The quality of data in electronic healthcare databases is a critical component when used for research and health practice. The aim of the present study was to assess the data quality in the Paulista Cardiovascular Surgery Registry II (REPLICCAR II) using two different audit methods, direct and indirect. The REPLICCAR II database contains data from 9 hospitals in São Paulo State with over 700 variables for 2229 surgical patients. The data collection was performed in REDCap platform using trained data managers to abstract information. We directly audited a random sample (n = 107) of the data collected after 6 months and indirectly audited the entire sample after 1 year of data collection. The indirect audit was performed using the data management tools in REDCap platform. We computed a modified Aggregate Data Quality Score (ADQ) previously reported by Salati et al. (2015). The agreement between data elements was good for categorical data (Cohen κ = 0.7, 95%CI = 0.59-0.83). For continuous data, the intraclass coefficient (ICC) for only 2 out of 15 continuous variables had an ICC < 0.9. In the indirect audit, 77% of the selected variables (n = 23) had a good ADQ score for completeness and accuracy. Data entry in the REPLICCAR II database proved to be satisfactory and showed competence and reliable data for research in cardiovascular surgery in Brazil.
Objectives: The aim of the study was to evaluate mid-to late clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) with Acurate neo™ (Boston Scientific, Boston, MA). Background: TAVR is an established treatment for aortic stenosis (AS). Few data exist on mid-to long-term outcomes and durability after new-generation valves. Methods: All consecutive patients (n = 104) who underwent Acurate neo™ implantation from 2012 to 2018 were included. Follow-up was systematically performed at 1, 6, 12, and 24 months and yearly thereafter. Outcomes were reported according to VARC-2, and structural valve deterioration (SVD) or bioprosthetic valve failure defined accordingly to new definitions. Results: Mean age was 82 ± 5.4 years, 56.7% were female and the Society of Thoracic Surgeons score for mortality was 5.9 ± 4%. Patients were followed for a median of 3 years (1,092 days; IQR 1.5-4 years), and the maximum follow-up was 7 years. All-cause mortality values at 1 and 5 years were 8.5% and 40.5%, respectively. No relevant changes in mean gradient and orifice area occurred (7.9 ± 3.8 mmHg and 1.9 ± 0.3 cm 2 at 1 year; 6.6 ± 2.1 mmHg and 1.8 ± 0.3 cm 2 at 5 years), and there was a significant rate of paravalvular leaks resolution at 1, 2, and 3 years (p = .004; p < .001; p < .001, respectively). None of the patients had leaflet thrombosis or endocarditis. One patient developed SVD at 84 months. Conclusions: Acurate neo™ was associated with sustained echocardiographic results. Reassuring mid-to long-term outcomes was observed in this cohort of elderly patients with severe AS.
IntroductionActive infective endocarditis is associated with high morbidity and mortality. Surgery is indicated in high-risk conditions, and the main determinants of mortality in surgical treatment should be evaluated.ObjectiveTo identify mortality predictors in the surgical treatment of active infective endocarditis in a long-term follow-up.MethodsThis prospective observational study involved 88 consecutive patients diagnosed with active infective endocarditis, who underwent surgery between January 2005 and December 2015. Fifty-eight (65.9%) patients were male, the mean age was 50.87±16.15 years. A total of 31 (35.2%) patients had a history of rheumatic fever; 48 (54.5%) had had heart surgery with prosthetic valve implantation; 45 (93.8%) had biological prosthetic valve endocarditis and 3 (6.3%) mechanical prosthetic valve; 40 (45.5%) patients had the disease in their native valve. The mean EuroSCORE II was 8.9±6.5%, and the main surgical indication was refractory heart failure in 38 (43.2%) patients. A total of 68 bioprosthesis (36 aortic, 32 mitral) and 29 mechanical prostheses (12 aortic, 17 mitral) were implanted and three mitral valve plasties performed. A total of 25 (28.4%) patients underwent double or triple valve procedures. Aortic annulus reconstruction by abscess was performed in 18 (20.5%) and six (6.81%) patients had combined procedure. The mean surgery time was 359±97.6 minutes.ResultsThe overall survival in up to a 10-year follow-up period was 79.5%. In the univariate analysis, the main mortality predictors were positive blood cultures (P=0.003), presence of typical microorganisms (P=0.008), most frequently Streptococcus viridans (12 cases; 25%); C-reactive protein (hazard ratio [HR] 1.034, 95% confidence interval [CI] 1.000 to 1.070, P=0.04); creatinine clearance (HR 0.977, 95% CI 0.962 to 0.993, P=0.005); length of surgery: every five minutes multiplies the chance of death 1.005-fold (HR 1.005, 95% CI 1.001 to 1.009, P=0.0307); age (HR 1.060, 95% CI 1.026 to 1.096, P=0.001); and EuroSCORE II (HR 1.089, 95% CI 1.030 to 1.151, P=0.003).ConclusionA positive blood culture with typical microorganism, C-reactive protein, age, EuroSCORE II, total surgical time and the presence of postoperative complications were the major predictors of mortality and significantly impacted survival in up to a 10-year follow-up period.
Revascularização do miocárdio com emprego de ambas artérias mamárias internas em pacientes com diabetes mellitusCoronary artery bypass grafting using both internal mammary arteries in patients with diabetes mellitus Abstract Objective: We sought to describe the use of both internal thoracic arteries (ITA) in patients with diabetes mellitus (DM) submitted to a coronary artery bypass grafting (CABG).Method: Between January 1995 to August 2005, 4,569 patients received isolated CABG in our institution. Of the initial population, 1,298 had DM. The median age of the patients was 62 years and total mortality rate was 2.18% (100 patients). Both internal thoracic arteries were used in 700 patients. Patients were divided into two groups: with DM (group I, 148 patients), and without DM (group II, 552 patients). Patient selection for double ITA grafting was based on coronary artery anatomy and on the quality of sternum. The later was evaluated during the sternal transsection. When these two factors were considered favorable, we have both ITAs dissected, regardless whether the patient had DM. During the dissection of both internal thoracic arteries, one must take care not to open the pleural spaces.Results: There was a small difference between the two groups in terms of morbidity and mortality.Conclusion: Our data suggests that patients with DM can benefit with the efficient use of both internal thoracic arteries with a small increase in the risk of complications, if its application is carefully indicated.
IntroductionThe great saphenous vein is widely used as a graft in coronary artery bypass grafting surgery. Complications due to saphenous vein harvesting can be minimized when using ultrasonography mapping and marking.ObjectiveTo analyze by clinical trial the use of vascular ultrasonography to map the saphenous vein in coronary artery bypass grafting to determine viability and dissection site.MethodsA total of 151 consecutive patients submitted to coronary artery bypass surgery with the use of the great saphenous vein as a graft were selected for this prospective study. They were divided into two groups: Group 1 - 84 patients were submitted to ultrasonographic mapping and marking of the saphenous vein; Group 2 - 67 patients had saphenous vein harvested without any previous study. Both groups were coupled with follow-up on the 1st, 5th and 30th postoperative days. Primary endpoints were need for incision of the contralateral leg and wound complications within 30 days.ResultsBoth legs had to be incised in 6 (8.95%) patients from Group 2 (P=0.0067). Wound complications occurred in 33 (23.4%) patients within 30 days, 21 (35%) from Group 2 e 12 (14.8%) from Group 1 (OR 3.095, 1.375-6.944, CI 95%, P=0.008). Within 30 days there were 4 (2.8%) deaths, all in Group 2 (P=0.036).ConclusionThe use of vascular ultrasonography for mapping of the great saphenous vein in coronary artery bypass surgery has properly identified and evaluated the saphenous vein, significantly reducing wound complications and unnecessary incisions. It would be advisable to use this noninvasive and easy to use method routinely in coronary artery bypass surgery.
IntroductionAdvances 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.MethodsFRAGILE 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.DiscussionFRAGILE 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 registrationClinicalTrials.gov, ID: NCT02338947. Registered on August 29th 2014; last updated on March 21st 2016.
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