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1.
Circulation ; 139(16): 1865-1871, 2019 04 16.
Artigo em Inglês | MEDLINE | ID: mdl-30732456

RESUMO

BACKGROUND: The 30-day and 1-year follow-up analysis of the GOPCABE trial (German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients) revealed no significant difference in the composite end point consisting of death, stroke, myocardial infarction, new renal replacement therapy, or repeat revascularization. The 5-year follow-up data of this trial are reported here. METHODS: From June 2008 to September 2011, a total of 2539 patients aged ≥75 years were randomly assigned to undergo off-pump or on-pump coronary artery bypass grafting (CABG) at 12 centers in Germany. The primary outcome was all-cause mortality at 5 years. The secondary 5-year outcomes were a composite of death, myocardial infarction, and repeat revascularization. Furthermore, the impact of complete versus incomplete revascularization was assessed. RESULTS: After a median follow-up of 5 years, 361 patients (31%) assigned to off-pump CABG and 352 patients (30%) assigned to on-pump CABG had died (hazard ratio off-pump/on-pump CABG, 1.03; 95% CI, 0.89-1.19; P=0.71). The composite outcome of death, myocardial infarction, and repeat revascularization occurred in 397 (34%) after off-pump and in 389 (33%) after on-pump CABG (hazard ratio, 1.03; 95% CI, 0.89-1.18; P=0.704). Incomplete revascularization occurred in 403 (34%) patients randomly assigned to off-pump and 354 (29%) patients randomly assigned to on-pump CABG ( P<0.001). Five-year survival rates were 72% (95% CI, 67-76) with incomplete versus 76% (95% CI, 74-80) with complete revascularization (log-rank test: P=0.02) after off-pump CABG and 72% (95% CI, 67-76) versus 77% (95% CI, 74-80) after on-pump CABG (log-rank test: P=0.03), respectively. Cox regression analysis revealed a hazard ratio incomplete/complete revascularization of 1.19 (95% CI, 1.01-1.39; P=0.04). CONCLUSIONS: In elderly patients ≥75 years of age, the 5-year survival rates and the combined outcome of death, myocardial infarction, and repeat revascularization, as well, were similar after on-pump and off-pump CABG. Incomplete revascularization was associated with a lower 5-year survival rate, irrespective of the type of surgery. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00719667.


Assuntos
Ponte de Artéria Coronária , Coração Auxiliar , Infarto do Miocárdio/cirurgia , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Análise de Sobrevida , Fatores de Tempo , Resultado do Tratamento
2.
J Cardiovasc Electrophysiol ; 30(11): 2256-2261, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31559655

RESUMO

INTRODUCTION: Ablation index (AI), a novel parameter defining energy application at single ablation lesions, calculated by integration of ablation time, energy, catheter stability, and contact force, has been documented to be associated with effective lesions and higher ablation efficacy. Using a prespecified target AI in addition to acute lesion efficacy may affect local collateral damage like esophageal thermal injury when used for guiding radiofrequency (RF) ablation at the posterior left atrial (LA) wall. METHODS AND RESULTS: Consecutive patients undergoing first AF ablations using AI were included. Ablation energy was reduced to 25 W when ablating at posterior LA wall. Two different individually defined AI target values were used (300 and 350 for posterior wall ablation). Esophageal endoscopy (EE) was performed 1 to 3 days after ablation procedure to document and categorize endoscopically detected esophageal thermal lesion (EDEL). Two-hundred and eleven consecutive patients with postprocedural EE were included. Incidence of EDEL was 14% (29 of 211 patients; mild category 1 lesions in 22 of 29 patients (76%) and severe category 2 lesions (ulcers > 5 mm) in 7 of 29 patients (24% of EDEL group, 3% of total group). Ablation time at posterior LA wall (9.5 vs 9.0 minutes [P = .67]) was comparable in patients with and without EDEL. CONCLUSION: LA posterior wall RF ablation adopting AI ≤350 was associated with 14% esophageal thermal injury including 3% of severe esophageal thermal ulcers. This incidence is comparable to historic control groups with non AI-guided AF ablation.


Assuntos
Fibrilação Atrial/cirurgia , Queimaduras/epidemiologia , Ablação por Cateter/efeitos adversos , Esôfago/lesões , Temperatura Alta/efeitos adversos , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Queimaduras/diagnóstico , Queimaduras/tratamento farmacológico , Esofagoscopia , Esôfago/efeitos dos fármacos , Esôfago/patologia , Feminino , Alemanha/epidemiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Inibidores da Bomba de Prótons/administração & dosagem , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Cicatrização
3.
Thorac Cardiovasc Surg ; 66(6): 464-469, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29566406

RESUMO

BACKGROUND: Coronary artery bypass grafting (CABG) without cardiopulmonary bypass (off-pump CABG) may reduce severe adverse events including stroke. METHODS: In the German Off-Pump Coronary Artery Bypass Grafting in Elderly patients trial, the rate of major adverse cardiovascular events was compared in 2,394 elderly (≥ 75 years) patients undergoing CABG with (on-pump) or without (off-pump) cardiopulmonary bypass. This exploratory post-hoc analysis investigated the impact of surgical aortic manipulation on the rate of stroke. RESULTS: There was no significant difference in the rate of stroke within 30 days after surgery between both groups (off-pump: 2.2%; on-pump: 2.7%; odds ratio [OR]: 0.83 [0.5-1.38]; p = 0.47). Within the off-pump group, different degrees of aortic manipulation did not lead to significant different stroke rates (tangential clamping: 2.3%; OR 0.86 [0.46-1.60]; clampless device: 1.8%; OR 0.67 [0.26-1.75]; no aortic manipulation: 2.4%; OR 0.88 [0.37-2.14]). An aggregate analysis including more than 10,000 patients out of the four recent major trials also yielded comparable stroke rates for on- and off-pump CABG (off-pump: 1.4%; on-pump: 1.7%; OR 0.87 [0.64-1.20]). CONCLUSION: Within recent prospective randomized multicenter trials off-pump CABG did not result in lower stroke rates. The possible intrinsic benefit of off-pump CABG may be offset by the complexity of the operative therapy as well as the multiple pathomechanisms involved in perioperative stroke.


Assuntos
Ponte Cardiopulmonar/efeitos adversos , Ponte de Artéria Coronária sem Circulação Extracorpórea/efeitos adversos , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Projetos de Pesquisa , Acidente Vascular Cerebral/etiologia , Fatores Etários , Idoso , Ponte Cardiopulmonar/mortalidade , Distribuição de Qui-Quadrado , Ponte de Artéria Coronária/métodos , Ponte de Artéria Coronária/mortalidade , Ponte de Artéria Coronária sem Circulação Extracorpórea/mortalidade , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Feminino , Alemanha , Humanos , Masculino , Razão de Chances , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Fatores de Tempo , Resultado do Tratamento
4.
Catheter Cardiovasc Interv ; 90(2): 313-320, 2017 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-27649934

RESUMO

OBJECTIVES: We sought to determine the effects of experience on the Mitraclip® procedure steps as well as procedure safety and functional results. BACKGROUND: MR has proven deleterious in heart failure. Mitraclip® therapy evolved an important option in patients with severely reduced left ventricular function (LVEF). METHODS: Between 2011 and 2016, 126 consecutive patients were grouped in three groups and investigated in a prospective observational study. We evaluated the duration of procedural steps, safety endpoints, and functional results. RESULTS: The median logistic EuroScore was 32% (7-40%). Ninety-five percent of patients were in NYHA-stage ≥III and 51% had a LVEF <30%. Groups were homogeneous as to their baseline NYHA status and right heart catheterization data. Echocardiography data are comparable, albeit with a decreasing effective regurgitant orifice area (0.44 ± 0.21 group I vs. 0.34 ± 0.22 group III, P = 0.02). Frailty was less frequent and baseline 6 min walking test results improved from group I to group III. Duration of a first clip placement decreased from 106 ± 50 to 50 ± 21 min (P < 0.001). Total procedure time decreased from 221 ± 70 to 144 ± 68 (P < 0.001). The number of clips implanted increased from 66 to 79 (P = 0.02). MitraClip® implantation was effective in either group but the combined safety endpoint was reached less frequent in group III (P = 0.01). There was no difference in MACCE rate, 30 day- or intrahospital-mortality between groups. CONCLUSION: Safety and duration of procedure steps improved substantially with experience. MR reduction was sustained from the beginning without further improvement. Patient selection is a key factor for success. © 2016 Wiley Periodicals, Inc.


Assuntos
Cateterismo Cardíaco/instrumentação , Competência Clínica , Insuficiência Cardíaca/terapia , Insuficiência da Valva Mitral/terapia , Valva Mitral/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Distribuição de Qui-Quadrado , Ecocardiografia , Tolerância ao Exercício , Feminino , Alemanha , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Humanos , Curva de Aprendizado , Modelos Logísticos , Masculino , Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/fisiopatologia , Estudos Prospectivos , Recuperação de Função Fisiológica , Fatores de Risco , Volume Sistólico , Fatores de Tempo , Resultado do Tratamento , Função Ventricular Esquerda , Teste de Caminhada
5.
Catheter Cardiovasc Interv ; 90(6): 1038-1045, 2017 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-28568427

RESUMO

OBJECTIVES: This study sought to investigate whether the percutaneous mitral regurgitation (MR) reduction with the MitraClip® system in end-stage heart failure patients with a left ventricular ejection fraction (LVEF) of <20% also effects beneficial outcome or whether the underlying myogenic problem is leading and therefore of prognostic relevance. BACKROUND: The interventional treatment of functional mitral regurgitation (FMR) with the MitraClip® system could improve the clinical and hemodynamic outcome in patients with severely impaired left ventricular function. MATERIALS AND METHODS: Between 2011 and 2016, a total of 147 patients with FMR were treated with MitraClip® at our institution. The cohort was divided into two groups: LVEF ≥ 20% (N = 126) and <20% (N = 21). Follow-up assessments included exercise capacity, 6-min walk test, probrain natriuretic peptide-measurement (ProBNP), echocardiography and right heart catheterization. Only three patients with an LVEF ≥ 20% and one patient with an LVEF < 20% were lost for follow-up. RESULTS: In the vast majority of patients, a reduction from severe to mild MR was demonstrated with no difference between both groups (P = 0.422). At follow-up, both subgroups experienced similar improvements in exercise capacity and hemodynamics. Patients with an LVEF < 20% were on average 5.8 years younger, while mortality rates were comparable in both groups (P = 0.760). CONCLUSION: By careful selection, even patients in the end stage of advanced LV dysfunction as the result of the underlying myogenic problem and the additional harmful effects of the high volume loading due to the FMR can exhibit significant clinical and hemodynamic improvement after MitraClip© therapy.


Assuntos
Cateterismo Cardíaco/métodos , Procedimentos Cirúrgicos Cardíacos/instrumentação , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Volume Sistólico/fisiologia , Instrumentos Cirúrgicos , Função Ventricular Esquerda/fisiologia , Idoso , Angiografia , Ecocardiografia , Desenho de Equipamento , Feminino , Seguimentos , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/diagnóstico , Insuficiência da Valva Mitral/fisiopatologia , Prognóstico , Estudos Retrospectivos , Índice de Gravidade de Doença
6.
N Engl J Med ; 368(13): 1189-98, 2013 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-23477657

RESUMO

BACKGROUND: The benefits of coronary-artery bypass grafting (CABG) without cardiopulmonary bypass in the elderly are still undetermined. METHODS: We randomly assigned patients 75 years of age or older who were scheduled for elective first-time CABG to undergo the procedure either without cardiopulmonary bypass (off-pump CABG) or with it (on-pump CABG). The primary end point was a composite of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy at 30 days and at 12 months after surgery. RESULTS: A total of 2539 patients underwent randomization. At 30 days after surgery, there was no significant difference between patients who underwent off-pump surgery and those who underwent on-pump surgery in terms of the composite outcome (7.8% vs. 8.2%; odds ratio, 0.95; 95% confidence interval [CI], 0.71 to 1.28; P=0.74) or four of the components (death, stroke, myocardial infarction, or new renal-replacement therapy). Repeat revascularization occurred more frequently after off-pump CABG than after on-pump CABG (1.3% vs. 0.4%; odds ratio, 2.42; 95% CI, 1.03 to 5.72; P=0.04). At 12 months, there was no significant between-group difference in the composite end point (13.1% vs. 14.0%; hazard ratio, 0.93; 95% CI, 0.76 to 1.16; P=0.48) or in any of the individual components. Similar results were obtained in a per-protocol analysis that excluded the 177 patients who crossed over from the assigned treatment to the other treatment. CONCLUSIONS: In patients 75 years of age or older, there was no significant difference between on-pump and off-pump CABG with regard to the composite outcome of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy within 30 days and within 12 months after surgery. (Funded by Maquet; GOPCABE ClinicalTrials.gov number, NCT00719667.).


Assuntos
Ponte de Artéria Coronária sem Circulação Extracorpórea , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/cirurgia , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/mortalidade , Feminino , Seguimentos , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Infarto do Miocárdio/etiologia , Complicações Pós-Operatórias , Modelos de Riscos Proporcionais , Qualidade de Vida , Insuficiência Renal/etiologia , Reoperação/estatística & dados numéricos , Acidente Vascular Cerebral/etiologia
7.
J Heart Valve Dis ; 25(4): 475-482, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-28009952

RESUMO

BACKGROUND: Functional mitral regurgitation (FMR) is common in patients with advanced heart failure and impaired left ventricular function. The study aim was to examine functional and hemodynamic effects at three months after MitraClip® implantation in high-risk surgical patients with FMR. METHODS: A group of 93 patients was rejected for surgical treatment by heart-team decisions due to an inacceptable risk for conventional mitral valve surgery. Between October 2011 and May 2015, 89 of these patients (96%) were treated successfully with MitraClip implantation. A subsequent complete follow up was performed over three months in 32 patients with FMR, including pro-brain natriuretic peptide (pro-BNP) measurements, six-minute walk test, echocardiography, and right heart catheterization. RESULTS: The patients (mean age 73 ± 7 years) presented with a mean left ventricular ejection fraction (LVEF) of 32 ± 13%, and mitral regurgitation (MR) grade ≥3 in 30 of 32 cases (93%). All patients suffered from severe FMR and were highly symptomatic (NYHA functional class III or IV). The mean logistic EuroSCORE was 33%. MitraClip implantation resulted in a significant clinical improvement and reverse cardiac remodelling with a decrease in LV end-diastolic and LV endsystolic diameters, while LVEF was unchanged. In addition, a statistically relevant reduction of systolic, diastolic and mean pulmonary artery pressures (PAPsystolic -7.2 mmHg, p = 0.011; PAPdiastolic -4.5 mmHg, p = 0.003; and PAPmean -5.3 mmHg, p = 0.007) were measured, while the cardiac index (+0.3 l/min/m2, p <0.001) and cardiac output (+0.5 l/min, p <0.001) were increased significantly. The 30-day mortality was 8.6% (n = 8). CONCLUSIONS: Among the study population, MitraClip implantation led to clinical improvement, reverse cardiac remodeling, and a sustained hemodynamic benefit during the three-month follow up period.


Assuntos
Insuficiência Cardíaca/complicações , Implante de Prótese de Valva Cardíaca/instrumentação , Hemodinâmica , Insuficiência da Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/cirurgia , Idoso , Feminino , Seguimentos , Insuficiência Cardíaca/fisiopatologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Mortalidade Hospitalar , Humanos , Masculino , Insuficiência da Valva Mitral/etiologia , Instrumentos Cirúrgicos , Resultado do Tratamento , Disfunção Ventricular Esquerda/fisiopatologia , Remodelação Ventricular
8.
Sci Rep ; 13(1): 889, 2023 01 17.
Artigo em Inglês | MEDLINE | ID: mdl-36650206

RESUMO

Comprehensive data on factors influencing left atrial appendage (LAA) thrombus formation, resolution and impact on survival are limited. In this single-center, retrospective study 7759 (2010-2015) patients with symptomatic ongoing atrial fibrillation (AF) on admission were screened for LAA thrombi. 450 patients had LAA thrombi. 481 patients without LAA thrombi were randomly selected as controls. We assessed clinical, echocardiographic, laboratory parameters and long-term survival of both groups. Patients with LAA thrombi compared to controls were older, had more strokes, higher CHA2DS2 -VASc scores, worse renal function, less controlled diabetes, advanced heart failure, lower LAA emptying velocities, higher levels of cardiac and inflammatory markers (all p < 0.001). 56.3% of followed-up patients (304) dissolved their LAA thrombi. Chances of thrombus resolution increased with rising LAA flow velocities (OR 1.061, p = 0.022), whereas advanced age (OR 0.950, p < 0.001) and presence of permanent AF (OR 0.354, p < 0.001) decreased chances of thrombus resolution. Presence of LAA thrombi was associated with a markedly reduced 10-year survival probability (31% versus 69%). LAA thrombus formation is promoted by advanced structural heart disease, inflammation, diabetes and impaired renal function. Younger age, non-permanent AF and higher LAA flow velocities were predictors of thrombus resolution. Thrombus formation was associated with poor prognosis.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Cardiopatias , Trombose , Humanos , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/complicações , Ecocardiografia Transesofagiana , Prognóstico , Estudos Retrospectivos
9.
Hellenic J Cardiol ; 2023 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-37611868

RESUMO

OBJECTIVES: This study aimed to analyze the incidence, surgical management of major vascular complications, and outcomes in patients undergoing transfemoral (TF) transcatheter aortic valve replacement (TAVR) at our center after strict selection of the access route, carefully considering all known major predictors. METHODS: Data of 494 consecutive patients with pre-interventional multi-slice computed tomography (CT) of the aorta who had undergone TF TAVR from 2009 to 2019 were analyzed. RESULTS: In total, 23/494 (4.7%) patients had major vascular and access-related complications of peripheral vessels and/or infrarenal aorta. These included hematomas that met the Valve Academic Research Consortium 3-criteria of major vascular complications (7/494, 1.4%), arterial dissections (3/494, 0.6%), pseudoaneurysm (6/494, 1.2%), thrombus of the external iliac artery leading to acute limb ischemia (1/494, 0.2%), fistula (1/494, 0.2%), and perforation (5/494, 1.0%). In total, 17/23 (73.9%) major vascular complications required immediate endovascular and/or open surgery. In 16/17 (94%) cases, only 1 surgical procedure was performed. The long-term survival of patients with and without major vascular complications of the peripheral vessels was determined after 2 years. CONCLUSIONS: Early vascular surgery intervention reversed the mortality disadvantage in patients with major complications of the peripheral vessels after TAVR. This underscores the importance of immediate vascular surgery stand-by as an indispensable requirement.

10.
Eur J Cardiothorac Surg ; 62(5)2022 10 04.
Artigo em Inglês | MEDLINE | ID: mdl-35385074

RESUMO

OBJECTIVES: We evaluate the mid-term results of mitral valve (MV) repair with patch augmentation of the posterior leaflet in secondary mitral regurgitation. METHODS: Patients were included after diagnosis of a severe symptomatic secondary MV insufficiency with grade III and IV according to the Carpentier classification IIIb. Indication for a patch augmentation technique was a dilatation of the left ventricle leading to a displacement of the papillary muscles, causing restricted leaflet motion and a marked leaflet tenting height. Data were collected prospectively between December 2011 and March 2020. RESULTS: In total, 174 patients (mean age: 65 ± 12 years) received an MV repair with patch augmentation of the posterior leaflet and a true-sized remodelling annuloplasty (mean size 30.8 mm). Causes of the MV incompetence were dilatative cardiomyopathy in 126 patients and ischaemic myocardial disease in 48 patients. Concomitant bypass surgery was performed in 28 patients, and the tricuspid valve was repaired in 68 patients. The mean follow-up was 40 ± 28.2 months. There was no 30-day mortality. In-hospital mortality was 1.2% (n = 2); late mortality was 10.9% (n = 19). At 8 years, overall survival was 62.48%, freedom from moderate or severe recurrent mitral regurgitation was 91.9% and freedom from reoperation due to MV insufficiency was 97.1%. CONCLUSIONS: Augmentation of the posterior MV leaflet in addition to remodelling annuloplasty is a safe and reproducible mitral reconstruction technique that renders sustainable MV competence.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Anuloplastia da Valva Mitral , Insuficiência da Valva Mitral , Humanos , Pessoa de Meia-Idade , Idoso , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Músculos Papilares/cirurgia , Procedimentos Cirúrgicos Cardíacos/métodos , Valva Tricúspide , Dilatação Patológica , Resultado do Tratamento , Anuloplastia da Valva Mitral/métodos
11.
Hellenic J Cardiol ; 65: 8-14, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35231607

RESUMO

OBJECTIVES: The PASCAL device is a transcatheter edge-to-edge repair system (TEER) for treatment of mitral regurgitation (MR). The PASCAL Ace as a newer version of the PASCAL device consists of a thinner profile without a spacer. The aim of the study was to examine the functional and hemodynamic outcome after TEER with the PASCAL Ace device in a real-world cohort. METHODS: Between September 2020 and August 2021, all consecutive patients with MR 3+/4+ treated percutaneously with PASCAL Ace were included in this study. Primary endpoints included successful device implantation, device success, improvement of exercise capacity, quality of life, and a composite of all-cause mortality, non-fatal stroke, myocardial infarction, new need for renal replacement therapy or severe bleeding at 30 days and 5 month. RESULTS: 49/66 patients had a functional etiology. Overall success rate was 98.5%. At follow-up, 84.7% of the patients had MR grade ≤ 1. TEER was associated with an improvement of LV ejection fraction (45% to 53%, p = 0.048). 86.5% were in NYHA class I or II. 6-minute-walking distance improved by 79m (p = 0.009). Kansas City Cardiomyopathy Questionnaire (KCCQ) improved by 19 points (p = 0.012). NT-proBNP levels decreased from 4832 to 2137 pg/dl (p = 0.003). Mean pulmonary capillary wedge pressures improved from 21 to 15mmHg (p = 0.001). At 5 month, a total of 3 patients died, none of cardiovascular cause. CONCLUSION: PASCAL Ace is safe and effective in treating MR, resulting in a sustained MR reduction, a reverse cardiac remodelling, improvement of exercise capacity, quality of life, NT-proBNP levels and hemodynamics at follow-up.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Hemodinâmica , Humanos , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/cirurgia , Qualidade de Vida , Resultado do Tratamento
13.
J Heart Valve Dis ; 20(3): 313-8, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21714423

RESUMO

BACKGROUND AND AIM OF THE STUDY: Thrombocytopenia after implantation of the Sorin Freedom Solo (FS) stentless aortic bioprosthesis has been described previously. Thus, relevant data acquired at the authors' institution were analyzed. METHODS: A comparison of platelet counts was made in patients operated on between January and August 2008 following implantation of either the FS valve (n = 26) or a stented pericardial prosthesis (n = 238). Thrombocyte levels were measured before surgery and on days 0, 1, 2, 3, 5 and 7 after surgery; a comparison was made using absolute and hematocrit-adjusted platelet counts. Clinical adverse events were investigated in both groups, and a multivariate analysis was performed to identify predictors for the occurrence of thrombocytopenia. RESULTS: After implantation of the FS valve, the mean absolute and hematocrit-adjusted platelet counts were significantly lower on days 2, 3, 5 and 7 after surgery. An additional decrease occurred between days 1 and 3 after surgery, but this was not associated with any adverse clinical outcome. Independent determinants for thrombocytopenia were age and the type of aortic prosthesis. Postoperative echocardiography revealed lower gradients after FS valve implantation. CONCLUSION: Given the superior hemodynamic performance of the FS valve, and the absence of any adverse effects, implantation with this valve may be justified in selected patients. Further clarification of the mechanisms causing thrombocytopenia is required.


Assuntos
Valva Aórtica/cirurgia , Bioprótese , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Trombocitopenia/etiologia , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Feminino , Alemanha , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hematócrito , Humanos , Modelos Lineares , Masculino , Seleção de Pacientes , Contagem de Plaquetas , Desenho de Prótese , Medição de Risco , Fatores de Risco , Trombocitopenia/sangue , Trombocitopenia/diagnóstico , Fatores de Tempo , Ultrassonografia
14.
Clin Res Cardiol ; 110(5): 628-639, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-32845361

RESUMO

AIMS: To examine the functional and hemodynamic mid-term outcome at 5 months of mitral regurgitation (MR) reduction using the PASCAL repair system. METHODS AND RESULTS: Between July 2019 and February 2020 31 consecutive patients with MR 3 +/4 + (mean age 77.5 years, all in New York Heart Association (NYHA) class III-IV, STS score 9.1 ± 7.4) underwent MR reduction in our institute using the PASCAL device. 61.3% had a functional, 29.0% a degenerative, and 9.7% a mixed etiology. Successful implantation was achieved in 30/31 (96.8%) patients. 27/31 patients (87.1%) completed 5-month follow-up with clinical, echocardiographic, laboratory and hemodynamic assessment. At 5 months, 70.4% of the patients had MR grade ≤ 1 (p < 0.001). 85.2% were in NYHA class I or II (p < 0.001). Six-minute walk distance improved by 145 m (p = 0.010), Kansas City cardiomyopathy questionnaire and European quality of life 5 dimensions questionnaire (EQ5D) improved by 31 (p < 0.001) and 9 points (p = 0.001), respectively. Mean pulmonary capillary wedge pressure decreased significantly from 22.1 ± 9 mmHg to 17.3 ± 8 mmHg (p = 0.041) and right atrial pressure from 10.3 ± 6 mmHg to 8.0 ± 6 mmHg (p = 0.013) from baseline to 5 months. In addition, propensity score matching showed that PASCAL and MitraClip procedures resulted in equally hemodynamic and functional improvement. CONCLUSION: MR reduction of severe MR with the PASCAL device is feasible and safe regardless of etiologies. Mid-term follow-up at 5 months showed a sustained MR reduction, improvement of exercise capacity, quality of life, proBNP levels and hemodynamics regarding pulmonary capillary wedge pressure and right atrial pressure.


Assuntos
Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Pressão Arterial/fisiologia , Tolerância ao Exercício , Feminino , Seguimentos , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/instrumentação , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Pressão Propulsora Pulmonar/fisiologia , Qualidade de Vida , Inquéritos e Questionários
15.
J Cardiol ; 78(6): 577-585, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34479788

RESUMO

BACKGROUND: The PASCAL system (Edwards Lifescience, Irvine, CA, USA) is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of our study was to examine the functional and hemodynamic outcome after repair of functional (FMR) and degenerative mitral regurgitation (DMR) using the PASCAL system in a real-world setting. METHODS: A total 92 consecutive patients with symptomatic MR 3+/4+ were treated in our institute using the PASCAL device. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days and 7 months. RESULTS: 68.5% had a functional and 31.5% a degenerative etiology. Overall success rate was achieved in 97.8% patients (98.4% FMR, 96.6% DMR). At follow-up, 85.7% of the patients (89.2% FMR, 78.3% DMR) had MR grade ≤ 1. 96.4% (97.4% FMR, 94.4% DMR) were in New York Heart Association class I or II. Six-minute walking distance improved by 96 m (92 m FMR, 106 m DMR), Kansas City Cardiomyopathy Questionnaire improved by 19 points (19 points FMR, 19 points DMR). Pro-B-type natriuretic peptide (proBNP) levels decreased from 4673 to 2179 pg/dl (5239-2018 pg/ml FMR, 3418-2530 pg/ml DMR) and mean pulmonary capillary wedge pressure from 21 to 16 mmHg (21-17 mmHg FMR, 19-13 mmHg DMR). At 30 days, there was 1 cardiovascular death (1.2%) with DMR. At 1 year, Kaplan-Meier survival was 86% (86% FMR, 86% DMR). CONCLUSIONS: Severe MR can successfully and safely be treated with the PASCAL device regardless of etiologies. This interventional approach resulted in a sustained MR reduction, improvement in exercise capacity, quality of life, proBNP levels, and hemodynamics in FMR and DMR at follow-up.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemodinâmica , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/cirurgia , Qualidade de Vida , Resultado do Tratamento
16.
J Thorac Cardiovasc Surg ; 159(4): 1176-1184.e1, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31128903

RESUMO

OBJECTIVES: To evaluate long-term results after valve-sparing surgery of acutely dissected aortic root in which a restoration of root anatomy adjusted to the existing aortic annulus diameter, rather than any kind of downsizing, was performed. METHODS: Among 286 consecutive patients operated on because of type A aortic dissection during the last 17 years were 100 patients (35.0%), mean age 63 ± 13 years (range, 29-88 years), in whom an anatomical restoration of the involved root was performed. Twenty-eight patients presented with severe (3+ or 4+), 37 with mild to moderate (2+), and 24 with mild (1+) insufficiency. In 5 patients, the valve was bicuspid. In all patients, a curative root repair with replacement of all dissected aortic wall was performed, containing a selective replacement of pathologic/dissected aortic sinuses, which were 1, 2, or all 3 sinuses in 62, 32, and 6 patients, respectively. Concomitant cusp repair was necessary in 18 patients. RESULTS: Thirty-day mortality was 1.0%. Survival was estimated starting with surgery and was 89.4 ± 3.4% (95% confidence interval, 80.5-94.4) and 68.8 ± 6.4% (95% confidence interval, 54.4-79.5) at 5 and 12 years, respectively. No patient required reoperation on the aortic root and/or valve during the follow-up period of 70 ± 50 (range, 3-202) months. A freedom from any aortic valve/root reintervention and/or relevant (>2+) aortic insufficiency at 12 years was 100%. CONCLUSIONS: Selective replacement of pathologic sinuses offers an anatomophysiological albeit curative restoration of acutely dissected aortic root resulting in excellent and durable outcomes in selected patients with acute aortic dissection.


Assuntos
Aneurisma da Aorta Torácica/cirurgia , Dissecção Aórtica/cirurgia , Valva Aórtica/cirurgia , Procedimentos de Cirurgia Plástica/métodos , Procedimentos Cirúrgicos Vasculares/métodos , Doença Aguda , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Taxa de Sobrevida , Resultado do Tratamento
17.
J Cardiol ; 75(2): 134-139, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31474498

RESUMO

BACKGROUND: Nonagenarians are at increased risk for morbidity and mortality after transcatheter aortic valve replacement (TAVR) based solely on their age. The aim of our study was to evaluate survival of nonagenarians with severe aortic valve stenosis (AS) after TAVR as compared to an age- and sex-matched general population. METHODS: From 2009 to 2017, 1052 consecutive patients ≥80 years scheduled for TAVR were included. Patients were divided into three groups depending on their age at the time of the procedure: 80-84 (Group 1), 85-89 (Group 2) and ≥90 years (Group 3). Survival of patients treated with TAVR was compared to the life expectancy of an age- and sex-matched cohort in the general population. RESULTS: Nonagenarians were more likely to experience major access-site complications than their younger counterparts (7.6% Group 1 vs. 10.1% Group 2 vs. 17.6% Group 3, p=0.016). One-year mortality in nonagenarians was higher as compared to the general population (27.8% vs. 20.0%). After two years, the mortality curves between the TAVR patients and the general population converged (39.2% vs. 37.5%) and were lower after five years. CONCLUSIONS: During the observation period of five years, carefully selected nonagenarians treated with TAVR had at least the same mortality rate as an age- and sex-matched general population after two years despite procedure-associated complications. The negative prognostic impact of the severe AS was completely eliminated by TAVR.


Assuntos
Estenose da Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/mortalidade , Feminino , Humanos , Masculino , Prognóstico
18.
Eur J Cardiothorac Surg ; 57(6): 1122-1129, 2020 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-32011670

RESUMO

OBJECTIVES: There is an ongoing discussion about how to treat coronary stents during bypass surgery: Should patent stents be left alone and the stented vessels be ungrafted, or should every stented coronary artery receive a bypass graft? This study aims to determine the relevance of perioperative stent stenosis or occlusion on postoperative outcomes up to 3 years postoperatively. METHODS: Patients undergoing coronary artery bypass grafting surgery (CABG) (±concomitant procedures) with previous percutaneous coronary intervention from 4 centres were prospectively included in this observatory study between April 2015 and June 2017. A coronary angiography was conducted between the fifth and seventh postoperative days. The preoperative and postoperative angiograms were assessed in a core laboratory, assessing the patencies of coronary stents and bypass grafts. The core lab investigators were blinded to the patients' characteristics and perioperative course. RESULTS: A total of 107 patients were included in the study. In the postoperative coronary angiography, 265 bypass grafts and 189 coronary stents were examined angiographically. Ninety-seven percent of preoperatively patent stents remained patent. New coronary stent stenoses were observed in 5 patients (4.7%). All 5 patients were asymptomatic and managed conservatively. Bypass stenoses were observed in 12 patients (11%), of whom were managed conservatively, 4 underwent percutaneous coronary intervention and 1 underwent redo-CABG. Two years postoperatively, 97% of patients were alive. Patients with new stent stenosis tended to have a better survival compared with patients with bypass stenosis (100% vs 73%; P = 0.09) up to 3 years postoperatively. CONCLUSIONS: Perioperative coronary stent stenosis occurs rarely. It is safe to leave a patently stented coronary vessel without bypass grafting.


Assuntos
Estenose Coronária , Intervenção Coronária Percutânea , Constrição Patológica , Angiografia Coronária , Ponte de Artéria Coronária/efeitos adversos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Stents , Resultado do Tratamento
19.
Eur J Cardiothorac Surg ; 55(4): 744-750, 2019 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-30418538

RESUMO

OBJECTIVES: Transapical transcatheter aortic valve implantation (TAVI) is associated with increased mortality as compared to the transfemoral (TF) access. Possible mechanisms include different patient risk profiles as well as an intrinsic injury caused by the access route itself. METHODS: All consecutive patients scheduled for TAVI between January 2009 and June 2016 at a single centre were evaluated. A comparison of 30-day mortality and morbidity rates for patients undergoing TF or transapical (TA) TAVI was performed according to the criteria of the Valve Academic Research Consortium 2. RESULTS: During the investigated period, 1130 patients (TF: n = 619, TA: n = 511) were scheduled for TAVI. TA patients had a higher operative risk profile (logistic EuroSCORE: 24% vs 17%; P < 0.001). Unadjusted 30-day mortality rate was higher in TA than in TF patients, albeit this difference was not significant [TA: 6.7%, TF: 4.8%; odds ratio (OR) 1.3 (0.8-2.3); P = 0.216]. The multivariate logistic regression analysis revealed the logistic EuroSCORE and institutional experience, but not the access mode as independent predictors of 30-day mortality. Major access-site complications occurred with a similar frequency in both groups [TA: 9.4%; TF: 9.2%; OR 1.02 (0.68-1.53); P = 0.915]. Unadjusted long-term mortality rate was higher after TA TAVI. After adjustment, the Cox regression analysis revealed similar long-term mortality rates after TF and TA TAVI [hazard ratio 1.1 (0.88-1.36)]. CONCLUSIONS: The increased mortality of patients undergoing TA TAVI is associated with the patient risk profile and the institutional experience but not with the access mode itself.


Assuntos
Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
20.
Ann Thorac Surg ; 108(1): 115-121, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30690022

RESUMO

BACKGROUND: The aim of the study was to evaluate operative and long-term results after acute type A aorta dissection (AAAD) operation, in which complete resection of all dissected aortic segments (curative repair) was achieved. METHODS: Among 205 consecutive patients operated on between 2002 and 2014 because of AAAD were 88 patients (42.9%), in whom the dissection did not extend into the downstream aorta. The distal extension of the dissection ended before the origin of the innominate artery in 50 patients of the study cohort (56.8%) or extended throughout the arch, necessitating a total/subtotal arch replacement to achieve a curative distal repair in 38 remaining patients (43.2%). The aortic root was involved in 52 patients (59.1%) and was repaired using valve-sparing repair (31) or replacement with a valve composite graft (21). Combination of root and open arch surgery was reported in 46 patients (52.3%). RESULTS: Thirty-day and in-hospital mortalities were 3.4% and 5.7%, respectively. Survival was estimated starting with the operation and was 81.9% ± 4.5% and 56.6% ± 8.7% at 5 and 10 years, respectively. No patient required reoperation on the aortic root and/or distal thoracoabdominal aorta; however 2 cardiac reoperations were unrelated to the primary surgical procedure. Moreover, the freedom of aortic and/or sudden/unknown death was 100%. CONCLUSIONS: Curative aortic repair can be achieved in a relevant share of AAAD patients and is mostly limited by the distal extension of dissection. This kind of repair is advisable, whenever possible, because it can provide very low risk of aortic complications and/or reoperations over time.


Assuntos
Aorta/cirurgia , Aneurisma Aórtico/cirurgia , Dissecção Aórtica/cirurgia , Procedimentos Cirúrgicos Vasculares/métodos , Doença Aguda , Adulto , Idoso , Idoso de 80 Anos ou mais , Dissecção Aórtica/diagnóstico por imagem , Dissecção Aórtica/mortalidade , Aneurisma Aórtico/diagnóstico por imagem , Aneurisma Aórtico/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Morbidade , Reoperação , Estudos Retrospectivos , Técnicas de Sutura
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