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1.
EuroIntervention ; 17(10): 809-817, 2021 Nov 19.
Artigo em Inglês | MEDLINE | ID: mdl-34031021

RESUMO

BACKGROUND: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality. AIMS: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study. METHODS: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team. RESULTS: Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p<0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all p<0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p<0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p<0.001) with improvements in overall KCCQ score by 17 points (p<0.001). CONCLUSIONS: In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Cateterismo Cardíaco , Seguimentos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Estudos Prospectivos , Qualidade de Vida , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/cirurgia
2.
Clin Res Cardiol ; 110(5): 699-710, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33744987

RESUMO

BACKGROUND: In recent studies, a 5-stage cardiac damage classification in severe aortic stenosis (AS) based on echocardiographic parameters has shown to provide predictive value regarding clinical outcome. The objective of this study was to investigate the prognostic impact of a cardiac damage classification based on invasive hemodynamics in patients with AS undergoing transcatheter aortic valve replacement (TAVR). METHODS: A total of 1400 patients with symptomatic AS and full invasive hemodynamic assessment before TAVR were included. Patients were categorized according to their cardiac damage stage into five groups that are defined as: stage 0, no cardiac damage; stage 1, left ventricular damage; stage 2, left atrial and/or mitral valve damage; stage 3, pulmonary vasculature and/or tricuspid valve damage; stage 4, right ventricular damage. RESULTS: 9.9% patients were classified as stage 0, 23.6% as stage 1, the majority of patients as stage 2 (33.5%), 23.1% as stage 3 and 10% as stage 4. One- and 4-year mortality were 10.1%/29.5% in stage 0, 16.1%/60.6% in stage 1, 17.3%/39.4% in stage 2, 22%/54.6% in stage 3, 27.1%/62.2% in stage 4 (p = 0.001/p < 0.001). The extent of cardiac damage was independently associated with increased mortality after TAVR (HR 1.16 per each increment in stage, 95% confidence interval 1.03-1.18; p = 0.018). CONCLUSIONS: Cardiac damage staging in severe AS patients based on invasive hemodynamics appears to show strong association between the extent of cardiac damage and post-TAVR mortality. This staging classification provides predictive value and may improve risk stratification, therapy management and decision-making in patients with AS. Invasive Staging Classification of Cardiac Damage in Severe Symptomatic Aortic Stenosis has an Impact on Outcome after TAVR. (Top) Invasive staging criteria for cardiac damage in five stages using left ventricular end-diastolic pressure (LVEDP) for stage 1 (red), post-capillary wedge pressure (PCWP) for stage 2 (green), systolic pulmonary artery pressure (SPAP) for stage 3 (purple) and right atrial pressure (RAP) for stage 4 (yellow). The cake chart shows the distribution of the different stage in the whole cohort. (Bottom) Survival Analyses According to Stage of Cardiac Damage after Transcatheter Aortic Valve Replacement using Invasive Criteria. Kaplan-Meier plots comparing overall (left) and cardiovascular (right) 4-year survival showing with the more advancing stage a higher mortality rate.


Assuntos
Estenose da Valva Aórtica/cirurgia , Cardiopatias/classificação , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/fisiopatologia , Ecocardiografia , Feminino , Cardiopatias/diagnóstico por imagem , Cardiopatias/mortalidade , Hemodinâmica , Humanos , Masculino , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Índice de Gravidade de Doença
3.
Echocardiography ; 37(3): 380-387, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32049400

RESUMO

OBJECTIVES: The aim of this study was to investigate reliability and accuracy of noninvasive measurement method by echocardiography compared to invasive measurement of systolic pulmonary artery pressure (SPAP) in a large cohort of aortic stenosis (AS) patients. BACKGROUND: Pulmonary hypertension (PH) is common in patients with cardiac disease, especially in left heart disease like severe AS. Invasive measurement by right heart catheterization (RHC) is the gold standard to assess pulmonary pressures. Nevertheless, echocardiography is widely used in everyday practice for estimation of pulmonary pressures and diagnosing PH. METHODS: A total of 1400 patients with AS and full invasive hemodynamic assessment by RHC and noninvasive measurements by Doppler echocardiography were included. RESULTS: Mean patient age was 81.5 ± 6.8 years, and 46.3% were males. SPAP was 44.7 ± 15.1 mm Hg by echocardiography and 45.3 ± 15.2 mm Hg by RHC. Pearson's correlation coefficient was r = .820 (P < .0001). Bland-Altman analysis showed a bias of -0.56 mm Hg (95% limits of agreement -18.38 to + 17.26 mm Hg) and 80.6% measurement accuracy. Pulmonary hypertension defined by RHC as a mean PAP ≥25 mm Hg was reliably diagnosed via an echocardiographically measured SPAP of >40 mm Hg (82.2% sensitivity, 80.2% specificity, 83.1% positive predictive value, 79.2% negative predictive value). CONCLUSIONS: In a large cohort of patients with severe aortic stenosis, we could demonstrate a very good correlation of SPAP between Doppler echocardiography and invasive RHC measurement. Pulmonary hypertension could be diagnosed by echocardiography with high sensitivity and specificity.


Assuntos
Estenose da Valva Aórtica , Cateterismo Cardíaco , Artéria Pulmonar , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/diagnóstico por imagem , Ecocardiografia Doppler , Feminino , Humanos , Masculino , Artéria Pulmonar/diagnóstico por imagem , Reprodutibilidade dos Testes
4.
EuroIntervention ; 15(13): 1181-1189, 2020 Jan 17.
Artigo em Inglês | MEDLINE | ID: mdl-31566569

RESUMO

AIMS: Approximately 40% of severe aortic stenosis (AS) patients have a low-gradient (<40 mmHg) AS (LG-AS). The aim of this study was to investigate the invasively measured haemodynamic changes and long-term outcome after transcatheter aortic valve replacement (TAVR) in the subgroups of LG-AS. METHODS AND RESULTS: A total of 600 LG-AS patients with haemodynamic assessment by left and right heart catheterisation were divided into three groups: normal-flow (NFLG-AS; n=296), paradoxical low-flow (PLFLG-AS; n=153), and classic low-flow (CLFLG-AS; n=151). Post TAVR, PLFLG-AS and CLFLG-AS showed a significant reduction in global afterload (p<0.005), as well as a significant elevation of stroke volume index (SVI), and left and right ventricular stroke work index (p<0.001). NFLG-AS was associated with an elevation of global afterload and a decrease of SVI (p<0.05). Overall survival was highest in NFLG-AS, followed by PLFLG-AS and CLFLG-AS. All subgroups experienced similar symptomatic improvement. CONCLUSIONS: NFLG-AS was the most prevalent form of LG severe AS and was associated with adequate left ventricular compensation and good prognosis. On the other hand, CLFLG-AS represents the heart failure with reduced ejection fraction (HFrEF) form of AS and was associated with the worst prognosis, whereas PLFLG-AS represents the heart failure with preserved ejection fraction (HFpEF) form of AS with intermediate prognosis. Both groups showed early haemodynamic reverse response after TAVR.


Assuntos
Estenose da Valva Aórtica , Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Valva Aórtica , Estenose da Valva Aórtica/cirurgia , Hemodinâmica , Humanos , Índice de Gravidade de Doença , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda
5.
JACC Cardiovasc Interv ; 12(21): 2155-2168, 2019 11 11.
Artigo em Inglês | MEDLINE | ID: mdl-31699377

RESUMO

OBJECTIVES: The aim of this study was to investigate the prognostic impact and development of pulmonary hypertension (PH) in the different hemodynamic subtypes of PH in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: PH is a frequent finding in patients with severe AS and predicts outcome after TAVR. Nevertheless, outcomes among PH subtypes and the impact of residual PH after TAVR are controversial. METHODS: A total of 1,400 patients with symptomatic AS and full invasive hemodynamic assessment before and after TAVR were included. Patients were stratified into 4 groups: no PH (n = 658); isolated pre-capillary PH (n = 139), isolated post-capillary PH (Ipc-PH; n = 534), and combined post-capillary and pre-capillary PH (n = 69). RESULTS: The mean overall patient age was 81.5 ± 6.8 years, and 46.3% were men. Acute device success was achieved in 94.9%. Patients without PH showed significantly lower mortality rates compared with patients with PH (1 year, 13.8% vs. 22.4% [p < 0.001]; 4 years, 37.2% vs. 51.5% [p < 0.001]). Patients with pre-capillary PH showed 1.9-fold increased 1-year mortality and those with Ipc-PH showed 1.5-fold increased 1-year mortality compared with patients without pH (p = 0.001). No differences regarding survival were found among the subgroups. Only in patients with Ipc-PH, residual PH was associated with 2.1-fold increased mortality (p = 0.010). All patients benefited in terms of functional capacity after TAVR. CONCLUSIONS: Patients with pre-capillary PH and those with Ipc-PH showed significantly higher risk for death after TAVR compared with those without PH. Reversible PH had no benefit for survival except in patients with Ipc-PH. Hemodynamic stratification of PH is helpful for risk and response prediction in patients with AS undergoing TAVR.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Hemodinâmica , Hipertensão Pulmonar/fisiopatologia , Artéria Pulmonar/fisiopatologia , Substituição da Valva Aórtica Transcateter , 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 , Feminino , Humanos , Hipertensão Pulmonar/diagnóstico , Hipertensão Pulmonar/mortalidade , Masculino , Recuperação de Função Fisiológica , Estudos Retrospectivos , Medição de Risco , 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
6.
Int J Cardiol ; 285: 21-26, 2019 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-30871803

RESUMO

BACKGROUND: Many candidates with ischaemic functional mitral regurgitation (FMR) have previously undergone coronary artery bypass grafting (CABG), in which transcatheter mitral valve repair can be reasonable for ameliorating the deteriorated hemodynamic and heart failure symptoms. We sought to elucidate the outcomes of MitraClip (MC) implantation in patients with symptomatic ischaemic FMR after CABG. METHODS: We investigated clinical characteristics, outcomes and predictive impact of previous CABG on mortality in ischaemic FMR patients who underwent MC implantation from two high-volume centres in Germany. RESULTS: We enrolled 159 patients who previously underwent CABG. Compared with a reference group that did not previously undergo CABG (n = 182), the cohort consisted of more elderly patients (75.0, standard deviation [SD] 7.7 versus 72.9, SD 9.6 years, p = 0.028), more men (84% vs. 69%, p < 0.001), and reduced tricuspid annular plane systolic excursion (14.0, SD 4.0, vs. 16.6, SD 4.6 mm, p < 0.0001). The CABG group showed similar outcomes regarding procedural success (91% vs. 94%, p = 0.24) and 30-day mortality (5.0% vs. 6.0%, p = 0.68), but worse survival after MC implantation (log-rank p = 0.019, hazard ratio 1.56 [95% confidence interval (CI) 1.08-2.26]). After propensity score matching (n = 224), the hazard ratio was 1.18 [95%CI 0.76-1.84] without statistical significance (p = 0.46). CONCLUSIONS: Transcatheter mitral valve repair using the MC is a viable treatment option for patients with symptomatic ischaemic FMR after CABG. Although the baseline characteristics seemed to point to sick patients, CABG itself had only a modest impact on survival.


Assuntos
Ponte de Artéria Coronária/métodos , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral/cirurgia , Isquemia Miocárdica/complicações , Idoso , Feminino , Seguimentos , Alemanha/epidemiologia , Humanos , Masculino , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/mortalidade , Isquemia Miocárdica/mortalidade , Isquemia Miocárdica/cirurgia , Período Pós-Operatório , Prognóstico , Desenho de Prótese , Estudos Retrospectivos , Taxa de Sobrevida/tendências
7.
Clin Res Cardiol ; 108(3): 264-272, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30097683

RESUMO

INTRODUCTION: Transcatheter edge-to-edge mitral valve repair using the MitraClip has been widely performed in surgical high-risk patients with reduced left ventricular systolic function and severe functional mitral regurgitation (FMR). Ischaemic heart disease is the leading aetiology of heart disease worldwide. We aimed to assess the clinical implications of ischaemic aetiology in patients with severe FMR who underwent MitraClip implantation. METHODS AND RESULTS: From two high-volume centres in Germany, we retrospectively compared the clinical outcomes and clinical predictors of all-cause mortality after MitraClip implantation in patients with ischaemic (I-FMR) and non-ischaemic FMR (NI-FMR). In the overall FMR cohort (n = 575), there were 336 (58%) patients with I-FMR and 239 (42%) with NI-FMR. There was no significant difference in survival between the two groups (log-rank p = 0.78). In a multivariable Cox regression analysis of all-cause mortality, different predictors were observed for either group. In I-FMR patients, decreasing tricuspid annular systolic excursion [adjusted hazard ratio (HRadj) 1.06, 95% confidence interval (95% CI) 1.01-1.14 /1 mm, p = 0.028] and increasing logistic EuroSCORE (HRadj 1.02, 95% CI 1.00-1.03, p = 0.037) were independent predictors, whereas in NI-FMR patients, NT-pro BNP (HRadj 1.05, 95% CI 1.02-1.08, p = 0.001) and age (HRadj 1.06, 95% CI 1.01-1.11, p = 0.013) were independently predictive of mortality. CONCLUSIONS: Despite the similar survival between ischaemic and non-ischaemic FMR, different predictors of all-cause mortality were demonstrated. Further clinical studies are mandated to focus on each FMR subgroup with stratification by ischaemic origin.


Assuntos
Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Hospitais com Alto Volume de Atendimentos/estatística & dados numéricos , Insuficiência da Valva Mitral/epidemiologia , Valva Mitral/cirurgia , Isquemia Miocárdica/complicações , Função Ventricular Esquerda/fisiologia , Idoso , Causas de Morte/tendências , Angiografia Coronária , Vasos Coronários/diagnóstico por imagem , Feminino , Alemanha/epidemiologia , Ventrículos do Coração/diagnóstico por imagem , Ventrículos do Coração/fisiopatologia , Humanos , Incidência , Masculino , Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/cirurgia , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/mortalidade , Complicações Pós-Operatórias/epidemiologia , Prognóstico , Desenho de Prótese , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Sístole , Resultado do Tratamento
8.
Clin Res Cardiol ; 108(7): 741-748, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30506481

RESUMO

AIMS: We sought to assess the impact of different manifestations of heart failure (HF) at baseline on the short- and long-term outcomes of transcatheter aortic valve implantation (TAVI) for aortic stenosis (AS). METHODS AND RESULTS: Of 361 patients undergoing TAVI between May 2013 and April 2015, 185 (51%) showed clinical signs of HF at the time of admission. HF was diagnosed as isolated left ventricular (LV) and biventricular in 63 (34%) and 122 patients (66%), respectively. Acute device success (VARC-2) was achieved in 97% of patients without HF, in all patients with LV HF, and in 97% of patients with biventricular HF. Follow-up for a median of 427 days revealed significantly poorer survival in patients with biventricular HF (1-year estimate, 72.1% [95% confidence interval, 64.0-80.2%]) than in patients with LV HF (84.5% [75.2-93.8%]; p = 0.0203) or no HF (94.3% [90.7-97.9%]; p < 0.0001). Survival in the latter two patient subgroups was statistically not different. A diagnosis of biventricular HF was associated with a hazard ratio of 2.62 (p = 0.0089) vs. no HF in the likelihood of death; NT-proBNP and the logistic EuroSCORE were not significantly associated with survival. Half of all deaths in patients with biventricular HF occurred within 42 days of TAVI. CONCLUSION: Biventricular HF is a strong predictor of mortality following TAVI for severe AS. AS in patients with LV HF should be treated without delay to avoid progression to biventricular HF. Patients with AS and biventricular HF should be monitored closely after TAVI to possibly prevent early death.


Assuntos
Estenose da Valva Aórtica/cirurgia , Insuficiência Cardíaca/etiologia , Medição de Risco , Substituição da Valva Aórtica Transcateter/métodos , Doença Aguda , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/fisiopatologia , Ecocardiografia Transesofagiana , Feminino , Seguimentos , Alemanha/epidemiologia , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Hemodinâmica/fisiologia , Humanos , Incidência , Masculino , Período Pós-Operatório , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Resultado do Tratamento
9.
EuroIntervention ; 14(3): e301-e305, 2018 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-29808820

RESUMO

AIMS: The recently released Medtronic CoreValve Evolut R 34 mm is the largest self-expanding transcatheter heart valve ever developed. Clinical data for this device size are scarce. We therefore aimed to evaluate the clinical performance and safety of the new device. METHODS AND RESULTS: We report on the first 101 consecutive patients treated with transfemoral transcatheter aortic valve implantation (TAVI) using the 34 mm Evolut R device in a multicentre registry. Clinical parameters were determined before the procedure and echocardiography was performed at baseline and discharge. VARC-2 criteria were assessed at 30 days. Mean age was 80.7 years; mean logistic EuroSCORE was 19.8%. Procedural duration was 71.6 min. Echocardiography at discharge revealed a mean AVA of 2.0 cm2, moderate aortic regurgitation (AR) in 4.0% and severe AR in 1.0%. VARC-2 device success was achieved in 92.1%, while the early safety endpoint occurred in 11 patients (10.9%). New permanent pacemakers were implanted in 17 patients (18.7%). Thirty-day mortality was 2.0%, a stroke occurred in 3.0%, with a disabling stroke in one patient. The incidence of major vascular complications and bleeding was 1.0% and 5.0%, respectively. CONCLUSIONS: Initial experience with the new self-expanding CoreValve Evolut R 34 mm valve is characterised by high procedural success, good haemodynamic performance and a low early complication rate.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Valva Aórtica , Humanos , Desenho de Prótese , Sistema de Registros , Resultado do Tratamento
10.
Int J Cardiol ; 261: 37-41, 2018 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-29572082

RESUMO

AIMS: Conduction abnormalities (CA), in particular complete atrioventricular block (CAVB), requiring permanent pacemaker (PPM) implantation, are frequent complications after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS). However, the potential mechanisms are still incompletely understood. The objective of this retrospective study was to determine further predictors of CAVB after TAVI in patients without the known predictors. METHODS AND RESULTS: This study included patients without prior CA/PPM who underwent TAVI of a balloon-expandable valve (Sapien or Sapien XT or Sapien 3). Of 563 patients (81.2 ±â€¯6.9 years, 245 men [43.5%], logistic EuroSCORE 22.2 ±â€¯14.1%, STS PROM 5.9 [3.4-8.0]) who were treated by TAVI at our institution between July 2008 and January 2016, 61 (10.8%) developed a permanent CAVB after the procedure. In a multivariable logistic regression analysis moderate/severe tricuspid regurgitation (TR) (OR 2.05; 95% CI 1.18-3.55; p = 0.010) was identified as an independent predictor for new CAVB after TAVI. Moreover, patients with more pronounced TR presented with increased left and right ventricular overload (left ventricular (LV) end-diastolic diameter, LV end-diastolic pressure), pulmonary pressures, NT-proBNP, and prevalence of mitral regurgitation ≥II, whereas LV ejection fraction, TAPSE and cardiac output were decreased. CONCLUSIONS: PPM implantation is a frequent complication in patients undergoing TAVI. Increasing severity of TR seems to be a consequence of left and right ventricular overload caused by severe AS and is a significant predictor of new CAVB after TAVI. CONDENSED ABSTRACT: Conduction abnormalities (CA) requiring permanent pacemaker (PPM) implantation, are frequent complications after transcatheter aortic valve implantation (TAVI). This study included patients without prior CA/PPM who underwent TAVI. Of 563 patients 61 (10.8%) developed a permanent CAVB after the procedure. In a multivariable logistic regression analysis moderate/severe tricuspid regurgitation (TR) (OR 2.05; 95% CI 1.18-3.55; p = 0.010) was identified as an independent predictor for new CAVB. Therefore, in patients with moderate/severe TR utmost care should be taken to avoid procedural factors conducive to mechanical irritation of the conduction system, resulting in pacemaker dependency.


Assuntos
Bloqueio Atrioventricular/epidemiologia , Marca-Passo Artificial/tendências , Complicações Pós-Operatórias/epidemiologia , Substituição da Valva Aórtica Transcateter/tendências , Insuficiência da Valva Tricúspide/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Bloqueio Atrioventricular/terapia , Feminino , Humanos , Masculino , Complicações Pós-Operatórias/terapia , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Insuficiência da Valva Tricúspide/terapia
11.
Int J Cardiol ; 232: 147-154, 2017 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-28089458

RESUMO

BACKGROUND: In high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) diabetes mellitus (DM) is a common comorbidity. It is known to increase the risk of arteriosclerosis and adversely affect morbidity, mortality for all types of cardiovascular disease, and post-procedural outcome after percutaneous and surgical procedures. Moreover, DM is known to facilitate the genesis of renal failure (RF). Pre-existing RF seems to increase the rate of acute kidney injury (AKI), which is a powerful short- and midterm predictor of mortality in patients undergoing TAVR. Therefore, the aim of the present study was to investigate the impact of DM on AKI, short- and midterm prognosis after TAVR, especially in patients with pre-existing RF. METHODS AND RESULTS: In 337(30%) of 1109 patients DM was documented. The incidence of RF at baseline (GFR <60mL/min) was statistically similar in both patient groups (no DM vs. DM: 54% vs. 61%; p=0.057). Also, the incidence of AKI stage 3 was similar in all patients (no DM vs. DM: 1.6% vs. 1.8%; p=0.799). There were no significant differences regarding the procedure-related complications according to VARC-2 and mortality between patients neither with nor without DM. Even after differentiating patients according to baseline renal function, similar incidence of AKI and midterm mortality were documented. CONCLUSION: In patients undergoing TAVR, neither in case of preserved nor impaired renal function, we couldn't find any evidence for influence of DM on overall acute and midterm prognosis nor the incidence of AKI.


Assuntos
Injúria Renal Aguda/epidemiologia , Estenose da Valva Aórtica/epidemiologia , Diabetes Mellitus/epidemiologia , Medição de Risco/métodos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Injúria Renal Aguda/etiologia , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Comorbidade , Ecocardiografia Transesofagiana , Feminino , Seguimentos , Alemanha/epidemiologia , Mortalidade Hospitalar/tendências , Humanos , Incidência , Masculino , Complicações Pós-Operatórias , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Taxa de Sobrevida/tendências , Fatores de Tempo
12.
J Am Heart Assoc ; 5(11)2016 11 10.
Artigo em Inglês | MEDLINE | ID: mdl-27930358

RESUMO

BACKGROUND: Histopathological analyses of debris captured by a cerebral protection system during transcatheter aortic valve replacement have been reported, but the origin of the captured debris was not determined and risk factors were not defined. METHODS AND RESULTS: Embolic debris was analyzed from 322 filters used in a dual-cerebral-filter protection system implemented during transcatheter aortic valve replacement for 161 patients (mean age 81 years, 82 male [51%], logistic EuroSCORE 19% [interquartile range 12-31%]). The debris capture rate was high, with debris from 97% of all patients (156 of 161). No differences by filter location were found (brachiocephalic trunk 86% [139 of 161], left carotid artery 91% [147 of 161]; adjusted P=0.999). Five prevalent types of debris were identified: thrombus (91%), arterial wall tissue (68%), valve tissue (53%), calcification (46%), and foreign material (30%). Female sex (P=0.0287, odds ratio 1.364, 95% CI 1.032-1.812) and diabetes mellitus (P=0.0116, odds ratio 1.474, 95% CI 1.089-2.001) were significant risk factors for embolic debris. Additional analysis showed significantly more valve tissue in patients with predilation (P=0.0294). Stroke and transient ischemic attack rates were 0.6% each (1 of 161). CONCLUSION: This study showed a high rate of embolic debris consisting of typical anatomic structures known to be altered in patients with aortic stenosis undergoing transcatheter aortic valve replacement. Female patients with diabetes mellitus have increased risk of embolic debris and should be protected by a cerebral protection system during transcatheter aortic valve replacement. Because valve tissue embolizes more often in patients with predilation, procedural planning should consider this finding. Both cerebral arteries (brachiocephalic trunk, left carotid artery) should be protected in the same way.


Assuntos
Estenose da Valva Aórtica/cirurgia , Dispositivos de Proteção Embólica , Complicações Pós-Operatórias/prevenção & controle , Sistema de Registros , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica , Artérias , Tronco Braquiocefálico , Calcinose , Artérias Carótidas , Diabetes Mellitus/epidemiologia , Embolia , Feminino , Corpos Estranhos , Humanos , Ataque Isquêmico Transitório/epidemiologia , Masculino , Razão de Chances , Complicações Pós-Operatórias/epidemiologia , Fatores Sexuais , Acidente Vascular Cerebral/epidemiologia , Trombose
13.
EuroIntervention ; 12(12): 1520-1526, 2016 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-27998844

RESUMO

AIMS: The study sought to assess outcomes of transcatheter mitral valve-in-valve implantation (TMVIV) for degenerated bioprostheses and transcatheter mitral valve-in-ring implantation (TMVIR) for failed annuloplasty rings according to access route and the Mitral Valve Academic Research Consortium (MVARC) criteria. METHODS AND RESULTS: Twenty-four patients (72±13 years; eight men [33%]) underwent TMVIV (n=14) or TMVIR (n=10) for mitral regurgitation (MR; n=17) or stenosis (n=7) using balloon-expandable bioprostheses. Transapical (TA) access was chosen in 13, and transseptal (TS) access in 11 patients. MVARC technical success, device success and procedural success were 95.8%, 41.7% and 33.3%, respectively, with no differences between access routes. Cardiac output (CO) increased significantly by 1.1±0.8 l/min in TS patients, but not in TA patients (ΔCO=0.0±0.5 l/min; p=0.0051). Overall three-year survival was estimated at 57.6% (95% confidence interval: 33.9-81.3; TA 35.5% [5.2-65.9]; TS 90.9% [73.9-100]). Survival up to four years according to vascular access showed a clear benefit in patients treated transseptally (p=0.045). CONCLUSIONS: Regardless of the access route, TMVIV/TMVIR was associated with high technical success yet impaired device success. In the long term, TA access had a significant adverse impact on survival.


Assuntos
Valva Aórtica/cirurgia , Bioprótese , Próteses Valvulares Cardíacas , Anuloplastia da Valva Mitral , Valva Mitral/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/instrumentação , Feminino , Próteses Valvulares Cardíacas/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Anuloplastia da Valva Mitral/métodos , Insuficiência da Valva Mitral/terapia , Resultado do Tratamento
14.
Heart ; 102(19): 1573-80, 2016 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-27220695

RESUMO

OBJECTIVE: Histological analyses of debris captured by a cerebral protection system (CPS) during transcatheter valve-in-valve (VIV) procedures have not been reported. METHODS: Fifteen consecutive patients with stenotic aortic (n=13) or mitral (n=2) surgical or transcatheter bioprostheses were treated with implantation of a transcatheter heart valve (THV) in the presence of a dual-filter CPS. Mean patient age was 75 years; mean logistic EuroSCORE was 31%. Filters were collected and histological assessment of debris was performed. Patients were followed clinically until discharge. RESULTS: Debris captured by either or both filters was detected in all patients. Acute thrombus was the most common type of debris, found in all patients, followed in frequency by arterial wall tissue (n=12 patients (80%)), calcification (n=11 (73%)) and valve tissue (n=9 (60%)). Less frequently found were organised thrombus (n=5 (30%)), foreign material (n=4 (27%)) and myocardium (n=2 (13%)). A median of 123 debris particles per patient was detected, with a trend towards a greater median number of particles collected in proximal filters (78 vs 39, p=0.065). The average maximum particle diameter was 88 (range 56-175) µm, with a median of 20 particles ≥150 µm. No stroke or transient ischaemic attack (TIA) had occurred by the time of discharge (mean 8 days). CONCLUSIONS: Transcatheter VIV procedures were associated with the release of particulate debris into the cerebral circulation in all patients. The type of debris suggests that debris originates predominantly from arterial and valvular passage of the THV.


Assuntos
Estenose da Valva Aórtica/terapia , Bioprótese , Cateterismo Cardíaco/instrumentação , Dispositivos de Proteção Embólica , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Trombose Intracraniana/prevenção & controle , Estenose da Valva Mitral/terapia , Falha de Prótese , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/patologia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Feminino , Alemanha , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Trombose Intracraniana/etiologia , Trombose Intracraniana/patologia , Masculino , Pessoa de Meia-Idade , Estenose da Valva Mitral/diagnóstico por imagem , Estenose da Valva Mitral/patologia , Desenho de Prótese , Retratamento , Resultado do Tratamento
15.
EuroIntervention ; 11(13): 1530-6, 2016 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-25751886

RESUMO

AIMS: To assess outcomes of TAVR as a rescue therapy in patients with cardiogenic shock due to acutely decompensated aortic stenosis. METHODS AND RESULTS: Of 771 high-risk patients who underwent TAVR, 27 (3.5%; 78±9 years; 12 men) were treated emergently due to acutely decompensated aortic stenosis with cardiogenic shock. SAPIEN and CoreValve prostheses were implanted in 11 and 16 patients, respectively: the transfemoral access route was used in 25. Three patients died within 72 hours of successful valve deployment, and a further six died within a month, giving a 30-day mortality of 33.3%, which was significantly higher than in electively treated patients (7.7%, p<0.0001). Univariate predictors of 30-day mortality in cardiogenic-shock patients were baseline cardiac output <3.0 l/min, reduced cardiac power index, impaired renal function, and mechanical ventilation, as well as severe acute kidney injury after TAVR. Estimated one-year survival was 59.3% in emergently and 82.7% in electively treated patients (p=0.0009). However, 30-day landmark analysis showed no difference in cumulative survival between TAVR modalities. In cardiogenic-shock patients without concomitant reduced cardiac output and impaired renal function at baseline (n=22), estimated one-year survival was 72.7%. CONCLUSIONS: TAVR should be considered a reasonable rescue therapy in patients with cardiogenic shock secondary to decompensated aortic stenosis.


Assuntos
Estenose da Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Choque Cardiogênico/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/métodos , Feminino , Próteses Valvulares Cardíacas/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
16.
Clin Res Cardiol ; 105(1): 59-71, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26175117

RESUMO

BACKGROUND: Low-flow and low-gradient (LFLG) aortic stenosis (AS), which can occur with reduced or preserved left ventricular ejection fraction (LVEF), represents a challenging patient subset. Since outcomes in patients with LFLG AS are worse following surgical aortic valve replacement, we analyzed outcomes in patients after transcatheter aortic valve implantation (TAVI) in our large database. METHODS AND RESULTS: Among 841 treated patients, a total of 676 patients with complete dataset of invasive right- and left-sided hemodynamics were analyzed. Patients were subdivided into normal flow, high-gradient AS (NFHG: dPmean >40 mmHg, LVEF > 50%), paradoxical LFLG AS (PLFLG: dPmean ≤ 40 mmHg, LVEF > 50%, stroke volume index ≤ 35 ml/m(2)), and classical LFLG AS (CLFLG: dPmean ≤ 40 mmHg, LVEF ≤ 30%). Finally, global hemodynamics and patient outcomes and were compared. Patients with CLFLG AS had a higher prevalence of comorbidities and much higher logistic euro SCORE (35.8 ± 21.7) compared to PLFLG AS (20.0 ± 13.1) and NFHG AS (17.0 ± 11.9). Despite high procedural success rates in all groups, patients with CLFLG AS demonstrated a much higher 30-day and 1-year mortality (NFHG/PLFLG/CLFLG 30-day: 5.9/9.6/18.3 %; 1-year: 11.4/22.4/38.2%). Nevertheless, nearly all survivors demonstrated an improvement of functional capacity (NYHA class) and a decrease of NTproBNP levels during the follow-up. CONCLUSION: The higher mortality in patients with CLFLG AS reflects an advanced disease state, possibly indicating a futile condition before TAVI. Nevertheless, high procedural success rates and a functional improvement in nearly all survivors support the concept of TAVI.


Assuntos
Estenose da Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/métodos , Função Ventricular Esquerda/fisiologia , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/fisiopatologia , Feminino , Seguimentos , Hemodinâmica , Humanos , Masculino , Resultado do Tratamento
18.
JACC Cardiovasc Interv ; 8(5): 692-700, 2015 Apr 27.
Artigo em Inglês | MEDLINE | ID: mdl-25946442

RESUMO

OBJECTIVES: This study sought to investigate the prevalence of abnormal von Willebrand multimers (AbM) in patients undergoing transcatheter aortic valve replacement (TAVR) and the impact of TAVR on the underlying factor variances. BACKGROUND: An association between the acquired von Willebrand syndrome (aVWS) and valvular aortic stenosis (AS) has been established in the past and surgical aortic valve replacement (SAVR) shown to lead to factor recovery. Prevalence and course of AbM in patients treated with TAVR though has not yet been described comprehensively. METHODS: Ninety-five consecutive patients underwent TAVR at our institution. Hemostaseologic testing was performed before and up to 1 week after TAVR. Transvalvular and right heart hemodynamics as well as bleeding episodes were recorded and analyzed with descriptive statistics. RESULTS: Baseline prevalence of AbM was 42% with an average high-molecular-weight multimer (HMWM) count of 16.2 ± 3.3%. Pressure gradients correlated significantly with the extent of HMWM deficiency (r = -0.63 [p < 0.0001]). Following valve implantation, HMWM increased proportional to the drop in mean pressure gradient and normalized in most of the patients. However, residual aortic regurgitation/leakage led to inferior HMWM recovery but prosthesis-patient mismatch (PPM) was rare and left HMWM uninfluenced. We saw no association of transfusion with AbM and 1-year mortality was unaffected by AbM. CONCLUSIONS: AbM in patients with AS undergoing TAVR is frequent. However, TAVR is capable of correcting AbM and therefore possibly aVWS in patients with AS. As opposed to SAVR, bleeding and transfusion requirement in TAVR patients was not associated with severe HMWM deficiency; PPM was rare and HMWM were uninfluenced by the procedure. Aortic regurgitation after TAVR adversely influenced HMWM recovery.


Assuntos
Estenose da Valva Aórtica/terapia , Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Doenças de von Willebrand/terapia , Idoso , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/fisiopatologia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Feminino , Alemanha/epidemiologia , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Hemodinâmica , Humanos , Masculino , Prevalência , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Doenças de von Willebrand/sangue , Doenças de von Willebrand/diagnóstico , Doenças de von Willebrand/epidemiologia
19.
J Invasive Cardiol ; 27(5): 229-36, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25929299

RESUMO

BACKGROUND: We compare the feasibility and outcomes of "off-label" transcatheter aortic valve implantation (TAVI) patients with a standard "on-label" TAVI population. METHODS: A total of 591 high-risk patients (pts) underwent a TAVI procedure at our institution. Of these, 435 pts (73.6%) were treated for an on-label indication (group A) and 156 pts (26.4%) were treated for an off-label indication (group B). Group B was further subdivided into patients with pure aortic regurgitation (n = 22; group B.1), anatomical considerations (n = 26; group B.2), very low ejection fraction ≤20% (n = 12; group B.3), concomitant severe mitral regurgitation >2+ (n = 44; group B.4), degenerated aortic bioprosthesis (n = 30; group B.5), and hemodynamic instability with the need for cardiopulmonary bypass (n = 22; group B.6). Outcome parameters were classified according to the Valve Academic Research Consortium-2 criteria. RESULTS: The mean log EuroSCORE of the entire study group was 25 ± 16% (33 ± 21% in group B vs 22 ± 14% in group A; P<.001). Overall device success was 90% (91.3% in group A vs 86.5% in group B; P=.02). Overall 30-day mortality was 9.7%. Group B had a higher 30-day mortality compared with group A (14.7% vs 7.8%, respectively; P=.01). Group B.5 had the lowest 30-day mortality (3.3%). CONCLUSION: Corresponding to the higher surgical risk of group B, 30-day mortality was higher for off-label pts. Patients treated as valve-in-valve had the lowest 30-day mortality, emphasizing its great potential as opposed to redo open-heart surgery.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/métodos , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Masculino , Seleção de Pacientes , Desenho de Prótese , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
20.
Int J Cardiol ; 178: 275-81, 2015 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-25464269

RESUMO

AIMS: Transcatheter aortic valve implantation (TAVI) is an accepted alternative for patients with severe aortic valve stenosis who cannot undergo surgery. Acute kidney injury (AKI) is a serious complication in any invasive cardiovascular intervention. The objectives of the study were to determine (i) the influence of kidney function before TAVI and (ii) the impact of changes in kidney function after TAVI, including acute kidney injury (AKI), on mortality. METHODS AND RESULTS: A total of 540 patients undergoing TAVI were included. Patients were divided into three groups according to glomerular filtration rate (GFR) before TAVI (A: normal renal function i.e. GFR ≥60ml/min; B: impaired renal function i.e. GFR 30-59ml/min; C: severe impaired renal function i.e. GFR <30ml/min). Multivariate analysis showed a significant impact of GFR on mortality (p<0.0008). Subgroup analysis showed significant differences between the groups in 30-day (A: 5.4%, B: 9.0%, C: 25.0%) and 12-month mortality (A: 15.0%, B: 32.0%, C: 49%). Patients who had an increase in GFR after TAVI by more than 22% (p=0.0068) had an improved survival rate, whereas a decrease in GFR by more than 15% was associated with an increased mortality rate (p=0.0051). AKI occurred in 30 patients (5.6%), of which 22 patients (73.3%) died within 12months. CONCLUSION: Outcome is significantly related to pre-procedural kidney function. In addition, changes in kidney function after TAVI have a significant impact on mortality. Due to a very poor prognosis in patients with AKI, any effort to prevent this serious complication after TAVI needs to be taken.


Assuntos
Injúria Renal Aguda/mortalidade , Estenose da Valva Aórtica/mortalidade , Rim/fisiologia , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/mortalidade , Injúria Renal Aguda/diagnóstico , Injúria Renal Aguda/etiologia , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Feminino , Humanos , Masculino , Estudos Retrospectivos , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/tendências , Resultado do Tratamento
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