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| Name | Class |
|---|---|
| Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado | OTHER_GOV |
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Background: The intra-aortic balloon balloon pump (IABP) has been used as a method of percutaneous circulatory assistance high surgical risk patients undergoing coronary artery bypass graft surgery (CABG); Although its applicability has been questioned by clinical trials showing poor impact to reduce the mortality due to cardiogenic shock associated with postoperative acute myocardial infarction (AMI), the real benefit reducing mortality in the postoperative context (PO) has not been determined examined through a prospective study with an adequate design.
Objective: To compare PO complications such as mortality, perioperative infarction and other complications in patients with high surgical risk undergoing CABG in comparison with controls.
Methods: Quasi-experimental, prospective, comparative, non-randomized study. The decision to place the BIAC is not part of the study and depends on the multidisciplinary decision of a Heart Team, based on the individualized risk / benefit. The study population consists on high surgical risk patients with atherosclerotic coronary disease undergoing CABG in our centre between 2014-2018. Patients are excluded if any condition is present: cardiogenic shock, with AMI 48 hours prior and / or severe aortic insufficiency. In one group BIAC will be inserted 1-6 hours before surgery (BIAC group) and a second group is control (non-BIAC group). A minimum 30-day postoperative follow-up of will be performed, with primary end points (mortality and AMI type V) and secondary end points (additional PO complications).
Analysis: An evaluation of normality distribution K-S will be performed, the means of quantitative (t-Test) and categorical variables (Fisher or χ² Pearson) will be compared. A multivariate analysis will be performed with linear logistic regression to evaluate the influence of age, sex, peripheral arterial disease (PAD) and EuroSCORE-II on the primary goal. Statistical significance will be considered when p <0.05. Softwares: GraphPad-Prism-5.0 and SPSS-15.0
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IABP group | Over 18 years With ischemic heart disease Multivessel disease with/without LMCA involvement High-risk coronary disease Intra-Aortic Ballon Pump insertion 1-6 hours prior to surgery |
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| No-IABP group | Over 18 years With ischemic heart disease Multivessel disease with/without LMCA involvement High-risk coronary disease No IABP |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-Aortic Ballon Pump insertion | Device | The IABP (Ultraflex IAB 7.5F, 2.5mm; Arrow International, Reading, PA) was inserted percutaneously through the right femoral artery in the previous 1 - 6 hours before the scheduled surgery. Positioning of the IABP was guided by radioscopy. The balloon size was based on the patient's height (30, 40 or 50 cc). Transesophageal echocardiography was used to confirm correct IABP placement before and after CABG |
| Measure | Description | Time Frame |
|---|---|---|
| 30-Day All-Cause Mortality | 30-Day Mortality | 30 days |
| 30-Day Postoperative Myocardial Infarction | Based on the third universal definition on MI criteria | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day occurrence rate of PCI | 30-day occurrence rate of emergent percutaneous coronary intervention | 30 days |
| Requirement of mechanical ventilation | Requirement of mechanical ventilation for longer than 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for cardiac surgery were assessed for the inclusion/exclusion criteria, provided signed informed consent, and were allocated to one of two treatments: IABP insertion before skin incision (IABP group) or no IABP insertion (control group). In all cases, the decision of the IABP insertion was generated in a previous Heart Team session, this team was integrated by a Clinical Cardiologist, Cardiac Interventionist, Cardiothoracic Surgeon and Anesthesiologist, in base on the personal risk/benefit of each patient. There was no blinding for patients or physicians in aware of the Heart Team decisions. Outcome assessors were unaware of the assigned treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Juán Antonio Suárez-Cuenca | CMN "20 de Noviembre" | Principal Investigator |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 30 days |
| acute kidney injury | AKIN classification | 30 days |
| Need for renal replacement therapy | Need for RRT (hemodialysis, peritoneal) | 30 days |
| ICU length of stay | ICU and in-hospital length of stay | 30 days |
| Postoperative use of inotropes and vasopressors | Postoperative use of inotropes and vasopressors | 30 days |