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1.
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.
J Heart Valve Dis ; 13(2): 217-27, 2004 Mar.
Article in English | MEDLINE | ID: mdl-15086260

ABSTRACT

BACKGROUND AND AIM OF THE STUDY: Although described in a number of necropsy studies, endocarditis on mitral annular calcification (MAC) has rarely been reported during life. The study aim was to assess the frequency and specific features of bacterial endocarditis complicating MAC. METHODS: Data relating to 62 cases of infective endocarditis of the native mitral valve diagnosed with multiplane transesophageal echocardiography (TEE) over a five-year period were collected prospectively. RESULTS: Among 62 patients, 15 (24%) had vegetations originating from a calcified mitral annulus (group 1), while 47 had classic leaflet endocarditis (group 2). Group 1 patients differed significantly from group 2 patients with regard to: (i) higher incidence of diabetes mellitus and cancers; (ii) initial clinical presentation, with febrile coma or meningoencephalitis in 53% of cases; (iii) echocardiographic features, with significantly greater vegetations, presence of calcium-dense echoes within the vegetation, high frequency of ring abscess, and high frequency of para-annular ventriculoatrial leakage; and (iv) poorer clinical outcome, with 53% in-hospital mortality. CONCLUSION: MAC appears to be an underestimated predisposing factor for a particularly severe type of bacterial endocarditis. The use of multiplane TEE should improve current knowledge of this disease.


Subject(s)
Calcinosis/microbiology , Endocarditis, Bacterial/microbiology , Heart Valve Diseases/microbiology , Mitral Valve/microbiology , Staphylococcal Infections/microbiology , Streptococcal Infections/microbiology , Adult , Aged , Aged, 80 and over , Biomarkers/blood , Calcinosis/diagnostic imaging , Calcinosis/epidemiology , Cardiac Surgical Procedures , Echocardiography , Echocardiography, Transesophageal , Endocarditis, Bacterial/diagnostic imaging , Endocarditis, Bacterial/epidemiology , Female , Heart Valve Diseases/diagnostic imaging , Heart Valve Diseases/epidemiology , Humans , Male , Middle Aged , Mitral Valve/diagnostic imaging , Patient Admission , Postoperative Complications/etiology , Postoperative Complications/mortality , Prevalence , Prospective Studies , Staphylococcal Infections/diagnostic imaging , Staphylococcal Infections/epidemiology , Streptococcal Infections/diagnostic imaging , Streptococcal Infections/epidemiology , Treatment Outcome
4.
Pacing Clin Electrophysiol ; 26(1P2): 233-8, 2003 Jan.
Article in English | MEDLINE | ID: mdl-12687819

ABSTRACT

The aim of this prospective multicenter study was to assess the clinical benefits of the Selection (Vitatron) pacemaker diagnostic functions (AF 1.0) in the management of AF. Forty patients (71 +/- 9 years of age), with documented AF and conventional pacing indications, received a Selection. The AF 1.0 function of the pacemaker was programmed to document the AF burden, onset, daily distribution, duration, premature atrial beats before onset, and mode of onset of the last 12 episodes for AF episodes exceeding 180 beats/min. By comparing patients' symptoms records, patient conventional assessment at follow-up and AF 1.0 data, the investigators evaluated the usefulness of AF 1.0 in AF management at 3- and 6-month follow-ups. Usefulness was defined as a change in arrhythmia management prompted by the disclosure of AF 1.0 data. AF recurrences were recorded in 71% of the follow-ups with symptoms reported by patients in only 16%. Thirty-nine percent of therapeutic changes based on conventional assessment were confirmed by AF 1.0 data, and in 61% of instances, the initial changes were modified by AF 1.0 data. Changes included pacing parameters in 56% of cases, AF prevention with pacing algorithms in 37%, and medical treatment in 7%. All investigators indicated that AF 1.0 was useful in all patients. The AF 1.0 diagnostic functions offered a unique documentation of AF in asymptomatic patients, and allowed therapeutic adjustments impossible otherwise.


Subject(s)
Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , Pacemaker, Artificial , Aged , Atrial Fibrillation/complications , Cardiac Pacing, Artificial/methods , Female , Humans , Male , Prospective Studies , Sick Sinus Syndrome/complications
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