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1.
PLoS One ; 17(5): e0268330, 2022.
Article in English | MEDLINE | ID: mdl-35576227

ABSTRACT

Coronary microvascular dysfunction (CMVD) is common and associated with poorer outcomes in patients with ST Segment Elevation Myocardial Infarction (STEMI). The index of microcirculatory resistance (IMR) and the index of hyperemic microvascular resistance (HMR) are both invasive indexes of microvascular resistance proposed for the diagnosis of severe CMVD after primary percutaneous coronary intervention (pPCI). However, these indexes are not routinely assessed in STEMI patients. Our main objective was to clarify the association between IMR or HMR and long-term major adverse cardiovascular events (MACE), through a systematic review and meta-analysis of observational studies. We searched Medline, PubMed, and Google Scholar for studies published in English until December 2020. The primary outcome was a composite of cardiovascular death, non-cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and rehospitalization for heart failure occurring after at least 6 months following CMVD assessment. We identified 6 studies, reporting outcomes in 1094 patients (mean age 59.7 ± 11.4 years; 18.2% of patients were women) followed-up from 6 months to 7 years. Severe CMVD, defined as IMR > 40 mmHg or HMR > 3mmHg/cm/sec was associated with MACE with a pooled HR of 3.42 [2.45; 4.79]. Severe CMVD is associated with an increased risk of long-term adverse cardiovascular events in patients with STEMI. Our results suggest that IMR and HMR are useful for the early identification of severe CMVD in patients with STEMI after PCI, and represent powerful prognostic assessments as well as new therapeutic targets for clinical intervention.


Subject(s)
Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Aged , Coronary Circulation , Female , Humans , Male , Microcirculation , Middle Aged , Observational Studies as Topic , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Predictive Value of Tests , Prognosis , ST Elevation Myocardial Infarction/diagnosis , Treatment Outcome , Vascular Resistance
2.
J Am Coll Cardiol ; 78(19): 1875-1885, 2021 11 09.
Article in English | MEDLINE | ID: mdl-34736563

ABSTRACT

BACKGROUND: There is limited evidence that fractional flow reserve (FFR) is effective in guiding therapeutic strategy in multivessel coronary artery disease (CAD) beyond prespecified percutaneous coronary intervention or coronary graft surgery candidates. OBJECTIVES: The FUTURE (FUnctional Testing Underlying coronary REvascularization) trial aimed to evaluate whether a treatment strategy based on FFR was superior to a traditional strategy without FFR in the treatment of multivessel CAD. METHODS: The FUTURE trial is a prospective, randomized, open-label superiority trial. Multivessel CAD candidates were randomly assigned (1:1) to treatment strategy based on FFR in all stenotic (≥50%) coronary arteries or to a traditional strategy without FFR. In the FFR group, revascularization (percutaneous coronary intervention or surgery) was indicated for FFR ≤0.80 lesions. The primary endpoint was a composite of major adverse cardiac or cerebrovascular events at 1 year. RESULTS: The trial was stopped prematurely by the data safety and monitoring board after a safety analysis and 927 patients were enrolled. At 1-year follow-up, by intention to treat, there were no significant differences in major adverse cardiac or cerebrovascular events rates between groups (14.6% in the FFR group vs 14.4% in the control group; hazard ratio: 0.97; 95% confidence interval: 0.69-1.36; P = 0.85). The difference in all-cause mortality was nonsignificant, 3.7% in the FFR group versus 1.5% in the control group (hazard ratio: 2.34; 95% confidence interval: 0.97-5.18; P = 0.06), and this was confirmed with a 24 months' extended follow-up. FFR significantly reduced the proportion of revascularized patients, with more patients referred to exclusively medical treatment (P = 0.02). CONCLUSIONS: In patients with multivessel CAD, we did not find evidence that an FFR-guided treatment strategy reduced the risk of ischemic cardiovascular events or death at 1-year follow-up. (Functional Testing Underlying Coronary Revascularisation; NCT01881555).


Subject(s)
Coronary Artery Bypass , Coronary Artery Disease , Coronary Stenosis , Coronary Vessels , Fractional Flow Reserve, Myocardial/physiology , Percutaneous Coronary Intervention , Postoperative Complications/mortality , Aged , Coronary Angiography/methods , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/methods , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Coronary Artery Disease/physiopathology , Coronary Artery Disease/surgery , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/etiology , Coronary Stenosis/surgery , Coronary Vessels/diagnostic imaging , Coronary Vessels/physiopathology , Early Termination of Clinical Trials , Female , Humans , Long Term Adverse Effects/mortality , Male , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Predictive Value of Tests , Risk Assessment/methods , Severity of Illness Index
3.
JACC Cardiovasc Interv ; 14(15): 1704-1713, 2021 08 09.
Article in English | MEDLINE | ID: mdl-34274294

ABSTRACT

OBJECTIVES: Using French transcatheter aortic valve replacement (TAVR) registries linked with the nationwide administrative databases, the study compared the rates of long-term mortality, bleeding, and ischemic events after TAVR in patients requiring oral anticoagulation with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). BACKGROUND: The choice of optimal drug for anticoagulation after TAVR remains debated. METHODS: Data from the France-TAVI and FRANCE-2 registries were linked to the French national health single-payer claims database, from 2010 to 2017. Propensity score matching was used to reduce treatment-selection bias. Two primary endpoints were death from any cause (efficacy) and major bleeding (safety). RESULTS: A total of 24,581 patients who underwent TAVR were included and 8,962 (36.4%) were treated with OAC. Among anticoagulated patients, 2,180 (24.3%) were on DOACs. After propensity matching, at 3 years, mortality (hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.12-1.67; P < 0.005) and major bleeding including hemorrhagic stroke (HR: 1.64; 95% CI: 1.17-2.29; P < 0.005) were lower in patients on DOACs compared with those on VKAs. The rates of ischemic stroke (HR: 1.32; 95% CI: 0.81-2.15; P = 0.27) and acute coronary syndrome (HR: 1.17; 95% CI: 0.68-1.99; P = 0.57) did not differ among groups. CONCLUSIONS: In these large multicenter French TAVR registries with an exhaustive clinical follow-up, the long-term mortality and major bleeding were lower with DOACs than VKAs at discharge. The present study supports preferential use of DOACs rather than VKAs in patients requiring oral anticoagulation therapy after TAVR.


Subject(s)
Atrial Fibrillation , Transcatheter Aortic Valve Replacement , Administration, Oral , Anticoagulants/adverse effects , Atrial Fibrillation/drug therapy , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome , Vitamin K
4.
Circulation ; 138(23): 2597-2607, 2018 12 04.
Article in English | MEDLINE | ID: mdl-30571260

ABSTRACT

BACKGROUND: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry. METHODS: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions. RESULTS: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%). CONCLUSIONS: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.


Subject(s)
Aortic Valve Stenosis/surgery , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve Stenosis/mortality , Equipment Failure , Female , Follow-Up Studies , Heart Failure/diagnosis , Heart Failure/epidemiology , Hemodynamics , Humans , Male , Proportional Hazards Models , Registries , Risk Factors , Stroke/diagnosis , Stroke/epidemiology , Survival Analysis , Time Factors , Treatment Outcome
5.
Obes Surg ; 28(8): 2560-2571, 2018 08.
Article in English | MEDLINE | ID: mdl-29948871

ABSTRACT

Obstructive sleep apnea (OSA) results from a combination of several factors leading to the obstruction of the upper respiratory tract (URT). OSA represents a systemic pathophysiological entity and leads to many comorbidities such as hypertension, coronary ischemia, and stroke. Patients with this pathophysiological entity experience also an increased risk of postoperative complications. Obesity is certainly the main cause of developing OSA. However, many other predisposing factors influence the genesis of obstructive apnea. It is important to understand the complexity of the interactions between predisposing factors to understand the relationship between weight loss following obesity surgery and the improvement in the severity of OSA. In this narrative review, we expose the seven major categories of predisposing factors that interact to generate obstructive apneas in patients, namely the anatomic abnormalities of the URT, the mechanical and the metabolic responses of the upper airway musculature, the loop gain, the arousal threshold, and the hormonal abnormalities. The genesis of apnea is the result of a complex dynamic interaction between the anatomical risk factors and the compensatory neuromuscular reflexes. All of these points are integrally part of the perioperative care of the obese patients. Finally, we will discuss different options for weight reduction.


Subject(s)
Muscles/physiopathology , Obesity/complications , Respiratory System/physiopathology , Sleep Apnea, Obstructive/etiology , Hormones/metabolism , Humans , Muscles/metabolism , Obesity/metabolism , Respiratory System Abnormalities , Risk Factors , Sleep Apnea, Obstructive/metabolism , Sleep Apnea, Obstructive/physiopathology , Weight Loss
6.
Am J Cardiol ; 120(9): 1633-1638, 2017 Nov 01.
Article in English | MEDLINE | ID: mdl-28864319

ABSTRACT

Cardiac computed tomography (CT) provides additional information with ultrasound in the transcatheter heart valve (THV) size selection. However, the influence of these incremental data on outcomes has not been evaluated in a randomized study. A single-center prospective, randomized, and open study was performed. Patients referred for transfemoral transcatheter aortic valve implantation with a balloon-expandable endoprothesis were included. THV size selection was performed using either transthoracic and transesophageal echocardiography data (control group) or ultrasound and CT results (CT group). The primary composite end point included the occurrence of stroke, major vascular complications, and moderate or severe paravalvular aortic regurgitation (PAR) at 1 year. Fifty patients (n = 25 in the control and CT groups) were enrolled. The primary composite end point occurred in 40% and 8% of patients from the control and CT groups, respectively (p = 0.008). The Kaplan-Meier analysis revealed a pejorative association with not performing the CT (p = 0.007). A decrease in the occurrence of PAR was observed in the CT group compared with the control group (PAR 28% vs 4%, p = 0.04; major vascular complications 12% vs 4%, p = 0.6; all-cause death 16% vs. 4%, p = 0.34; no stroke). In conclusion, the use of cardiac CT in addition to ultrasound data in THV size selection reduced the long-term occurrence of cardiovascular events.


Subject(s)
Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Echocardiography, Transesophageal , Multidetector Computed Tomography , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve Stenosis/mortality , Disease-Free Survival , Female , Humans , Kaplan-Meier Estimate , Male , Prospective Studies , Treatment Outcome
7.
N Engl J Med ; 377(11): 1011-1021, 2017 09 14.
Article in English | MEDLINE | ID: mdl-28902593

ABSTRACT

BACKGROUND: Trials of patent foramen ovale (PFO) closure to prevent recurrent stroke have been inconclusive. We investigated whether patients with cryptogenic stroke and echocardiographic features representing risk of stroke would benefit from PFO closure or anticoagulation, as compared with antiplatelet therapy. METHODS: In a multicenter, randomized, open-label trial, we assigned, in a 1:1:1 ratio, patients 16 to 60 years of age who had had a recent stroke attributed to PFO, with an associated atrial septal aneurysm or large interatrial shunt, to transcatheter PFO closure plus long-term antiplatelet therapy (PFO closure group), antiplatelet therapy alone (antiplatelet-only group), or oral anticoagulation (anticoagulation group) (randomization group 1). Patients with contraindications to anticoagulants or to PFO closure were randomly assigned to the alternative noncontraindicated treatment or to antiplatelet therapy (randomization groups 2 and 3). The primary outcome was occurrence of stroke. The comparison of PFO closure plus antiplatelet therapy with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 2, and the comparison of oral anticoagulation with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 3. RESULTS: A total of 663 patients underwent randomization and were followed for a mean (±SD) of 5.3±2.0 years. In the analysis of randomization groups 1 and 2, no stroke occurred among the 238 patients in the PFO closure group, whereas stroke occurred in 14 of the 235 patients in the antiplatelet-only group (hazard ratio, 0.03; 95% confidence interval, 0 to 0.26; P<0.001). Procedural complications from PFO closure occurred in 14 patients (5.9%). The rate of atrial fibrillation was higher in the PFO closure group than in the antiplatelet-only group (4.6% vs. 0.9%, P=0.02). The number of serious adverse events did not differ significantly between the treatment groups (P=0.56). In the analysis of randomization groups 1 and 3, stroke occurred in 3 of 187 patients assigned to oral anticoagulants and in 7 of 174 patients assigned to antiplatelet therapy alone. CONCLUSIONS: Among patients who had had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt, the rate of stroke recurrence was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. PFO closure was associated with an increased risk of atrial fibrillation. (Funded by the French Ministry of Health; CLOSE ClinicalTrials.gov number, NCT00562289 .).


Subject(s)
Anticoagulants/therapeutic use , Foramen Ovale, Patent/drug therapy , Foramen Ovale, Patent/therapy , Platelet Aggregation Inhibitors/therapeutic use , Secondary Prevention/methods , Septal Occluder Device , Stroke/prevention & control , Adolescent , Adult , Anticoagulants/adverse effects , Atrial Fibrillation/etiology , Combined Modality Therapy , Female , Follow-Up Studies , Foramen Ovale, Patent/complications , Heart Aneurysm/complications , Humans , Intention to Treat Analysis , Kaplan-Meier Estimate , Male , Middle Aged , Platelet Aggregation Inhibitors/adverse effects , Recurrence , Septal Occluder Device/adverse effects , Stroke/epidemiology , Stroke/etiology , Young Adult
8.
J Am Coll Cardiol ; 70(1): 42-55, 2017 Jul 04.
Article in English | MEDLINE | ID: mdl-28662806

ABSTRACT

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited. OBJECTIVES: The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period. METHODS: TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers. RESULTS: A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased. CONCLUSIONS: The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).


Subject(s)
Aortic Valve Stenosis/surgery , Registries , Transcatheter Aortic Valve Replacement/trends , Aged, 80 and over , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/epidemiology , Echocardiography, Transesophageal , Female , Follow-Up Studies , France/epidemiology , Humans , Incidence , Male , Prognosis , Prospective Studies , Survival Rate/trends , Time Factors
9.
J Am Coll Cardiol ; 68(15): 1637-1647, 2016 10 11.
Article in English | MEDLINE | ID: mdl-27712776

ABSTRACT

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. OBJECTIVES: This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. METHODS: The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. RESULTS: A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. CONCLUSIONS: The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time.


Subject(s)
Aortic Valve Stenosis/surgery , Transcatheter Aortic Valve Replacement , Aged, 80 and over , Female , France , Humans , Male , Prospective Studies , Registries , Risk Assessment , Time Factors , Treatment Outcome
10.
Catheter Cardiovasc Interv ; 88(6): 988-993, 2016 Nov 15.
Article in English | MEDLINE | ID: mdl-27510946

ABSTRACT

OBJECTIVES: We sought to demonstrate the safety and efficacy of rapid left ventricular (LV) pacing through the guidewire during balloon aortic valvuloplasty (BAV) and Transaortic valve implantation (TAVI). BACKGROUND: Right ventricular temporary pacing during TAVI and BAV is time-consuming and associated with vascular and pericardial complications. METHODS: Rapid left ventricular pacing was provided via the back-up 0.035″ guidewire. The cathode of an external pacemaker was placed on the tip of the 0.035″ wire and the anode on a needle inserted into the groin. Insulation was ensured by the balloon or TAVI catheter. RESULTS: 38 BAV and 87 TAVI procedures were performed in 113 consecutive patients in three centers with one for one pacing (160-200 bpm) in all patients. A significant reduction in blood pressure was achieved with a mean systolic pressure of 44 mm Hg during stimulation. Mean procedural time was 49.7 ± 31 min for BAV and 68.7 ± 30.9 for TAVI. A temporary venous pacemaker was required in 12 patients; only 12% of TAVI patients had a femoral central venous catheter. Femoral venous puncture was not performed in BAV patients. No venous vascular complications were observed. One case of successfully treated tamponade (0.8%) occurred 8 hr post procedure. In-hospital mortality rates were 4.6% and 2.6% in the TAVI and BAV groups, respectively. CONCLUSIONS: Use of the LV guidewire for rapid pacing during BAV and TAVI was shown to be simple, reproducible, and prevented complications associated with RV temporary leads thus potentially simplifying TAVI and enhancing its safety. © 2016 Wiley Periodicals, Inc.


Subject(s)
Balloon Valvuloplasty/methods , Cardiac Catheterization/methods , Heart Ventricles/physiopathology , Pacemaker, Artificial , Postoperative Complications/prevention & control , Transcatheter Aortic Valve Replacement/methods , Aged, 80 and over , Aortic Valve Stenosis , Echocardiography , Electrocardiography , Female , Follow-Up Studies , Heart Ventricles/diagnostic imaging , Humans , Intraoperative Period , Male , Postoperative Complications/epidemiology , Prospective Studies
11.
Int J Stroke ; 11(6): 724-32, 2016 08.
Article in English | MEDLINE | ID: mdl-27056964

ABSTRACT

RATIONALE: Currently available data do not provide definitive evidence on the comparative benefits of closure of patent foramen ovale, oral anticoagulants and antiplatelet therapy in patients with patent foramen ovale-associated cryptogenic stroke AIM: To assess whether transcatheter patent foramen ovale closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy, for secondary stroke prevention in patients aged 16 to 60 years with a large patent foramen ovale or a patent foramen ovale associated with an atrial septal aneurysm, and an otherwise unexplained ischaemic stroke or retinal ischaemia. SAMPLE SIZE: Six hundred and sixty-four patients were included in the study. METHODS AND DESIGN: CLOSE is an academic-driven, multicentre, randomized, open-label, three-group, superiority trial with blinded adjudication of outcome events. The trial has been registered with Clinical Trials Register (Clinicaltrials.gov, NCT00562289). Patient recruitment started in December 2007. Patient follow-up will continue until December 2016. Expected mean follow-up = 5.6 years. STUDY OUTCOMES: The primary efficacy outcome is the occurrence of fatal or nonfatal stroke. Safety outcomes include fatal, life-threatening or major procedure- or device-related complications and fatal, life-threatening or major haemorrhagic complications. DISCUSSION: CLOSE is the first specifically designed trial to assess the superiority of patent foramen ovale closure over antiplatelet therapy alone and the superiority of oral anticoagulants over antiplatelet therapy to prevent stroke recurrence in patients with patent foramen ovale-associated cryptogenic stroke.


Subject(s)
Anticoagulants/therapeutic use , Foramen Ovale, Patent/drug therapy , Foramen Ovale, Patent/surgery , Platelet Aggregation Inhibitors/therapeutic use , Administration, Oral , Adolescent , Adult , Anticoagulants/adverse effects , Anticoagulants/economics , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/economics , Female , Follow-Up Studies , Humans , Male , Middle Aged , Patient Selection , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/economics , Postoperative Complications/economics , Secondary Prevention/economics , Stroke/prevention & control , Treatment Outcome , Young Adult
12.
N Engl J Med ; 366(18): 1705-15, 2012 May 03.
Article in English | MEDLINE | ID: mdl-22551129

ABSTRACT

BACKGROUND: Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. METHODS: All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. RESULTS: A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. CONCLUSIONS: This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).


Subject(s)
Aortic Valve Stenosis/therapy , Cardiac Catheterization , Heart Valve Prosthesis Implantation/methods , Registries , Aged , Aged, 80 and over , Aortic Valve Stenosis/complications , Cardiac Catheterization/methods , Female , France/epidemiology , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/adverse effects , Hemorrhage/epidemiology , Hemorrhage/etiology , Humans , Incidence , Male , Multivariate Analysis , Prospective Studies , Stroke/epidemiology , Stroke/etiology
13.
Clin Res Cardiol ; 101(10): 787-93, 2012 Oct.
Article in English | MEDLINE | ID: mdl-22487724

ABSTRACT

BACKGROUND: The Premere™ PFO closure device has a special design for closure of patent foramen ovale (PFO) including a flexible distance and angulation between the right and left disc providing minimal septal distortion. The primary objective of the study was to determine the degree of risk for stroke or transient ischemic attack (TIA) in patients after Premere™ PFO closure device implantation. METHODS: In this multicenter, prospective observational registry, patients with a clinical indication for PFO closure were included. Patients had a history of stroke or TIA with right to left shunt. Follow-up visits were scheduled according to routine clinical practice. RESULTS: In 23 centers from 10 countries, 267 patients with successful device implantation were included. Assessment of right to left shunt after device implantation revealed no residual shunt in 71 %, small shunts in 16.8 %, and moderate or large residual shunts in 5.6 and 6.5 %. With common clinical practice, use of Coumadin or heparin decreased from 27 % pre- to 3 % post-implantation, while use of acetylsalicylic acid or thienopyridines increased from 64 to 95 % and 27 to 80 %, respectively; 18 % of patients were discharged with anti-platelet monotherapy. Mean follow-up was 11 ± 9 months (range 1-24 months). There was no stroke or TIA. During follow-up, there was one sudden death. Atrial fibrillation occurred in five (1.9 %) patients. One (0.4 %) patient with a thrombophilic diathesis developed a thrombus. CONCLUSIONS: In this prospective, international, multicenter PRECISE registry, the use of the Premere™ PFO closure device for closure of PFO after stroke or TIA resulted in good clinical results with no recurrent event.


Subject(s)
Foramen Ovale, Patent/surgery , Ischemic Attack, Transient/prevention & control , Registries/statistics & numerical data , Septal Occluder Device , Stroke/prevention & control , Adolescent , Adult , Aged , Equipment Design , Female , Follow-Up Studies , Foramen Ovale, Patent/complications , Humans , Internationality , Ischemic Attack, Transient/etiology , Male , Middle Aged , Prospective Studies , Prosthesis Implantation , Risk , Secondary Prevention , Stroke/etiology , Treatment Outcome , Young Adult
15.
Curr Allergy Asthma Rep ; 11(2): 146-62, 2011 Apr.
Article in English | MEDLINE | ID: mdl-21274665

ABSTRACT

Rhinosinusitis (RS) is a heterogeneous group of diseases. It is a significant and increasing health problem that affects about 15% of the population in Western countries. It has a substantial impact on patients' health-related quality of life and daily functioning and represents a huge financial burden to society and the health care system as a result of the direct and indirect costs. In addition, RS is not well-understood, and little is known about the etiology and pathophysiology. In the past decade, many papers have been published that have changed our understanding of RS. RS is commonly classified into acute and chronic RS based on symptom duration. In acute RS, an inflammatory reaction initiated by a viral infection characterizes most uncomplicated, mild to moderate cases. Therefore, the first line of treatment for these cases are intranasal steroids and not antibiotics. In severe and complicated cases, antibiotics combined with topical steroids remain the treatment of choice. On the other hand, chronic RS is actually subdivided into two distinct entities (chronic rhinosinusitis with and without polyps), as growing evidence indicates that these entities have specific inflammatory pathways and cytokine profiles. The authors review recent data regarding the clinical presentations, cytokine profiles, tissue remodeling, and modalities of treatment for each form of RS.


Subject(s)
Cytokines/immunology , Rhinitis , Sinusitis , Animals , Humans , Inflammation , Rhinitis/diagnosis , Rhinitis/immunology , Rhinitis/pathology , Rhinitis/therapy , Sinusitis/diagnosis , Sinusitis/immunology , Sinusitis/pathology
16.
Can J Cardiol ; 24(10): e73-4, 2008 Oct.
Article in English | MEDLINE | ID: mdl-18841264

ABSTRACT

Behçet's disease is an autoimmune, multisystem disease presenting with recurrent oral and genital ulceration as well as ocular involvement. Aneurysmal degeneration of coronary arteries remains a rare phenomenon in Behçet's disease. The case of a patient with Behçet's disease who presented with severe stenosis of the left anterior descending artery associated with a giant aneurysm of the proximal segment is described. Surgical revascularization was proposed, followed by percutaneous embolization of the aneurysm.


Subject(s)
Behcet Syndrome/complications , Coronary Aneurysm/complications , Coronary Stenosis/etiology , Adult , Behcet Syndrome/diagnostic imaging , Coronary Aneurysm/diagnostic imaging , Coronary Aneurysm/therapy , Coronary Angiography , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/surgery , Diagnosis, Differential , Embolization, Therapeutic , Humans , Male , Myocardial Revascularization , Severity of Illness Index , Tomography, X-Ray Computed
17.
Am J Rhinol ; 22(6): 598-601, 2008.
Article in English | MEDLINE | ID: mdl-19178796

ABSTRACT

BACKGROUND: The aim of this study was to assess the volume of the olfactory bulb (OB) in patients with chronic rhinosinusitis (without nasal polyposis at the endoscopic evaluation) and to evaluate the correlation between this measure and the degree of sinonasal inflammation. METHODS: Patients with sinonasal disease (SND; n = 22) were compared with healthy controls (n = 16) using orthonasal and retronasal olfactory test results and OB volumes measurement calculated by planimetric manual contouring using standardized methods. The Lund-Mackay score (originally described for CT scan) was also used to gauge sinonasal inflammation (SND score). RESULTS: The two groups were not significantly different in terms of age or distribution of sex. Patients had significantly higher right- and left-sided SND scores than controls. There was no significant group difference between patients and controls with regard to OB volume. However, patients with an SND score < or =12 had larger OB volumes than patients with higher SND scores (p < 0.001). Even when controlling for the subjects' age, a significant correlation was present between OB volume and SND score (r = -0.52; p = 0.001) with smaller OB volumes being associated with a higher degree of sinonasal pathology. CONCLUSION: OB volume correlated with the SND score, which is an indicator of the degree of sinonasal inflammation. SND patients with a slight decrease or even normal olfactory function may already exhibit changes in their OB volume. This study also seems to emphasize the idea that OB volume changes are more sensitive to subtle changes in the olfactory system than results from psychophysical testing.


Subject(s)
Olfactory Bulb/pathology , Paranasal Sinus Diseases/pathology , Adult , Aged , Female , Humans , Male , Middle Aged , Organ Size , Paranasal Sinus Diseases/physiopathology , Rhinitis/pathology , Sinusitis/pathology
18.
Clin Ophthalmol ; 2(1): 211-5, 2008 Mar.
Article in English | MEDLINE | ID: mdl-19668408

ABSTRACT

JNA (Juvenile nasopharyngeal angiofibroma) is a benign but highly vascular and aggressive tumor that takes its origin in the basisphenoid region close to the sphenopalatine foramen. It occurs invariably in male teenagers. Surgery is the treatment of choice. In the past, external transfacial approaches were recommended. Nowadays endonasal endoscopic approach is performed by experienced teams even for extended tumor. The authors report a case of a pyocele of the lachrymal sac occurring 60 years after a transantral surgery for a JNA. The patient was then successfully operated with an endonasal endoscopic dacryocystorhinostomy using a powered instrumentation and a navigation system. This case confirms the necessity of a long follow-up for all the patients who had a transantral surgery with resection of the medial wall of the maxillary sinus and dissection of the nasolacrymal duct.

19.
Am J Rhinol ; 21(5): 548-50, 2007.
Article in English | MEDLINE | ID: mdl-17999787

ABSTRACT

BACKGROUND: Lack of an olfactory bulb (OB) is typically associated with anosmia. METHODS: We present a patient with subnormal olfactory function in whom the OB could not be detected with magnetic resonance imaging (MRI). RESULTS: Olfactory function was evaluated on two occasions. Orthonasal olfactory function was assessed with the "Sniffin' Sticks" test providing a score equivalent to hyposmia. Retronasal olfactory function was studied with "smell powders" indicating a decreased, but not absence of, olfactory function. Importantly, chemosensory event-related potentials were clearly present in response to olfactory and trigeminal stimuli. CONCLUSION: This indicates that olfactory function may be present in some subjects even when an OB can not be detected with MRI.


Subject(s)
Evoked Potentials , Olfaction Disorders/physiopathology , Olfactory Bulb/physiology , Smell/physiology , Adult , Brain/pathology , Female , Humans , Magnetic Resonance Imaging/methods , Odorants , Olfactory Bulb/anatomy & histology , Olfactory Bulb/pathology , Olfactory Pathways , Sensory Thresholds , Stimulation, Chemical , Tomography, Emission-Computed, Single-Photon/methods
20.
Laryngoscope ; 117(6): 1096-101, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17460578

ABSTRACT

OBJECTIVE: The purpose of this study was to evaluate the likelihood of recording olfactory event-related potentials (OERPs) in patients with an olfactory dysfunction and to correlate the electrophysiological responses to orthonasal and retronasal olfactory testing. DESIGN/MATERIALS AND METHODS: This was a prospective study of 65 patients with different origins of their olfactory loss. Orthonasal olfactory function was assessed with the "Sniffin' Sticks" test (orthonasal score; maximal score 48) and retronasal olfactory function with odorized powders presented intraorally (retronasal score; maximal score 20). The OERPs were obtained after presentation of 2-phenyl ethyl alcohol, the selected olfactory stimulus. Causes of olfactory dysfunction included postinfectious olfactory loss (n = 15), head trauma (n = 26), nasal polyposis (n = 15), and mixed causes (idiopathic, toxic, drug induced) (n = 9). RESULTS: Based on orthonasal testing, 32 and 33 patients were diagnosed with anosmia and hyposmia, respectively. Twenty-two patients from the hyposmic group demonstrated reliable OERPs. No OERPs were recorded in the anosmic group. Prevalence of OERPs in a cohort of patients with olfactory dysfunction was 33.8% (22 of 65). Median score (expressed as the percentage of the maximal score that could be obtained theoretically) in which OERPs were recorded was 50% (24 of 48) with orthonasal testing and 80% (16 of 20) with retronasal testing. CONCLUSIONS: Patients with olfactory dysfunction usually demonstrate OERPs in one third of the cases. When olfactory dysfunction is in the range that separates normosmic subjects from anosmic patients, patients may have identifiable OERPs. Interpretation of both orthonasal and retronasal psychophysical olfactory testing should be supported by the recording of OERPs in a clinical setting.


Subject(s)
Evoked Potentials/physiology , Olfaction Disorders/diagnosis , Olfaction Disorders/physiopathology , Physical Stimulation/methods , Adult , Electrophysiology/instrumentation , Female , Humans , Male , Psychophysics/methods , Severity of Illness Index , Trigeminal Nerve/physiology
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