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OBJECTIVES: Clinical trials that are terminated prematurely may generate incomplete and potentially biased data and the reasons for premature trials termination are poorly understood. Our objective was to describe the incidence of premature trial termination and identify factors associated with it. METHODS: We performed a systematic search on ClinicalTrials.gov to identify all cardiac surgery trials from 1991 to 2023. Trials that were terminated prematurely were identified. Factors independently associated with premature termination were identified using multivariable logistic regression analysis. RESULTS: A total of 746 clinical trials were included; of them 577 were completed and 169 (22.6%) were terminated prematurely. Most of the trials originated from North America (294 [39.4%]), Europe (264 [35.4%]) or Asia (141 [18.9%]). Fourteen of the trials terminated prematurely (8.3%) were phase 1, 75 (44.4%) phase 2, 49 (29.0%) phase 3, and 31 (18.3%) phase 4. Fifty (29.6%) trials were terminated because of slow recruitment, 20 (11.8%) because of sponsor decision and 12 (7.1%) because lack of funding. Left ventricular assist device (LVAD) trials (odds ratio [OR] 3.65, 95% CI: [1.65-8.00] P = 0.001), valve surgery trials (OR 4.30, 95% CI: [2.33-8.00] P < 0.001), aortic surgery trials (OR 2.86 95% CI [1.22-6.43] P = 0.012), Phase 2 (OR 3.02, 95% CI [1.31-7.93] P = 0.015) and phase 4 trials (OR 3.62, 95% CI: [1.43-10.23] P = 0.010) were at higher risk of premature termination while trials performed in Asia (OR 0.18, 95% CI [0.07-0.39] P ≤ 0.001) and Europe (OR 0.49, 95% CI: [0.30-0.80] P = 0.004) were less likely to be terminated prematurely. CONCLUSIONS: Slow recruitment is the most common reason for premature termination of cardiac surgery trials. Trials on LVAD, valve surgery, aortic surgery, phase 2 trials and phase 4 trials are more likely to be terminated, while trials conducted in Asia and Europe are less likely to be terminated prematurely.
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OBJECTIVE: Evaluate outcomes of valve-sparing root replacement (VSRR) in patients with bicuspid aortopathy (BAV) versus other connective tissue disorder (CTD). METHODS: Single-center cohort study of consecutive patients undergoing VSRR via reimplantation from 2000-2023 with BAV or CTD. Operative outcomes, Kaplan-Meier survival estimates, and cumulative risk of reoperation and recurrent aortic insufficiency (AI) with the competing risk of death were assessed. RESULTS: Of 516 VSRR patients, 109 (51.9%) had BAV and 101 (48.1%) had CTD. BAV patients were older (46.9±10.4 vs 38.4±14 years, p<0.001) and more likely male ( 89.0% vs 56.4%, p<0.001) and hypertensive (66.1% vs 28.7%, p<0.001). Preoperative AI was similar (p=0.57) between groups (30.3% mild, 18.3% moderate, 11.1% severe). Most patients had no/trivial immediate postoperative residual AI (96.3% vs 93.1%). Operative mortality was zero; postoperative adverse events were minimal. Mean clinical follow-up was 5.2±4.4 years; ten-year survival was 95.6% vs 95.7% (p=0.70). Echocardiographic follow-up was 3.9±4.1 years; incidence of >2+ AI (9.7% vs 10.1%, p=1.0) was similar between groups, while incidence of moderate or greater aortic stenosis (AS) was higher with BAV (7.5% vs 0%, p=0.02). Reoperation was low in both groups (3.7% vs 5.9%, p=0.65). Competing risk analysis found no difference in reoperation hazard between BAV and CTD groups (hazard ratio 0.36, 95% confidence interval 0.07-1.81, p=0.21). CONCLUSIONS: BAV and CTD patients have excellent operative outcomes, no mortality, and minimal residual AI after VSRR. While the incidence of recurrent AI was similar, BAV patients are at risk for AS.
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INTRODUCTION: Lipoprotein(a) (Lp[a]) is a variant of low-density lipoprotein (LDL) and has been associated with increased risk of vascular inflammation and thrombosis. Coronary artery bypass grafting (CABG) has been associated with local inflammation of the myocardium. It is plausible, therefore, that patients with elevated baseline Lp(a) may be prone to unfavorable clinical outcomes following CABG. We evaluate differences in outcomes between CABG patients with high and low serum Lp(a) in this meta-analysis. EVIDENCE ACQUISITION: A comprehensive literature search was performed to identify studies reporting outcomes in CABG patients stratified by preoperative Lp(a) level. When possible, the outcomes were pooled in a meta-analysis. We assessed post-operative mortality, major cardiovascular events, stroke occurrence and saphenous graft occlusion. EVIDENCE SYNTHESIS: Eight studies involving 8681 patients were included. Articles used varying cut-offs for high versus low Lp(a), and outcomes varied. In the three studies evaluating mortality, two showed no statistically significant difference between groups while one reported increased mortality associated with high Lp(a) level. Both studies investigating major adverse cardiovascular events reported higher risk in patients with high Lp(a). A study-level meta-analysis of four studies reporting saphenous vein graft occlusion incidence after CABG was performed. High (≥30 mg/dL) preoperative Lp(a) was not associated with an increased risk of graft occlusion compared with low (<30 mg/dL) preoperative Lp(a) (OR=1.88, 95% CI: 0.66-5.36; P=0.15). CONCLUSIONS: Studies evaluating the impact of Lp(a) on outcomes in CABG patients are few, with heterogenous cut-offs and outcomes. In the limited published studies, Lp(a) level was not associated with graft occlusion.
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BACKGROUND: Postoperative bleeding requiring re-exploration is a serious complication that occurs in 2.8% to 4.6% of patients undergoing cardiac surgery. Re-exploration has previously been associated with a higher risk of short-term mortality. However, a comprehensive analysis of long-term outcomes after re-exploration for bleeding has not been published. MATERIALS AND METHODS: We performed a systematic, three databases search to identify studies reporting long-term outcomes in patients who required re-exploration for bleeding after cardiac surgery compared to patients who did not, with at least 1 year of follow-up. Long-term survival was the primary outcome. Secondary outcomes were operative mortality, myocardial infarction, stroke, renal and respiratory complications, and hospital length of stay. Random-effects models was used. Individual patient survival data was extracted from available survival curves and reconstructed using restricted mean survival time. RESULTS: Six studies totaling 135,456 patients were included. The average follow-up was 5.5 years. In the individual patient data, patients who required re-exploration had a significantly higher risk of death compared with patients who did not (hazard ratio [HR]: 1.21; 95% confidence interval [CI]: 1.14-1.27; P<0.001), which was confirmed by the study-level survival analysis (HR: 1.32; 95% CI: 1.12-1.56; P<0.01). Re-exploration was also associated with a higher risk of operative mortality (odds ratio [OR]: 5.25, 95% CI, 4.74-5.82, P<0.0001), stroke (OR: 2.05, 95% CI, 1.72-2.43, P<0.0001), renal (OR: 4.13, 95% CI, 3.43-4.39 P<0.0001) respiratory complications (OR: 3.91, 95% CI, 2.96-5.17, P<0.0001), longer hospital length of stay (mean difference [MD]: 2.69, 95% CI, 1.68 to 3.69, P<0.0001), and myocardial infarction (OR: 1.85, 95% CI, 1.30-2.65, P=0.0007). CONCLUSION: Postoperative bleeding requiring re-exploration is associated with lower long-term survival and increased risk of short-term adverse events including operative mortality, stroke, renal and respiratory complications, and longer hospital length of stay. To improve both short- and long-term outcomes, strategies to prevent the need for re-exploration are necessary.
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OBJECTIVES: The association between obesity and graft failure after coronary artery bypass grafting has not been previously investigated. METHODS: We pooled individual patient data from randomized clinical trials with systematic postoperative coronary imaging to evaluate the association between obesity and graft failure at the individual graft and patient levels. Penalized cubic regression splines and mixed-effects multivariable logistic regression models were performed. RESULTS: Six trials comprising 3928 patients and 12 048 grafts were included. The median time to imaging was 1.03 (interquartile range 1.00-1.09) years. By body mass index (BMI) category, 800 (20.4%) patients were normal weight (BMI 18.5-24.9), 1668 (42.5%) were overweight (BMI 25-29.9), 983 (25.0%) were obesity class 1 (BMI 30-34.9), 344 (8.8%) were obesity class 2 (BMI 35-39.9) and 116 (2.9%) were obesity class 3 (BMI 40+). As a continuous variable, BMI was associated with reduced graft failure [adjusted odds ratio (aOR) 0.98 (95% confidence interval (CI) 0.97-0.99)] at the individual graft level. Compared to normal weight patients, graft failure at the individual graft level was reduced in overweight [aOR 0.79 (95% CI 0.64-0.96)], obesity class 1 [aOR 0.81 (95% CI 0.64-1.01)] and obesity class 2 [aOR 0.61 (95% CI 0.45-0.83)] patients, but not different compared to obesity class 3 [aOR 0.94 (95% CI 0.62-1.42)] patients. Findings were similar, but did not reach significance, at the patient level. CONCLUSIONS: In a pooled individual patient data analysis of randomized clinical trials, BMI and obesity appear to be associated with reduced graft failure at 1 year after coronary artery bypass grafting.
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Índice de Masa Corporal , Puente de Arteria Coronaria , Obesidad , Sobrepeso , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Puente de Arteria Coronaria/efectos adversos , Obesidad/complicaciones , Sobrepeso/complicaciones , Sobrepeso/epidemiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de RiesgoRESUMEN
BACKGROUND: We compared the outcomes of aortic root replacement by composite valve grafts (CVG) and valve-sparing root replacement (VSRR) operations, with an emphasis on postoperative conduction block and the need for permanent pacemaker implantation (PPM). METHODS: From 1997 to 2023, 1712 consecutive patients underwent ARR by VSRR (501 [29%]) or CVG (1211 [71%]) at a high-volume aortic center. RESULTS: Patients undergoing CVG were older (59 ± 14 vs 49 ± 14 years, P < .001), with more cardiovascular comorbidities. Compared with CVG, there were more women undergoing VSRR (17% vs. 13%, P = .042) and more patients with connective tissue disease (22% vs 7.3%, P < .001). Multivariable analysis found that the risk for PPM was higher after CVG compared with VSRR (6.5% vs 1.2%; odds ratio [OR], 2.83; 95% CI, 1.23-7.69; P = .024). Other variables associated with PPM include older age (OR, 1.03; 95% CI, 1.01-1.05; P = .006) preoperative renal impairment (OR, 2.69; 95% CI, 1.24-5.6; P = .010), previous operation (OR, 2.76; 95% CI, 1.29-5.62; P = .007), and bicuspid aortic valve (OR, 3.63; 95% CI, 2.13-6.33; P < .001). Among the CVG population, patients who are at increased risk are especially those with some degree of aortic stenosis (OR, 2.06; 95% CI, 1.18-3.61; P = .011). Patients who required PPM had no additive risk for long-term mortality (hazard ratio, 1.01; 95% CI, 0.47-2.17; P = .986); however, they were more likely to have reduced ejection fraction (29.3% vs 16%, P = .014). CONCLUSIONS: The incidence of PPM after ARR is low, but rates were higher after CVG compared with VSRR.
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OBJECTIVES: Mechanisms of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) differ as CABG provides surgical collateralization and may prolong life by preventing future myocardial infarctions (MIs). However, evidence for CABG in patients with chronic total occlusion (CTO) has not been fully elucidated and the impact of PCI is discussed controversially. METHODS: We performed a meta-analysis of studies comparing outcomes in patients with/without multivessel disease undergoing CABG or PCI for CTO. The primary outcome was long-term all-cause mortality (≥5 years). Secondary outcomes were MIs, repeat revascularization, cardiac mortality, major adverse cardiovascular events, and stroke, as well as short-term mortality (30 days/in-hospital) and stroke. A pooled Kaplan-Meier survival curve after reconstruction analysis was generated. Random-effects models were used. RESULTS: Six studies totaling 12,504 patients were included. In the pooled Kaplan-Meier analysis, PCI showed a significantly higher risk of death in the follow-up compared with CABG (hazard ratio [HR]: 2.12, 95% confidence interval [CI]: 1.88-2.38, p < 0.01). During the observation period, PCI was also associated with higher rates of MI (odds ratio [OR]: 2.86, 95% CI: 1.82-4.48, p < 0.01) and more repeat revascularization (OR: 4.88, 95% CI: 1.99-11.91, p = 0.0005). The other outcomes did not show significant differences. CONCLUSION: CABG is associated with superior survival to PCI over time in patients with CTO who are eligible for both PCI and CABG. This survival advantage is associated with fewer events of MI and repeat revascularization.
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Background: Subclinical hypothyroidism (SCH) is associated with major adverse cardiovascular events. Despite the recognized negative impact of SCH on cardiovascular health, research on cardiac postoperative outcomes with SCH has yielded conflicting results, and patients are not currently treated for SCH before cardiac surgery procedures. Methods: We performed a study-level meta-analysis on the impact of SCH on patients undergoing nonurgent cardiac surgery, including coronary artery bypass grafting and valve and aortic surgery. The primary outcome was operative mortality. Secondary outcomes were hospital length of stay (LOS), intensive care unit (ICU) stay, postoperative atrial fibrillation (POAF), intra-aortic balloon pump (IABP) use, renal complications, and long-term all-cause mortality. Results: Seven observational studies, with a total of 3445 patients, including 851 [24.7%] diagnosed with SCH and 2594 [75.3%] euthyroid patients) were identified. Compared to euthyroid patients, the patients with SCH had higher rates of operative mortality (odds ratio [OR], 2.57; 95% confidence interval [CI], 1.09-6.04; P = .03), prolonged hospital LOS (standardized mean difference, 0.32; 95% CI, 0.02-0.62; P = .04), a higher rate of renal complications (OR, 2.53; 95% CI, 1.74-3.69; P < .0001), but no significant differences in ICU stay, POAF, or IABP use. At mean follow-up of 49.3 months, the presence of SCH was associated with a higher rate of all-cause mortality (incidence rate ratio, 1.82; 95% CI, 1.18-2.83; P = .02). Conclusions: Patients with SCH have higher operative mortality, prolonged hospital LOS, and increased renal complications after cardiac surgery. Achieving and maintaining a euthyroid state prior to and after cardiac surgery procedures might improve outcomes in these patients.
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OBJECTIVES: Midline sternotomy is the main surgical access for cardiac surgeries. The most prominent complication of sternotomy is sternal wound infection (SWI). The use of a thorax support vest (TSV) that limits thorax movement and ensures sternal stability has been suggested to prevent postoperative SWI. METHODS: We performed a meta-analysis to evaluate differences in clinical outcomes with and without the use of TSV after cardiac surgery in randomized trials. The primary outcome was deep SWI (DSWI). Secondary outcomes were superficial SWI, sternal wound dehiscence, and hospital length of stay (LOS). A trial sequential analysis was performed. Fixed (F) and random effects (R) models were calculated. RESULTS: A total of 4 studies (3820 patients) were included. Patients who wore the TSV had lower incidence of DSWI [odds ratio (OR) = F: 0.24, 95% confidence interval (CI), 0.13-0.43, P < 0.01; R: 0.24, 0.04-1.59, P = 0.08], sternal wound dehiscence (OR = F: 0.08, 95% CI, 0.02-0.27, P < 0.01; R: 0.10, 0.00-2.20, P = 0.08) and shorter hospital LOS (standardized mean difference = F: -0.30, -0.37 to -0.24, P < 0.01; R: -0.63, -1.29 to 0.02, P = 0.15). There was no difference regarding the incidence of superficial SWI (OR = F: 0.71, 95% CI, 0.34-1.47, P = 0.35; R: 0.64, 0.10, 4.26, P = 0.42). The trial sequential analysis, however, showed that the observed decrease in DSWI in the TSV arm cannot be considered conclusive based on the existing evidence. CONCLUSIONS: This meta-analysis suggests that the use of a TSV after cardiac surgery could potentially be associated with a reduction in sternal wound complications. However, despite the significant treatment effect in the available studies, the evidence is not solid enough to provide strong practice recommendations.
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BACKGROUND: Women undergoing coronary artery bypass grafting (CABG) have higher operative mortality than men. OBJECTIVES: The purpose of this study was to evaluate the relationship between intraoperative anemia (nadir intraoperative hematocrit), CABG operative mortality, and sex. METHODS: This was a cohort study of 1,434,225 isolated primary CABG patients (344,357 women) from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (2011-2022). The primary outcome was operative mortality. The attributable risk (AR) (the risk-adjusted strength of the association of female sex with CABG outcomes) for the primary outcome was calculated. Causal mediation analysis derived the total effect of female sex on operative mortality risk and the proportion of that effect mediated by intraoperative anemia. RESULTS: Women had lower median nadir intraoperative hematocrit (22.0% [Q1-Q3: 20.0%-25.0%] vs 27.0% [Q1-Q3: 24.0%-30.0%], standardized mean difference 97.0%) than men. Women had higher operative mortality than men (2.8% vs 1.7%; P < 0.001; adjusted OR: 1.36; 95% CI: 1.30-1.41). The AR of female sex for operative mortality was 1.21 (95% CI: 1.17-1.24). After adjusting for nadir intraoperative hematocrit, AR was reduced by 43% (1.12; 95% CI: 1.09-1.16). Intraoperative anemia mediated 38.5% of the increased mortality risk associated with female sex (95% CI: 32.3%-44.7%). Spline regression showed a stronger association between operative mortality and nadir intraoperative hematocrit at hematocrit values <22.0% (P < 0.001). CONCLUSIONS: The association of female sex with increased CABG operative mortality is mediated to a large extent by intraoperative anemia. Avoiding nadir intraoperative hematocrit values below 22.0% may reduce sex differences in CABG operative mortality.
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Anemia , Procedimientos Quirúrgicos Cardíacos , Adulto , Humanos , Femenino , Masculino , Estudios de Cohortes , Puente de Arteria Coronaria/efectos adversos , Anemia/epidemiología , Hematócrito , Factores de Riesgo , Resultado del Tratamiento , Estudios RetrospectivosRESUMEN
BACKGROUND: There is limited report of outcomes in women undergoing isolated coronary artery bypass grafting (CABG) with left internal thoracic artery and different second conduits (saphenous vein graft [SVG], radial artery [RA], and right internal thoracic artery [RITA]). METHODS: The National Adult Cardiac Surgery Audit database was queried for women undergoing isolated CABG with left internal thoracic artery graft in the United Kingdom from 1996 to 2019. Propensity score-based pairwise comparisons were performed between graft types. The primary outcome was in-hospital mortality. RESULTS: The study included 58,063 women (SVG, n = 48,881 [84.2%]; RA, n = 6136 [10.6%]; RITA, n = 2445 [4.2%]). SVG use was stable over the years; RA and RITA use decreased. In-hospital mortality was similar between the RA and RITA grafts (2.3% vs 2.8%; odds ratio [OR], 0.80; 95% CI, 0.53-1.22; P = .39) and between the RA and SVG (2.3% vs 2.0%; OR, 1.20; 95% CI, 0.93-1.55; P = .17) but higher in the RITA group compared with the SVG (2.7% vs 1.4%; OR, 2.04; 95% CI, 1.27-3.36; P = .004). Women receiving the RITA graft were more likely to have sternal wound infection (SWI) compared with the RA (0.6% vs 0.06%; P = .004) and the SVG (0.6% vs 0.2%; P = .032). SWI was consistently associated with higher risk of in-hospital mortality. CONCLUSIONS: Conduit selection may affect operative outcomes in women undergoing CABG. The RA shows similar mortality and risk of deep SWI as the SVG.
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Enfermedad de la Arteria Coronaria , Arterias Mamarias , Adulto , Humanos , Femenino , Resultado del Tratamiento , Estudios Retrospectivos , Puente de Arteria Coronaria , Arterias Mamarias/trasplante , Reino Unido/epidemiología , Arteria Radial/trasplante , Vena Safena/trasplante , Enfermedad de la Arteria Coronaria/cirugíaRESUMEN
OBJECTIVES: The aim of this meta-analysis was to compare clinical and angiographic outcomes of skeletonized versus pedicled internal thoracic artery for coronary artery bypass grafting. METHODS: A comprehensive search on Ovid MEDLINE, Ovid EMBASE and Scopus was performed from inception to December 2022. The primary outcome was follow-up mortality and graft failure. Secondary outcomes were repeat revascularization, cardiovascular death and operative mortality, myocardial infarction, stroke, and sternal wound complications (SWCs). Pooled estimate for follow-up outcomes was summarized as incidence rate ratio (IRR) and 95% confidence interval (CI) while short-term outcomes were pooled as odds ratio (OR) and 95% CI. For all outcomes, inverse variance weighting was used for pooling. RESULTS: Twenty-eight studies, including 7 randomized trials and 21 observational studies, for a total of 5664 patients in the skeletonized group and 7434 in the pedicled group, were included in the analysis. At a mean weighted follow-up of 4.8 years, there was no difference in mortality between the two groups (IRR 1.14; 95% CI 0.59-2.20). However, the skeletonized group had a higher incidence of graft failure compared to the pedicled group (IRR 1.87, 95% CI 1.33-2.63) but a lower risk of SWCs (OR 0.42; 95% CI 0.30-0.60). There was no difference in short-term outcomes. CONCLUSIONS: Compared to the pedicled harvesting technique, skeletonization of the internal thoracic artery is associated with higher rate of graft failure and lower risk of SWCs without mortality difference.
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Arterias Mamarias , Humanos , Arterias Mamarias/trasplante , Puente de Arteria Coronaria/métodos , Resultado del TratamientoRESUMEN
The external stenting of saphenous vein grafts (SVGs) during coronary artery bypass grafting (CABG) has been proven to reduce intimal hyperplasia (IH) in animal models, paving the way for human randomized controlled trials (RCTs) to be conducted. Herein, we performed a study-level meta-analysis to assess the impact of the Venous External SupporT (VEST) device, an external stent, on the outcomes of SVGs. A systematic search was conducted to identify all RCTs comparing VEST-stented to non-stented SVGs in patients undergoing CABG. The primary outcome was graft occlusion. The main secondary outcomes were repeat revascularization, SVG IH area, and intimal-medial thickness. Two RCTs totaling 407 patients were included. At a mean follow-up of 1.5 years, there was no difference in graft occlusion between groups (incidence rate ratio: 1.11; 95% confidence interval (CI): 0.80-1.53). The rate of repeat revascularization was also similar (odds ratio: 0.66; 95% CI: 0.27-1.64). The IH area (standardized mean difference (SMD): -0.45; 95% CI: -0.79 to -0.10) and intimal-medial thickness (SMD: -0.50; 95% CI: -0.90 to -0.10) were significantly reduced in the VEST group. Our findings show that significant reductions in the IH area and the intimal-medial thickness in VEST-stented SVGs do not currently translate into a lesser need for repeat revascularization or less graft occlusion events compared to non-stented SVGs at 1.5 years after CABG.
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OBJECTIVE: To review the available literature on the use of coronary artery bypass grafting (CABG) as a treatment option for anomalous origin of coronary artery in adults. METHODS: A systematic literature search was performed in March 2023 (including Ovid MEDLINE, Ovid Embase, and the Cochrane Library databases) to identify studies reporting the use of CABG in adult patients with anomalous origin of coronary artery. RESULTS: A total of 31 studies and 62 patients were included, 32 patients (52%) were women, and the mean age was 45.1±16.1 years. The most common coronary anomaly was the right coronary artery arising from the left coronary sinus in 26 patients (42%), followed by an anomalous left coronary artery from the pulmonary artery in 23 patients (37%). A total of 65 conduits were used in 61 patients, and 1 case report did not report conduit type. Reported grafts included saphenous vein (23 of 65 [35.4%]), left internal thoracic artery (15 of 65 [23.1%]), right internal thoracic artery (23 of 65 [35.4%]), and radial artery (2 of 65 [3.1%]); right gastroepiploic artery and basilic vein were used once (1.5%) each. Ligation of the native coronary artery was performed in 42 (67.7%) patients. Patient follow-up was available in 19 studies with a mean of 31.2 months. Only 1 operative mortality was reported. CONCLUSIONS: Based on the limited available data, CABG can be performed with good early results. Use of arterial conduits and ligation of the native coronary artery may improve long-term graft patency.
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Vasos Coronarios , Arterias Mamarias , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Angiografía Coronaria , Puente de Arteria Coronaria/métodos , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugía , Arterias Mamarias/trasplante , Arteria Radial/trasplante , Vena Safena/trasplante , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
Saphenous vein grafts (SVGs) are the most frequently used conduits in coronary artery bypass grafting (CABG), but their higher rate of occlusion compared to arterial conduits remains a concern. Previous studies have shown that SVG failure is mainly driven by intimal hyperplasia, an adaptative response to higher pressures of the arterial circulation. The VESTTM device (Vascular Graft Solutions, Tel Aviv, Israel), an external support designed to mitigate intimal hyperplasia in SVGs, has been tested in few clinical trials (RCTs). Herein, we descriptively evaluated the randomized evidence on the VEST device.
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Aims: Postoperative atrial fibrillation (POAF) is the most common complication of cardiac surgery and has been associated with increased postoperative morbidity and hospital costs. The Posterior left pericardiotomy for the prevention of AtriaL fibrillation After Cardiac Surgery (PALACS) trial found that posterior pericardiotomy significantly reduced the incidence of POAF (17% vs. 32%, P < 0.001). We present the protocol for The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up study (PALACS-EF): a prospective, extended follow-up of the original PALACS trial. The aim of PALACS-EF is to gain more data regarding the effect of posterior pericardiotomy on postdischarge clinical outcomes. The primary outcome is the time to the first occurrence of the composite of all-cause mortality or hospital cardiovascular readmission. The key secondary outcome is the time to the first occurrence of the composite of all-cause mortality and all-cause hospital readmission. Hospital readmission, myocardial infarction, stroke, transient ischaemic attack, heart failure, systemic embolism, or new arrhythmias with onset since 30-day follow-up will also be recorded. Methods and results: All 420 patients enrolled in the PALACS trial will be included; extended follow-up will be conducted via telephone by blinded research personnel utilizing a standardized script to ensure uniformity and completeness of follow-up. If an event has occurred, documentation will be obtained, and an independent adjudication committee blinded to group assignment will adjudicate outcome events. Results will be reported when a median follow-up of 5 years is achieved. Conclusion: PALACS-EF will provide data to answer the question of whether posterior pericardiotomy improves postdischarge outcomes in patients undergoing cardiac surgery, and it will provide information on the relationship between POAF and adverse postdischarge outcomes including mortality, hospitalization, heart failure, and stroke. Registration: PALACS: NCT02875405, PALACS-EF: NCT05903222.
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Background: Spinal cord injury (SCI) is a rare but severe complication after open or endovascular repair of descending thoracic aneurysms (DTAs) or thoracoabdominal aortic aneurysms (TAAAs). This meta-analysis aims to provide a comprehensive assessment of SCI rates and factors associated with SCI. Methods: A systematic literature search was performed in September 2022 looking for studies on open and/or endovascular repair of DTA and/or TAAA published after 2018, to update the results of our previously published meta-analysis. The primary outcome was permanent SCI. Secondary outcomes were temporary SCI, 30-day and in-hospital mortality, follow-up mortality, postoperative stroke, and cerebrospinal fluid (CSF) drain-related complications. Data were pooled as proportions using inverse-variance weighting. Results: A total of 239 studies (71 new studies and 168 from our previous meta-analysis) and 61,962 patients were included. The overall pooled rate of permanent SCI was 3.3% [95% confidence interval (CI), 2.9-3.8%]. Open repair was associated with a permanent SCI rate of 4.0% (95% CI, 3.3-4.8%), and endovascular repair was associated with a permanent SCI rate of 2.9% (95% CI, 2.4-3.5%). Permanent SCI was 2.0% (95% CI, 1.2-3.3%) after DTA repair, and 4.7% (95% CI, 3.9-5.6%) after TAAA repair; permanent SCI rate was 3.8% (95% CI, 2.9-5.0%) for Crawford extent I, 13.4% (95% CI, 9.0-19.5%) for extent II, 7.1% (95% CI, 5.7-8.9%) for extent III, 2.3% (95% CI, 1.6-3.5%) for extent IV, and 6.7% (95% CI, 1.7-23.1%) for extent V TAAA aneurysms. The pooled rate of CSF drain related complications was 1.9% (95% CI, 0.8-4.7%) for severe, 0.4% (95% CI, 0.0-4.0%) for moderate, and 1.8% (95% CI, 0.6-5.6%) for minor complications. Conclusions: Permanent SCI occurs after both endovascular and open DTA or TAAA repairs. Open repairs and TAAA repairs have higher risk of SCI compared with endovascular or DTA repairs. In particular, extent II aneurysms present the highest overall risk of SCI.
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Background and Objective: Coronary artery bypass grafting (CABG) is the most commonly performed cardiac surgery globally and in the United States, however, women have worse outcomes than men. We aim to examine the possible drivers of this sex difference in CABG outcomes. Methods: A narrative review using a current search of the most recent literature on this topic. Key Content and Findings: The sex difference in outcomes after CABG has persisted despite advances in the field, with women having well-described worse operative mortality and morbidity than men. Several explanatory mechanisms have been proposed for these differences. These include, but are not limited to, preoperative factors such as the natural history of coronary artery disease in women, older age, and higher prevalence of comorbidities at the time of presentation for CABG surgery. Intraoperative factors have also been proposed to play a role, including the smaller coronary artery size and greater coronary artery reactivity in women, the degree of intraoperative hemodilution anemia, the type of grafting, and the completeness of revascularization. However, no definitive etiology has been identified to date. Conclusions: The sex difference in outcomes after CABG remains present, and despite numerous proposed etiopathologies, the main driver remains unclear. Further research is needed to identify, and address, the root cause of this difference, and greater participation of women in cardiovascular and cardiac surgery trials is crucial.
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BACKGROUND: Postoperative atrial fibrillation (POAF) is the most frequent complication of cardiac surgery. Despite clinical and economic implications, ample variability in POAF assessment method and definition exist across studies. We performed a study-level meta-analysis to evaluate the influence of POAF assessment method and definition on its incidence and association with clinical outcomes. METHODS AND RESULTS: A systematic literature search was conducted to identify studies comparing the outcomes of patients with and without POAF after cardiac surgery that also reported POAF assessment method. The primary outcome was POAF incidence. The secondary outcomes were in-hospital mortality, stroke, intensive care unit length of stay, and postoperative length of stay. Fifty-nine studies totaling 197 774 patients were included. POAF cumulative incidence was 26% (range: 7.3%-53.1%). There were no differences in POAF incidence among assessment methods (27%, [range: 7.3%-53.1%] for continuous telemetry, 27% [range: 7.9%-50%] for telemetry plus daily ECG, and 19% [range: 7.8%-42.4%] for daily ECG only; P>0.05 for all comparisons). No differences in in-hospital mortality, stroke, intensive care unit length of stay, and postoperative length of stay were found between assessment methods. No differences in POAF incidence or any other outcomes were found between POAF definitions. Continuous telemetry and telemetry plus daily ECG were associated with higher POAF incidence compared with daily ECG in studies including only patients undergoing isolated coronary artery bypass grafting. CONCLUSIONS: POAF incidence after cardiac surgery remains high, and detection rates are variable among studies. POAF incidence and its association with adverse outcomes are not influenced by the assessment method and definition used, except in patients undergoing isolated coronary artery bypass grafting.
Asunto(s)
Fibrilación Atrial , Procedimientos Quirúrgicos Cardíacos , Accidente Cerebrovascular , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Fibrilación Atrial/etiología , Incidencia , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Puente de Arteria Coronaria/efectos adversos , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/complicaciones , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Factores de RiesgoRESUMEN
OBJECTIVE: Total aortic arch replacement (TAR) after previous cardiovascular surgery is technically challenging and is becoming more frequent as outcomes for primary arch repair have improved. primary. We analyzed outcomes of reoperative compared with first-time TAR. METHODS: The institutional aortic database was queried to identify consecutive patients undergoing TAR between 1997 and 2022. In total, 426 patients underwent TAR, of whom 150 (35%) had previous cardiovascular surgery (reop TAR) and 276 (65%) underwent their first cardiovascular operation. RESULTS: The reop TAR group was younger (61 ± 13 vs 71 ± 11, P < .001) with more comorbidities such as ischemic heart disease (12% vs 4.3%, P = .006), previous stroke (36% vs 14.5%, P < .001), and renal impairment (24% vs 12.7%, P = .004). Reop TAR had longer cardiac ischemic times (119.3 ± 45.5 minutes vs 98 ± 31.9 minutes, P < .001), a greater operative mortality (3.3% vs 0.4%, P = .040), and incurred a 4-fold increased risk of major adverse event (95% confidence interval [CI], 1.41-11.49, P = .009). Ten-year survival was also lower in the reop TAR cohort (76% vs 82.2%; hazard ratio, 1.79; 95% CI, 1.12-2.86, P = .015) and there was greater need for late reinterventions, mainly on the downstream aorta (hazard ratio, 1.29; 95% CI, 1.03-1.62, P = .024). CONCLUSIONS: Reop TAR is a technically challenging operation and is associated with increased operative mortality and adverse events. Gratifying results can be obtained with meticulous surgical planning and focused attention on end-organ protection. Late reinterventions occur in a significantly greater percentage of patients undergoing reop TAR, and future studies should focus attention on identifying those at-risk groups who may benefit from a more aggressive index procedure.