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1.
EuroIntervention ; 2021 Oct 21.
Artigo em Inglês | MEDLINE | ID: mdl-34669586

RESUMO

BACKGROUND: Creatinine clearance (CrCl) is an independent determinant of mortality in predictive models of revascularisation outcomes for complex coronary artery disease. AIMS: This study aimed to investigate the impact of preprocedural biological markers on 10-year mortality following coronary revascularisation. METHODS: The SYNTAX Extended Survival (SYNTAXES) study evaluated the 10-year vital status follow-up of 1,800 patients with de novo three-vessel (3VD) and/or left main coronary artery disease (LMCAD) randomised to include percutaneous or surgical coronary revascularisation. The associations between mortality and preprocedural C-reactive protein (CRP), haemoglobin, HbA1c, CrCl, fasting triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol were analysed. RESULTS: Out of 1,800 patients, 460 patients died before the 10-year follow-up. CRP, HbA1c and CrCl with threshold values of ≥2 mg/L, ≥6% (42 mmol/mol) and <60 ml/min, respectively, were associated with 10-year all-cause death (adjusted hazard ratio [95% confidence interval]: 1.35 [1.01-1.82], 1.51 [1.16-1.95], and 1.46 [1.07-2.00], respectively). There was no significant interaction between the biological markers on all-cause mortality and the type of revascularisation. Preprocedural lipid markers were not significantly associated with 10-year all-cause death, but the non-use of statins was a determinant factor of worse prognosis (adjusted confidence interval [95% confidence interval]: 1.68 [1.26-2.25]). CONCLUSIONS: Preprocedural biomarkers, such as CRP and HbA1c, are associated with long-term mortality post revascularisation, regardless of the revascularisation technique. Conventional lipidic biomarkers associated with high-risk of cardiovascular events seem to be effectively mitigated by the long-term use of statins, whereas the non-use of statins was a factor of a worse prognosis, emphasising the importance of pharmacological treatment. TRIAL REGISTRATION: SYNTAXES ClinicalTrials.gov reference: NCT03417050. SYNTAX ClinicalTrials.gov reference: NCT00114972.

2.
Int J Cardiol ; 341: 9-12, 2021 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-34375706

RESUMO

BACKGROUND: The significant interaction between major infection and 5-year mortality after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for complex coronary artery disease (CAD) was observed previously. However, the very long-term outcomes beyond 5 years remains unclear. METHODS AND RESULTS: This is a subgroup analysis of the SYNTAX Extended Survival (SYNTAXES) trial, which is the extended follow-up of the randomized SYNTAX trial comparing PCI versus CABG in patients with three-vessel disease (3VD) or left-main CAD (LMCAD). Out of 1517 patients enrolled in the SYNTAX trial with available survival status from 5 to 10 years, 140 patients had experienced major infections and survived at 5 years (major infection group). From 5 to 10 years, the mortality of major infection group was 19.8% whereas the mortality of no major infection group was 15.1% (p = 0.157). After the adjustment of other clinical factors, the risk of mortality from 5 to 10 years did not significantly differ between major infection and no major infection groups (HR: 1.10; 95% CI: 0.62-1.96; p = 0.740). When stratified by the presence or absence of periprocedural major infections, defined as a major infection within 60 days after index procedure, there was also no significant difference in 10-year mortality between two groups (30.8% vs. 24.5%; p = 0.057). CONCLUSIONS: Despite the initial association between major infections and 5 years mortality, postprocedural major infection was not evident in the 10 years follow-up, suggesting that the impact of major infection on mortality subsided over time beyond 5 years. TRIAL REGISTRATION: SYNTAXES ClinicalTrials.gov reference: NCT03417050 SYNTAX ClinicalTrials.gov reference: NCT00114972.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Ponte de Artéria Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Seguimentos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares
3.
J Am Coll Cardiol ; 78(4): 365-383, 2021 Jul 27.
Artigo em Inglês | MEDLINE | ID: mdl-34294272

RESUMO

Coronary artery bypass grafting (CABG) was introduced in the 1960s as the first procedure for direct coronary artery revascularization and rapidly became one of the most common surgical procedures worldwide, with an overall total of more than 20 million operations performed. CABG continues to be the most common cardiac surgical procedure performed and has been one of the most carefully studied therapies. Best CABG techniques, optimal bypass conduits, and appropriate patient selection have been rigorously tested in landmark clinical trials, some of which have resolved controversy and most of which have stoked further debate and trials. The evolution of CABG cannot be properly portrayed without presenting it in the context of the parallel development of percutaneous coronary intervention. In this Historical Perspective, we a provide a broad overview of the history of coronary revascularization with a focus on the foundations, evolution, best evidence, and future directions of CABG.

4.
J Am Coll Cardiol ; 77(22): 2761-2773, 2021 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-34082905

RESUMO

BACKGROUND: The optimal revascularization strategy for the elderly with complex coronary artery disease remains unclear. OBJECTIVES: The goal of this study was to investigate 10-year all-cause mortality, life expectancy, 5-year major adverse cardiac or cerebrovascular events (MACCE), and 5-year quality of life (QOL) after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in elderly individuals (>70 years old) with 3-vessel disease (3VD) and/or left main disease (LMD). METHODS: In the present pre-specified analysis on age of the SYNTAX Extended Survival study, 10-year all-cause death and 5-year MACCE were compared with Kaplan-Meier estimates and Cox proportional hazards models among elderly or nonelderly patients. Life expectancy was estimated by restricted mean survival time within 10 years, and QOL status according to the Seattle Angina Questionnaire up to 5 years was assessed by linear mixed-effects models. RESULTS: Among 1,800 randomized patients, 575 patients (31.9%) were elderly. Ten-year mortality did not differ significantly between PCI and CABG in elderly (44.1% vs. 41.1%; hazard ratio [HR]: 1.08; 95% confidence interval [CI]: 0.84 to 1.40) and nonelderly patients (21.1% vs. 16.6%; HR: 1.30; 95% CI: 1.00 to 1.69; pinteraction = 0.332). Among elderly patients, 5-year MACCE was comparable between PCI and CABG (39.4% vs. 35.1%; HR: 1.18; 95% CI: 0.90 to 1.56), whereas it was significantly higher in PCI over CABG among nonelderly patients (36.3% vs. 23.0%; HR: 1.69; 95% CI: 1.36 to 2.10; pinteraction = 0.043). There were no significant difference in life expectancy (mean difference: 0.2 years in favor of CABG; 95% CI: -0.4 to 0.7) and 5-year QOL status between PCI and CABG among elderly patients. CONCLUSIONS: Elderly patients with 3VD and/or LMD had comparable 10-year all-cause death, life expectancy, 5-year MACCE, and 5-year QOL status irrespective of revascularization mode. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050) (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).


Assuntos
Ponte de Artéria Coronária/mortalidade , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea/mortalidade , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/mortalidade , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Humanos , Expectativa de Vida , Masculino , Pessoa de Meia-Idade , América do Norte/epidemiologia , Qualidade de Vida
5.
Catheter Cardiovasc Interv ; 98(3): E379-E387, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33951265

RESUMO

OBJECTIVES: We investigated the impact of total stent length (TSL) and average nominal stent diameter (ASD) on 10-year mortality after percutaneous coronary intervention (PCI) in the SYNTAXES trial. BACKGROUND: TSL and ASD in patients treated with PCI are associated with major adverse cardiovascular events. However, the treatment effect of PCI with extensive and/or small stenting as compared with coronary artery bypass grafting (CABG) for complex coronary artery disease has not been fully evaluated. METHODS: Impacts on mortality of extensive stenting defined as TSL >100 mm and small stenting as ASD <3 mm were analyzed in 893 PCI patients and were compared to 865 CABG patients. RESULTS: TSL as a continuous variable was significantly associated with 10-year mortality (adjusted hazard ratio [HR], 1.05 [1.01-1.09] per 10 mm increase). PCI patients with extensive stenting had a higher 10 year mortality than CABG patients (adjusted HR, 1.97 [1.41-2.74]) or not- extensive stenting PCI (adjusted HR, 1.94 [1.36-2.77]). Although ASD did not have a significant association with 10 year mortality (adjusted HR, 0.97 [0.85-1.11] per 0.25 mm increase), PCI with small stents was associated with a higher 10 year mortality, compared to CABG (adjusted HR, 1.66 [1.23-2.26]) and PCI performed with large stents (adjusted HR, 1.74 [1.19-2.53]). Patients treated with not-extensive and large stents had similar mortality rates (24.0 versus 23.8%) as those treated with CABG. CONCLUSIONS: Extensive and small stenting were associated with higher 10 year mortality, compared with CABG. When patients have to be treated with extensive or small stenting, revascularization with CABG should be preferred.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Stents , Resultado do Tratamento
6.
Clin Res Cardiol ; 110(7): 1083-1095, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33710385

RESUMO

AIMS: To evaluate the impact of chronic obstructive pulmonary disease (COPD) on 10-year all-cause death and the treatment effect of CABG versus PCI on 10-year all-cause death in patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) and COPD. METHODS: Patients were stratified according to COPD status and compared with regard to clinical outcomes. Ten-year all-cause death was examined according to the presence of COPD and the revascularization strategy. RESULTS: COPD status was available for all randomized 1800 patients, of whom, 154 had COPD (8.6%) at the time of randomization. Regardless of the revascularization strategy, patients with COPD had a higher risk of 10-year all-cause death, compared with those without COPD (43.1% vs. 24.9%; hazard ratio [HR]: 2.03; 95% confidence interval [CI]: 1.56-2.64; p < 0.001). Among patients with COPD, CABG appeared to have a slightly lower risk of 10-year all-cause death compared with PCI (42.3% vs. 43.9%; HR: 0.96; 95% CI: 0.59-1.56, p = 0.858), whereas among those without COPD, CABG had a significantly lower risk of 10-year all-cause death (22.7% vs. 27.1%; HR: 0.81; 95% CI: 0.67-0.99, p = 0.041). There was no significant differential treatment effect of CABG versus PCI on 10-year all-cause death between patients with and without COPD (p interaction = 0.544). CONCLUSIONS: COPD was associated with a higher risk of 10-year all-cause death after revascularization for complex coronary artery disease. The presence of COPD did not significantly modify the beneficial effect of CABG versus PCI on 10-year all-cause death. TRIAL REGISTRATION: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.

7.
Eur J Cardiothorac Surg ; 60(1): 48-55, 2021 07 14.
Artigo em Inglês | MEDLINE | ID: mdl-33538301

RESUMO

OBJECTIVES: Minimally invasive staged segmental artery (SA) coil- and plug embolization is a new method for paraplegia prevention associated with extensive aortic procedures. Near-infrared spectroscopy of the paraspinal collateral network (cnNIRS) has emerged as a non-invasive method for spinal cord monitoring. The aim of this study was to evaluate cnNIRS to guide minimally invasive SA occlusion. METHODS: In a chronic large animal experiment, 18 juvenile pigs underwent two-stage minimally invasive staged SA coil- and plug embolization for complete SA occlusion. Coil-embolization was performed either by SA main stem occlusion (characteristic of pig anatomy) or separately for the left- and right SA. Lumbar cnNIRS was recorded during and after the procedure. Neurological status was assessed up to 3 days after complete SA occlusion. RESULTS: Mean time from SA coil embolization to minimum cnNIRS values was 11 ± 5 min with an average decrease from 101 ± 2% to 78 ± 8% of baseline (difference: -23 ± 9, P < 0.001). Lumbar cnNIRS demonstrated significant differences between left and right when SAs were occluded separately in all cases (-7 ± 4%, 1 min after first SA occlusion; P = 0.001). Permanent paraplegia occurred in 2 (11%) and any kind of neurological deficit-temporary or permanent-in 7 animals (39%). Association between lumbar cnNIRS and neurological outcome after minimally invasive staged SA coil- and plug embolization suggests positive correlation (R = 0.5, P = 0.052). CONCLUSIONS: Lumbar cnNIRS independently reacts to unilateral SA occlusion. cnNIRS-guided SA occlusion is feasible and may become a useful adjunct facilitating adequate and complete vessel occlusion.


Assuntos
Aneurisma da Aorta Torácica , Embolização Terapêutica , Procedimentos Endovasculares , Isquemia do Cordão Espinal , Animais , Aorta , Espectroscopia de Luz Próxima ao Infravermelho , Suínos , Resultado do Tratamento
8.
J Am Coll Cardiol ; 76(14): 1622-1639, 2020 10 06.
Artigo em Inglês | MEDLINE | ID: mdl-33004127

RESUMO

BACKGROUND: Numerous definitions for peri-procedural myocardial infarction (PMI) following percutaneous coronary intervention (PCI) and coronary bypass grafting (CABG) surgery exist. OBJECTIVES: The purpose of this study was to investigate the PMI rates according to various definitions, their clinically relevant association with all-cause mortality at 10 years, and their impact on composite endpoints at 5 years in the SYNTAXES (Synergy between PCI with Taxus and Cardiac Surgery Extended Survival) trial. METHODS: PMI was classified as a myocardial infarction occurring within 48 h of the procedure according to definitions of the SYNTAX (TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries), ISCHEMIA (International Study Of Comparative Health Effectiveness With Medical And Invasive Approaches), and EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trials; the Fourth Universal Definition of MI; and the Society for Cardiovascular Angiography and Interventions (SCAI). Of the 1,800 patients enrolled, 1,652 with creatine kinase and/or creatine kinase-myocardial band (CK-MB) post-procedure were included. The association between PMI and mortality was analyzed by Cox regression. RESULTS: PMI rates according to the SYNTAX and Fourth Universal Definition of MI, both of which required CK-MB elevation and electrocardiographic evidence of permanent myocardial damage, were 2.7% and 3.0%, respectively, in the PCI arm versus 2.4% and 2.1%, respectively, in the CABG arm. PMI rates according to the SCAI or EXCEL definition were higher in the PCI (5.7%) and CABG (16.5%) arms. PMIs according to the SYNTAX and Fourth Universal Definition of MI were more strongly associated with mortality than EXCEL and SCAI PMIs defined by isolated enzyme elevation when CK-MB was more than 10 times ULN. The impact of these "enzyme-driven events" on time-to-event curves and the composite endpoints was greater in the surgical cohort. PMIs after PCI were associated with 10-year mortality regardless of definition, whereas their impact on mortality after CABG was limited to 1 year. CONCLUSIONS: The rates of PMI are highly dependent on their definition, which affects time-to-event curves, composite endpoints, and their lethal prognostic relevance. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).


Assuntos
Ponte de Artéria Coronária/mortalidade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/mortalidade , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/tendências , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Feminino , Seguimentos , Humanos , Masculino , Mortalidade/tendências , Infarto do Miocárdio/diagnóstico , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/tendências , Complicações Pós-Operatórias/diagnóstico , Resultado do Tratamento
9.
J Am Coll Cardiol ; 76(8): 889-899, 2020 08 25.
Artigo em Inglês | MEDLINE | ID: mdl-32819461

RESUMO

BACKGROUND: The poorer prognosis of coronary artery disease in females compared with males is related mainly to differences in baseline characteristics. In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, the effect of treatment with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting surgery (CABG) on mortality at 5 years differed significantly between females and males; however, the optimal revascularization beyond 5 years according to sex has not been evaluated. OBJECTIVES: The aim of this study was to investigate the impact of sex on mortality and sex-treatment interaction at 10 years. METHODS: The SYNTAXES (SYNTAX Extended Survival) study evaluated vital status up to 10 years in 1,800 patients with de novo 3-vessel and/or left main coronary artery disease randomized to treatment with PCI or CABG in the SYNTAX trial. All-cause death at 10 years was separately evaluated in female and male patients with complex coronary artery disease. RESULTS: Of 1,800 patients, 402 (22.3%) were female and 1,398 (77.7%) were males. Females had a higher 10-year mortality rate compared with males (32.8% vs. 24.7%; log-rank p = 0.002), but female sex was not an independent predictor of mortality (adjusted hazard ratio: 1.02; 95% confidence interval: 0.76 to 1.36). Mortality at 10 years tended to be lower after CABG than after PCI, with a similar treatment effect for female and male patients (adjusted hazard ratio for females: 0.90 [95% confidence interval: 0.54 to 1.51]; adjusted hazard ratio for males: 0.76 [95% confidence interval: 0.56 to 1.02]; p for interaction = 0.952). CONCLUSIONS: Female sex was not an independent predictor of mortality at 10 years in patients with complex coronary artery disease. The interaction between sex and treatment with PCI or CABG that was observed at 5 years was no longer present at 10 years. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972).


Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Efeitos Adversos de Longa Duração/mortalidade , Intervenção Coronária Percutânea , Fatores Sexuais , Idoso , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Feminino , Humanos , Efeitos Adversos de Longa Duração/diagnóstico , Efeitos Adversos de Longa Duração/etiologia , Masculino , Pessoa de Meia-Idade , Mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Prognóstico , Fatores de Risco
10.
Int J Cardiol ; 300: 80-86, 2020 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-31740140

RESUMO

BACKGROUND: The use of bioprostheses for surgical aortic valve replacement increased substantially within the last years. In case of prosthesis failure, re-SAVR is standard of care, whereas valve-in-valve deployment of a transfemoral transcatheter aortic valve prosthesis (VinV-TFAVI) has recently emerged as an alternative. We sought to evaluate early safety, clinical efficacy, and all-cause 1-year-mortality of VinV-TFAVI and redo surgery for failing aortic bioprostheses (re-SAVR). METHODS AND RESULTS: Patients receiving either VinV-TFAVI (n = 147) or re-SAVR (n = 111) for a degenerated aortic bioprosthesis between 01/2006 and 05/2017 were included in this analysis. All-cause 1-year mortality was the primary outcome measure. Early safety and clinical efficacy according to VARC-2 endpoint definitions were evaluated at 30 days. Baseline characteristics differed significantly between both groups including age, STS-PROM, and incidence of relevant comorbidities. Re-stenosis was the predominant mode of failure in 45.9% of re-SAVR and 63.1% of VinV-TFAVI patients. The rate of "early safety" endpoints was lower with VinV-TFAVI (17.7% vs. 64.9%, p < 0.01), the rate of "clinical efficacy" endpoints was lower, e.g. better with re-SAVR (53.1% vs. 32.4%, p < 0.01). All-cause 1-year-mortality (VinV-TFAVI 8.8% vs re-SAVR 9.9%, p = 0.84) was not different. Treatment strategy was not associated with 1-year-mortality in a Cox regression analysis. The incidence of prosthesis-patient-mismatch was higher in VinV-TFAVI compared to re-SAVR. CONCLUSION: VinV-TFAVI represents a viable alternative for treatment of degenerated aortic bioprostheses in patients at increased surgical risk. However, in patients at low risk for reoperation, a better clinical efficacy and acceptable safety may favour re-SAVR.


Assuntos
Estenose da Valva Aórtica/cirurgia , Bioprótese/normas , Artéria Femoral/cirurgia , Próteses Valvulares Cardíacas/normas , Falha de Prótese , Reoperação/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Bioprótese/tendências , Estudos de Coortes , Feminino , Próteses Valvulares Cardíacas/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Falha de Prótese/tendências , Reoperação/tendências , Substituição da Valva Aórtica Transcateter , Falha de Tratamento , Resultado do Tratamento
11.
Eur J Cardiothorac Surg ; 56(1): 126-134, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-30668733

RESUMO

OBJECTIVES: Minimally invasive staged segmental artery coil- and plug embolization (MIS2ACE) has been introduced for spinal cord injury prevention prior to open or endovascular thoraco-abdominal aortic aneurysm repair. To date, no optimal pattern has been developed. The aim of this study was to identify the optimal MIS2ACE occlusion pattern. METHODS: Twenty-five juvenile pigs were randomly assigned to 3 MIS2ACE occlusion patterns (2 stages) and a control group [single-stage segmental artery (SA) occlusion, N = 7]. The first pattern started with occlusion of all lumbar segmental arteries in the first stage and the remaining thoracic arteries in the second stage (regional pattern, N = 6). In group 2, an alternating approach with occlusion of every other SA in the first stage and the remainder in the second stage was used (alternating pattern, N = 6). The third pattern started with occluding the watershed area between thoracic level 12 and lumbar level 2 in the first stage and the remaining arteries in the second stage (watershed pattern, N = 6). Neurological assessment at 6-h intervals and spinal cord tissue perfusion measurements via microspheres at 6 time points were performed. At the end of the experiments, the spinal cord was histopathologically examined. RESULTS: An average of 6 ± 2 coils were used per SA. In the control group a total of 57% (N = 4) of animals experienced permanent paraplegia, 1 animal (16%) of the alternating and watershed intervention group suffered from permanent paraplegia. Animals from the staged regional pattern did not experience permanent paraplegia. Furthermore, no evidence of significant tissue damage was observed (P < 0.05 vs control). Tissue perfusion of the lumbar spinal cord in the regional pattern group recovered within 3 days after the second stage to 89.2 ± 47 percent-of-baseline (P = 0.393), whereas mean perfusion of the other 2 intervention groups and the control remained significantly lower compared to the baseline (35.7 ± 16%, 30.2 ± 11% and 63.2 ± 19, P < 0.05). CONCLUSIONS: This study provides evidence that MIS2ACE (minimally invasive staging) may result in less ischaemic spinal cord injury and favourable neurological outcomes compared to complete (1 stage) SA occlusion. A regional-based occlusion pattern (starting with the lumbar segmental arteries) seems to be the best 2-stage approach.


Assuntos
Aorta/cirurgia , Embolização Terapêutica , Procedimentos Cirúrgicos Minimamente Invasivos , Animais , Aneurisma Aórtico/cirurgia , Modelos Animais de Doenças , Embolização Terapêutica/efeitos adversos , Embolização Terapêutica/métodos , Feminino , Região Lombossacral/irrigação sanguínea , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Paraplegia/prevenção & controle , Complicações Pós-Operatórias/prevenção & controle , Isquemia do Cordão Espinal/prevenção & controle , Suínos
12.
J Thorac Cardiovasc Surg ; 158(1): 155-164.e5, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30686484

RESUMO

OBJECTIVE: Ischemic spinal cord injury remains the most devastating complication after open and endovascular aortic repair. Collateral network near-infrared spectroscopy has been introduced to noninvasively monitor real-time spinal cord oxygenation. In view of recent advancements in endovascular treatment and minimally invasive staged preconditioning before aortic repair, this study sought to evaluate collateral network near-infrared spectroscopy during and after segmental artery occlusion in a chronic porcine model. METHODS: Surgery for segmental artery occlusion was performed in 12 juvenile pigs, and bilateral lumbar collateral network near-infrared spectroscopy was recorded. Two intervention groups were designed: Group 1 received subtotal segmental artery occlusion (mimicking reimplantation of crucial segmental arteries with patent T12/T13, N = 5), and group 2 received total occlusion (T4-L5, N = 7). Pigs were monitored over 3 days. RESULTS: All animals were paraplegic during the first 24 hours. The subtotal occlusion group completely recovered, whereas 57% of the total occlusion group remained paraplegic (N = 4/7). After segmental artery occlusion, collateral network near-infrared spectroscopy decreased from 92.3% ± 8% of baseline to 69.3% ± 18% after 10 minutes in the subtotal group (P = .003-.017) and from 90.1% ± 4% to 58.2% ± 9% in the total group (P < .001-.008). Throughout the postoperative period, collateral network near-infrared spectroscopy in the total occlusion group remained lower compared with the subtotal group (<30% baseline threshold, P < .05). Lumbar collateral network near-infrared spectroscopy and neurologic outcome were significantly correlated (R = 0.7, P < .001). CONCLUSIONS: Lumbar collateral network near-infrared spectroscopy reacts to occlusion of segmental arteries and correlates with neurologic outcome. The preliminary data suggest that collateral network near-infrared spectroscopy may be a valuable noninvasive tool for detecting imminent spinal cord ischemia during and after aortic procedures involving segmental artery occlusion.


Assuntos
Aorta Torácica/cirurgia , Circulação Colateral , Espectroscopia de Luz Próxima ao Infravermelho , Medula Espinal/diagnóstico por imagem , Animais , Aneurisma da Aorta Torácica/cirurgia , Circulação Colateral/fisiologia , Modelos Animais de Doenças , Feminino , Vértebras Lombares , Monitorização Intraoperatória/métodos , Paraplegia/etiologia , Espectroscopia de Luz Próxima ao Infravermelho/métodos , Medula Espinal/irrigação sanguínea , Medula Espinal/metabolismo , Medula Espinal/patologia , Suínos
13.
Clin Res Cardiol ; 108(1): 39-47, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29943273

RESUMO

BACKGROUND: Diabetes mellitus (DM) is a risk factor for cardiovascular disease. However, its effect on procedural and follow-up performance after transcatheter aortic valve replacement (TAVR) remains controversial. METHODS AND RESULTS: We performed an observational study of all consecutive patients treated with a transfemoral TAVR in a single-center cohort (n = 1818). All patients were stratified by diabetes status and gender. All-cause 3-year mortality was the primary endpoint. Male patients with DM were identified to have substantially increased 3-year mortality [125/314 (39.8%)] compared to males without DM [142/478 (29.7%), p < 0.01]. Male patients with DM had significantly higher 3-year mortality in comparison to female patients with (p < 0.01) or without DM (p < 0.01). There was no difference in 3-year mortality for female patients with [135/465 (29.0%)] and without DM [151/554 (27.3%); p = 0.70]. This increase in mortality in male DM patients was triggered by both cardiovascular and non-cardiovascular mortality. Furthermore, DM served as an independent predictor of 3-year mortality after TAVR selectively only in men. The interaction between male gender and diabetes mellitus was identified as an independent predictor of 3-year mortality [HR 1.88 (1.25; 2.82); p < 0.01]. DM did not affect 30-day mortality for the overall cohort and for males. CONCLUSION: Males with DM are a high-risk subgroup of patients after TAVR and require close medical attention including aggressive therapy of modifiable risk factors. Intensified diabetes management may improve long-term survival after TAVR.


Assuntos
Estenose da Valva Aórtica/cirurgia , Diabetes Mellitus/mortalidade , Medição de Risco/métodos , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/mortalidade , Causas de Morte/tendências , Feminino , Seguimentos , Alemanha/epidemiologia , Humanos , Masculino , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Distribuição por Sexo , Fatores Sexuais , Taxa de Sobrevida/tendências , Fatores de Tempo
14.
Europace ; 21(1): 73-79, 2019 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-29444219

RESUMO

Aims: Results of catheter based interventional treatment for pulmonary vein stenosis (PVS) following radiofrequency ablation (RFA) for atrial fibrillation remain suboptimal. Surgical repair may represent an alternative therapy, though long-term results have not been thoroughly investigated. Methods and results: We retrospectively assessed all patients in our centre undergoing surgical repair for radiofrequency-induced PVS. Data regarding surgical technique, clinical outcome, and rate of pulmonary vein (PV) restenosis were collected and analysed. Between 2004 and 2016, the rate for PVS resulting from RFA for atrial fibrillation in our institution was 0.79% (76/9633). During this period, five male patients with multiple PVS (3 ± 1) underwent surgical repair of a total of 13 symptomatic PVS. Surgery was performed in a standard setting under cardiopulmonary bypass. Stenotic veins were incised longitudinally followed by a patch augmentation plasty using either bovine pericard (n = 7) or polytetrafluoroethylene (PTFE) patches (n = 5). Localization of incision was on the anterior side of the PV only (n = 8) or on both the anterior and posterior sides (n = 4). In one PVS lesion, mechanical dilatation was sufficient. Long-term follow-up after 60 ± 69 months revealed an average restenosis rate of 38%. Restenosis was defined as narrowing >70%. All patients reported clinical improvement of symptoms at follow-up. Conclusion: Even in the era of wide circumferential lesions, PVS still occurs. While surgical PV patch plasty represents a valuable treatment option, restenosis remains an issue during follow-up. Nevertheless, surgical repair achieves highly acceptable long-term results for RFA-acquired PVS. Hence, it should be routinely discussed as a therapeutic option in cases with multiple PVS.


Assuntos
Fibrilação Atrial/cirurgia , Implante de Prótese Vascular , Ablação por Cateter/efeitos adversos , Veias Pulmonares/cirurgia , Pneumopatia Veno-Oclusiva/cirurgia , Adulto , Anticoagulantes/administração & dosagem , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Bioprótese , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Xenoenxertos , Humanos , Masculino , Pessoa de Meia-Idade , Pericárdio/transplante , Politetrafluoretileno , Veias Pulmonares/fisiopatologia , Pneumopatia Veno-Oclusiva/diagnóstico por imagem , Pneumopatia Veno-Oclusiva/etiologia , Pneumopatia Veno-Oclusiva/fisiopatologia , Recidiva , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
15.
Circulation ; 138(23): 2611-2623, 2018 12 04.
Artigo em Inglês | MEDLINE | ID: mdl-30571255

RESUMO

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used for treatment of severe aortic valve stenosis in patients at intermediate risk for surgical aortic valve replacement (SAVR). Currently, real-world data comparing indications and clinical outcomes of patients at intermediate surgical risk undergoing isolated TAVR with those undergoing SAVR are scarce. METHODS: We compared clinical characteristics and outcomes of patients with intermediate surgical risk (Society of Thoracic Surgeons score 4%-8%) who underwent isolated TAVR or conventional SAVR within the prospective, all-comers German Aortic Valve Registry. RESULTS: A total of 7613 patients at intermediate surgical risk underwent isolated TAVR (n=6469) or SAVR (n=1144) at 92 sites in Germany between 2012 and 2014. Patients treated by TAVR were significantly older (82.5±5.0 versus 76.6±6.7 years, P<0.001) and had higher risk scores (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 21.2±12.3% versus 14.2±9.5%, P<0.001; Society of Thoracic Surgeons score: 5.6±1.1 versus 5.2±1.0, P<0.001). Multivariable analyses revealed that advanced age, coronary artery disease, New York Heart Association class III/IV, pulmonary hypertension, prior cardiac decompensation, elective procedure, arterial occlusive disease, no diabetes mellitus, and a smaller aortic valve area were associated with performing TAVR instead of SAVR (all P<0.001). Unadjusted in-hospital mortality rates were equal for TAVR and SAVR (3.6% versus 3.6%, P=0.976), whereas unadjusted 1-year mortality was significantly higher in patients after TAVR (17.5% versus 10.8%, P<0.001). After propensity score matching, the difference in 1-year mortality between patients with TAVR and SAVR was no longer significant (17.1% versus 15.7%, P=0.59). CONCLUSIONS: Patients at intermediate risk undergoing TAVR differ significantly from those treated with SAVR with regard to age and baseline characteristics. Isolated TAVR and SAVR were associated with an in-hospital mortality rate of 3.6%. In the propensity score analysis, there was no significant difference in 1-year mortality between patients with TAVR and SAVR.


Assuntos
Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Feminino , Seguimentos , Alemanha , Mortalidade Hospitalar , Humanos , Estimativa de Kaplan-Meier , Masculino , Pontuação de Propensão , Sistema de Registros , Fatores de Risco , Resultado do Tratamento
16.
J Am Coll Cardiol ; 72(4): 386-398, 2018 07 24.
Artigo em Inglês | MEDLINE | ID: mdl-30025574

RESUMO

BACKGROUND: Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are used for coronary revascularization in patients with multivessel and left main coronary artery disease. Stroke is among the most feared complications of revascularization. Due to its infrequency, studies with large numbers of patients are required to detect differences in stroke rates between CABG and PCI. OBJECTIVES: This study sought to compare rates of stroke after CABG and PCI and the impact of procedural stroke on long-term mortality. METHODS: We performed a collaborative individual patient-data pooled analysis of 11 randomized clinical trials comparing CABG with PCI using stents; ERACI II (Argentine Randomized Study: Coronary Angioplasty With Stenting Versus Coronary Bypass Surgery in Patients With Multiple Vessel Disease) (n = 450), ARTS (Arterial Revascularization Therapy Study) (n = 1,205), MASS II (Medicine, Angioplasty, or Surgery Study) (n = 408), SoS (Stent or Surgery) trial (n = 988), SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial (n = 1,800), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) trial (n = 600), FREEDOM (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes) trial (n = 1,900), VA CARDS (Coronary Artery Revascularization in Diabetes) (n = 198), BEST (Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease) (n = 880), NOBLE (Percutaneous Coronary Angioplasty Versus Coronary Artery Bypass Grafting in Treatment of Unprotected Left Main Stenosis) trial (n = 1,184), and EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial (n = 1,905). The 30-day and 5-year stroke rates were compared between CABG and PCI using a random effects Cox proportional hazards model, stratified by trial. The impact of stroke on 5-year mortality was explored. RESULTS: The analysis included 11,518 patients randomly assigned to PCI (n = 5,753) or CABG (n = 5,765) with a mean follow-up of 3.8 ± 1.4 years during which a total of 293 strokes occurred. At 30 days, the rate of stroke was 0.4% after PCI and 1.1% after CABG (hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.20 to 0.53; p < 0.001). At 5-year follow-up, stroke remained significantly lower after PCI than after CABG (2.6% vs. 3.2%; HR: 0.77; 95% CI: 0.61 to 0.97; p = 0.027). Rates of stroke between 31 days and 5 years were comparable: 2.2% after PCI versus 2.1% after CABG (HR: 1.05; 95% CI: 0.80 to 1.38; p = 0.72). No significant interactions between treatment and baseline clinical or angiographic variables for the 5-year rate of stroke were present, except for diabetic patients (PCI: 2.6% vs. CABG: 4.9%) and nondiabetic patients (PCI: 2.6% vs. CABG: 2.4%) (p for interaction = 0.004). Patients who experienced a stroke within 30 days of the procedure had significantly higher 5-year mortality versus those without a stroke, both after PCI (45.7% vs. 11.1%, p < 0.001) and CABG (41.5% vs. 8.9%, p < 0.001). CONCLUSIONS: This individual patient-data pooled analysis demonstrates that 5-year stroke rates are significantly lower after PCI compared with CABG, driven by a reduced risk of stroke in the 30-day post-procedural period but a similar risk of stroke between 31 days and 5 years. The greater risk of stroke after CABG compared with PCI was confined to patients with multivessel disease and diabetes. Five-year mortality was markedly higher for patients experiencing a stroke within 30 days after revascularization.


Assuntos
Ponte de Artéria Coronária/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Complicações Pós-Operatórias , Acidente Vascular Cerebral , Idoso , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia
17.
Eur J Cardiothorac Surg ; 54(6): 1045-1051, 2018 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-29741604

RESUMO

OBJECTIVES: Our objective was to evaluate the impact of reimplantation techniques of the supra-aortic branches in total arch replacement on the rates of permanent neurological deficit (PND) and survival. METHODS: We identified patients enrolled in the ARCH registry who underwent total arch replacement between 2000 and 2015 with either en bloc or separate reimplantation of the supra-aortic branches. RESULTS: A total of 3345 patients were included in the present analysis. From this cohort, 686 patients underwent en bloc and 2659 patients had separate reimplantation of the supra-aortic branches. Propensity score analysis identified 461 matched patient pairs. In the matched cohort, there were no differences regarding the mortality rate (15.6% vs 15.7%, P = 0.710) or PND (9.2% vs 12.1%, P = 0.231). Although separate reimplantation of the supra-aortic branches was not associated with an increased mortality rate on multivariable logistic regression, it increased the risk of PND [odds ratio (OR) 1.56, 95% confidence interval (CI) 1.06-2.29; P = 0.023]. Propensity-adjusted regression confirmed these findings and found a similar risk for PND with separate reimplantation of the supra-aortic branches (OR 1.50, 95% CI 1.01-2.23; P = 0.047), although this significance was not found with conditional logistic regression (P = 0.20). No significant differences between survival were seen between the 2 matched cohorts (stratified log rank P = 0.35). CONCLUSIONS: Separate reimplantation of the supra-aortic branches in total arch replacement is a significant predictor of stroke in the overall group, although comparable stroke rates were observed in the matched cohort. The current trend towards separate reimplantation of supra-aortic branches may expose certain subgroups of patients to an increased risk of stroke, e.g. those with a high atherosclerotic burden.


Assuntos
Aorta Torácica/cirurgia , Implante de Prótese Vascular , Complicações Pós-Operatórias , Reoperação , Acidente Vascular Cerebral , Idoso , Aneurisma Dissecante/epidemiologia , Aneurisma Dissecante/mortalidade , Aneurisma Dissecante/cirurgia , Aneurisma da Aorta Torácica/epidemiologia , Aneurisma da Aorta Torácica/mortalidade , Aneurisma da Aorta Torácica/cirurgia , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/mortalidade , Implante de Prótese Vascular/estatística & dados numéricos , Intervalo Livre de Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Reoperação/efeitos adversos , Reoperação/instrumentação , Reoperação/mortalidade , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade
18.
J Am Heart Assoc ; 7(8)2018 04 13.
Artigo em Inglês | MEDLINE | ID: mdl-29654191

RESUMO

BACKGROUND: Impaired left ventricular (LV) ejection fraction is a common finding in patients with aortic stenosis and serves as a predictor of morbidity and mortality after transcatheter aortic valve replacement. However, conflicting data on the most accurate measure for LV function exist. We wanted to examine the impact of LV ejection fraction, mean pressure gradient, and stroke volume index on the outcome of patients treated by transcatheter aortic valve replacement. METHODS AND RESULTS: Patients treated by transcatheter aortic valve replacement were primarily separated into normal flow (NF; stroke volume index >35 mL/m2) and low flow (LF; stroke volume index ≤35 mL/m2). Afterwards, patients were divided into 5 groups: "NF-high gradient," "NF-low gradient" (NF-LG), "LF-high gradient," "paradoxical LF-LG," and "classic LF-LG." The 3-year mortality was the primary end point. Of 1600 patients, 789 (49.3%) were diagnosed as having LF, which was characterized by a higher 30-day (P=0.041) and 3-year (P<0.001) mortality. LF was an independent predictor of all-cause (hazard ratio, 1.29; 95% confidence interval, 1.03-1.62; P=0.03) and cardiovascular (hazard ratio, 1.37; 95% confidence interval, 1.06-1.77; P=0.016) mortality. Neither mean pressure gradient nor LV ejection fraction was an independent predictor of mortality. Patients with paradoxical LF-LG (35.0%), classic LF-LG (35.1%) and LF-high gradient (38.1%) had higher all-cause mortality at 3 years compared with NF-high gradient (24.8%) and NF-LG (27.9%) (P=0.001). However, surviving patients showed a similar improvement in symptoms regardless of aortic stenosis entity. CONCLUSIONS: LF is a common finding within the aortic stenosis population and, in contrast to LV ejection fraction or mean pressure gradient, an independent predictor of all-cause and cardiovascular mortality. Despite increased long-term mortality, high procedural success and excellent functional improvement support transcatheter aortic valve replacement in patients with LF severe aortic stenosis.


Assuntos
Estenose da Valva Aórtica/mortalidade , Valva Aórtica/cirurgia , Ventrículos do Coração/fisiopatologia , Volume Sistólico/fisiologia , Substituição da Valva Aórtica Transcateter/métodos , Função Ventricular Esquerda/fisiologia , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Ecocardiografia , Feminino , Seguimentos , Alemanha/epidemiologia , Ventrículos do Coração/diagnóstico por imagem , Humanos , Masculino , Estudos Retrospectivos , Índice de Gravidade de Doença , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento
19.
J Am Coll Cardiol ; 71(13): 1417-1428, 2018 04 03.
Artigo em Inglês | MEDLINE | ID: mdl-29598861

RESUMO

BACKGROUND: Surgical aortic valve replacement using conventional biological valves (CBVs) is the standard of care for treatment of old patients with aortic valve disease. Recently, rapid deployment valves (RDVs) have been introduced. OBJECTIVES: The purpose of this study was to report the nationwide German experience concerning RDVs for treatment of aortic valve stenosis and provide a head-to-head comparison with CBVs. METHODS: A total of 22,062 patients who underwent isolated surgical aortic valve replacement using CBV or RDV between 2011 and 2015 were enrolled into the German Aortic Valve Registry. Baseline, procedural, and in-hospital outcome parameters were analyzed for CBVs and RDVs using 1:1 propensity score matching. Furthermore, 3 RDVs were compared with each other. RESULTS: A total of 20,937 patients received a CBV, whereas 1,125 patients were treated with an RDV. Patients treated with an RDV presented with significantly reduced procedure (160 min [25th to 75th percentile: 135 to 195 min] vs. 150 min [25th to 75th percentile: 127 to 179 min]; p < 0.001), cardiopulmonary bypass (83 min [25th to 75th percentile: 68 to 104 min] vs. 70 min [25th to 75th percentile: 56 to 87 min]; p < 0.001), and aortic cross clamp times (60 min [25th to 75th percentile: 48 to 75 min] vs. 44 min [25th to 75th percentile: 35 to 57 min]; p < 0.001), but showed significantly elevated rates of pacemaker implantation (3.7% vs. 8.8%; p < 0.001) and disabling stroke (0.9% vs. 2.2%; p < 0.001), whereas in-hospital mortality was similar (1.7% vs. 2.2%; p = 0.22). These findings persisted after 1:1 propensity score matching. Comparison of the 3 RDVs revealed statistically nonsignificant different pacemaker rates and significantly different post-operative transvalvular gradients. CONCLUSIONS: In this large, all-comers database, the incidence of pacemaker implantation and disabling stroke was higher with RDVs, whereas no beneficial effect on in-hospital mortality was seen. The 3 RDVs presented different complication profiles with regard to pacemaker implantation and transvalvular gradients. (German Aortic Valve Registry [GARY]; NCT01165827).


Assuntos
Estenose da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/cirurgia , Bioprótese , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Desenho de Prótese/instrumentação , Idoso , Estenose da Valva Aórtica/diagnóstico por imagem , Feminino , Alemanha/epidemiologia , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Estudos Prospectivos , Desenho de Prótese/métodos , Sistema de Registros , Fatores de Tempo
20.
Lancet ; 391(10124): 939-948, 2018 03 10.
Artigo em Inglês | MEDLINE | ID: mdl-29478841

RESUMO

BACKGROUND: Numerous randomised trials have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) for patients with coronary artery disease. However, no studies have been powered to detect a difference in mortality between the revascularisation strategies. METHODS: We did a systematic review up to July 19, 2017, to identify randomised clinical trials comparing CABG with PCI using stents. Eligible studies included patients with multivessel or left main coronary artery disease who did not present with acute myocardial infarction, did PCI with stents (bare-metal or drug-eluting), and had more than 1 year of follow-up for all-cause mortality. In a collaborative, pooled analysis of individual patient data from the identified trials, we estimated all-cause mortality up to 5 years using Kaplan-Meier analyses and compared PCI with CABG using a random-effects Cox proportional-hazards model stratified by trial. Consistency of treatment effect was explored in subgroup analyses, with subgroups defined according to baseline clinical and anatomical characteristics. FINDINGS: We included 11 randomised trials involving 11 518 patients selected by heart teams who were assigned to PCI (n=5753) or to CABG (n=5765). 976 patients died over a mean follow-up of 3·8 years (SD 1·4). Mean Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score was 26·0 (SD 9·5), with 1798 (22·1%) of 8138 patients having a SYNTAX score of 33 or higher. 5 year all-cause mortality was 11·2% after PCI and 9·2% after CABG (hazard ratio [HR] 1·20, 95% CI 1·06-1·37; p=0·0038). 5 year all-cause mortality was significantly different between the interventions in patients with multivessel disease (11·5% after PCI vs 8·9% after CABG; HR 1·28, 95% CI 1·09-1·49; p=0·0019), including in those with diabetes (15·5% vs 10·0%; 1·48, 1·19-1·84; p=0·0004), but not in those without diabetes (8·7% vs 8·0%; 1·08, 0·86-1·36; p=0·49). SYNTAX score had a significant effect on the difference between the interventions in multivessel disease. 5 year all-cause mortality was similar between the interventions in patients with left main disease (10·7% after PCI vs 10·5% after CABG; 1·07, 0·87-1·33; p=0·52), regardless of diabetes status and SYNTAX score. INTERPRETATION: CABG had a mortality benefit over PCI in patients with multivessel disease, particularly those with diabetes and higher coronary complexity. No benefit for CABG over PCI was seen in patients with left main disease. Longer follow-up is needed to better define mortality differences between the revascularisation strategies. FUNDING: None.


Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea , Stents , Humanos , Taxa de Sobrevida , Resultado do Tratamento
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