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1.
Int Heart J ; 62(1): 104-111, 2021 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-33455986

RESUMO

There is scant information about the incidence, risk factors, and outcomes of coronary obstruction (CO) following valve-in-valve transcatheter aortic valve replacement (VIV-TAVR). A meta-analysis of the published studies from January 2000 to April 2020 was conducted, and the endpoint was CO. A total of 2858 patients were enrolled in this study. The mean age was 77.7 ± 9.8, and 39.9% of them were female. The Society of Thoracic Surgeons (STS) score, European System for Cardiac Operative Risk Evaluation (EuroSCORE), and Logistic EuroSCORE were 8.9 ± 7.8, 16.0 ± 10.9, and 26.3 ± 16.3, respectively. The overall incidence of CO was 2.58%. CO incidence between patients with prior stented and stentless valves were significantly different (1.67% versus 7.17%), with an odds ratio (OR) of 0.25 and a 95% confidence interval (CI) of 0.14-0.44 (P < 0.00001). The first-generation valves were significantly associated with higher CO incidence compared with the second-generation valves (7.09% versus 2.03%; OR, 2.44; 95%CI, 1.06-5.62; P = 0.04), while no statistical difference was found between self-expandable valves and balloon-expandable valves (2.45% versus 2.60%; OR, 0.99; 95%CI, 0.55-1.79; P = 0.98). Virtual transcatheter to coronary ostia (VTC) distance (3.3 ± 2.1 mm, n = 29 versus 5.8 ± 2.4 mm, n = 169; mean difference, -2.70; 95%CI, -3.46 to -1.95; P < 0.00001) and the sinus of Valsalva (SOV) diameter (27.5 ± 3.8 mm, n = 23 versus 32.3 ± 4.0 mm, n = 101; mean difference, -3.80; 95%CI, -6.55 to -1.05; P = 0.007) were enormously shorter in patients with CO. The 24-hour, in-hospital, and 30-day mortality of patients with CO were 10.5%, 30.8%, and 37.1%, respectively. In conclusion, device selections, VTC distances, and SOV diameters may be important factors in assessing the CO risk in VIV-TAVR.


Assuntos
Estenose da Valva Aórtica/cirurgia , Oclusão Coronária/epidemiologia , Oclusão Coronária/cirurgia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Bioprótese/efeitos adversos , Ponte de Artéria Coronária/métodos , Ponte de Artéria Coronária/estatística & dados numéricos , Oclusão Coronária/mortalidade , Feminino , Próteses Valvulares Cardíacas/tendências , Mortalidade Hospitalar , Humanos , Incidência , Masculino , Intervenção Coronária Percutânea/métodos , Intervenção Coronária Percutânea/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Desenho de Prótese , Fatores de Risco , Seio Aórtico/diagnóstico por imagem , Stents , Tomografia Computadorizada por Raios X/métodos , Substituição da Valva Aórtica Transcateter/instrumentação
2.
Am J Cardiol ; 144: 118-124, 2021 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-33383007

RESUMO

Patients with symptomatic aortic stenosis are often treated with a surgical valve replacement. Surgical bioprosthetic valves degenerate over time and therefore may necessitate a redo surgery. This analysis reports the 2-year clinical outcomes of the Valve-in-Valve study, which evaluated transcatheter aortic valve implantation using the CoreValve and Evolut R devices in patients with degenerated surgical aortic bioprostheses at high risk for surgery. The prospective Valve-in-Valve study enrolled 202 eligible patients with failing surgical aortic bioprostheses due to stenosis, regurgitation, or a combination of both. The Evolut R bioprosthesis was used in 90.5% of valve-in-valve transcatheter aortic valve implantation cases. Two-year all-cause and cardiovascular mortality rates were 16.5% and 11.1%, respectively. Other clinical events included stroke (7.9%), disabling stroke (1.7%), and new pacemaker implantation (10.1%). The 2-year all-cause mortality rate was significantly higher in patients with discharge mean gradients ≥20 mmHg vs. those with lower mean gradients (21.0% vs 7.6%, p = 0.025). Discharge mean gradients ≥20 mm Hg were associated with smaller surgical bioprostheses (OR, 7.2 [95% CI 2.3 to 22.1]. In patients with failing surgical aortic bioprostheses, valve-in-valve treatment using a supra-annular self-expanding bioprosthesis provides significant functional improvements with acceptable rates of complications, especially if a postprocedural mean gradient of <20 mmHg can be achieved.


Assuntos
Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Desenho de Prótese , Falha de Prótese , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Vigilância de Produtos Comercializados , Modelos de Riscos Proporcionais , Estudos Prospectivos , Reoperação , Substituição da Valva Aórtica Transcateter/métodos
3.
BMJ Case Rep ; 13(12)2020 Dec 29.
Artigo em Inglês | MEDLINE | ID: mdl-33376091

RESUMO

Transcatheter aortic valve implantation (TAVI) is a rapidly evolving treatment option with an inherent risk of causing cerebral infarctions. The mechanism of cerebral infarction during TAVI mainly involves embolisms from the aortic wall and valve. Transoesophageal echocardiography (TEE) is useful for detecting aortic atheromas. We present the case of a patient in whom the dispersal of aortic atheromas was monitored by TEE during TAVI. This report demonstrates the importance of preoperatively predicting embolisms from aortic atheromas in patients with severe aortic stenosis.


Assuntos
Aorta/diagnóstico por imagem , Estenose da Valva Aórtica , Aterosclerose , Infarto Cerebral , Ecocardiografia Transesofagiana/métodos , Complicações Intraoperatórias/diagnóstico por imagem , Placa Aterosclerótica/diagnóstico por imagem , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/cirurgia , Aterosclerose/complicações , Aterosclerose/diagnóstico , Infarto Cerebral/diagnóstico por imagem , Infarto Cerebral/etiologia , Humanos , Complicações Intraoperatórias/prevenção & controle , Masculino , Monitorização Intraoperatória/métodos , Cuidados Pré-Operatórios/métodos , Risco Ajustado , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
4.
Int Heart J ; 61(5): 1059-1069, 2020 Sep 29.
Artigo em Inglês | MEDLINE | ID: mdl-32921666

RESUMO

Because of its rigidity and non-steerability, the presence of a horizontal aortic root poses a major anatomical issue during transcatheter aortic valve replacement (TAVR) with Evolut self-expanding valve. Previous studies have elucidated the difficulties of coaxial implantation of the self-expanding valve in patients with horizontal aorta, often resulting in increased complications and a lower device success rate. To date, most patients with extremely horizontal aorta (aortic root angle ≥ 70°) have been excluded from major TAVR clinical trials. Therefore, available data on TAVR with Evolut in this challenging anatomy are limited, and standardized treatment strategies and clinical results remain unknown. Herein, we report a clinical case series of TAVR with Evolut in extremely horizontal aorta. Among seven patients (aged 80-92 years; STS score, 12.6% ± 7.9%) who underwent TAVR with Evolut system, aortic root angle ranged from 71° to 83° (mean, 75.1°± 4.5°). All patients achieved device success with dedicated strategies and were clinically stable at 3-month follow-up. None of the patients had more than mild paravalvular leakage (PVL) at any point during follow-up.Complications in three patients included complete atrioventricular block requiring a permanent pacemaker implantation, cerebral infarction because of atrial fibrillation 3 days after TAVR, and cardiac tamponade requiring pericardiocentesis. In this case series, Evolut self-expanding TAVR in extremely horizontal aorta was effective and feasible with a high device success rate. Based on anatomical features, some dedicated strategies majorly contribute to the success of this procedure. Large-scale multicenter studies are required to confirm our findings.


Assuntos
Aorta Torácica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/métodos , Idoso de 80 Anos ou mais , Aorta Torácica/anatomia & histologia , Fibrilação Atrial/complicações , Fibrilação Atrial/epidemiologia , Bloqueio Atrioventricular/epidemiologia , Bloqueio Atrioventricular/terapia , Estimulação Cardíaca Artificial , Tamponamento Cardíaco/epidemiologia , Infarto Cerebral/epidemiologia , Infarto Cerebral/etiologia , Angiografia por Tomografia Computadorizada , Feminino , Próteses Valvulares Cardíacas , Humanos , Masculino , Tomografia Computadorizada Multidetectores , Marca-Passo Artificial , Pericardiocentese , Complicações Pós-Operatórias/epidemiologia , Desenho de Prótese , Substituição da Valva Aórtica Transcateter/instrumentação , Resultado do Tratamento
5.
Am Heart J ; 228: 27-35, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32745733

RESUMO

BACKGROUND: Limited data suggest that transcatheter (TAVR) as compared with surgical aortic valve replacement (SAVR) may be more effective in female than male patients. To date, most evidence is derived from subgroup analyses of large trials, and a dedicated randomized trial evaluating whether there is a difference in outcomes between these interventions in women is warranted. The RHEIA trial will compare the safety and efficacy of TAVR with SAVR in women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk. METHODS/DESIGN: The RHEIA trial is a prospective, randomized, controlled study that will enroll up to 440 patients across 35 sites in Europe. Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status, will be randomized 1:1 to undergo aortic valve intervention with either transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra device or SAVR and followed up for 1 year. The objective is to determine whether TAVR is non-inferior to SAVR in this patient population and, if this is fulfilled whether TAVR is actually superior to SAVR. The primary safety/efficacy endpoint is a composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure) at 1 year post-procedure. Other outcomes (assessed at 30 days and/or 1 year) include all-cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life. DISCUSSION: The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk. The results will be the first to provide specific randomized evidence to guide treatment selection in female patients with severe symptomatic aortic stenosis. TRIAL REGISTRATION: clinicaltrials.gov: NCT04160130.


Assuntos
Estenose da Valva Aórtica , Valva Aórtica , Próteses Valvulares Cardíacas , Complicações Pós-Operatórias , Qualidade de Vida , Risco Ajustado/métodos , Substituição da Valva Aórtica Transcateter , Idoso , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/psicologia , Estenose da Valva Aórtica/cirurgia , Feminino , Nível de Saúde , Próteses Valvulares Cardíacas/efeitos adversos , Próteses Valvulares Cardíacas/classificação , Humanos , Avaliação de Processos e Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/fisiopatologia , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/métodos
6.
Rev Cardiovasc Med ; 21(2): 263-274, 2020 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-32706214

RESUMO

Infective endocarditis (IE) represents one of the most challenging clinical entities, requiring a multidisciplinary approach. The increasing number of surgical and transcatheter heart valves replacements performed annually lead to a higher incidence of prosthetic valve endocarditis. Transcatheter aortic valve implantation (TAVI) brought a new alternative for the treatment of aortic stenosis and a new subgroup of IE with its features. We aimed to compare the incidence of IE in TAVI and surgical valve replacement (SAVR) to identify risk factors for TAVI-IE, evaluate the possible impact on mortality, and clarify the best treatment strategies. A digital scan in PubMed and SCOPUS databases was performed. 68 publications were selected to perform a meta-analysis and systematic review on epidemiology, risk factors, and mortality predictors in TAVI-IE. No significant difference in IE rate was noted between patients with TAVI and those with SAVR for in-hospital, early, mid-term and late IE. Male gender, intubation, new pacemaker implantation IE and CKD were correlated with TAVI-IE. Surgical treatment was performed in 22.3% of cases. Overall mortality for the pooled cohort was 38.3%. In a multivariate logistic regression model, surgical treatment and self-expandable device were linked to lower mortality in TAVI-IE. Even if the invasive procedure can trigger bacteremia, exposing the TAVI valve to future infection, no significant difference in IE rate was noted in our analysis between patients with TAVI and those with SAVR for in-hospital, early, mid-term and late IE. Surgical treatment of TAVI-IE can be a viable option in patients with a prohibitive risk score.


Assuntos
Endocardite/epidemiologia , Próteses Valvulares Cardíacas/efeitos adversos , Infecções Relacionadas à Prótese/epidemiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Endocardite/microbiologia , Endocardite/mortalidade , Endocardite/terapia , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Prognóstico , Infecções Relacionadas à Prótese/microbiologia , Infecções Relacionadas à Prótese/mortalidade , Infecções Relacionadas à Prótese/terapia , Medição de Risco , Fatores de Risco
7.
J Card Surg ; 35(8): 2093-2096, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32652566

RESUMO

Balloon rupture is an uncommon complication during balloon-expandable transcatheter aortic valve replacement (TAVR). We describe a balloon rupture and tearing with intraventricular entrapment complicating transapical-TAVR, as well as our bailout retrieval of the failed device.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Falha de Equipamento , Corpos Estranhos/cirurgia , Ventrículos do Coração/lesões , Ventrículos do Coração/cirurgia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso de 80 Anos ou mais , Corpos Estranhos/etiologia , Humanos , Doença Iatrogênica
8.
J Cardiothorac Surg ; 15(1): 157, 2020 Jun 29.
Artigo em Inglês | MEDLINE | ID: mdl-32600369

RESUMO

BACKGROUND: There is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). The aim of this study was to compare the mid-term outcomes after TAVR with Sapien 3 and SAVR with Perimount Magna Ease bioprostheses for severe aortic stenosis. METHODS: In a retrospective study, we included patients who underwent transfemoral TAVR with Sapien 3 or SAVR with Perimount Magna Ease bioprosthesis between January 2008 and October 2017 from the nationwide FinnValve registry. Propensity score matching was performed to adjust for differences in the baseline characteristics. The Kaplan-Meir method was used to estimate late mortality. RESULTS: A total of 2000 patients were included (689 in the TAVR cohort and 1311 in the SAVR cohort). Propensity score matching resulted in 308 pairs (STS score, TAVR 3.5 ± 2.2% vs. SAVR 3.5 ± 2.8%, p = 0.918). In-hospital mortality was 3.6% after SAVR and 1.3% after TAVR (p = 0.092). Stroke, acute kidney injury, bleeding and atrial fibrillation were significantly more frequent after SAVR, but higher rate of vascular complications was observed after TAVR. The cumulative incidence of permanent pacemaker implantation at 4 years was 13.9% in the TAVR group and 6.9% in the SAVR group (p = 0.0004). At 4-years, all-cause mortality was 20.6% for SAVR and 25.9% for TAVR (p = 0.910). Four-year rates of coronary revascularization, prosthetic valve endocarditis and repeat aortic valve intervention were similar between matched cohorts. CONCLUSIONS: The Sapien 3 bioprosthesis achieves comparable midterm outcomes to a surgical bioprosthesis with proven durability such as the Perimount Magna Ease. However, the Sapien 3 bioprosthesis was associated with better early outcome. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03385915 .


Assuntos
Estenose da Valva Aórtica/cirurgia , Bioprótese , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/cirurgia , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Mortalidade Hospitalar , Humanos , Masculino , Complicações Pós-Operatórias , Pontuação de Propensão , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
9.
Int J Cardiovasc Imaging ; 36(11): 2291-2297, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32621038

RESUMO

To determine the potential impact of automated computed tomography (CT) software used for aortic annular sizing for transcatheter aortic valve replacement (TAVR) on paravalvular leak (PVL) and major adverse cardiovascular events (MACE) as compared to standard CT manual measurement. In 60 TAVR patients (84 ± 7 years, 60% male), we evaluated the preprocedural CT scans. For the standard manual measurement, we measured the perimeter and area from a single cardiac phase deemed to be of maximum systolic opening. Valve type and size were determined by a multidisciplinary TAVR team per clinical routine. From the dynamic automated software, we determined the aortic annular perimeter and area as the maximum value from an entire cardiac cycle. Valve size was readjudicated by a blinded interventional cardiologist who was provided with valve type and automated values. Clinical endpoints were adjudicated for presence of at least mild PVL and MACE at 30 days. There were 16 (28%) patients with PVL and 4 (7%) with 30-day MACE. When reclassifying valve size using dynamic automated values, 12 (20%) patients were undersized and 3 (5%) patients were oversized. Undersized patients were more likely to have mild-to-moderate PVL at 30 days (27% vs 4%, p = 0.04) than those not undersized. Of the 5 (45%) undersized patients with at least mild PVL, all were balloon-expandable valves. Automated dynamic CT annular measurements have the potential to reclassify patients with PVL with larger TAVR valve size, particularly balloon-expandable valves.


Assuntos
Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Tomografia Computadorizada Multidetectores , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/fisiopatologia , Automação , Estudos de Viabilidade , Feminino , Humanos , Masculino , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/fisiopatologia , Valor Preditivo dos Testes , Desenho de Prótese , Interpretação de Imagem Radiográfica Assistida por Computador , Estudos Retrospectivos , Fatores de Risco , Software , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
10.
J Interv Cardiol ; 2020: 3070427, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32518532

RESUMO

RESPOND is a prospective, single-arm study enrolling 1014 transcatheter aortic valve replacement (TAVR) patients. The objective of this analysis is to assess the impact of cerebral embolic protection (CEP) devices and prosthetic valve repositioning on the risk of neurologic complications in patients treated with the fully repositionable Lotus Valve in the RESPOND postmarket study. Valve repositioning and CEP use were at the operators' discretion. Stroke events were adjudicated by an independent medical reviewer. This analysis assessed the baseline differences among patients according to CEP use and valve repositioning and evaluated the neurological complications at 72 hours after TAVR, hospital discharge, and 30-day follow-up. A multivariate analysis was performed to identify the potential predictors of stroke. Of the 996 patients implanted with the Lotus Valve (mean age: 80.8 years, 50.8% female, STS score 6.0 ± 6.9), 92 cases (9.2%) used CEP. The overall rate of acute stroke/transient ischemic attack (TIA) was 3.0% at 72 hours after TAVR. The 72-hour stroke/TIA rate was 1.1% in patients who had CEP and 3.2% in those who did not. Use of CEP was associated with a 2.1% absolute reduction in the risk of acute neurological events (relative risk reduction: 65.6%), although the difference was not statistically significant (p=0.51). Repositioning of the Lotus Valve occurred in 313/996 procedures (31.4%). The 72-hour rate of stroke/TIA was similar in patients who had valve repositioning (2.9%) compared with those who did not (3.1%; p=0.86). The selective use of a CEP device in the RESPOND study was associated with a nonsignificantly lower risk for stroke within 72 hours. The use of the repositioning feature of the Lotus Valve did not increase the stroke risk.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Dispositivos de Proteção Embólica , Embolia Intracraniana , Complicações Pós-Operatórias , Risco Ajustado/métodos , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Desenho de Equipamento , Feminino , Próteses Valvulares Cardíacas/efeitos adversos , Humanos , Embolia Intracraniana/diagnóstico , Embolia Intracraniana/etiologia , Embolia Intracraniana/prevenção & controle , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/métodos
11.
Am J Cardiol ; 128: 202-209, 2020 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-32534734

RESUMO

There are two commercially available transcatheter heart valve systems: balloon expandable valves (BEV) and self-expanding valves (SEV). However, there is a paucity of randomized trials comparing both systems. Electronic databases (Medline, the Cochrane Library, Web of Science, and clinicaltrials.gov) and major conference proceedings were searched for randomized trials of patients with symptomatic severe aortic stenosis and received transcatheter aortic valve implantation (TAVI) with a SEV or BEV or surgical aortic valve replacement. The main efficacy outcomes were all-cause mortality and stroke at the longest available follow-up. The main analysis was performed using a random-effects network meta-analysis complemented by several subgroup and sensitivity analyses. Ten trials with 9,439 patients (mostly undergoing transfemoral TAVI) were included. At a median of 27 months, there was no difference between BEV and SEV valves in terms of all-cause mortality (odds ratio [OR] 1.05, 95% confidence interval [CI] 0.79 to 1.42). The incidence of any stroke was higher with BEV (OR 1.51, 95% CI 1.01 to 2.26), but there was no difference in the incidence of disabling stroke. At 30-days, BEV valves were associated with lower incidence of new permanent pacemaker placement (OR 0.50, 95% CI 0.32 to 0.79) and moderate/severe paravalvular regurgitation (OR 0.39, 95% CI 0.22 to 0.68). In conclusion, in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI, SEV and BEV were associated with similar all-cause mortality. BEV were associated with a higher incidence of any stroke driven by nondisabling strokes, but lower incidence of new permanent pacemaker placement and moderate/severe paravalvular regurgitation compared with SEV.


Assuntos
Insuficiência da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/cirurgia , Arritmias Cardíacas/epidemiologia , Estimulação Cardíaca Artificial/estatística & dados numéricos , Próteses Valvulares Cardíacas , Complicações Pós-Operatórias/epidemiologia , Desenho de Prótese , Acidente Vascular Cerebral/epidemiologia , Substituição da Valva Aórtica Transcateter/instrumentação , Arritmias Cardíacas/terapia , Causas de Morte , Humanos , Incidência , Mortalidade , Marca-Passo Artificial/estatística & dados numéricos
12.
PLoS One ; 15(6): e0233894, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32479546

RESUMO

BACKGROUND: Transcatheter aortic valve-in-valve (VIV) procedure is a safe alternative to conventional reoperation for bioprosthetic dysfunction. Balloon-expandable valve (BEV) and self-expanding valve (SEV) are the 2 major types of devices used. Evidence regarding the comparison of the 2 valves remains scarce. METHODS: A systematic review and meta-analysis was conducted to compare the outcomes of BEV and SEV in transcatheter VIV for aortic bioprostheses dysfunction. A computerized search of Medline, PubMed, Embase, and Cochrane databases was performed. English-language journal articles reporting SEV or BEV outcomes of at least 10 patients were included. RESULTS: In total, 27 studies were included, with 2,269 and 1,671 patients in the BEV and SEV groups, respectively. Rates of 30-day mortality and stroke did not differ significantly between the 2 groups. However, BEV was associated with significantly lower rates of postprocedural permanent pacemaker implantation (3.8% vs. 12%; P < 0.001). Regarding echocardiographic parameters, SEV was associated with larger postprocedural effective orifice area at 30 days (1.53 cm2 vs. 1.23 cm2; P < 0.001) and 1 year (1.55 cm2 vs. 1.22 cm2; P < 0.001). CONCLUSIONS: For patients who underwent transcatheter aortic VIV, SEV was associated with larger postprocedural effective orifice area but higher rates of permanent pacemaker implantation. These findings provide valuable information for optimizing device selection for transcatheter aortic VIV.


Assuntos
Valva Aórtica/cirurgia , Bioprótese/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Falha de Prótese , Substituição da Valva Aórtica Transcateter/instrumentação , Tomada de Decisão Clínica , Humanos , Marca-Passo Artificial/estatística & dados numéricos , Reoperação/instrumentação , Reoperação/métodos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
14.
JACC Cardiovasc Interv ; 13(9): 1019-1027, 2020 05 11.
Artigo em Inglês | MEDLINE | ID: mdl-32381181

RESUMO

OBJECTIVES: The aim of this study was to evaluate clinical outcomes and transcatheter heart valve hemodynamic parameters after transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic stenosis (AS). BACKGROUND: TAVR is approved for low-risk patients in the United States. However, patients with bicuspid AS were excluded from the randomized cohorts of the pivotal low-risk trials. METHODS: The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and was the first and only U.S. Food and Drug Administration-approved investigational device exemption trial to evaluate the feasibility of TAVR with either balloon-expandable or self-expanding valves in low-risk patients with bicuspid AS. The primary endpoint was all-cause mortality at 30 days. Baseline and follow-up echocardiography and computed tomography to detect leaflet thickening were analyzed in an independent core laboratory. RESULTS: Sixty-one low-risk patients with symptomatic, severe AS and bicuspid aortic valves (78.3% Sievers type 1 morphology) underwent TAVR at 6 centers from 2016 to 2019. The mean age was 68.6 years, and 42.6% were men. At 30 days, there was zero mortality and no disabling strokes. The rate of new permanent pacemaker implantation was 13.1%; just 1 patient had a moderate paravalvular leak at 30 days. Hypoattenuated leaflet thickening was observed in 10% of patients at 30 days. CONCLUSIONS: TAVR appears to be safe in patients with bicuspid AS, with short length of hospital stay, zero mortality, and no disabling strokes at 30 days. Subclinical leaflet thrombosis was observed in a minority of patients at 30 days but did not appear to be associated with clinical events.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/anormalidades , Doenças das Valvas Cardíacas/complicações , Substituição da Valva Aórtica Transcateter , Idoso , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/etiologia , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Estudos de Viabilidade , Feminino , Doenças das Valvas Cardíacas/mortalidade , Doenças das Valvas Cardíacas/fisiopatologia , Próteses Valvulares Cardíacas , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Recuperação de Função Fisiológica , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Estados Unidos
15.
Artigo em Inglês | MEDLINE | ID: mdl-32356620

RESUMO

Postoperative stroke after cardiac surgery is an ominous complication. Clinical manifestations range from cognitive disturbances and altered states of consciousness to focal neurological deficits. Stroke is also a well-documented risk of catheter-based cardiac interventions. Recently, the growth of transcatheter procedures has led to the increasing development of devices that are designed to minimize neurological events during valve implantation.  In this video tutorial we demonstrate how to transfer a catheter-based cerebral protection technology into an open cardiac surgical intervention. The operation shown in this tutorial was an aortic valve replacement and the cerebral protection device implanted was the  Sentinel Cerebral Protection System (Boston Scientific, Marlborough, MA, USA).


Assuntos
Estenose da Valva Aórtica/cirurgia , Complicações Pós-Operatórias/prevenção & controle , Acidente Vascular Cerebral/prevenção & controle , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Feminino , Humanos , Masculino , Complicações Pós-Operatórias/etiologia , Acidente Vascular Cerebral/etiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
16.
Ann Thorac Surg ; 110(5): e375-e376, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32376351

RESUMO

The HAART 300 (BioStable Science and Engineering, Austin, TX) is a rigid, elliptical device introduced to facilitate aortic valve repair providing annular stabilization in the setting of aortic regurgitation. Percutaneous strategies have been described for patients with dysfunctional biological prostheses or recurrence insufficiency after mitral ring annuloplasty. This report shows the feasibility of aortic valve-in-ring transcatheter aortic valve replacement (TAVR). The sufficient ring stability to support the implanted TAVR-prosthesis and the fact that the elliptical shape of the HAART-ring did not result in a problem concerning paravalvular leakage were important for the success of this procedure.


Assuntos
Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Insuficiência da Valva Aórtica/cirurgia , Feminino , Humanos
17.
Artigo em Inglês | MEDLINE | ID: mdl-32459076

RESUMO

As the number of young and relatively low-risk patients undergoing transcatheter aortic valve implantation increases, the number who will require open heart surgery months or years later will also increase. Only a few cases of late transcatheter heart valve explantation (without root replacement) have been reported in the literature, and this rare procedure can be surgically very challenging. In this video tutorial we present the case of a patient with a valve-in-valve subacute thrombosis, and we describe the surgical technique for valve explantation.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica , Remoção de Dispositivo/métodos , Reoperação/métodos , Trombose , Substituição da Valva Aórtica Transcateter , Idoso , Valva Aórtica/patologia , Valva Aórtica/cirurgia , Bioprótese/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Humanos , Masculino , Trombose/etiologia , Trombose/cirurgia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
18.
Ann Thorac Cardiovasc Surg ; 26(3): 158-165, 2020 Jun 20.
Artigo em Inglês | MEDLINE | ID: mdl-32249256

RESUMO

PURPOSE: Our study aimed to investigate the structural valve deterioration (SVD) after transcatheter aortic valve implantation (TAVI) using J-Valve. METHODS: In all, 14 patients with aortic stenosis (AS) and 4 patients with pure aortic regurgitation (PAR) were available in the study. Four-year follow-up was performed in all patients, and the clinical data and echocardiographic findings were recorded and analyzed. RESULTS: All patients survived at the 4-year follow-up. There was no evidence of morphological SVD or prosthetic valve thrombosis in enrolled patients. None of the hemodynamic SVD occurred in patients with PAR. Mean gradients decreased from 61.93 ± 15.42 mm Hg (pre-TAVI) to 19.64 ± 9.16 mm Hg (discharge) in patients with AS (p <0.001); subsequently, a slight increase was observed in the mean trans-aortic gradient throughout follow-up (p = 0.967). Overall, in patients with AS, six individuals suffered moderate (3/14, 21.4%) or severe (3/14, 21.4%) hemodynamic SVD at 4-year follow-up. CONCLUSIONS: The limited number of cases provides a preliminary indication of the long-term efficacy of TAVI using J-Valve in patients with PAR. In patients with AS, although the higher rate of SVD was observed, the overall transcatheter heart valve (THV) hemodynamics remained stable over time after prosthetic valve implantation and the long-term durability of J-Valve was convincing.


Assuntos
Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Hemodinâmica , Falha de Prótese , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Pequim , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
20.
JACC Cardiovasc Interv ; 13(9): 1071-1082, 2020 05 11.
Artigo em Inglês | MEDLINE | ID: mdl-32305398

RESUMO

OBJECTIVES: The purpose of this study was to evaluate clinical and echocardiographic outcome data of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial at 5 years. BACKGROUND: The CHOICE trial was designed to compare device performance of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV. METHODS: The CHOICE trial is an investigator-initiated trial that randomized 241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, and echocardiographic evaluation of valve function and THV durability. RESULTS: After 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%; p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75). SE patients had larger prosthetic valve area (1.6 ± 0.5 cm2 vs. 1.9 ± 0.5 cm2; p = 0.02) with a lower mean transprosthetic gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg; p = 0.001) at 5 years. No differences were observed in the rates of paravalvular regurgitation. Clinical valve thrombosis occurred in 7 BE patients (7.3%) and 1 SE patient (0.8%; p = 0.06), and moderate or severe structural valve deterioration in 6 BE patients (6.6%) and no SE patient (0%; p = 0.018). The rate of bioprosthetic valve failure was low and not significantly different between both groups (4.1% vs. 3.4%; p = 0.63). CONCLUSIONS: Five-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with early-generation BE and SE valves that were not statistically significantly different, with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial [CHOICE]; NCT01645202).


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Valvuloplastia com Balão , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Valvuloplastia com Balão/efeitos adversos , Valvuloplastia com Balão/mortalidade , Feminino , Alemanha , Hemodinâmica , Humanos , Masculino , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Desenho de Prótese , Falha de Prótese , Recuperação de Função Fisiológica , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
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