ABSTRACT
Abstract Introduction: Advances in modern medicine have led to people living longer and healthier lives. Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When it comes to CABG surgery, randomized controlled clinical trials have primarily focused on low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on frail patients. Therefore, we believe that off-pump CABG could be an important technique in patients with limited functional capacity to respond to surgical stress. In this study, the authors introduce the new national, multicenter, randomized, controlled trial "FRAGILE", to be developed in the main cardiac surgery centers of Brazil, to clarify the potential benefit of off-pump CABG in frail patients. Methods: FRAGILE is a two-arm, parallel-group, multicentre, individually randomized (1:1) controlled trial which will enroll 630 patients with blinded outcome assessment (at 30 days, 6 months, 1 year, 2 years and 3 years), which aims to compare adverse cardiac and cerebrovascular events after off-pump versus on-pump CABG in pre-frail and frail patients. Primary outcomes will be all-cause mortality, acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome/cardiogenic shock, stroke, and coronary reintervention. Secondary outcomes will be major adverse cardiac and cerebrovascular events, operative time, mechanical ventilation time, hyperdynamic shock, new onset of atrial fibrillation, renal replacement therapy, reoperation for bleeding, pneumonia, length of stay in intensive care unit, length of stay in hospital, number of units of blood transfused, graft patency, rate of complete revascularization, neurobehavioral outcomes after cardiac surgery, quality of life after cardiac surgery and costs. Discussion: FRAGILE trial will determine whether off-pump CABG is superior to conventional on-pump CABG in the surgical treatment of pre-frail and frail patients. Trial registration: ClinicalTrials.gov, ID: NCT02338947. Registered on August 29th 2014; last updated on March 21st 2016.
Subject(s)
Humans , Aged , Coronary Artery Bypass/methods , Coronary Artery Bypass, Off-Pump/methods , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/mortality , Follow-Up Studies , Frail Elderly , Treatment Outcome , Risk Assessment , Coronary Artery Bypass, Off-Pump/adverse effects , Coronary Artery Bypass, Off-Pump/mortalityABSTRACT
FUNDAMENTO: De um modo geral, as operações estão cada vez menos invasivas e a cirurgia cardíaca começa a seguir por este caminho. OBJETIVO: Avaliar a evolução de cem pacientes submetidos à operação de revascularização do miocárdio minimamente invasiva. MÉTODOS: O acesso ao coração deu-se através de pequena toracotomia lateral no 4º espaço intercostal esquerdo, com 6 cm, iniciando-se ao nível do mamilo. Pelo mesmo espaço intercostal, 3 cm após o término da incisão principal, foi inserida ótica de 6,5 mm com 30º. Nos casos em que a veia safena foi utilizada, o pericárdio foi aberto em cima da aorta e, com uma pressão sistólica de 80 mmhg, foi pinçada parcialmente, sendo a anastomose proximal feita de maneira convencional. As anastomoses distais foram feitas de modo convencional. O procedimento foi realizado sem circulação extracorporal (CEC) com auxílio de ventilação monopulmonar. RESULTADOS: A idade média foi de 63,9 ± 10,66 anos. Sessenta e oito (68%) eram do sexo masculino. Cinquenta e três (53%) encontravam-se em classe funcional III ou IV. A função do ventrículo esquerdo era normal em cinquenta e três (53%) pacientes. Quarenta e dois (42%) haviam sido submetidos à angioplastia prévia. Foram realizadas 153 anastomoses distais, variando de 1 a 3. O tempo médio de ventilação foi de 4,06 ± 4,08 horas. Dezessete (17%) pacientes apresentaram fibrilação atrial e oito (8%) pneumonias. Houve dois óbitos nesta série. CONCLUSÃO: A revascularização mostrou-se segura, com baixa mortalidade e morbidade. Com novos dispositivos, essa operação poderá ter uma aplicabilidade maior.
BACKGROUND: In general, surgeries currently tend to be less invasive and cardiac surgery has started to follow this trend. OBJECTIVE:To evaluate the evolution of one hundred patients undergoing minimally-invasive coronary artery bypass grafting. METHODS: Access to the heart was attained through a small; 6-cm thoracotomy, located in the 4th left intercostal space, starting at the nipple. Through the same intercostal space, 3 cm after the primary incision, a 6.5-mm optical device was inserted at 30º. Where the saphenous vein was used, the pericardium was opened above the aorta and the latter was partially clamped with a systolic pressure of 80 mmHg, with the proximal anastomosis being carried out in the conventional manner. The distal anastomoses were carried out in the conventional manner. The procedure was performed off-pump using single lung ventilation. RESULTS: The mean age was 63.9 ± 10.66 years. Sixty-eight (68%) patients were males. Fifty-three (53%) were in functional class III or IV. Left ventricular function was normal in fifty-three (53%) patients. Forty-two (42%) had undergone previous angioplasty. A total of 153 anastomoses were performed, ranging from 1 to 3. The average ventilation time was 4.06 ± 4.08 hours. Seventeen (17%) patients had atrial fibrillation and eight (8%) had pneumonia. There were two deaths in this series. CONCLUSION: Revascularization was safe with low mortality and morbidity. With the advent of new devices, this surgery may have a greater applicability.