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2.
ESC Heart Fail ; 2020 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-32909680

RESUMO

AIMS: Heart failure (HF) and type 2 diabetes (T2D), common co-morbidities, translate into worse patient prognoses and higher direct costs than for either condition alone. Empagliflozin has been shown to markedly reduce cardiovascular (CV) deaths and HF hospitalizations (HHF) in HF patients with T2D. This study evaluated the lifetime cost-effectiveness of supplementing standard of care (SoC) with empagliflozin, relative to SoC alone, in HF patients with T2D from the UK payer perspective. METHODS AND RESULTS: An existing discrete-event simulation model was adapted for the economic evaluation. Risk equations developed from time-dependent parametric survival analyses using patient-level HF subpopulation data from the EMPA-REG OUTCOME trial were employed to predict CV and renal events. Non-CV death, utility weights, and costs were drawn from UK sources. Quality-adjusted life years (QALYs) and costs were discounted at 3.5% per annum. Relative to SoC, empagliflozin with SoC yielded fewer first HHF, recurrent HHF, CV death, and non-fatal myocardial infarction but more non-fatal stroke events. Empagliflozin with SoC vs. SoC alone was associated with increased average life expectancy (10.80 vs. 9.59 LYs) and quality of life (6.27 vs. 5.62 QALYs), though at higher lifetime cost (£18 197 vs. £16 829) per person, resulting in an incremental cost-effectiveness ratio of £2093 per QALY. The probability of empagliflozin being cost-effective in the HF subpopulation at a £20 000 per QALY willingness-to-pay threshold was 91%. CONCLUSIONS: This analysis suggests that adding empagliflozin to SoC in HF patients with T2D constitutes a cost-effective use of UK healthcare resources and may provide long-term health benefits to patients.

3.
Cardiovasc Res ; 2020 Sep 22.
Artigo em Inglês | MEDLINE | ID: mdl-32960964

RESUMO

Many biomarkers that could be used to assess ejection fraction, heart failure, or myocardial infarction fail to translate into clinical practice because they lack essential performance characteristics or fail to meet regulatory standards for approval. Despite their potential, new technologies have added to the complexities of successful translation into clinical practice. Biomarker discovery and implementation requires a standardised approach that includes: identification of a clinical need; identification of a valid surrogate biomarker; stepwise assay refinement, demonstration of superiority over current standard-of-care; development and understanding of a clinical pathway; and demonstration of real-world performance. Successful biomarkers should improve efficacy or safety of treatment, while being practical at a realistic cost. Everyone involved in cardiovascular healthcare, including researchers, clinicians, and industry partners, are important stakeholders in facilitating the development and implementation of biomarkers. This paper provides suggestions for a development pathway for new biomarkers, discusses regulatory issues and challenges, and suggestions for accelerating the pathway to improve patient outcomes. Real life examples of successful biomarkers-high sensitivity cardiac troponin (hs-cTn), T2* cardiovascular magnetic resonance (CMR) imaging, and echocardiography-are used to illustrate the value of a standardised development pathway in the translation of concepts into routine clinical practice.

4.
Curr Cardiol Rep ; 22(10): 113, 2020 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-32770393

RESUMO

PURPOSE OF REVIEW: Device-related thrombus (DRT) formation and incomplete left atrial appendage closure (LAAC) are the two major complications that can occur after LAAC and can potentially limit the success of such a procedure. This review discusses the incidence, clinical and/or prognostic significance, detection methods, treatment options, and potential strategies to prevent these complications. RECENT FINDINGS: It has recently been proven that the presence of a DRT represents an independent predictor for ischemic stroke after LAAC. Continued need for anticoagulation due to incomplete LAAC is clinically relevant to the patient. The appearances of a DRT or an incompletely closed LAA after a LAAC procedure are not rare complications. Due to the clinical and/or prognostic significance of these complications, it is important to detect them in a timely manner during follow-up by using the appropriate diagnostic imaging techniques. Since a DRT is associated with an increased risk of stroke, the therapy should be aggressive. In the case of incomplete LAA closure, an additional closure device may be used to complete occlusion and avoid lifelong anticoagulation therapy.

5.
Eur Heart J ; 41(34): 3255-3268, 2020 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-32484517

RESUMO

AIMS: Takotsubo syndrome (TTS) is an acute heart failure syndrome, which shares many features with acute coronary syndrome (ACS). Although TTS was initially described with angiographically normal coronary arteries, smaller studies recently indicated a potential coexistence of coronary artery disease (CAD) in TTS patients. This study aimed to determine the coexistence, features, and prognostic role of CAD in a large cohort of patients with TTS. METHODS AND RESULTS: Coronary anatomy and CAD were studied in patients diagnosed with TTS. Inclusion criteria were compliance with the International Takotsubo Diagnostic Criteria for TTS, and availability of original coronary angiographies with ventriculography performed during the acute phase. Exclusion criteria were missing views, poor quality of angiography loops, and angiography without ventriculography. A total of 1016 TTS patients were studied. Of those, 23.0% had obstructive CAD, 41.2% had non-obstructive CAD, and 35.7% had angiographically normal coronary arteries. A total of 47 patients (4.6%) underwent percutaneous coronary intervention, and 3 patients had acute and 8 had chronic coronary artery occlusion concomitant with TTS, respectively. The presence of CAD was associated with increased incidence of shock, ventilation, and death from any cause. After adjusting for confounders, the presence of obstructive CAD was associated with mortality at 30 days. Takotsubo syndrome patients with obstructive CAD were at comparable risk for shock and death and nearly at twice the risk for ventilation compared to an age- and sex-matched ACS cohort. CONCLUSIONS: Coronary artery disease frequently coexists in TTS patients, presents with the whole spectrum of coronary pathology including acute coronary occlusion, and is associated with adverse outcome. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT01947621.

6.
EuroIntervention ; 2020 May 26.
Artigo em Inglês | MEDLINE | ID: mdl-32451320

RESUMO

AIMS: Several left atrial appendage (LAA) closure systems are available and due to differences in device design results of specific occluders derived from trials cannot be simply generalized to all devices. The present analysis sought to assess two contemporary LAA closure devices in clinical practice. METHODS AND RESULTS: The work represents a non-randomized sub-analysis of the prospective, multicenter, Left-Atrium-Appendage Occluder Register - GErmany (LAARGE) registry. The WATCHMAN (group 1) and the Amplatzer Cardiac Plug (ACP) or Amulet occluder (group 2) were assessed. A total of 641 patients at 38 centers were enrolled. Of them, 278 (43%) and 340 (53%) patients received the WATCHMAN and ACP/Amulet occluder, respectively. High technical success was achieved with a slight difference between the groups (96% in group 1 vs. 99% in group 2; p=0.007). Procedural safety did not differ (98% in group 1 vs. 97% in group 2; p=0.55). The Kaplan Meier estimated 1-year composite of death or stroke was 12.0% and 12.9%, respectively (p=0.79). CONCLUSIONS: Both the WATCHMAN and the ACP/Amulet occluder provide excellent procedural results with comparable implantation success and no differences with respect to procedural safety and long-term effectiveness.

7.
J Am Coll Cardiol ; 75(16): 1869-1877, 2020 Apr 28.
Artigo em Inglês | MEDLINE | ID: mdl-32327096

RESUMO

BACKGROUND: Takotsubo syndrome (TTS) occurs predominantly in post-menopausal women but is also found in younger patients. OBJECTIVES: This study aimed to investigate age-related differences in TTS. METHODS: Patients diagnosed with TTS and enrolled in the International Takotsubo Registry between January 2011 and February 2017 were included in this analysis and were stratified by age (younger: ≤50 years, middle-age: 51 to 74 years, elderly: ≥75 years). Baseline characteristics, hospital course, as well as short- and long-term mortality were compared among groups. RESULTS: Of 2,098 TTS patients, 242 (11.5%) patients were ≤50 years of age, 1,194 (56.9%) were 51 to 74 years of age, and 662 (31.6%) were ≥75 years of age. Younger patients were more often men (12.4% vs. 10.9% vs. 6.3%; p = 0.002) and had an increased prevalence of acute neurological (16.3% vs. 8.4% vs. 8.8%; p = 0.001) or psychiatric disorders (14.1% vs. 10.3% vs. 5.6%; p < 0.001) compared with middle-aged and elderly TTS patients. Furthermore, younger patients had more often cardiogenic shock (15.3% vs. 9.1% vs. 8.1%; p = 0.004) and had a numerically higher in-hospital mortality (6.6% vs. 3.6% vs. 5.1%; p = 0.07). At multivariable analysis, younger (odds ratio: 1.60; 95% confidence interval: 0.86 to 3.01; p = 0.14) and older age (odds ratio: 1.09; 95% confidence interval: 0.66 to 1.80; p = 0.75) were not independently associated with in-hospital mortality using the middle-aged group as a reference. There were no differences in 60-day mortality rates among groups. CONCLUSIONS: A substantial proportion of TTS patients are younger than 50 years of age. TTS is associated with severe complications requiring intensive care, particularly in younger patients.

8.
Am Heart J ; 222: 73-82, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32018204

RESUMO

BACKGROUND: Underweight and obesity represent classical risk factors for adverse outcome in patients treated for cardiovascular disease. AIMS: The current analysis examines the impact of underweight, overweight and obesity on intra-hospital, short and long-term outcomes in patients treated by MitraClip therapy. METHODS AND RESULTS: From August 2010 until July 2013, 799 patients (age 75.3 ±â€¯8.6 years, male gender 60.7%, median logistic EuroSCORE 20% [12; 31], functional mitral regurgitation (MR): 69.3%) were prospectively enrolled into the multicenter German Transcatheter Mitral Valve Interventions registry. Patients were stratified according to body mass index (BMI) into 4 groups: BMI <20 kg/m2 (underweight), BMI 20.0 to <25.0 kg/m2 (normal weight, reference group), BMI 25.0 to <30.0 kg/m2 (overweight) and BMI ≥30 kg/m2 (obese). Significant increased rates of procedural failure, transfusion/bleeding, sepsis or multiorgan failure and low cardiac output failure were found for underweight patients only. Kaplan-Meier survival curves demonstrated inferior survival for underweight patients, but comparable outcomes for all other patients (global log rank test, P < .01). Multivariable Cox-regression analysis (adjusted for age, gender, creatinine ≥1.5 mg/dL, diabetes, left ventricular ejection fraction <30% and chronic obstructive pulmonary disease) confirmed underweight (as compared to normal weight) as an independent risk factor of death (hazard ratio [HR]: 1.58, 95% confidence interval (CI): 1.01-2.46, P = .044) and overweight as protective against death (HR: 0.71; 95%-CI: 0.55-0.93; P = .011). CONCLUSIONS: Compared to other weight groups, underweight patients undergoing MitraClip implantation are exposed to increased rates of procedural failure, bleeding and low cardiac output as well as increased short- and long-term mortality rates and should therefore be carefully discussed in the heart-team.


Assuntos
Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral/cirurgia , Complicações Pós-Operatórias/epidemiologia , Sistema de Registros , Magreza/complicações , Ecocardiografia , Seguimentos , Alemanha/epidemiologia , Mortalidade Hospitalar/tendências , Incidência , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/complicações , Insuficiência da Valva Mitral/diagnóstico , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento
9.
Arterioscler Thromb Vasc Biol ; 40(1): 279-287, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31766870

RESUMO

OBJECTIVE: Takotsubo syndrome (TTS) is characterized by acute left ventricular dysfunction, which can contribute to intraventricular thrombus and embolism. Still, prevalence and clinical impact of thrombus formation and embolic events on outcome of TTS patients remain unclear. This study aimed to investigate clinical features and outcomes of patients with and without intraventricular thrombus or embolism. Additionally, factors associated with thrombus formation or embolism, as well as predictors for mortality, were identified. Approach and Results: TTS patients enrolled in the International Takotsubo Registry at 28 centers in Australia, Europe, and the United States were dichotomized according to the occurrence/absence of intraventricular thrombus or embolism. Patients with intraventricular thrombus or embolism were defined as the ThrombEmb group. Of 1676 TTS patients, 56 (3.3%) patients developed intraventricular thrombus and/or embolism following TTS diagnosis (median time interval, 2.0 days [range, 0-38 days]). Patients in the ThrombEmb group had a different clinical profile including lower left ventricular ejection fraction, higher prevalence of the apical type, elevated levels of troponin and inflammatory markers, and higher prevalence of vascular disease. In a Firth bias-reduced penalized-likelihood logistic regression model apical type, left ventricular ejection fraction ≤30%, previous vascular disease, and a white blood cell count on admission >10×103 cells/µL emerged as independent predictors for thrombus formation or embolism. CONCLUSIONS: Intraventricular thrombus or embolism occur in 3.3% of patients in the acute phase of TTS. A simple risk score including clinical parameters associated with intraventricular thrombus formation or embolism identifies patients at increased risk. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01947621.


Assuntos
Embolia/etiologia , Sistema de Registros , Medição de Risco/métodos , Cardiomiopatia de Takotsubo/complicações , Trombose/etiologia , Idoso , Austrália/epidemiologia , Angiografia Coronária , Eletrocardiografia , Embolia/diagnóstico , Embolia/epidemiologia , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Cardiopatias/diagnóstico , Cardiopatias/epidemiologia , Cardiopatias/etiologia , Ventrículos do Coração , Humanos , Incidência , Imagem Cinética por Ressonância Magnética , Masculino , Ventriculografia com Radionuclídeos , Fatores de Risco , Taxa de Sobrevida/tendências , Cardiomiopatia de Takotsubo/diagnóstico , Trombose/diagnóstico , Trombose/epidemiologia , Fatores de Tempo , Estados Unidos/epidemiologia
10.
Eur J Heart Fail ; 22(2): 330-337, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31863563

RESUMO

AIMS: The aim of the present study was to investigate the impact of aspirin on prognosis in takotsubo syndrome (TTS). METHODS AND RESULTS: Patients from the International Takotsubo (InterTAK) Registry were categorized into two groups based on aspirin prescription at discharge. A comparison of clinical outcomes between groups was performed using an adjusted analysis with propensity score (PS) stratification; results from the unadjusted analysis were also reported to note the effect of the PS adjustment. Major adverse cardiac and cerebrovascular events (MACCE: a composite of death, myocardial infarction, TTS recurrence, stroke or transient ischaemic attack) were assessed at 30-day and 5-year follow-up. A total of 1533 TTS patients with known status regarding aspirin prescription at discharge were included. According to the adjusted analysis based on PS stratification, aspirin was not associated with a lower hazard of MACCE at 30-day [hazard ratio (HR) 1.24, 95% confidence interval (CI) 0.50-3.04, P = 0.64] or 5-year follow-up (HR 1.11, 95% CI 0.78-1.58, P = 0.58). These results were confirmed by sensitivity analyses performed with alternative PS-based methods, i.e. covariate adjustment and inverse probability of treatment weighting. CONCLUSION: In the present study, no association was found between aspirin use in TTS patients and a reduced risk of MACCE at 30-day and 5-year follow-up. These findings should be confirmed in adequately powered randomized controlled trials. ClinicalTrials.gov Identifier: NCT01947621.

11.
J Am Heart Assoc ; 8(21): e011194, 2019 11 05.
Artigo em Inglês | MEDLINE | ID: mdl-31672100

RESUMO

Background Left ventricular (LV) recovery in takotsubo syndrome (TTS) occurs over a wide-ranging interval, varying from hours to weeks. We sought to investigate the clinical predictors and prognostic impact of recovery time for TTS patients. Methods and Results TTS patients from the International Takotsubo Registry were included in this study. Cut-off for early LV recovery was determined to be 10 days after the acute event. Multivariable logistic regression was used to assess factors associated with the absence of early recovery. In-hospital outcomes and 1-year mortality were compared for patients with versus without early recovery. We analyzed 406 patients with comprehensive and serial imaging data regarding time to recovery. Of these, 191 (47.0%) had early LV recovery and 215 (53.0%) demonstrated late LV improvement. Patients without early recovery were more often male (12.6% versus 5.2%; P=0.011) and presented more frequently with typical TTS (76.3% versus 67.0%, P=0.040). Cardiac and inflammatory markers were higher in patients without early recovery than in those with early recovery. Patients without early recovery showed unfavorable 1-year outcome compared with patients with early recovery (P=0.003). On multiple logistic regression, male sex, LV ejection fraction <45%, and acute neurologic disorders were associated with the absence of early recovery. Conclusions TTS patients without early LV recovery have different clinical characteristics and less favorable 1-year outcome compared with patients with early recovery. The factors associated with the absence of early recovery included male sex, reduced LV ejection fraction, and acute neurologic events. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01947621.

13.
Curr Cardiol Rep ; 21(8): 85, 2019 07 22.
Artigo em Inglês | MEDLINE | ID: mdl-31332552

RESUMO

PURPOSE OF REVIEW: In this review, we provide a comprehensive approach to assess degenerative mitral regurgitation. RECENT FINDINGS: In the evaluation of MR, it is important to differentiate between primary (degenerative/organic) MR in which an intrinsic mitral valve lesion(s) is responsible for the occurrence of MR and secondary (functional) MR where the mitral valve is structurally normal, but alterations of the left ventricular geometry cause deterioration of the MV apparatus. Advanced imaging modalities, foremost two-dimensional and three-dimensional echocardiography, are essential for this determination. In the evaluation of degenerative MR, the exact mechanism, the extent of the disease, associated valve lesions, the grade of mitral regurgitation severity, and hemodynamic consequences require careful assessment in order to provide patients with appropriate monitoring and treatment.


Assuntos
Ecocardiografia Tridimensional , Insuficiência da Valva Mitral/diagnóstico por imagem , Valva Mitral/diagnóstico por imagem , Exame Físico/métodos , Humanos , Prolapso da Valva Mitral
14.
J Am Heart Assoc ; 8(15): e010881, 2019 08 06.
Artigo em Inglês | MEDLINE | ID: mdl-31311438

RESUMO

Background Clinical characteristics and outcomes of takotsubo syndrome (TTS) patients with malignancy have not been fully elucidated. This study sought to explore differences in clinical characteristics and to investigate short- and long-term outcomes in TTS patients with or without malignancy. Methods and Results TTS patients were enrolled from the International Takotsubo Registry. The TTS cohort was divided into patients with and without malignancy to investigate differences in clinical characteristics and to assess short- and long-term mortality. A subanalysis was performed comparing long-term mortality between a subset of TTS patients with or without malignancy and acute coronary syndrome (ACS) patients with or without malignancy. Malignancy was observed in 16.6% of 1604 TTS patients. Patients with malignancy were older and more likely to have physical triggers, but less likely to have emotional triggers compared with those without malignancy. Long-term mortality was higher in patients with malignancy (P<0.001), while short-term outcome was comparable (P=0.17). In a subanalysis, long-term mortality was comparable between TTS patients with malignancies and ACS patients with malignancies (P=0.13). Malignancy emerged as an independent predictor of long-term mortality. Conclusions A substantial number of TTS patients show an association with malignancy. History of malignancy might increase the risk for TTS, and therefore, appropriate screening for malignancy should be considered in these patients. Clinical Trial Registration URL: http://www.clinicaltrial.gov. Unique identifier: NCT01947621.

15.
Eur Heart J ; 40(26): 2142-2151, 2019 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-31098611

RESUMO

AIMS: We aimed to evaluate the frequency, clinical features, and prognostic implications of cardiac arrest (CA) in takotsubo syndrome (TTS). METHODS AND RESULTS: We reviewed the records of patients with CA and known heart rhythm from the International Takotsubo Registry. The main outcomes were 60-day and 5-year mortality. In addition, predictors of mortality and predictors of CA during the acute TTS phase were assessed. Of 2098 patients, 103 patients with CA and known heart rhythm during CA were included. Compared with patients without CA, CA patients were more likely to be younger, male, and have apical TTS, atrial fibrillation (AF), neurologic comorbidities, physical triggers, and longer corrected QT-interval and lower left ventricular ejection fraction on admission. In all, 57.1% of patients with CA at admission had ventricular fibrillation/tachycardia, while 73.7% of patients with CA in the acute phase had asystole/pulseless electrical activity. Patients with CA showed higher 60-day (40.3% vs. 4.0%, P < 0.001) and 5-year mortality (68.9% vs. 16.7%, P < 0.001) than patients without CA. T-wave inversion and intracranial haemorrhage were independently associated with higher 60-day mortality after CA, whereas female gender was associated with lower 60-day mortality. In the acute phase, CA occurred less frequently in females and more frequently in patients with AF, ST-segment elevation, and higher C-reactive protein on admission. CONCLUSIONS: Cardiac arrest is relatively frequent in TTS and is associated with higher short- and long-term mortality. Clinical and electrocardiographic parameters independently predicted mortality after CA.

17.
Circulation ; 139(3): 413-415, 2019 01 15.
Artigo em Inglês | MEDLINE | ID: mdl-30586690
18.
J Am Coll Cardiol ; 72(8): 874-882, 2018 08 21.
Artigo em Inglês | MEDLINE | ID: mdl-30115226

RESUMO

BACKGROUND: Prognosis of Takotsubo syndrome (TTS) remains controversial due to scarcity of available data. Additionally, the effect of the triggering factors remains elusive. OBJECTIVES: This study compared prognosis between TTS and acute coronary syndrome (ACS) patients and investigated short- and long-term outcomes in TTS based on different triggers. METHODS: Patients with TTS were enrolled from the International Takotsubo Registry. Long-term mortality of patients with TTS was compared to an age- and sex-matched cohort of patients with ACS. In addition, short- and long-term outcomes were compared between different groups according to triggering conditions. RESULTS: Overall, TTS patients had a comparable long-term mortality risk with ACS patients. Of 1,613 TTS patients, an emotional trigger was detected in 485 patients (30%). Of 630 patients (39%) related to physical triggers, 98 patients (6%) had acute neurologic disorders, while in the other 532 patients (33%), physical activities, medical conditions, or procedures were the triggering conditions. The remaining 498 patients (31%) had no identifiable trigger. TTS patients related to physical stress showed higher mortality rates than ACS patients during long-term follow-up, whereas patients related to emotional stress had better outcomes compared with ACS patients. CONCLUSIONS: Overall, TTS patients had long-term outcomes comparable to age- and sex-matched ACS patients. Also, we demonstrated that TTS can either be benign or a life-threating condition depending on the inciting stress factor. We propose a new classification based on triggers, which can serve as a clinical tool to predict short- and long-term outcomes of TTS. (International Takotsubo Registry [InterTAK Registry]; NCT01947621).


Assuntos
Sistema de Registros , Cardiomiopatia de Takotsubo/diagnóstico , Cardiomiopatia de Takotsubo/mortalidade , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Eletroencefalografia/mortalidade , Eletroencefalografia/tendências , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Mortalidade/tendências , Doenças do Sistema Nervoso/diagnóstico , Doenças do Sistema Nervoso/fisiopatologia , Prognóstico , Estresse Psicológico/diagnóstico , Estresse Psicológico/mortalidade , Estresse Psicológico/fisiopatologia , Cardiomiopatia de Takotsubo/fisiopatologia , Cardiomiopatia de Takotsubo/psicologia , Fatores de Tempo
19.
Eur J Heart Fail ; 20(3): 598-608, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-28834079

RESUMO

AIMS: The aim of the present study was to assess the safety and efficacy of percutaneous mitral valve repair using the MitraClip™ device in patients with severely reduced systolic left ventricular (LV) function. METHODS AND RESULTS: Among 777 MitraClip™ implantations included in the German mitral valve registry, we identified 256 patients suffering from severely reduced LV function [ejection fraction (EF) <30%] in whom successful percutaneous mitral valve repair was performed. Procedural safety, efficacy, and 1-year outcome was compared with 241 patients with preserved LV function (EF >50%) and 280 patients presenting with an EF 30-50% prior to MitraClip™ therapy. High procedural success rates, low periprocedural complication rates, and low residual mitral regurgitation grades at discharge were achieved throughout all groups. In-hospital mortality was low and comparable in all groups. After 1 year, mortality rates were 24.2% (EF <30%), 17.3% (EF 30-50%), and 18.9% (EF >50%). Major adverse cardiac or cardiovascular event rates were 29.7% (EF <30%), 24.4% (EF 30-50%), and 23.5% (EF >50%). Procedural failure was the main predictor for mortality in EF <30% patients (hazard ratio 10.38; 95% CI 3.71-29.02). Improved clinical symptoms were observed in the majority of patients in all groups. Thus, 69.5% of EF <30% patients improved by one or more New York Heart Association functional class. Compared with patients with preserved LV function, this is a significantly larger proportion (EF >50%: 56.8%; P < 0.05). Moreover, quality of life, being very poor at baseline, improved distinctively in severe heart failure patients. CONCLUSION: In patients with severely reduced systolic LV function undergoing MitraClip™ therapy, procedural safety, efficacy, and clinical improvement after 1 year are comparable to patients with preserved LV function.


Assuntos
Cateterismo Cardíaco/métodos , Insuficiência Cardíaca/complicações , Implante de Prótese de Valva Cardíaca/métodos , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Sistema de Registros , Volume Sistólico/fisiologia , Idoso , Idoso de 80 Anos ou mais , Ecocardiografia , Feminino , Seguimentos , Alemanha/epidemiologia , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Mortalidade Hospitalar , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/complicações , Insuficiência da Valva Mitral/fisiopatologia , Qualidade de Vida , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento , Função Ventricular Esquerda
20.
Clin Res Cardiol ; 107(3): 241-248, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29209786

RESUMO

AIMS: The 6-min walk test (6 MWT) has been established as an important tool for functional assessment in heart failure patients. However, its prognostic impact on the outcome in subjects with mitral regurgitation undergoing transcatheter mitral valve repair is unknown. METHODS: This present work represents a sub-analysis of the German, prospective, multicenter, Transcatheter Mitral Valve Interventions (TRAMI) registry. Of the main study cohort (n = 828) 326 patients underwent 6 MWT prior to the procedure. Patients were assigned to two groups depending on the preprocedural 6 MWT distance using the median (< 200 m [group 1] vs. ≥ 200 m [group 2]). RESULTS: No differences regarding procedural success (97 vs. 96%; p = 0.71) and 30-day mortality (3 vs. 4%; p = 0.96) were observed between the groups. With regards to 1-year outcome, patients with a walking distance < 200 m had higher all-cause mortality (26 vs. 14%; p = 0.013) as compared to those with a 6 MWT distance 200 m. After adjustment of baseline risk factors, 6 MWT distance < 200 m still showed a strong trend towards increased 1-year all-cause mortality (HR 1.63, 95% confidence interval 0.96-2.76; p = 0.071). CONCLUSIONS: In the present study preprocedural 6 MWT distance < 200 m showed a strong trend towards increased 1-year mortality in patients undergoing MitraClip implantation.


Assuntos
Cateterismo Cardíaco/métodos , Teste de Esforço/métodos , Tolerância ao Exercício/fisiologia , Implante de Prótese de Valva Cardíaca/métodos , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Idoso , Idoso de 80 Anos ou mais , Causas de Morte/tendências , Feminino , Seguimentos , Alemanha/epidemiologia , Mortalidade Hospitalar/tendências , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/fisiopatologia , Período Pré-Operatório , Estudos Prospectivos , Taxa de Sobrevida/tendências , Fatores de Tempo
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