aged > or =75 years. There was no evidence of gender disparity in the non-emergency PCI group (n=7336) or in secondary endpoints for either PCI group. Similar results were obtained in pair analyses of men and women with matching propensity scores. CONCLUSIONS Elderly women have a disproportionately high in-hospital mortality rate during the first 48h after emergency PCI for treatment of STEMI; however, there is no gender discrepancy in younger patients or patients of any age who receive non-emergency procedures.

Relation between left ventricular outflow tract obstruction and left ventricular shape in patients with hypertrophic cardiomyopathy: A cardiac magnetic resonance imaging study

BACKGROUND Hypertrophic cardiomyopathies (HCM) are often associated with left ventricular (LV) outflow tract obstruction, which can explain symptoms and impact prognosis. AIMS To better understand the mechanisms that link obstruction and LV shape in HCM. METHODS Patients with HCM who underwent cardiac magnetic resonance (CMR) imaging were included retrospectively. Obstructive HCM was defined as LV outflow gradient more than 30 mm Hg at rest by transthoracic echocardiography. The LV shape and mitral angle were assessed by CMR. Results were compared with control subjects. RESULTS Mean LV-mitral angle was smaller in patients with obstructive HCM (n=29) than in patients with non-obstructive HCM (n=15) or control subjects (n=15) (80 ± 5° vs 87 ± 7° [P=0.0002] and 89 ± 2° [P<0.0001]). Mean mitral papillary muscles angle was greater in patients with non-obstructive HCM than in patients with obstructive HCM or control subjects (136 ± 17° vs 123 ± 16° [P=0.007] and 118 ± 10° [P=0.002]). Patients with non-obstructive HCM had a greater mean LV-aortic root angle than patients with obstructive HCM or control subjects (139 ± 6° vs 135 ± 7° [P=0.04] and 133 ± 7° [P=0.03]). CONCLUSION There is a relation between morphological and functional parameters in HCM within which the mitral valve is probably part of pathophysiogenesis.

First Evidence of Increased Plasma Serotonin Levels in Tako-Tsubo Cardiomyopathy

Background. There is no data about the serotonergic activity during the acute phase of Tako-Tsubo Cardiomyopathy (TTC). The objective of our study was to investigate evidence of serotonin release from patients with TTC in comparison with patients with ST elevation myocardial infarction (STEMI) and healthy control subjects (HCS). Methods and Results. Plasma serotonin levels in 14 consecutive patients with TTC were compared with those in 14 patients with STEMI and 14 HCS. Plasma serotonin levels at admission were markedly higher in patients with TTC and STEMI as compared to HCS (3.9 ± 4.6, P = 0.02 versus control; 5.7 ± 5.6, P = 0.001 versus control; and 1 ± 0.4 ng/mL, resp.). There was no difference in serotonin levels between patients with TTC and those with STEMI (P = 0.33). Conclusion. This finding suggests that serotonin could participate to the pathophysiology of TTC.

Patent foramen ovale appearance with association of left ventricular assist device and mechanical ventilation.

We report on a 62-year-old man referred to the cardiac intensive care unit less than 24 hours after anterior ST-segment elevated myocardial infarction. The patient developed cardiogenic shock requiring elective intubation, vasopressor, and inotropic support. Emergency coronary angiography, revascularization, and insertion of an intraaortic balloon pump were performed. Nevertheless, the hemodynamic situation remained unstable, and a left ventricular assist device (LVAD) was inserted. Severe hypoxemia occurred several minutes after initiating the Impella Recover LD/LP 5.0 (Abiomed, Danvers, MA). Transesophageal echocardiography allowed diagnosis of patent foramen ovale. The shunt resulted from abnormal left-to-right pressure gradient due to left ventricular unloading and increased right ventricular afterload induced by mechanical ventilation. Transesophageal echocardiography was used to regulate both LVAD output and positive end-expiratory pressure settings to optimize oxygen transport. Because patent foramen ovale is common in humans, transesophageal echocardiography should be performed systematically after LVAD insertion.