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2.
Artigo em Inglês | MEDLINE | ID: mdl-31180497

RESUMO

OBJECTIVES: Using data from the CORONARY trial (n = 4752), we evaluated the incidence and prognostic significance of myocardial infarction (MI) applying different definitions based on peak postoperative creatine kinase-MB isoenzyme and cardiac troponin levels. We then aimed to identify the peak cardiac troponin during the first 3 postoperative days that was independently associated with a 2-fold increase in 30-day mortality. METHODS: To combine different assays, we analysed cardiac troponins in multiples of their respective upper limit of normal (ULN). We identified the lowest threshold with a hazard ratio (HR) >2 for 30-day mortality independent of EuroSCORE and on- versus off-pump surgery. RESULTS: Depending on the definition used based on creatine kinase-MB, the incidence of MI after coronary artery bypass grafting (CABG) ranged from 0.6% to 19% and the associated HRs for 30-day mortality ranged from 2.7 to 6.9. Using cardiac troponin (1528 patients), the incidence of MI ranged from 1.7% to 13% depending on the definition used with HRs for 30-day mortality ranging from 5.1 to 7.2. The first cardiac troponin threshold we evaluated, 180xULN, was associated with an adjusted HR for 30-day mortality of 7.6 [95% confidence interval (CI) 3.4-17.1] when compared to <130xULN. The next independent threshold was 130xULN with an adjusted HR for 30-day mortality of 7.8 (95% CI 2.3-26.1). The next cardiac troponin tested threshold (70xULN) did not meet criteria for significance. CONCLUSIONS: Our results illustrate that the incidence and prognosis of a post-CABG MI varies based on the definition used. Validated post-CABG MI diagnostic criteria formulated from their independent association with important clinical outcomes are needed.

3.
Artigo em Inglês | MEDLINE | ID: mdl-31170736

RESUMO

BACKGROUND: This meta-analysis was conducted to investigate the evidence for the efficacy and safety of intrapericardial tranexamic acid (TXA) in cardiac surgery. METHODS: We searched MEDLINE from 2000 to 2017 for randomized controlled trials that compared intrapericardial TXA to placebo. We performed a meta-analysis for the eligible trials that focused on chest tube drainage measured during the first 24 hours after surgery as a primary outcome. We also examined the secondary outcome measures of these trials such as the incidence of transfusion requirements following surgery and the evidence for any increase in complication rates. RESULTS: A total of seven randomized controlled trials (six on-pump and one off-pump) comparing topical application of TXA to placebo in 692 patients were eligible for the blood loss outcome data. These trials randomized 372 patients to receive TXA and 320 patients as controls. The use of intrapericardial TXA was associated with a considerable reduction in 24-hour blood loss in all seven studies and a weighted mean difference of -343.56 mL (95% confidence interval: -316.41, -370.72) significantly differed from zero (p = 0.005) with a heterogeneity of I 2 = 0%. The incidence of packed RBC transfusion in TXA patients was significantly lower in one study and was not significant but with trend in favor of TXA in five out of the six studies in which it was reported. In one trial, TXA was not detected in any patient and in another the studied groups were similar in postoperative complications, such as graft patency, myocardial infarction, cerebral infarction, atrial fibrillation, seizures, and infections. CONCLUSIONS: Findings from this meta-analysis suggest that intrapericardial use of TXA in patients undergoing cardiac surgery can decrease postoperative bleeding without increasing the risk of postoperative seizures. Future large randomized, double-blind, controlled clinical trials are needed to confirm these promising findings.

4.
J Thorac Cardiovasc Surg ; 158(2): e46-e47, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31060737
5.
J Am Coll Cardiol ; 73(18): 2360, 2019 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-31072584
6.
JACC Cardiovasc Interv ; 12(8): 781-789, 2019 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-31000014

RESUMO

OBJECTIVES: The authors sought to assess the distribution and prognostic significance of habitual physical activity (HPA) in older adults undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Low HPA is associated with mortality and disability in community-dwelling older adults. In the setting of TAVR, it is unclear whether low HPA is a risk factor for downstream morbidity or a byproduct of severe aortic stenosis that improves following its correction. METHODS: Older adults undergoing TAVR in the prospective multicentre FRAILTY-AVR (Frailty in Aortic Valve Replacement) study were interviewed to quantify their HPA in kilocalories/week using a validated questionnaire at baseline and follow-up. The primary endpoint was all-cause mortality at 12 months. RESULTS: The cohort consisted of 755 patients with a median age of 84.0 years (interquartile range [IQR]: 80.0 to 87.0 years). At baseline, median HPA was 1,116 kcal/week (IQR: 227 to 2,715 kcal/week) with 73% of patients performing <150 min/week of moderate or vigorous HPA. Sedentary patients were more likely to be older, female, frail, cognitively impaired, depressed, and have multimorbidity, although they had similar left ventricular function and aortic stenosis severity. In the logistic regression model adjusting for these covariates, HPA was found to be associated with mortality at 12 months (odds ratio: 0.84/100 kcal; 95% confidence interval: 0.73 to 0.98). HPA was associated with longer length of stay, discharge to health care facilities, and disability. At 12 months, median HPA among survivors was 933 kcal/week (IQR: 0 to 2,334 kcal/week) with pre-existing frailty being independently predictive of worsening HPA following TAVR. CONCLUSIONS: Sedentary patients have a higher risk of mortality and functional decline following TAVR.

7.
Circ Cardiovasc Qual Outcomes ; 12(3): e005363, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30879326

RESUMO

Background Women account for a large proportion of patients treated with transcatheter aortic valve replacement, yet there remain conflicting reports about the effect of sex on outcomes. Moreover, the sex-specific prevalence and prognostic impact of frailty has not been systematically studied in the context of transcatheter aortic valve replacement. Methods and Results A preplanned analysis of the FRAILTY-AVR study (Frailty Aortic Valve Replacement) was performed to analyze the determinants of outcomes in older women and men undergoing transcatheter aortic valve replacement. FRAILTY-AVR was a multinational, prospective, observational cohort assembled at 14 institutions in North America and Europe from 2012 to 2017. Multivariable logistic regression models were stratified by sex and adjusted for covariates. Interaction between sex and each of these covariates was assessed. The primary outcome was 12-month mortality, and the secondary outcome was 1-month composite mortality or major morbidity. The cohort consisted of 340 women and 419 men. Women were older and had higher predicted risk of mortality. Women were more likely to have physical frailty traits, but not cognitive or psychosocial frailty traits, and global indices of frailty were similarly associated with adverse events regardless of sex. Women were more likely to require discharge to a rehabilitation facility, particularly those with physical frailty at baseline, although their functional status was similar to men at 12 months. The risk of 1-month mortality or major morbidity was greater in women, particularly those treated with larger prostheses. The risk of 12-month mortality was not greater in women, with the exception of those with pulmonary hypertension, in whom, there was a significant interaction for increased mortality. Conclusions The present study highlights sex-specific differences in older adults undergoing transcatheter aortic valve replacement and draws attention to the impact of physical frailty in women and their potential risk associated with oversized prostheses and pulmonary hypertension.

8.
J Card Surg ; 34(5): 305-311, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30908754

RESUMO

BACKGROUND: Cardiac surgery patients are at high risk for postoperative bleeding. Intravenous (IV) tranexamic acid (TxA) is a commonly used antifibrinolytic drug, but is associated with postoperative seizures. We conducted this pilot randomized controlled trial (RCT) to determine the feasibility of a larger trial that will be designed to investigate the impact of TxA administration route, intrapericardial (IP) vs IV, on postoperative bleeding and seizures. METHODS: In this single-center, double-blinded, pilot RCT we enrolled adult patients undergoing nonemergent on-pump cardiac operations through a median sternotomy. Participants were randomized to IP or IV TxA groups. The primary outcomes were cumulative chest tube drainage, transfusion requirements, and incidence of postoperative seizures. RESULTS: A total of 97 participants were randomized to the intervention and control groups. Baseline characteristics were similar in both groups. Most participants underwent a CABG and/or aortic valve replacement. There was no statistical difference. The IP TxA group was found to have a tendency for less chest tube drainage in comparison to the IV TxA group, 500.5 (370.0-700.0) and 540.0 (420.0-700.0) mL, respectively, which was not statistically significant (P = 0.2854). Fewer participants in the IP TxA group with cardiac tamponade and/or required a reoperation for bleeding and fewer packed red blood cell transfusions. None of the IP TxA group developed seizure vs one from the IV TxA group. CONCLUSION: This is the first known pilot RCT to investigate the role of TxA route of administration in open cardiac surgery. Intrapericardial TxA shows promising results with decreased bleeding, transfusion requirements, reoperations, and postoperative seizures. A larger RCT is needed to confirm these results and lead to a change in practice.


Assuntos
Antifibrinolíticos/administração & dosagem , Perda Sanguínea Cirúrgica/prevenção & controle , Procedimentos Cirúrgicos Cardíacos , Hemorragia Pós-Operatória/prevenção & controle , Ácido Tranexâmico/administração & dosagem , Administração Tópica , Idoso , Valva Aórtica/cirurgia , Ponte de Artéria Coronária , Método Duplo-Cego , Emulsões , Ácidos Graxos , Feminino , Implante de Prótese de Valva Cardíaca , Humanos , Masculino , Pessoa de Meia-Idade , Fosfolipídeos , Projetos Piloto , Vitamina A , Vitamina D
9.
CMAJ ; 191(9): E247-E256, 2019 03 04.
Artigo em Inglês | MEDLINE | ID: mdl-30833491

RESUMO

BACKGROUND: Perioperative corticosteroid use may reduce acute kidney injury. We sought to test whether methylprednisolone reduces the risk of acute kidney injury after cardiac surgery. METHODS: We conducted a prespecified substudy of a randomized controlled trial involving patients undergoing cardiac surgery with cardiopulmonary bypass (2007-2014); patients were recruited from 79 centres in 18 countries. Eligibility criteria included a moderate-to-high risk of perioperative death based on a preoperative score of 6 or greater on the European System for Cardiac Operative Risk Evaluation I. Patients (n = 7286) were randomly assigned (1:1) to receive intravenous methylprednisolone (250 mg at anesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients, caregivers, data collectors and outcome adjudicators were unaware of the assigned intervention. The primary outcome was postoperative acute kidney injury, defined as an increase in the serum creatinine concentration (from the preoperative value) of 0.3 mg/dL or greater (≥ 26.5 µmol/L) or 50% or greater in the 14-day period after surgery, or use of dialysis within 30 days after surgery. RESULTS: Acute kidney injury occurred in 1479/3647 patients (40.6%) in the methylprednisolone group and in 1426/3639 patients (39.2%) in the placebo group (adjusted relative risk 1.04, 95% confidence interval 0.96 to 1.11). Results were consistent across several definitions of acute kidney injury and in patients with preoperative chronic kidney disease. INTERPRETATION: Intraoperative corticosteroid use did not reduce the risk of acute kidney injury in patients with a moderate-to-high risk of perioperative death who had cardiac surgery with cardiopulmonary bypass. Our results do not support the prophylactic use of steroids during cardiopulmonary bypass surgery. Trial registration: ClinicalTrials.gov, no. NCT00427388.

10.
BMJ Open ; 9(2): e022995, 2019 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-30826789

RESUMO

INTRODUCTION: Approximately 400 000 Americans and 36 000 Canadians undergo cardiac surgery annually, and up to 56% will develop chronic postsurgical pain (CPSP). The primary aim of this study is to explore the association of pain-related beliefs and gender-based pain expectations on the development of CPSP. Secondary goals are to: (A) explore risk factors for poor functional status and patient-level cost of illness from a societal perspective up to 12 months following cardiac surgery; and (B) determine the impact of CPSP on quality-adjusted life years (QALYs) borne by cardiac surgery, in addition to the incremental cost for one additional QALY gained, among those who develop CPSP compared with those who do not. METHODS AND ANALYSES: In this prospective cohort study, 1250 adults undergoing cardiac surgery, including coronary artery bypass grafting and open-heart procedures, will be recruited over a 3-year period. Putative risk factors for CPSP will be captured prior to surgery, at postoperative day 3 (in hospital) and day 30 (at home). Outcome data will be collected via telephone interview at 6-month and 12-month follow-up. We will employ generalised estimating equations to model the primary (CPSP) and secondary outcomes (function and cost) while adjusting for prespecified model covariates. QALYs will be estimated by converting data from the Short Form-12 (version 2) to a utility score. ETHICS AND DISSEMINATION: This protocol has been approved by the responsible bodies at each of the hospital sites, and study enrolment began May 2015. We will disseminate our results through CardiacPain.Net, a web-based knowledge dissemination platform, presentation at international conferences and publications in scientific journals. TRIAL REGISTRATION NUMBER: NCT01842568.

11.
Eur Heart J Qual Care Clin Outcomes ; 5(3): 266-271, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-30657891

RESUMO

AIMS: The Heart Outcomes Prevention Evaluation-3 (HOPE-3) found that rosuvastatin alone or with candesartan and hydrochlorothiazide (HCT) (in a subgroup with hypertension) significantly lowered cardiovascular events compared with placebo in 12 705 individuals from 21 countries at intermediate risk and without cardiovascular disease. We assessed the costs implications of implementation in primary prevention in countries at different economic levels. METHODS AND RESULTS: Hospitalizations, procedures, study and non-study medications were documented. We applied country-specific costs to the healthcare resources consumed for each patient. We calculated the average cost per patient in US dollars for the duration of the study (5.6 years). Sensitivity analyses were also performed with cheapest equivalent substitutes. The combination of rosuvastatin with candesartan/HCT reduced total costs and was a cost-saving strategy in United States, Canada, Europe, and Australia. In contrast, the treatments were more expensive in developing countries even when cheapest equivalent substitutes were used. After adjustment for gross domestic product (GDP), the costs of cheapest equivalent substitutes in proportion to the health care costs were higher in developing countries in comparison to developed countries. CONCLUSION: Rosuvastatin and candesartan/HCT in primary prevention is a cost-saving approach in developed countries, but not in developing countries as both drugs and their cheapest equivalent substitutes are relatively more expensive despite adjustment by GDP. Reductions in costs of these drugs in developing countries are essential to make statins and blood pressure lowering drugs affordable and ensure their use. CLINICAL TRIAL REGISTRATION: HOPE-3 ClinicalTrials.gov number, NCT00468923.

12.
J Am Coll Cardiol ; 73(2): 121-130, 2019 01 22.
Artigo em Inglês | MEDLINE | ID: mdl-30654882

RESUMO

BACKGROUND: Patients with recent coronary artery bypass graft (CABG) surgery are at risk for early graft failure, which is associated with a risk of myocardial infarction and death. In the COMPASS (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS) trial, rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily compared with aspirin 100 mg once daily reduced the primary major adverse cardiovascular events (MACE) outcome of cardiovascular death, stroke, or myocardial infarction. Rivaroxaban 5 mg twice daily alone did not significantly reduce MACE. OBJECTIVES: This pre-planned substudy sought to determine whether the COMPASS treatments are more effective than aspirin alone for preventing graft failure and MACE after CABG surgery. METHODS: The substudy randomized 1,448 COMPASS trial patients 4 to 14 days after CABG surgery to receive the combination of rivaroxaban plus aspirin, rivaroxaban alone, or aspirin alone. The primary outcome was graft failure, diagnosed by computed tomography angiogram 1 year after surgery. RESULTS: The combination of rivaroxaban and aspirin and the regimen of rivaroxaban alone did not reduce the graft failure rates compared with aspirin alone (combination vs. aspirin: 113 [9.1%] vs. 91 [8.0%] failed grafts; odds ratio [OR]: 1.13; 95% confidence interval [CI]: 0.82 to 1.57; p = 0.45; rivaroxaban alone vs. aspirin: 92 [7.8%] vs. 92 [8.0%] failed grafts; OR: 0.95; 95% CI: 0.67 to 1.33; p = 0.75). Compared with aspirin, the combination was associated with fewer MACE (12 [2.4%] vs. 16 [3.5%]; hazard ratio [HR]: 0.69; 95% CI: 0.33 to 1.47; p = 0.34), whereas rivaroxaban alone was not (16 [3.3%] vs. 16 [3.5%]; HR: 0.99, CI: 0.50 to 1.99; p = 0.98). There was no fatal bleeding or tamponade within 30 days of randomization. CONCLUSIONS: The combination of rivaroxaban 2.5 mg twice daily plus aspirin or rivaroxaban 5 mg twice daily alone compared with aspirin alone did not reduce graft failure in patients with recent CABG surgery, but the combination of rivaroxaban 2.5 mg twice daily plus aspirin was associated with similar reductions in MACE, as observed in the larger COMPASS trial. (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS [COMPASS]; NCT01776424).


Assuntos
Aspirina/uso terapêutico , Ponte de Artéria Coronária , Inibidores do Fator Xa/uso terapêutico , Fibrinolíticos/uso terapêutico , Oclusão de Enxerto Vascular/prevenção & controle , Rivaroxabana/uso terapêutico , Idoso , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
13.
Can J Anaesth ; 66(2): 182-192, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30535668

RESUMO

PURPOSE: Postoperative infection, particularly in cardiac surgery, results in significant morbidity, mortality, and healthcare cost. Identification of novel predictors of postoperative infection can target high-risk populations for prophylactic intervention. METHODS: Steroids in cardiac surgery (SIRS) was a multi-centre randomized-controlled trial assessing intraoperative administration of methylprednisone during cardiac surgery, which enrolled 7,507 patients across 80 centres in 18 countries. It demonstrated that administration of steroids had no effect on mortality or major morbidity after cardiac surgery. Our primary objective was to identify risk factors for postoperative surgical site infections using SIRS participants as a cohort. We excluded patients who did not undergo surgery, died intraoperatively, or died within 48 hr of the operation. Patients were assessed for development of "surgical site infection" over the first 30 days postoperatively. Using theoretical and previously identified risk factors, we used forward stepwise entry to create a binary logistic regression model. RESULTS: Follow-up at 30 days was complete for all patients; 7,406 were included in the cohort. Surgical site infection occurred in 180 (4.8%) and 184 (5.0%) of patients in the placebo and steroid arms respectively. Significant risk factors (P < 0.05 level) included: diabetes managed with insulin (adjusted odds ratio [aOR]: 1.55; 95% confidence interval [CI] 1.13 to 2.12), oral hypoglycemics (aOR 1.60; 95% CI 1.18 to 2.16), or diet (aOR 1.81; 95% CI 1.16 to 2.83), female sex (aOR 1.34; 95% CI 1.05 to 1.71), renal failure with (aOR 2.03; 95% CI 1.06 to 3.91), and without (aOR 1.50; 95% CI 1.04 to 2.14) dialysis, > 96 min cardiopulmonary bypass (CPB) time (aOR 1.84; 95% CI 1.44 to 2.35), body mass index (BMI) < 22.3 (aOR 0.44; 95% CI 0.28 to 0.71) or > 30 (aOR 1.49; 95% CI 1.17 to 1.89), peak intensive care unit blood glucose (aOR 1.02 per mmol·L-1; 95% CI 1.00 to 1.04), and coronary artery bypass grafting (CABG) operation type (aOR 2.59; 95% CI 1.87 to 3.59). CONCLUSIONS: Patients undergoing CABG, requiring longer CPB, with higher BMI, or with diabetes, are at elevated risk of surgical site infection. Strategies to mitigate this risk warrant further investigation.

14.
Artigo em Inglês | MEDLINE | ID: mdl-30413287
15.
JACC Cardiovasc Interv ; 11(21): 2185-2192, 2018 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-30343019

RESUMO

OBJECTIVES: The authors sought to determine whether frail older adults undergoing nonfemoral transcatheter aortic valve replacement (TAVR) procedures had a higher risk of 30-day and 12-month mortality. BACKGROUND: Frailty can help predict outcomes and guide therapy in older adults being considered for TAVR. Nonfemoral TAVR procedures are more invasive and impart a greater risk of adverse events, which may be less well tolerated in frail patients, compared with transfemoral TAVR procedures. METHODS: This study was a post hoc analysis of the FRAILTY-AVR (Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions) prospective multicenter cohort that consisted of older adults undergoing TAVR from 2012 to 2017. Frailty was assessed using the Essential Frailty Toolset (EFT). Endpoints of interest were 30-day and 12-month all-cause mortality. Interaction tables and multivariable logistic regression models were used to investigate statistical interaction on the additive and multiplicative scales. RESULTS: The cohort consisted of 723 patients with a mean age of 84 ± 6 years, of which 556 (77%) had femoral access and 167 (23%) had nonfemoral access. In frail patients with EFT scores ≥3 (35%), nonfemoral access was associated with increased 30-day mortality (odds ratio [OR]: 3.91; 95% confidence interval [CI]: 1.48 to 10.31); whereas in nonfrail patients with EFT scores <3 (65%), nonfemoral access had no effect (OR: 1.29; 95% CI: 0.34 to 4.94). There was statistical evidence of interaction between frailty and access site on 30-day mortality on the additive scale (relative excess risk due to interaction = 5.95). Nonfemoral access was associated with increased 1-year mortality in frail patients (OR: 1.98; 95% CI: 1.00 to 3.93) but not in nonfrail patients (OR: 1.83; 95% CI: 0.90 to 3.74), although there was no statistical evidence of interaction. CONCLUSIONS: Frail patients undergoing TAVR via a more invasive nonfemoral access face a substantially higher risk of 30-day mortality, whereas nonfrail older adults tolerate the procedure with a low short-term risk irrespective of access route.

16.
Can J Cardiol ; 34(7): 850-862, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29960614

RESUMO

Worldwide, more than 230 million adults have major noncardiac surgery each year. Although surgery can improve quality and duration of life, it can also precipitate major complications. Moreover, a substantial proportion of deaths occur after discharge. Current systems for monitoring patients postoperatively, on surgical wards and after transition to home, are inadequate. On the surgical ward, vital signs evaluation usually occurs only every 4-8 hours. Reduced in-hospital ward monitoring, followed by no vital signs monitoring at home, leads to thousands of cases of undetected/delayed detection of hemodynamic compromise. In this article we review work to date on postoperative remote automated monitoring on surgical wards and strategy for advancing this field. Key considerations for overcoming current barriers to implementing remote automated monitoring in Canada are also presented.

17.
Circulation ; 2018 Jul 05.
Artigo em Inglês | MEDLINE | ID: mdl-29976568

RESUMO

Background -Older adults undergoing aortic valve replacement are at risk for malnutrition. The association between pre-procedural nutritional status and midterm mortality has yet to be determined. Methods -The FRAILTY-AVR prospective multi-center international cohort study was conducted between 2012-2017 in 14 centers in 3 countries. Patients ≥70 years of age who underwent transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) were eligible. The Mini Nutritional Assessment-Short Form (MNA-SF) was assessed by trained observers pre-procedure, with scores ≤7 of 14 considered malnourished and 8-11 of 14 considered at-risk for malnutrition. The Short Performance Physical Battery (SPPB) was simultaneously assessed to measure physical frailty, with scores ≤5 of 12 considered severely frail and 6-8 of 12 considered mildly frail. The primary outcome was 1-year all-cause mortality and the secondary outcome was 30-day composite mortality or major morbidity. Multivariable regression models were used to adjust for potential confounders. Results -There were 1,158 patients (727 TAVR and 431 SAVR) with 45% females, a mean age of 81.3 years, a mean body mass index of 27.5 kg/m2, and a mean Society of Thoracic Surgeons-Predicted Risk of Mortality (STS-PROM) of 5.1%. Overall, 8.7% of patients were classified as malnourished and 32.8% were at-risk for malnutrition. MNA-SF scores were moderately correlated with SPPB scores (Spearman R=0.31, P<0.001). There were 126 deaths in the TAVR group (19.1 per 100 patient-years) and 30 deaths in the SAVR group (7.5 per 100 patient-years). Malnourished patients had a nearly 3-fold higher crude risk of 1-year mortality compared with those with normal nutritional status (28% vs 10%, P<0.001). After adjustment for frailty, STS-PROM, and procedure type, pre-procedural nutritional status was a significant predictor of 1-year mortality (OR 1.08 per MNA-SF point, 95% CI 1.01-1.16) and of the 30-day composite safety endpoint (OR 1.06 per MNA-SF point, 95% CI 1.00 to 1.12). Conclusions -Pre-procedural nutritional status is associated with mortality in older adults following aortic valve replacement. Clinical trials are needed to determine whether pre- and post-procedural nutritional interventions can improve clinical outcomes in these vulnerable patients.

18.
Can J Surg ; 61(3): 185-194, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29806816

RESUMO

BACKGROUND: Myocardial injury after noncardiac surgery (MINS) is a mostly asymptomatic condition that is strongly associated with 30-day mortality; however, it remains mostly undetected without systematic troponin T monitoring. We evaluated the cost and consequences of postoperative troponin T monitoring to detect MINS. METHODS: We conducted a model-based cost-consequence analysis to compare the impact of routine troponin T monitoring versus standard care (troponin T measurement triggered by ischemic symptoms) on the incidence of MINS detection. Model inputs were based on Canadian patients enrolled in the Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) study, which enrolled patients aged 45 years or older undergoing inpatient noncardiac surgery. We conducted probability analyses with 10 000 iterations and extensive sensitivity analyses. RESULTS: The data were based on 6021 patients (48% men, mean age 65 [standard deviation 12] yr). The 30-day mortality rate for MINS was 9.6%. We determined the incremental cost to avoid missing a MINS event as $1632 (2015 Canadian dollars). The cost-effectiveness of troponin monitoring was higher in patient subgroups at higher risk for MINS, e.g., those aged 65 years or more, or with a history of atherosclerosis or diabetes ($1309). CONCLUSION: The costs associated with a troponin T monitoring program to detect MINS were moderate. Based on the estimated incremental cost per health gain, implementation of postoperative troponin T monitoring seems appealing, particularly in patients at high risk for MINS.

19.
Can J Anaesth ; 65(7): 813-821, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29671186

RESUMO

Increasingly, clinicians and researchers recognize that studies of interventions need to evaluate not only their therapeutic efficacy (i.e., the effect on an outcome in ideal, controlled settings) but also their real-world effectiveness in broad, unselected patient groups. Effectiveness trials inform clinical practice by comparing variations in therapeutic approaches that fall within the standard of care. In this article, we discuss the need for studies of comparative effectiveness in anesthesia and the limitations of individual patient randomized-controlled trials in determining comparative effectiveness. We introduce the concept of randomized cluster crossover trials as a means of answering questions of comparative effectiveness in anesthesia, using the design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial (Clinicaltrials.gov identifier NCT03053869).

20.
J Am Coll Cardiol ; 71(6): 591-602, 2018 Feb 13.
Artigo em Inglês | MEDLINE | ID: mdl-29420954

RESUMO

BACKGROUND: Despite the well-established benefits of secondary cardiovascular prevention, the importance of concurrent medical therapy in clinical trials of coronary revascularization is often overlooked. OBJECTIVES: The goal of this study was to assess compliance with guideline-directed medical therapy (GDMT) in clinical trials and its potential impact on the comparison between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). METHODS: The Cochrane Central Register of Controlled Trials and MEDLINE were searched from 2005 to August 2017. Clinical trial registries and reference lists of relevant studies were also searched. Randomized controlled trials comparing PCI with drug-eluting stents versus CABG and reporting medical therapy after revascularization were included. The study outcome was compliance with GDMT, defined as the following: 1) any antiplatelet agent plus beta-blocker plus statin (GDMT1); and 2) any antiplatelet agent plus beta-blocker plus statin plus angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (GDMT2). Data collection and analysis were performed according to the methodological recommendations of The Cochrane Collaboration. RESULTS: From a total of 439 references, 5 trials were included based on our inclusion and exclusion criteria. Overall, compliance with GDMT1 was low and decreased over time from 67% at 1 year to 53% at 5 years. Compliance with GDMT2 was even lower and decreased from 40% at 1 year to 38% at 5 years. Compliance with both GDMT1 and GDMT2 was higher in PCI than in CABG at all time points. Meta-regression suggested an association between lower use of GDMT1 and adverse clinical outcomes in PCI versus CABG at 5 years. CONCLUSIONS: Compliance with GDMT in contemporary clinical trials remains suboptimal and is significantly lower after CABG than after PCI, which may influence the comparison of clinical trial endpoints between those study groups.

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