Abstract Population-based studies including systematic echocardiographic examinations are required to assess the prevalence of valvular heart disease. In industrialized countries, the prevalence of ...valvular heart disease is estimated at 2.5%. Because of the predominance of degenerative etiologies, the prevalence of valvular disease increases markedly after the age of 65 years, in particular with regard to aortic stenosis and mitral regurgitation, which accounts for 3 in 4 cases of valvular disease. Rheumatic heart disease still represents 22% of valvular heart disease in Europe. The prevalence of secondary mitral regurgitation cannot be assessed reliably but it seems to be a frequent disease. The incidence of infective endocarditis is approximately 30 cases per million individiuals per year. Its stability is associated with marked changes in its presentation. Patients are getting older and staphylococcus is now becoming the microorganism most frequently responsible. Heath care-associated infections are the most likely explanation of changes in the microbiology of infective endocarditis. In developing countries, rheumatic heart disease remains the leading cause of valvular heart disease. Its prevalence is high, between 20 and 30 cases per 1000 subjects when using systematic echocardiographic screening. In conclusion, the temporal and geographical heterogeneity illustrates the effect of socioeconomic status and changes in life expectancy on the frequency and presentation of valvular heart disease. A decreased burden of valvular disease would require the elaboration of preventive strategies in industrialized countries and an improvement in the socioeconomic environment in developing countries.
Atrial fibrillation (AF) is a common arrhythmia in patients with aortic stenosis. When these patients are treated medically or by surgical aortic valve replacement, AF is associated with increased ...risk of adverse events including death. Growing evidence suggests a significant impact of AF on outcomes also in patients with aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). Conversely, limited evidence is available regarding the optimal management of this condition. This review aims to summarize prevalence, pathophysiology, prognosis, and treatment of AF in patients undergoing TAVI.
Functional mitral regurgitation (FMR) is associated with poor outcomes in patients with heart failure (HF). However, it is not clear whether FMR is just a consequence of left ventricular (LV) ...remodelling or a factor contributing to cardiomyopathy progression. There will be more clarity about this controversy when the effects of FMR correction on outcomes will be shown. FMR correction can be performed surgically or, more often, percutaneously with the MitraClip procedure. MitraClip is the most widely used device with more than 70 000 implants performed to date. Observational studies suggest that MitraClip treatment of FMR is safe and associated with improved symptoms, quality of life and functional status in HF patients. Two recently randomized controlled clinical trials have investigated the impact of MitraClip on the outcomes of HF patients: Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation (MITRA‐FR) and Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT). Both trials randomized patients to MitraClip plus guideline‐directed medical therapy (GDMT) or GDMT alone. No reduction in the primary endpoint of all‐cause mortality or HF hospitalizations was shown in MITRA‐FR, whereas a significant reduction in HF hospitalizations (primary endpoint) as well as in mortality alone were shown in COAPT. The aim of this review is to summarize the pathophysiology, prevalence, prognostic role and management of FMR, focusing on the differences between MITRA‐FR and COAPT and trying to provide possible explanations for the diverging results. We speculate that the two trials should be interpreted as complementary rather than opposite. Patients with severe FMR (effective regurgitant orifice area > 30 mm2) despite maximum tolerated GDMT (including cardiac resynchronization therapy), and without too advanced cardiomyopathy seem to be the best candidates for MitraClip treatment. MITRA‐FR and COAPT provide us a long awaited ‘proof of concept’: FMR may be considered a leading actor in cardiomyopathy progression rather than a mere marker of severity.
In patients who have chronic heart failure with reduced left ventricular ejection fraction, severe secondary mitral-valve regurgitation is associated with a poor prognosis. Whether percutaneous ...mitral-valve repair improves clinical outcomes in this patient population is unknown.
We randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of >20 mm
or a regurgitant volume of >30 ml per beat), a left ventricular ejection fraction between 15 and 40%, and symptomatic heart failure, in a 1:1 ratio, to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group; 152 patients) or to receive medical therapy alone (control group; 152 patients). The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 12 months.
At 12 months, the rate of the primary outcome was 54.6% (83 of 152 patients) in the intervention group and 51.3% (78 of 152 patients) in the control group (odds ratio, 1.16; 95% confidence interval CI, 0.73 to 1.84; P=0.53). The rate of death from any cause was 24.3% (37 of 152 patients) in the intervention group and 22.4% (34 of 152 patients) in the control group (hazard ratio, 1.11; 95% CI, 0.69 to 1.77). The rate of unplanned hospitalization for heart failure was 48.7% (74 of 152 patients) in the intervention group and 47.4% (72 of 152 patients) in the control group (hazard ratio, 1.13; 95% CI, 0.81 to 1.56).
Among patients with severe secondary mitral regurgitation, the rate of death or unplanned hospitalization for heart failure at 1 year did not differ significantly between patients who underwent percutaneous mitral-valve repair in addition to receiving medical therapy and those who received medical therapy alone. (Funded by the French Ministry of Health and Research National Program and Abbott Vascular; MITRA-FR ClinicalTrials.gov number, NCT01920698 .).
Abstract Tricuspid valve (TV) disease has been relatively neglected, despite the known association between severe tricuspid regurgitation (TR) and mortality. Few patients undergo isolated tricuspid ...surgery, which remains associated with high in-hospital mortality rates, particularly in patients with prior left-sided valve surgery. Patients with severe TR are often managed medically for years before TV repair or replacement. Current guidelines recommend TV repair in the presence of a dilated tricuspid annulus at the time of a left-sided valve surgical intervention, even if regurgitation is mild. This proposed algorithm aims to prevent the inevitable progression to severe TR and the need for a second surgical intervention. Recently, novel transcatheter treatment options were developed for treating patients with severe TR and right heart failure with prohibitive surgical risk. Here we describe currently available transcatheter treatment options for severe TR implanted at different levels: the junction between vena cavae and right atrium; the tricuspid annulus; or between TV leaflets, improving coaptation.
Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous etiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) ...pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodeling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of transcatheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.
Summary The field of mitral valve disease diagnosis and management is rapidly changing. New understanding of disease pathology and progression, with improvements in and increased use of sophisticated ...imaging modalities, have led to early diagnosis and complex treatment. In primary mitral regurgitation, surgical repair is the standard of care. Treatment of asymptomatic patients with severe mitral regurgitation in valve reference centres, in which successful repair is more than 95% and surgical mortality is less than 1%, should be the expectation for the next 5 years. Transcatheter mitral valve repair with a MitraClip device is also producing good outcomes in patients with primary mitral regurgitation who are at high surgical risk. Findings from clinical trials of MitraClip versus surgery in patients of intermediate surgical risk are expected to be initiated in the next few years. In patients with secondary mitral regurgitation, mainly a disease of the left ventricle, the vision for the next 5 years is not nearly as clear. Outcomes from ongoing clinical trials will greatly inform this field. Use of transcatheter techniques, both repair and replacement, is expected to substantially expand. Mitral annular calcification is an increasing problem in elderly people, causing both mitral stenosis and regurgitation which are difficult to treat. There is anecdotal experience with use of transcatheter valves by either a catheter-based approach or as a hybrid technique with open surgery, which is being studied in early feasibility trials.
Abstract
Aims
The Cardioband™ (Edwards Lifesciences) is a transcatheter implant designed to reduce mitral annulus size and mitral regurgitation (MR) severity. We report the 1-year outcomes of ...consecutive patients who underwent the Cardioband procedure between 2013 and 2016.
Methods and results
Sixty patients with moderate or severe secondary MR (72 ± 7 years, 60% ischaemic origin) on guideline-recommended medical therapy were treated and analyzed at 11 European institutions. There were two in-hospital deaths (none device-related), one stroke, two coronary artery complications, and one tamponade. Anchor disengagement, observed in 10 patients (all but one in the first half of the population), resulted in device inefficacy in five patients and led to device modification half way through the study to mitigate this issue. Technical, device, and procedural successes, assessed based on Mitral Valve Academic Research Consortium (MVARC) criteria, were 97% (58/60), 72% (43/60), and 68% (41/60), respectively. At 1-year, overall survival, survival free of readmission for heart failure, and survival free of reintervention (performed in seven patients) were 87%, 66%, and 78%, respectively. In the overall population, MR grade at 12 months was moderate or less 61% and moderate or less in 95% of the 39 patients who underwent a transthoracic echocardiography at 1-year but worsened by at least one grade in 11 patients (22%). Functional status (79% vs. 14% in New York Heart Association Class I/II), quality of life (−19 points on the Minnesota Living with Heart Failure Questionnaire score), and exercise capacity (+58 m by 6MWT) improved significantly (all P < 0.01).
Conclusion
In this multicentre trial, the Cardioband mitral system demonstrated reasonable performance and safety. At 1 year, most patients had moderate or less MR and experienced significant functional improvements. A randomized controlled trial is underway to demonstrate the impact of Cardioband in patients on guideline-directed medical therapy.
Abstract
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