CO2 delivery techniques in mini-sternotomy surgery and neurological events: a multicentric study.

BACKGROUND: The impact of air bubbles into the cerebral circulation after open heart surgery has been a topic of discussion since the introduction of the heart-lung machine. The aim of the study was to evaluate whether the use of a dedicated commercial sponge diffuser is better than a custom-made narrow section cannula or the absence of CO2 in preventing neurological events after aortic valve replacement via J mini-sternotomy. METHODS: Three cohorts of J-shaped mini-sternotomy performed at three different centers were prospectively compared: CO2 supplied via sponge diffuser, CO2 supplied via cannula, and no CO2 supply. Propensity matching was used to obtain comparable groups. The primary endpoints were postoperative stroke, transitory ischemic attack, convulsions, and dizziness. Secondary endpoints were 30-day mortality, duration of mechanical ventilation, and intensive care unit length of stay. RESULTS: 275 patients were enrolled in the study. After propensity matching, the sponge diffuser cohort had a significantly lower duration of mechanical ventilation (P < 0.001) and 30-day mortality (P = 0.05) when compared to the cannula cohort and the no-CO2 cohort, a lower incidence of all neurological events (P = 0.03) and dizziness (P = 0.05) when compare to the no-CO2 cohort, and a lower intensive care unit length of stay when compared to the cannula cohort (P = 0.001). CONCLUSIONS: The sponge diffuser used to deliver the CO2 into the surgical field during aortic valve replacement via J mini-sternotomy has been demonstrated to guarantee better neurological outcomes compared to a custom-made narrow section cannula or the absence of CO2.

Coronary Artery Bypass Grafting versus Percutaneous Coronary Intervention in Patients with Chronic Total Occlusion.

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.

Percutaneous Versus Surgical Femoral Cannulation in Minimally Invasive Cardiac Surgery: A Systematic Review and Meta-Analysis.

OBJECTIVE: Minimally invasive cardiac surgery (MICS) is increasing worldwide. In most cases, the surgical technique includes cannulation of the groin for the establishment of cardiopulmonary bypass, requiring a second surgical incision (SC) for exposure and cannulation of the femoral vessels. With the introduction of arterial closure devices, percutaneous cannulation (PC) of the groin has become a possible alternative. We performed a meta-analysis and systematic review to compare clinical endpoints between the patients who underwent PC and SC for MICS. METHODS: Three databases were assessed. The primary outcome was any access site complication. Secondary outcomes were perioperative mortality, any wound complication, any vascular complication, lymphatic complications, femoral/iliac stenosis, stroke, procedural duration, and hospital length of stay (LOS). A random effects model was performed. RESULTS: A total of 5 studies with 2,038 patients were included. When compared with PC, patients who underwent SC showed a higher incidence of any access site complication (odds ratio [OR] = 3.09, 95% confidence interval [CI]: 1.87 to 5.10, P < 0.01), any wound complication (OR = 10.10, 95% CI: 3.31 to 30.85, P < 0.01), lymphatic complication (OR = 9.37, 95% CI: 2.15 to 40.81, P < 0.01), and longer procedural duration (standardized mean difference = 0.31, 95% CI: 0.12 to 0.51, P < 0.01). There was no significant difference between the 2 groups regarding perioperative mortality, any vascular complication, femoral/iliac stenosis, stroke, or hospital LOS. CONCLUSIONS: The analysis suggests that surgical groin cannulation in MICS is associated with a higher incidence of any access site complication (especially wound complication and lymphatic fistula) and with a longer procedural time compared with PC. There was no difference in perioperative mortality.

Predictors of premature termination of cardiac surgery trials: insights from the Clinicaltrial.gov database.

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 of lack of funding. Left ventricular assist device trials [odds ratio (OR) 3.65, 95% confidence interval (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 left ventricular assist device, 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.

Re-exploration for bleeding and long-term survival after adult cardiac surgery: a meta-analysis of reconstructed time-to-event data.

BACKGROUND: Postoperative bleeding requiring re-exploration is a serious complication that occurs in 2.8-4.6% 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: The authors 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% 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: 2.69, 95% CI: 1.68-3.69, 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-term and long-term outcomes, strategies to prevent the need for re-exploration are necessary.

Association between lipoprotein levels and outcomes after coronary artery bypass grafting surgery: a systematic review and meta-analysis.

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.

Subclinical hypothyroidism and clinical outcomes after cardiac surgery: A systematic review and meta-analysis.

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.

Outcomes of complete removal versus conservative therapy in cardiac implantable electronic device infections - A systematic review and Meta-analysis.

BACKGROUND: Complete removal of cardiac implantable electronic devices (CIEDs) is recommended in patients with CIED infections, including both systemic and localized pocket infection. The aim of the study was to provide an up-to-date and comprehensive assessment of evidence relating to the effect of complete CIED extraction in patients with a CIED infection. METHODS: We performed a systematic review and meta-analysis of studies reporting short- and mid-term outcomes in patients who had a device infection or infective endocarditis (IE) and underwent complete removal of the cardiac device (generator and leads) compared to those who received conservative therapy (no removal, partial removal, local antibiotic infiltration or isolated antibiotic therapy). The primary outcome was reinfection/relapse. Secondary outcomes were short-term (30-day/in-hospital) and mid-term (mean follow-up: 43.0 months) mortality. Random effects model was performed. RESULTS: Thirty-two studies met the criteria for inclusion in the final analysis. Patients with complete CIED extraction (n = 905) exhibited a lower rate of relapse/re-infection compared to patients (n = 195) with a conservative treatment approach (n = 195, OR 0.02, 95%CI 0.01-0.06, p < 0.0001, mean-follow-up: 16.1 months). Additionally, these patients displayed a lower short- (OR 0.40, 95%CI 0.23-0.69, p = 0.01) and mid-term (OR 0.52, 95%CI 0.34-0.78, p = 0.002) mortality. CONCLUSIONS: The analysis indicates that patients with a CIED infection who undergo complete CIED extraction exhibit a lower rate of relapse/re-infection. Additionally, a lower short- and mid-term mortality is observed, although it is acknowledged that this outcome may be influenced by treatment allocation bias.

Thorax support vest to prevent sternal wound infections in cardiac surgery patients-a systematic review and meta-analysis.

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.

Association between overweight and obesity with coronary artery bypass graft failure: an individual patient data analysis of clinical trials.

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.

The VEST External Support for Saphenous Vein Grafts in Coronary Surgery: A Review of Randomized Clinical Trials.

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.

External Stenting for Saphenous Vein Grafts in Coronary Surgery: A Systematic Review and Meta-Analysis.

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.