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1.
J Am Coll Cardiol ; 2019 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-31568868

RESUMO

BACKGROUND: Tricuspid Regurgitation (TR) is associated with increased rates of heart failure (HF) and mortality. Transcatheter tricuspid valve interventions (TTVI) are promising, but the clinical benefit is unknown. OBJECTIVES: To investigate the potential benefit of TTVI over medical therapy in a propensity score matched population. METHODS: The TriValve (Transcatheter Tricuspid Valve Therapies) registry collected 472 patients from 22 European and North American centers, who underwent TTVI from 2016 to 2018. A control cohort formed by two large retrospective registries enrolling medically managed patients with ≥moderate TR in Europe and North America (1179 pts) were propensity score 1:1 matched (distance ± 0.2 SD) using age, Euroscore II, and systolic pulmonary artery pressure. Survival was tested with Cox regression analysis. Primary endpoint was 1-year mortality or HF rehospitalization or the composite. RESULTS: After matching, 268 adequately matched pairs of patients were identified. Compared to controls, TTVI patients had lower 1-year mortality (23 ±3% vs 36 ±3%, p=0.001), rehospitalization (26 ±3% vs 47 ±3% p<0.0001), and composite endpoint (32 ±4% vs 49 ±3%; p=0.0003). TTVI was associated with greater survival and freedom from HF rehospitalization (HR 0.60 [0.46-0.79], p=0.003 unadjusted) which remained significant after adjusting for sex, NYHA class, right ventricular dysfunction and atrial fibrillation (HR 0.39 [0.26-0.59], p<0.0001) and after further adjustment for mitral regurgitation and pacemaker/defibrillator (HR 0.35 [0.23.54], p<0.0001). CONCLUSIONS: In this propensity matched case-control study, TTVI is associated with greater survival and reduced HF rehospitalization compared with medical therapy alone. Randomized trials should be performed to confirm these results.

3.
Arch Cardiovasc Dis ; 112(8-9): 512-522, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31474571

RESUMO

BACKGROUND: Despite the worldwide development of transcatheter aortic valve implantation (TAVI) over the last decade, strategies that take patient characteristics into account to guide the choice of transcatheter heart valve have not been evaluated. AIM: To evaluate the immediate results of TAVI using a tailored choice of balloon-expandable or self-expanding transcatheter heart valve, according to each patient's clinical and anatomical characteristics. METHODS: This single-centre observational study included all patients treated with TAVI from 2012 to 2017. The 30-day results were reported according to Valve Academic Research Consortium-2 criteria. A total of 502 patients were included (mean age, 81±9 years; 52% men; mean EuroSCORE II, 7.0±6.5%). Three main variables guided the choice of transcatheter heart valve: the anatomy of the iliofemoral arteries and of the aortic root, and the general condition of the patient. RESULTS: A SAPIEN™ balloon-expandable transcatheter heart valve was used in 275 patients (55%) and a CoreValve™ self-expanding transcatheter heart valve in 227 patients (45%). The approach was transfemoral in 427 patients (85%), and only 29 patients (6%) required transthoracic access. At 30-day follow-up, the rates of adverse events were as follows: mortality, 3.2%; stroke, 3.0%; major bleeding, 5.9%; and major vascular complications, 6.0%. Rates of complications at 30 days were similar in the SAPIEN™ and CoreValve™ groups, except for a higher rate of pacemaker implantation in the latter group (29.5% vs. 14.5%; P<0.001). CONCLUSION: The choice of balloon-expandable or self-expanding transcatheter heart valve tailored to the patient's clinical and anatomical characteristics allows for maximal use of the transfemoral approach, and is associated with low 30-day rates of major complications and mortality.

4.
Eur J Heart Fail ; 2019 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-31476260

RESUMO

AIMS: The MITRA-FR trial showed that among symptomatic patients with severe secondary mitral regurgitation, percutaneous repair did not reduce the risk of death or hospitalization for heart failure at 12 months compared with guideline-directed medical treatment alone. We report the 24-month outcome from this trial. METHODS AND RESULTS: At 37 centers, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm2 or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo percutaneous valve repair plus medical treatment (intervention group, n=152) or medical treatment alone (control group, n=152). The primary efficacy outcome was the composite of all-cause death and unplanned hospitalization for heart failure at 12 months. At 24 months, all-cause death and unplanned hospitalization for heart failure occurred in 63.8% of patients (97/152) in the intervention group and 67.1% (102/152) in the control group (hazard ratio, 1.01; 95% confidence interval [CI], 0.77 to 1.34). All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (hazard ratio, 1.02; 95% CI, 0.70 to 1.50). Unplanned hospitalization for heart failure occurred in 55.9% of patients (85/152) in the intervention group and 61.8% (94/152) in the control group (hazard ratio, 0.97; 95% CI 0.72 to 1.30). CONCLUSIONS: In patients with severe secondary mitral regurgitation, percutaneous repair added to medical treatment did not significantly reduce the risk of death or hospitalization for heart failure at two years compared with medical treatment alone.

5.
Circulation ; 2019 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-31510787

RESUMO

Background: Valvular heart disease (VHD) is an important cause of mortality and morbidity and has been subject to important changes in management. The VHD II survey was designed by the EURObservational Research Programme of the European Society of Cardiology (ESC) to analyze actual management of VHD and compare practice with guidelines. Methods: Patients with severe native VHD or previous valvular intervention were enrolled prospectively across 28 countries over a 3-month period in 2017. Indications for intervention were considered concordant if the intervention was performed or scheduled in symptomatic patients, corresponding to Class I recommendations specified in the 2012 ESC and in the 2014 American Heart Association/American College of Cardiology VHD guidelines. Results: 7247 patients (4483 hospitalized, 2764 out-patients) were included in 222 centers. Median age was 71 years (interquartile range 62-80); 1917 patients (26.5%) were aged ≥80 years and 3416 were female (47.1%). Severe native VHD was present in 5219 patients (72.0%): aortic stenosis (AS) in 2152 patients (41.2% of native VHD), aortic regurgitation (AR) in 279 (5.3%), mitral stenosis (MS) in 234 (4.5%), mitral regurgitation (MR) in 1114 (21.3%, primary in 746 and secondary in 368) multiple left-sided VHD in 1297 (24.9%) and right-sided VHD in 143 (2.7%). 2028 patients (28.0%) had undergone previous valvular intervention. Intervention was performed in 37.0% and scheduled in 26.8% of patients with native VHD. The decision for intervention was concordant with Class I recommendations in symptomatic patients with severe single left-sided native VHD in 79.4% (95% confidence interval [CI] 77.1-81.6%) for AS, 77.6% (95% CI 69.9-84.0%) for AR, 68.5% (95% CI 60.8-75.4%) for MS, and 71.0% (95% CI 66.4-75.3%) for primary MR. Valvular interventions were performed in 2150 patients during the survey; of them, 47.8% of patients with single left-sided native VHD were in New York Heart Association class III or IV. Transcatheter procedures were performed in 38.7% of patients with AS and 16.7% of those with MR. Conclusions: Despite good concordance between Class I recommendations and practice in patients with aortic VHD, the suboptimal figure in mitral VHD and late referral for valvular interventions suggest the need to improve further guideline implementation.

8.
Arch Cardiovasc Dis ; 2019 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-31494081

RESUMO

BACKGROUND: The severity of left ventricular (LV) remodelling is only partially related to the severity of aortic valve stenosis; additional factors, including diabetes, insulin resistance, obesity and metabolic syndrome, may play important roles. Epicardial adipose tissue (EAT), now considered as a metabolically active organ, is also linked to these factors. AIM: To analyse the association between EAT volume measured using computed tomography and LV remodelling in a prospective cohort of patients with aortic stenosis. METHODS: Consecutive asymptomatic patients with at least mild degenerative aortic stenosis enrolled in a prospective cohort that aimed to assess the determinants of aortic stenosis occurrence and progression constituted our population. RESULTS: We enrolled 143 patients (78±5 years; 65% men). Mean LV mass and EAT volume were 219±64g and 134±56mL, respectively. LV hypertrophy was diagnosed in 86 patients (60%), and concentric hypertrophy (32%) was the main remodelling pattern. EAT was associated with body mass index (P<0.001) and body surface area (P<0.001), but not with age (P=0.33) or aortic stenosis severity (all P>0.10). EAT was correlated with LV mass (r=0.41; P<0.0001), and after adjustment for age, sex, body mass index/body surface area, hypertension, waist circumference, low-density lipoprotein cholesterol and aortic stenosis severity, EAT was independently associated with LV mass (P=0.01/P=0.02). Similar results were found when EAT and LV mass index (adjusted for body surface area) were considered instead of absolute values (P=0.04). CONCLUSIONS: In this prospective cohort of patients with aortic stenosis, EAT volume was independently associated with LV mass. Further studies are warranted to elucidate the underlying mechanisms of this link.

9.
Pol Arch Intern Med ; 129(9): 586-591, 2019 09 30.
Artigo em Inglês | MEDLINE | ID: mdl-31389403

RESUMO

INTRODUCTION: A study by the European Society of Cardiology assessing international educational needs has identified educational and organizational barriers preventing the implementation of optimal therapy of atrial fibrillation (AF) across European countries. OBJECTIVES: Our aim was to investigate educational and organizational barriers in the implementation of guideline­recommended AF care that are specific to physicians and health-care system in Poland. PATIENTS AND METHODS: An internet­based survey was conducted to assess education, skills, and confidence in managing patients with AF among European cardiologists, neurologists, and family physicians (FPs) from 6 countries. RESULTS: Out of 571 respondents, the Polish sample included 90 physicians (16%): 44 cardiologists (15%), 21 neurologists (16%), and 25 FPs (18%). Polish physicians generally reported skills and confidence similar to those presented by their foreign colleagues, but there was high uncertainty concerning skills and confidence in the identification and pathophysiological classification of AF. Also, FPs reported low confidence in applying CHA2DS2­VASc and HAS­BLED scores to clinical practice. The need for access to long­term heart rhythm monitoring including implantable loop recorders was highlighted. There was a general dissatisfaction with the cooperation among Polish physicians, which was significantly higher than in other countries. CONCLUSIONS: The number of substantial educational gaps among physicians from Poland and other European countries is low. Nonetheless, educational programs tailored for different specialist groups separately to improve competence are warranted. There is a clear need for improvement of communication among different specialists treating patients with AF in Poland.

10.
J Am Heart Assoc ; 8(13): e012031, 2019 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-31256703

RESUMO

Background Percutaneous mitral commissurotomy ( PMC ) was the first available transcatheter technique for treatment of mitral valve diseases. Experience has led to extending the indications to patients with less favorable characteristics. We aimed to analyze (1) the temporal trends in characteristic and outcomes of patients undergoing PMC in a single center over 30 years and (2) the predictive factors of poor immediate results of PMC . Methods and Results From 1987 to 2016, 1 full year for each decade was analyzed: 1987, 1996, 2006, and 2016. Poor immediate results of PMC were defined as a mitral valve area <1.5 cm2 or MR (mitral regurgitation) grade >2. Mitral anatomy was assessed using the Cormier classification and the fluoroscopic extent of calcification. Six hundred three patients were included: 111, 202, 205, and 85, respectively. Mean age increased >10 years over time ( P<0.0001). Mitral anatomy was less favorable over the years: the presence of calcification increased from 25% of patients at the beginning of PMC to >40% during the past decade ( P<0.0001) with a 3-fold increase in severe mitral calcification. Consistently, the proportion of good immediate results decreased over time ( P<0.05) but remained at 76% in 2016. Multivariate analysis showed 3 predictive factors of poor immediate results: smaller baseline mitral valve area ( P<0.0001), pre- PMC MR grade 2 ( P<0.01), and the presence or amount of calcification ( P<0.001). Conclusions This clinic's patients became significantly older with more frequent and severe calcification in the past decade. Predictive factors of poor immediate results were related to valve anatomy, including calcification. Despite challenges raised by severe calcification, PMC was still successful in >3 out of 4 patients in recent years.

11.
12.
Eur J Heart Fail ; 21(7): 852-861, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31116485

RESUMO

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.

13.
EuroIntervention ; 15(4): e329-e335, 2019 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-30987963

RESUMO

AIMS: Percutaneous mitral valve repair has become an alternative to conventional surgery in patients suffering primary mitral regurgitation (MR) with a contraindication to surgery and could benefit patients at high surgical risk. The aim of the MITRA-HR study is to raise the level of evidence supporting the use of the MitraClip device in primary MR patients with a predefined high risk for surgery. METHODS AND RESULTS: MITRA-HR is a prospective, multicentre, randomised study designed to compare mitral valve repair using the MitraClip with conventional surgery in patients with severe primary mitral regurgitation at high risk for surgery. The surgical risk is defined by age, Society of Thoracic Surgeons (STS) risk estimate score, frailty, major organ system dysfunction, and procedure-specific impediments. The study will enrol 330 patients randomised between conventional surgery and MitraClip with a 1:1 ratio. The composite primary endpoint includes all-cause mortality, unplanned rehospitalisation for cardiovascular reasons, and mitral valve reintervention at 12 months. The main secondary safety endpoint is a major adverse event composite assessment evaluated 30 days after the procedure. CONCLUSIONS: The randomised MITRA-HR study is designed to provide additional supportive evidence of non-inferiority in efficacy and superiority in safety for percutaneous mitral valve repair using the MitraClip compared to conventional surgery in high surgical risk patients.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Valva Mitral , Insuficiência da Valva Mitral/cirurgia , Estudos Prospectivos , Resultado do Tratamento
14.
Eur Heart J ; 2019 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-30907409

RESUMO

AIMS: Reducing maternal mortality is a World Health Organization (WHO) global health goal. Although maternal deaths due to haemorrhage and infection are declining, those related to heart disease are increasing and are now the most important cause in western countries. The aim is to define contemporary diagnosis-specific outcomes in pregnant women with heart disease. METHODS AND RESULTS: From 2007 to 2018, pregnant women with heart disease were prospectively enrolled in the Registry Of Pregnancy And Cardiac disease (ROPAC). Primary outcome was maternal mortality or heart failure, secondary outcomes were other cardiac, obstetric, and foetal complications. We enrolled 5739 pregnancies; the mean age was 29.5. Prevalent diagnoses were congenital (57%) and valvular heart disease (29%). Mortality (overall 0.6%) was highest in the pulmonary arterial hypertension (PAH) group (9%). Heart failure occurred in 11%, arrhythmias in 2%. Delivery was by Caesarean section in 44%. Obstetric and foetal complications occurred in 17% and 21%, respectively. The number of high-risk pregnancies (mWHO Class IV) increased from 0.7% in 2007-2010 to 10.9% in 2015-2018. Determinants for maternal complications were pre-pregnancy heart failure or New York Heart Association >II, systemic ejection fraction <40%, mWHO Class 4, and anticoagulants use. After an increase from 2007 to 2009, complication rates fell from 13.2% in 2010 to 9.3% in 2017. CONCLUSION: Rates of maternal mortality or heart failure were high in women with heart disease. However, from 2010, these rates declined despite the inclusion of more high-risk pregnancies. Highest complication rates occurred in women with PAH.

15.
16.
Eur Heart J ; 40(5): 422-440, 2019 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-30608523

RESUMO

Transcatheter heart valve interventions have transformed the outcomes of patients with valvular heart disease (VHD) who are unfavourable candidates for surgery. Technological advances have allowed extension of these interventions to younger or lower risk patients and those with other forms of VHD and may in the future permit earlier treatment of VHD in less symptomatic patients or those with moderate disease. The balance of risks and benefits is likely to differ between lower and higher risk patients, and more evidence is needed to evaluate the net benefit of transcatheter technology in these groups. As academic researchers, clinicians, industry, and patient stakeholders collaborate to research these broader indications for transcatheter valve interventions, it is essential to address (i) device durability and deliverability, (ii) specific anatomical needs (e.g. bicuspid aortic valves, aortic regurgitation, mitral and tricuspid valve disease), (iii) operator training, and (iv) the reinforced importance of the multidisciplinary Heart Team.

17.
JACC Cardiovasc Interv ; 12(2): 155-165, 2019 01 28.
Artigo em Inglês | MEDLINE | ID: mdl-30594510

RESUMO

OBJECTIVES: A large, prospective international registry was developed to evaluate the initial clinical applications of transcatheter tricuspid valve intervention (TTVI) with different devices. BACKGROUND: TTVI for native tricuspid valve dysfunction has been emerging during the last few years as an alternative therapeutic option to serve a large high-risk population of patients with severe symptomatic tricuspid regurgitation (TR). METHODS: The TriValve Registry included 312 high-risk patients with severe TR (76.4 ± 8.5 years of age; 57% female; EuroSCORE II 9 ± 8%) at 18 centers. Interventions included repair at the level of the leaflets (MitraClip, Abbott Vascular, Santa Clara, California; PASCAL Edwards Lifesciences, Irvine, California), annulus (Cardioband, Edwards Lifesciences; TriCinch, 4tech, Galway, Ireland; Trialign, Mitraling, Tewksbury, Massachusetts), or coaptation (FORMA, Edwards Lifesciences) and replacement (Caval Implants, NaviGate, NaviGate Cardiac Structures, Lake Forest, California). Clinical outcomes were prospectively determined during mid-term follow-up. RESULTS: A total of 108 patients (34.6%) had prior left heart valve intervention (84 surgical and 24 transcatheter, respectively). TR etiology was functional in 93%, and mean annular diameter was 46.9 ± 9 mm. In 75% of patients the regurgitant jet was central (vena contracta 1.1 ± 0.5; effective regurgitant orifice area 0.78 ± 0.6 cm2). Pre-procedural systolic pulmonary artery pressure was 41 ± 14.8 mm Hg. Implanted devices included: MitraClip in 210 cases, Trialign in 18 cases, TriCinch first generation in 14 cases, caval valve implantation in 30 cases, FORMA in 24 cases, Cardioband in 13 cases, NaviGate in 6 cases, and PASCAL in 1. In 64% of the cases, TTVI was performed as a stand-alone procedure. Procedural success (defined as the device successfully implanted and residual TR ≤2+) was 72.8%. Greater coaptation depth (odds ratio: 24.1; p = 0.002) was an independent predictor of reduced device success. Thirty-day mortality was 3.6% and was significantly lower among patients with procedural success (1.9% vs. 6.9%; p = 0.04); Actuarial survival at 1.5 years was 82.8 ± 4% and was significantly higher among patients who had procedural success achieved. CONCLUSIONS: TTVI is feasible with different technologies, has a reasonable overall procedural success rate, and is associated with low mortality and significant clinical improvement. Mid-term survival is favorable in this high-risk population. Greater coaptation depth is associated with reduced procedural success, which is an independent predictor of mortality.

18.
Eur Heart J ; 2018 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-30226525

RESUMO

Aims: The provision of high-quality education allows the European Society of Cardiology (ESC) to achieve its mission of better cardiovascular practice and provides an essential component of translating new evidence to improve outcomes. Methods and results: The 4th ESC Education Conference, held in Sophia Antipolis (December 2016), brought together ESC education leaders, National Directors of Training of 43 ESC countries, and representatives of the ESC Young Community. Integrating national descriptions of education and cardiology training, we discussed innovative pathways to further improve knowledge and skills across different training programmes and health care systems. We developed an ESC roadmap supporting better cardiology training and continued medical education (CME), noting: (i) The ESC provides an excellent framework for unbiased and up-to-date cardiovascular education in close cooperation with its National Societies. (ii) The ESC should support the harmonization of cardiology training, curriculum development, and professional dialogue and mentorship. (iii) ESC congresses are an essential forum to learn and discuss the latest developments in cardiovascular medicine. (iv) The ESC should create a unified, interactive educational platform for cardiology training and continued cardiovascular education combining Webinars, eLearning Courses, Clinical Cases, and other educational programmes, along with ESC Congress content, Practice Guidelines and the next ESC Textbook of Cardiovascular Medicine. (v) ESC-delivered online education should be integrated into National and regional cardiology training and CME programmes. Conclusion: These recommendations support the ESC to deliver excellent and comprehensive cardiovascular education for the next generation of specialists. Teamwork between international, national and local partners is essential to achieve this objective.

19.
N Engl J Med ; 2018 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-30145927

RESUMO

Background 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. Methods We randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of >20 mm2 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. Results 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). Conclusions 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 .).

20.
Eur Heart J ; 2018 Aug 16.
Artigo em Inglês | MEDLINE | ID: mdl-30124798

RESUMO

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.

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