ABSTRACT
BACKGROUND: The first two randomized control trials (RCTs) studying the role of MitraClip in patients with secondary mitral regurgitation (MR) had antagonizing results. We, therefore, performed an updated meta-analysis of RCTs and propensity score-matched observational studies investigating the role of MitraClips in patients with secondary MR. A novel method of Kaplan Meier Curve reconstruction from derived individual patient data will be used to compare the survival probability of control groups in COAPT and MITRA HF trail, and hence, access inter-study heterogeneity. METHODS: Medline and Cochrane databases was used for systematic search. We used the Mantel-Haenszel method with a random-effect model to calculate risk ratio (RR) with 95% confidence interval (CI) and inverse variance method with a random-effect model to calculate the mean difference (MD) with 95% confidence interval (CI). We used a fixed-effect approach for meta-regression. RESULTS: MitraClip reduced the risk of all-cause mortality [RR: 0.72, CI: 0.55-0.95, P value = 0.02, I2 = 55%, χ2P-value = 0.08] and readmission [RR: 0.62, CI: 0.42-0.92, P value = 0.02, I2 = 90%, χ2P-value<0.01] at two years follow-up. There was no effect of MitraClip on change in cardiovascular mortality and 6 m walking distance at 12 months follow-up. Meta-regression indicated left ventricular end diastolic volume and age among the factors affecting outcomes. Reconstructed Kaplan Meier curves confirmed considerable heterogeneity among patients randomized in MITRA HF and COAPT trial. CONCLUSION: The present meta-analysis confirms the beneficial role of percutaneous mitral valve repair in patients with secondary MR. However, all the results were associated with considerable heterogeneity.
Subject(s)
Cardiac Surgical Procedures , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Humans , Mitral Valve/surgery , Mitral Valve Insufficiency/surgery , Treatment OutcomeABSTRACT
INTRODUCTION: An increased incidence of stent thrombosis after implantation of first-generation drug-eluting stents led to a recommendation of dual antiplatelet therapy (DAPT) for 12 months after the procedure. However, given the use of second-generation and newer drug-eluting stents, this recommendation needs to be revisited. Several randomized controlled trials (RCTs) have studied an abbreviated DAPT regimen of ≤ 3 months followed by P2Y12 inhibitor monotherapy, and results have been conflicting. OBJECTIVE: We performed a systematic review with meta-analysis of RCTs of abbreviated DAPT for ≤ 3 months followed by P2Y12 monotherapy compared with 12 months of DAPT. METHODS: We performed a systematic search of the MEDLINE/PubMed, Cochrane, and DARE (Database of Abstracts of Reviews of Effects) databases for eligible RCTs. Quantitative analysis was performed based on the intention-to-treat principle. We used the Mantel-Haenszel method with a random-effects model to calculate relative risks (RRs) with 95% confidence intervals (CIs). RESULTS: The final analysis included four RCTs. We found no difference in the risk of all-cause mortality (RR 0.90; 95% CI 0.77-1.05; p = 0.18; I2 = 0%; χ2p = 0.58), myocardial infarction (RR 0.99; 95% CI 0.86-1.15; p = 0.85; I2 = 0%; χ2p = 0.70), stroke (RR 1.14; 95% CI 0.65-1.98; p = 0.65; I2 = 59%; χ2p = 0.06), or stent thrombosis (RR 0.98; 95% CI 0.73-1.33; p = 0.90; I2 = 0%; χ2p = 0.48). Additionally, there was no difference in the risk for major bleeding, defined as BARC (Bleeding Academic Research Consortium) type 3 or 5, between the two groups (RR 0.62; 95% CI 0.37-1.05; p = 0.07; I2 = 79%; χ2p < 0.05). CONCLUSION: Abbreviated DAPT followed by P2Y12 monotherapy resulted in a similar risk of re-ischemic clinical outcomes post percutaneous coronary intervention as compared with the standard 12-month DAPT regimen. The risk of major bleeding (BARC type 3 or 5) also remained similar between the two groups. However, as trials have reported benefits with abbreviated DAPT followed by P2Y12 monotherapy in terms of combined endpoints and all bleeding (BARC type 2-5), additional research is needed.
Subject(s)
Coronary Artery Disease/drug therapy , Platelet Aggregation Inhibitors/therapeutic use , Purinergic P2Y Receptor Antagonists/therapeutic use , Coronary Artery Disease/metabolism , Coronary Artery Disease/surgery , Drug Therapy, Combination/methods , Humans , Myocardial Infarction/drug therapy , Myocardial Infarction/metabolism , Percutaneous Coronary Intervention/methods , Randomized Controlled Trials as Topic , Thrombosis/drug therapy , Thrombosis/metabolismABSTRACT
OBJECTIVE: To compare the incidence of complications and the duration of hospitalization of patients undergoing bariatric surgery admitted to the intensive care unit or a post-surgical hospitalization unit. METHODS: This retrospective observational study included 828 patients admitted between January 2010 and February 2015 during the immediate postoperative period of bariatric surgery in a hospital. Data were collected via electronic medical records. The Mann-Whitney test was used to compare continuous variables, and the chi-square was used to compare categorical variables. RESULTS: Patients in both groups had similar demographic characteristics, with no significant differences in anthropometric data and comorbidities. There was no significant difference in the comparison of complications between the two groups. However, the group admitted to the intensive care unit had longer hospitalization times (median of 3 days versus 2 days, p < 0.05), and hospital costs were 8% higher. CONCLUSION: The present study found no benefit in the routine admittance of patients to the intensive care unit after undergoing bariatric surgery. This practice increased hospitalization time and hospital costs, which wasted resources. It is necessary to create objective criteria to identify patients requiring intensive care unit admission after bariatric surgery.
OBJETIVO: Comparar a incidência de complicações e a duração da hospitalização de pacientes submetidos à cirurgia bariátrica internados na unidade de terapia intensiva ou de internação pós-cirúrgica. MÉTODOS: Estudo observacional, retrospectivo, que incluiu 828 pacientes admitidos entre janeiro de 2010 e fevereiro de 2015 em pós-operatório imediato de cirurgia bariátrica em um hospital. Os dados foram coletados em prontuários eletrônicos. As variáveis contínuas foram comparadas utilizando-se o teste de Mann-Whitney e as categóricas, o qui quadrado. RESULTADOS: Os pacientes dos dois grupos possuíam características demográficas semelhantes, sem diferença significativa dos dados antropométricos e comorbidades. Comparando-se as complicações entre os dois grupos, não houve diferença significativa. No entanto, o grupo admitido na unidade de terapia intensiva teve maior tempo de internação (mediana de 3 dias versus 2 dias; p < 0,05) e custo hospitalar 8% maior. CONCLUSÃO: O presente estudo não encontrou nenhum benefício na internação rotineira de pacientes submetidos à cirurgia bariátrica em unidade de terapia intensiva. Esta prática aumentou o tempo de internação e o custo hospitalar, desperdiçando recursos. É necessária a criação de critérios objetivos para identificar pacientes que necessitem de internação em unidade de terapia intensiva após cirurgia bariátrica.
Subject(s)
Bariatric Surgery/adverse effects , Hospitalization/statistics & numerical data , Intensive Care Units/statistics & numerical data , Postoperative Complications/epidemiology , Adolescent , Adult , Aged , Female , Hospital Costs , Hospitalization/economics , Humans , Incidence , Length of Stay , Male , Middle Aged , Postoperative Complications/economics , Retrospective Studies , Statistics, Nonparametric , Young AdultABSTRACT
RESUMO Objetivo: Comparar a incidência de complicações e a duração da hospitalização de pacientes submetidos à cirurgia bariátrica internados na unidade de terapia intensiva ou de internação pós-cirúrgica. Métodos: Estudo observacional, retrospectivo, que incluiu 828 pacientes admitidos entre janeiro de 2010 e fevereiro de 2015 em pós-operatório imediato de cirurgia bariátrica em um hospital. Os dados foram coletados em prontuários eletrônicos. As variáveis contínuas foram comparadas utilizando-se o teste de Mann-Whitney e as categóricas, o qui quadrado. Resultados: Os pacientes dos dois grupos possuíam características demográficas semelhantes, sem diferença significativa dos dados antropométricos e comorbidades. Comparando-se as complicações entre os dois grupos, não houve diferença significativa. No entanto, o grupo admitido na unidade de terapia intensiva teve maior tempo de internação (mediana de 3 dias versus 2 dias; p < 0,05) e custo hospitalar 8% maior. Conclusão: O presente estudo não encontrou nenhum benefício na internação rotineira de pacientes submetidos à cirurgia bariátrica em unidade de terapia intensiva. Esta prática aumentou o tempo de internação e o custo hospitalar, desperdiçando recursos. É necessária a criação de critérios objetivos para identificar pacientes que necessitem de internação em unidade de terapia intensiva após cirurgia bariátrica.
ABSTRACT Objective: To compare the incidence of complications and the duration of hospitalization of patients undergoing bariatric surgery admitted to the intensive care unit or a post-surgical hospitalization unit. Methods: This retrospective observational study included 828 patients admitted between January 2010 and February 2015 during the immediate postoperative period of bariatric surgery in a hospital. Data were collected via electronic medical records. The Mann-Whitney test was used to compare continuous variables, and the chi-square was used to compare categorical variables. Results: Patients in both groups had similar demographic characteristics, with no significant differences in anthropometric data and comorbidities. There was no significant difference in the comparison of complications between the two groups. However, the group admitted to the intensive care unit had longer hospitalization times (median of 3 days versus 2 days, p < 0.05), and hospital costs were 8% higher. Conclusion: The present study found no benefit in the routine admittance of patients to the intensive care unit after undergoing bariatric surgery. This practice increased hospitalization time and hospital costs, which wasted resources. It is necessary to create objective criteria to identify patients requiring intensive care unit admission after bariatric surgery.
