Search

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with COVID-19, but uncertainty remains about the determinants of in-hospital mortality and data on post-discharge outcomes are scarce. The aims of this study were to investigate the variables associated with in-hospital outcomes in patients who received ECMO during the first wave of COVID-19 and to describe the status of patients 6 months after ECMO initiation.METHODS: EuroECMO-COVID is a prospective, multicentre, observational study developed by the European Extracorporeal Life Support Organization. This study was based on data from patients aged 16 years or older who received ECMO support for refractory COVID-19 during the first wave of the pandemic-from March 1 to Sept 13, 2020-at 133 centres in 21 countries. In-hospital mortality and mortality 6 months after ECMO initiation were the primary outcomes. Mixed-Cox proportional hazards models were used to investigate associations between patient and management-related variables (eg, patient demographics, comorbidities, pre-ECMO status, and ECMO characteristics and complications) and in-hospital deaths. Survival status at 6 months was established through patient contact or institutional charts review. This study is registered with ClinicalTrials.gov, NCT04366921, and is ongoing.FINDINGS: Between March 1 and Sept 13, 2020, 1215 patients (942 [78%] men and 267 [22%] women; median age 53 years [IQR 46-60]) were included in the study. Median ECMO duration was 15 days (IQR 8-27). 602 (50%) of 1215 patients died in hospital, and 852 (74%) patients had at least one complication. Multiorgan failure was the leading cause of death (192 [36%] of 528 patients who died with available data). In mixed-Cox analyses, age of 60 years or older, use of inotropes and vasopressors before ECMO initiation, chronic renal failure, and time from intubation to ECMO initiation of 4 days or more were associated with higher in-hospital mortality. 613 patients did not die in hospital, and 547 (95%) of 577 patients for whom data were available were alive at 6 months. 102 (24%) of 431 patients had returned to full-time work at 6 months, and 57 (13%) of 428 patients had returned to part-time work. At 6 months, respiratory rehabilitation was required in 88 (17%) of 522 patients with available data, and the most common residual symptoms included dyspnoea (185 [35%] of 523 patients) and cardiac (52 [10%] of 514 patients) or neurocognitive (66 [13%] of 512 patients) symptoms.INTERPRETATION: Patient's age, timing of cannulation (FUNDING: None.

In-hospital mortality of adult veno-venous extracorporeal membrane oxygenation (V-V ECMO) patients remains invariably high. However, little is known regarding timing and causes of in-hospital death, either on-ECMO or after weaning. The current review aims to investigate the timing and causes of death of adult patients during hospital admittance for V-V ECMO, and to define the V-V ECMO gap, which is represented by the patients that are successfully weaned of ECMO but still die during hospital stay. A systematic search was performed using electronic MEDLINE and EMBASE databases through PubMed. Studies reporting on adult V-V ECMO patients from January 2006 to December 2020 were screened. Studies that did not report on at least on-ECMO mortality and discharge rate were excluded from analysis as they could not provide the required information regarding the proposed V-V ECMO-gap. Mortality rates on-ECMO and after weaning, as well as weaning and discharge rates, were analyzed as primary outcomes. Secondary outcomes were the causes of death and complications. Initially, 35 studies were finally included in this review. Merely 24 of these studies (comprising 975 patients) reported on prespecified V-V ECMO outcomes (on-ECMO mortality and discharge rate). Mortality on V-V ECMO support was 27.8% (95% confidence interval (CI) 22.5%-33.2%), whereas mortality after successful weaning was 12.7% (95% CI 8.8%-16.6%, defining the V-V ECMO gap). 72.2% of patients (95% CI 66.8%-77.5%) were weaned successfully from support and 56.8% (95% CI 49.9%-63.8%) of patients were discharged from hospital. The most common causes of death on ECMO were multiple organ failure, bleeding, and sepsis. Most common causes of death after weaning were multiorgan failure and sepsis. Although the majority of patients are weaned successfully from V-V ECMO support, a significant proportion of subjects still die during hospital stay, defining the V-V ECMO gap. Overall, timing and causes of death are poorly reported in current literature. Future studies on V-V ECMO should describe morbidity and mortality outcomes in more detail in relation to the timing of the events, to improve patient management, due to enhanced understanding of the clinical course.

Objective Timing and causes of hospital mortality in adult patients undergoing veno-arterial extracorporeal membrane oxygenation (V-A ECMO) have been poorly described. Aim of the current review was to investigate the timing and causes of death of adult patients supported with V-A ECMO, and subsequently define the "V-A ECMO gap", which represents the patients who are successfully weaned of ECMO but eventually die during hospital stay. Data sources A systematic search was performed using electronic MEDLINE and EMBASE databases through PubMed. Studies reporting on adult V-A ECMO patients from January 1993 to December 2020 were screened. Study selection The studies included in this review were studies that reported more than 10 adult, human patients, and no mechanical circulatory support other than V-A ECMO. Data extraction Information extracted from each study included mainly mortality and causes of death on ECMO and after weaning. Complications and discharge rates were also extracted. Data synthesis Sixty studies with 9,181 patients were included for analysis in this systematic review. Overall mortality was 38.0% (95% confidence intervals (CI) 34.2-41.9%) during V-A ECMO support (reported by 60 studies) and 15.3% (95% CI 11.1-19.5%, reported by 57 studies) after weaning. Finally, 44.0% of patients (95% CI 39.8-52.2) were discharged from hospital (reported by 60 studies). Most common causes of death on ECMO were multiple organ failure, followed by cardiac failure and neurological causes. Conclusions More than one-third of V-A ECMO patients die during ECMO support. Additionally, many of successfully weaned patients still decease during hospital stay, defining the "V-A ECMO gap". Underreporting and lack of uniformity in reporting of important parameters remains problematic in ECMO research. Future studies should uniformly define timing and causes of death in V-A ECMO patients to better understand the effectiveness and complications of this support.

Cardiopulmonary bypass (CPB) is associated with platelet dysfunction (PD), an important cause of postoperative bleeding. The etiology of PD is not completely understood. We mapped the platelets' function during CPB to determine the etiology of PD. Platelets activation, measured by procaspase activating compound-1 and P-selectin expression (CD62P), after activation by adenosine diphosphate and thrombin receptor activator peptide, were decreased by protamine. Changes during CPB were insignificant. Platelet-leukocyte aggregation was increased by CPB but not by protamine. Platelet apoptosis marker, annexin V, was increased by protamine. Changes during CPB were insignificant. Our findings demonstrate that protamine given after CPB plays a central role in PD and count decrease.

Summary Background Ventilator-associated pneumonia (VAP) following cardiac surgery is a preventable complication associated with adverse outcomes. Aims We aimed to assess risk factors and outcomes of VAP following cardiac surgery. Methods A matched 1:3 case:control study, including adult patients undergoing cardiac surgery through sternotomy between September 2014 and March 2017 was conducted in a tertiary-care hospital in Israel. Cases included all patients developing VAP within 30 days after surgery, defined using consensus criteria. Controls were matched for age, gender and surgery type. Operative data were collected prospectively, other data were collected retrospectively. Cox regression was used for adjusted analysis of matched data. Findings Out of 946 operated patients, we identified 57 patients with VAP after cardiac surgery (17.7 episodes per 1000 ventilator-days) matched to 149 controls. Significant independent risk factors for VAP included congestive heart failure (odds ratio (OR) 2.357, 95% confidence interval (CI) 1.052–5.281), chest re-exploration in the intensive care unit (OR 10.213, 95% CI 2.235–46.678), preoperative glucose levels (OR 1.1010 per 1 mg/dL increase 95% CI 1.004–1.019) intraoperative red blood cell transfusions (OR 1.542 per 1 unit, 95% CI 1.109–2.094) and pulmonary hypertension (OR 2.261, 95% CI 1.048–6.554). VAP was most commonly caused by Gram-negative pathogens. VAP was associated with higher mortality, longer length of stay, longer need for ventilator support and longer stay in ICU setting. Conclusions Postoperative VAP in cardiac surgery patients is associated with severe clinical outcomes. We identified risk factors that can aid in preventive measures implementation for high-risk patients.

Left ventricular free wall rupture (LVFWR) is one of the most lethal heart conditions where mortality rates reach 40% intraoperatively and 80% in hospital. A few days after the acute event, the rupture becomes subacute, and surgery is indicated to repair the frail myocardium. Despite the lack of strong evidence to support the efficacy of sutureless repair of subacute LVFWR in the literature, this technique has recently been gaining popularity with acceptable success rates. In this article, we present two techniques to repair the subacute LVFWR without using sutures: the direct glued-hemostatic patch technique and the glued pericardial patch technique. In both techniques, the healthy myocardium surrounding the infarcted zone is recruited, together with hemostatic materials, to seal the rupture. Moreover, we describe the clinical presentation of the acute and subacute LVFWR, peri-operative management, together with intra-operative tips and the advantages and disadvantages of each material used in these operations.

Evaluation of myocardial regional function is generally performed by visual "eyeballing" which is highly subjective. A robust quantifiable parameter of regional function is required to provide an objective, repeatable and comparable measure of myocardial performance. We aimed to evaluate the clinical utility of novel regional myocardial strain software from cardiac computed tomography (CT) datasets. 93 consecutive patients who had undergone retrospectively gated cardiac CT were evaluated by the software, which utilizes a finite element based tracking algorithm through the cardiac cycle. Circumferential (CS), longitudinal (LS) and radial (RS) strains were calculated for each of 16 myocardial segments and compared to a visual assessment, carried out by an experienced cardiologist on cine movies of standard "echo" views derived from the CT data. A subset of 37 cases was compared to speckle strain by echocardiography. The automated software performed successfully in 93/106 cases, with minimal human interaction. Peak CS, LS and RS all differentiated well between normal, hypokinetic and akinetic segments. Peak strains for akinetic segments were generally post-systolic, peaking at 50 ± 17% of the RR interval compared to 43 ± 9% for normokinetic segments. Using ROC analysis to test the ability to differentiate between normal and abnormal segments, the area under the curve was 0.84 ± 0.01 for CS, 0.80 ± 0.02 for RS and 0.68 ± 0.02 for LS. There was a moderate agreement with speckle strain. Automated 4D regional strain analysis of CT datasets shows a good correspondence to visual analysis and successfully differentiates between normal and abnormal segments, thus providing an objective quantifiable map of myocardial regional function.

Objectives Little data exist regarding the potential of external stents to mitigate long-term disease progression in saphenous vein grafts. We investigated the effect of external stents on the progression of saphenous vein graft disease. Methods A total of 184 patients undergoing isolated coronary artery bypass grafting, using an internal thoracic artery graft and at least 2 additional saphenous vein grafts, were enrolled in 14 European centers. One saphenous vein graft was randomized to an external stent, and 1 nonstented saphenous vein graft served as the control. The primary end point was the saphenous vein graft Fitzgibbon patency scale assessed by angiography, and the secondary end point was saphenous vein graft intimal hyperplasia assessed by intravascular ultrasound in a prespecified subgroup at 2 years. Results Angiography was completed in 128 patients and intravascular ultrasound in the entire prespecified cohort (n = 51) at 2 years. Overall patency rates were similar between stented and nonstented saphenous vein grafts (78.3% vs 82.2%, P = .43). However, the Fitzgibbon patency scale was significantly improved in stented versus nonstented saphenous vein grafts, with Fitzgibbon patency scale I, II, and III rates of 66.7% versus 54.9%, 27.8% versus 34.3%, and 5.5% versus 10.8%, respectively (odds ratio, 2.02; P = .03). Fitzgibbon patency scale was inversely related to saphenous vein graft minimal lumen diameter, with Fitzgibbon patency scale I, II, and III saphenous vein grafts having an average minimal lumen diameter of 2.62 mm, 1.98 mm, and 1.32 mm, respectively (P < .05). Externally stented saphenous vein grafts also showed significant reductions in mean intimal hyperplasia area (22.5%; P < .001) and thickness (23.5%; P < .001). Conclusions Two years after coronary artery bypass grafting, external stenting improves Fitzgibbon patency scales of saphenous vein grafts and significantly reduces intimal hyperplasia area and thickness. Whether this will eventually lead to improved long-term patency is still unknown.

Background: Practice guidelines emphasize the role of the SYNTAX score (SS; Synergy Between PCI With TAXUS and Cardiac Surgery) in choosing between percutaneous coronary intervention and coronary artery bypass graft surgery in cases of complex coronary artery disease. There is paucity of data on the implementation of these recommendations in daily practice, and on the consequences of guideline discordant revascularization. Methods: This was a retrospective analysis of a prospective national survey of consecutive real world patients undergoing coronary revascularization for complex coronary artery disease according to decisions of local heart team at each center. SS was calculated at a dedicated CoreLab, and patients were classified as heart team/guidelines agreement/discordant. Results: Nine hundred seventy-nine patients (571 percutaneous coronary intervention and 408 coronary artery bypass graft) were included. Mean age was 65 years and the mean SS was 22. Heart team/guidelines discordance occurred in 170 (17.3%) patients. Independent predictors of heart team/guidelines discordance were age, admission to a center with no cardiac surgery service, SS, and previous percutaneous coronary intervention/myocardial infarction. A multivariate model based on these characteristics had a C statistic of 0.83. Thirty-day outcomes were similar in the agreement/discordance groups, however, heart team/guidelines discordance was associated with a significant increase in 3 year mortality (17.6% versus 8.4%; hazard ratio, 2.05; P =0.002) after multivariate adjustment. Conclusions: Heart team/guidelines discordance is not infrequent in real world patients with complex coronary artery disease undergoing revascularization. This is more likely to occur in elderly patients, those with more complex coronary disease (as determined by the SS), and those treated at centers with no cardiac surgery service. These patients have a higher risk for mid-term mortality.

Stroke is the most devastating non-cardiac complication of cardiac surgery. It is second only to heart failure as a cause of morbidity and mortality and increases significantly the likelihood of requiring long-term care. Stroke sequelae (with specific reference to death, prolonged hospitalization, and long-term disability) were described as the main concern of patients undergoing invasive procedures by Sun and colleagues in a survey involving 3112 cardiac patients in 2018.

Background Isolated tricuspid valve replacement (TVR) is considered high-risk surgery. We investigated our outcomes of TVR with the aim of identifying variables that may influence morbidity and mortality of isolated TVR compared with combined TVR and left-sided valve surgery. Methods Retrospective analysis of patients undergoing TVR surgery. The primary endpoint was long-term mortality. The association of postoperative outcomes with isolated compared with combined replacement was analyzed. The association between type of surgery and mortality over time was evaluated using Cox proportional hazards regression models to estimate the hazard ratio. Results Overall, 70 patients underwent TVR. Mean age was 61 ± 12 years and 74% (52 of 70) were women. About two thirds (61%) of the study population had a diagnosis of rheumatic heart disease and 8% (6 of 70) had previous infectious endocarditis. Atrial fibrillation was prevalent (86%, 60 of 70). Comorbidities were similar between groups. Tricuspid valve replacement combined with left-sided valvular surgery was performed in 37 patients (53%), and isolated replacement in 33 patients (47%). Previous cardiac surgery was common (40 patients, 57%). One-month survival rate was 94.3% (66 of 70). During a median follow-up period of 3.6 years, 12 patients (17%) died. The cumulative 5-year survival tended to be lower among patients with isolated TVR compared with patients having combined surgery. Conclusions We showed that TVR can be performed with good outcomes. Isolated TVR did not increase morbidity and mortality when patients are referred for surgery early, including after previous sternotomy. This finding should perhaps lead to a more aggressive approach toward patients requiring isolated replacement.

Limitations of existing techniques for clampless proximal anastomosis (CPA) in coronary artery bypass grafting include air emboli and excessive bleeding. This study evaluated the safety and performance of a new device for performing CPA.The device includes a temporary adjustable sealing element that is connected by a catheter to a handle that controls its opening and closure. An aortic punch is mounted on the catheter and activated by a detachable handle.Six adult female swine underwent partial coronary artery bypass grafting that included construction of a CPA using autologous arterial or venous conduits. During anastomosis construction, good sealing was achieved in all cases, and a blower was not needed in 4 of 6 animals. In the first 2 cases, the blower was intermittently used in 14 % of the entire anastomosis construction time. A mean flow rate of 140.0 ± 52.9 mL/min was measured for the arterial grafts and 666.7 ± 230.9 mL/min for the venous grafts.The VIOLA device (Vascular Graft Solutions, Tel Aviv, Israel) is safe and associated with good hemostasis and minimal use of a blower during CPA construction in a swine model.

BACKGROUND Many of the complications of mechanical ventilation are related to inappropriate endotracheal tube (ETT) cuff pressure. The aim of the current study was to evaluate the effectiveness of automatic cuff pressure closed-loop control in patients under prolonged intubation, where presence of carbon dioxide (CO2) in the subglottic space is used as an indicator for leaks. The primary outcome of the study is leakage around the cuff quantified using the area under the curve (AUC) of CO2 leakage over time. METHODS This was a multicenter, prospective, randomized controlled, noninferiority trial including intensive care unit patients. All patients were intubated with the AnapnoGuard ETT, which has an extra lumen used to monitor CO2 levels in the subglottic space.The study group was connected to the AnapnoGuard system operating with cuff control adjusted automatically based on subglottic CO2 (automatic group). The control group was connected to the AnapnoGuard system, while cuff pressure was managed manually using a manometer 3 times/d (manual group). The system recorded around cuff CO2 leakage in both groups. RESULTS Seventy-two patients were recruited and 64 included in the final analysis. The mean hourly around cuff CO2 leak (mm Hg AUC/h) was 0.22 ± 0.32 in the manual group and 0.09 ± 0.04 in the automatic group (P = .01) where the lower bound of the 1-sided 95% confidence interval was 0.05, demonstrating noninferiority (>-0.033). Additionally, the 2-sided 95% confidence interval was 0.010 to 0.196, showing superiority (>0.0) as well. Significant CO2 leakage (CO2 >2 mm Hg) was 0.027 ± 0.057 (mm Hg AUC/h) in the automatic group versus 0.296 ± 0.784 (mm Hg AUC/h) in the manual group (P = .025). In addition, cuff pressures were in the predefined safety range 97.6% of the time in the automatic group compared to 48.2% in the automatic group (P < .001). CONCLUSIONS This study shows that the automatic cuff pressure group is not only noninferior but also superior compared to the manual cuff pressure group. Thus, the use of automatic cuff pressure control based on subglottic measurements of CO2 levels is an effective method for ETT cuff pressure optimization. The method is safe and can be easily utilized with any intubated patient.

Ventilator-associated pneumonia (VAP) following cardiac surgery is a preventable complication associated with adverse outcomes.We aimed to assess risk factors and outcomes of VAP following cardiac surgery.A matched 1:3 case:control study, including adult patients undergoing cardiac surgery through sternotomy between Sep-2014 to Mar-2017 was conducted in a tertiary-care hospital in Israel. Cases included all patients developing VAP within 30 days after surgery, defined using consensus criteria. Controls were matched for age, gender and surgery type. Operative data were collected prospectively, other data were collected retrospectively. Cox regression was used for adjusted analysis of matched data.Out of 946 operated patients, we identified 57 patients with VAP after cardiac surgery (17.7 episodes per 1000 ventilator-days) matched to 149 controls. Significant independent risk factors for VAP included congestive heart failure (OR 2.357 95%CI 1.052-5.281), Chest re-exploration in ICU (OR 10.213 95%CI: 2.235-46.678), preoperative glucose levels (OR 1.1010 per 1 mg/dl increase 95%CI: 1.004-1.019) intraoperative red blood cell transfusions (OR 1.542 per 1 unit 95%CI: 1.109-2.094) and pulmonary hypertension (OR 2.261 95%CI 1.048-6.554). VAP was most commonly caused by Gram-negative pathogens. VAP was associated with higher mortality, longer length of stay, longer need for ventilator support and longer stay in ICU setting.Postoperative VAP in cardiac surgery patients is associated with severe clinical outcomes. We identified risk factors that can aid in preventive measures implementation for high risk patients.

Background Timing and causes of hospital mortality in adult patients undergoing veno-arterial extracorporeal membrane oxygenation (V-A ECMO) have been poorly described. Aim of the current review was to investigate the timing and causes of death of adult patients treated with V-A ECMO, and subsequently define the “V-A ECMO gap”, which represents the patients who are successfully weaned of ECMO but eventually die during hospital stay.Methods A systematic search was performed using electronic MEDLINE and EMBASE databases through PubMed. Studies reporting on adult V-A ECMO patients from January 1993 to October 2018 were screened. Timing, rates and causes of in-hospital mortality were analyzed.Results Sixty studies with 9,181 patients were included in this systematic review. Overall mortality was 37.6% during V-A ECMO support (reported by 60 studies) and 28.9% (57 studies) after weaning. Finally, 32.6% were discharged from hospital (60 studies). Most common causes of death on ECMO were multiple organ failure (MOF, 49.8%), followed by cardiac failure (20.6%) and neurological causes (15.7%). Most common causes of death after weaning were MOF (55.3%), followed by neurological complications (12.6%), persistent heart failure (10.7%) and pulmonary infections (6.8%).Conclusions More than one-third of adult V-A ECMO patients die during ECMO therapy. Additionally, almost one half of successfully weaned patients still decease during hospital stay, defining the “V-A ECMO gap”. Underreporting and lack of uniformity in reporting of important parameters remains problematic in ECMO research. Future studies should uniformly define timing and causes of death in V-A ECMO patients to better understand the effectiveness and complications of this therapy. Systematic review registration PROSPERO 2019 number CRD42019130815

Aims To evaluate the safety, efficacy, and performance of the TriGuard™ HDH Embolic Deflection Device (TriGuard) compared with no cerebral protection in patients undergoing transcatheter aortic valve implantation (TAVI). Methods and results From February 2014 to March 2015, 85 subjects undergoing TAVI at 13 centres in Europe and Israel were randomized to TriGuard protection vs. no protection. Subjects underwent neurologic and cognitive evaluation at baseline, pre-discharge and 30 days; cerebral diffusion-weighted magnetic resonance imaging was performed at 4 ± 2 days post-procedure and at 30 days. Technical success, which included complete 3-vessel cerebral coverage, was achieved in 88.9% (40/45) of cases. The primary in-hospital procedural safety endpoint (death, stroke, life-threatening or disabling bleeding, stage 2 or 3 acute kidney injury, or major vascular complications) occurred in 21.7% of TriGuard and 30.8% of control subjects ( P = 0.34). In the Per Treatment population (subjects with complete three-vessel cerebral coverage), TriGuard use was associated with greater freedom from new ischaemic brain lesions (26.9 vs. 11.5%), fewer new neurologic deficits detected by the National Institutes of Health Stroke Scale (3.1 vs. 15.4%), improved Montreal Cognitive Assessment (MoCA) scores, better performance on a delayed memory task ( P = 0.028) at discharge, and a >2-fold increase in recovery of normal cognitive function (MoCA score >26) at 30 days. Conclusion TriGuard cerebral protection during TAVI is safe and complete cerebral vessel coverage was achieved in 89% of subjects. In this exploratory study, subjects undergoing protected TAVI had more freedom from ischaemic brain lesions, fewer neurologic deficits, and improved cognitive function in some domains at discharge and 30 days compared with controls.

We sought to assess real-world implementation of the guidelines in patients with multivessel coronary artery disease (CAD) using a prospective national registry in Israel.All consecutive patients with left main or 2- to 3-vessel CAD involving the proximal or mid left anterior descending artery were enrolled in a dedicated multicenter registry. Patients were managed at the discretion of the treating team at each hospital and were followed for 30 months.This registry included 1,064 patients, 55% treated with percutaneous coronary intervention (PCI) and 45% with coronary artery bypass surgery (CABG). Multivariate logistic regression analysis showed that chronic renal failure (odds ratio [OR], 2.43; p = 0.001) and prior myocardial infarction (OR, 1.7; p = 0.024) were associated with referral to PCI versus CABG, whereas male gender (OR, 2.27; p0.001), prior aspirin treatment (OR, 1.72; p = 0.005), diabetes mellitus (OR, 1.51; p = 0.007), 3-vessel CAD (OR, 3.45; p0.001) and SYNTAX score (SS) greater than 32 (OR, 10.0; p0.001) were associated with referral to CABG versus PCI. Each point increment in the SS was independently associated with a 9% greater likelihood of referral to CABG (p0.001). Survival analysis showed that mortality risk was lower among PCI patients less than 8 months after the procedure, and CABG was associated with a significant survival benefit thereafter.We found good agreement with current guidelines regarding revascularization strategies in real-world patients with multivessel CAD. The SS was the main independent predictor associated with the choice of revascularization strategy. The time-dependent association between revascularization strategy and long-term survival should be incorporated in the risk assessment of this population.

Background. Stroke is a major cause of morbidity and mortality during open-heart surgery. Up to 60% of intraoperative cerebral events are emboli induced. This randomized, controlled, multicenter trial is the first human study evaluating the safety and efficacy of a novel aortic cannula producing simultaneous forward flow and backward suction for extracting solid and gaseous emboli from the ascending aorta and aortic arch upon their intraoperative release. Methods. Sixty-six patients (25 females; 68 ± 10 years) undergoing elective aortic valve replacement surgery, with or without coronary artery bypass graft surgery, were randomized to the use of the CardioGard (CardioGard Medical, Or-Yehuda, Israel) Emboli Protection cannula (“treatment”) or a standard (“control”) aortic cannula. The primary endpoint was the volume of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI), performed preoperatively and postoperatively. Device safety was investigated by comparisons of complications rate, namely neurologic events, stroke, renal insufficiency and death. Results. Of 66 patients (34 in the treatment group), 51 completed the presurgery and postsurgery MRI (27 in the treatment group). The volume of new brain lesion for the treatment group was (mean ± standard error of the mean) 44.00 ± 64.00 versus 126.56 ± 28.74 mm 3 in the control group (p [ 0.004). Of the treatment group, 41% demonstrated new postoperative lesions versus 66% in the control group (p [ 0.03). The complication rate was comparable in both groups. Conclusions. The CardioGard cannula is safe and efficient in use during open-heart surgery. Efficacy was demonstrated by the removal of a substantial amount of emboli, a significant reduction in the volume of new brain lesions, and the percentage of patients experiencing new brain lesions.

Cerebral emboli originating in the ascending aorta are a major cause of noncardiac complications following cardiac surgery. The hemodynamics of the aortic cannula has been proven to play a significant role in emboli generation and distribution. The aim of the current study was to perform a thorough numerical investigation in order to examine the effect of the design and orientation of the cannula used during cardiopulmonary bypass on the risk to develop cerebral embolism. Hemodynamic analyses compared numerical models of 27 cases consisting of six different cannula orientations, four aortic anatomies, and three cannula designs. The cannula designs included a straight-tip (ST) cannula, a moderately curved tip cannula (TIP1 ), and a sharp-angle curved cannula (TIP2 ). Outcome measures included hemodynamic parameters such as emanating jet velocity, jet velocity drop, maximal shear stress, aortic wall reaction, emboli pathlines and distribution between upper and lower vessels, and stagnation regions. Based on these parameters, the risks for hemolysis, atheroembolism, and cerebral embolism were evaluated and compared. On one hand, the jet emerging from the ST cannula generated large wall-shear stress at the aortic wall; this may have triggered the erosion and distribution of embolic atheromatous debris from the aortic arch. On the other hand, it diverted more emboli from the clamp region to the descending aorta and thus reduced the risk for cerebral embolism. The TIP1 cannula demonstrated less shear stress on the aortic wall and diverted more emboli from the clamp region toward the upper vessels. The TIP2 cannula exhibited a stronger emanating jet, higher shear stress inside the cannula, and highly disturbed flow, which was more stagnant near the clamp region. Current findings support the significant impact of the cannula design and orientation on emboli generation and distribution. Specifically, the straight tip cannula demonstrated a reduced risk of cerebral embolism, which may be pivotal in the clinical setting.

Background Stroke after open heart surgery is a major cause of morbidity and mortality. Up to 60% of intraoperative cerebral events are caused by emboli generated by manipulations of the aorta during surgery. This is the first animal study evaluating the safety and efficacy of a novel aortic cannula designed to extract solid and gaseous emboli during cardiac surgery. Methods Seven domestic pigs were connected to cardiopulmonary bypass using a CardioGard 24F aortic cannula. Three pigs that were cannulated with a standard aortic cannula were defined as controls. Several main flow and suction regimens were carried out. Osseous particles of different sizes were injected into the proximal aorta to simulate emboli. Results The CardioGard cannula demonstrated an overall emboli retrieval rate of 77%. A rate of 88.45% was demonstrated during the low-flow regimen used clinically during aortic manipulation. Gaseous and solid emboli were eliminated by suction, as demonstrated by epi-carotid ultrasound. No significant changes were observed in hemodynamic and laboratory parameters. Conclusions The CardioGard cannula is as simple to use as a regular commercially available aortic cannula, having a similar safety profile and proven efficacy in capturing intraoperative emboli.

Calcium channel blocker (CCB) overdose is a potentially fatal poisoning. The use of intravenous lipid emulsion (ILE) therapy for CCB poisoning has emerged in the past few years. In 2017, the American College of Medical Toxicology published interim guidance for the use of ILE resuscitation in these cases. We report an uncommon complication of ILE, acute respiratory distress syndrome, treated with veno-venous extracorporeal membrane oxygenation (ECMO). Case report: A 40-year-old hypertensive woman presented with shock (blood pressure 62/34 mmHg, pulse 86/ min) following ingestion of 4,800 mg verapamil slow release and 1,500 mcg clonidine during a suicide attempt. She was treated with calcium gluconate, sodium bicarbonate, IV high dose insulin, IV glucagon, cardiac amines and vasopressors without response (blood pressure 69/37 mmHg, pulse 78/min). ILE was initiated, and two hours later, she developed acute respiratory failure necessitating intubation and mechanical ventilation. Due to poor oxygenation (pO2 44 mmHg; FiO2 100%) emergent veno-venous ECMO was instituted. After one hour her blood pressure increased to 104/50 mmHg (pulse 80, pO2 75 mmHg), and continued so until weaning from ECMO and ventilation. Conclusion: Acute respiratory distress syndrome can be a major life threating complication following ILE; venovenous ECMO is suggested for its treatment.

Objective Cardiac surgery patients are treated with antifibrinolytic agents to reduce intra- and postoperative bleeding. Until 2007, lysine analogues (aminocaproic acid and tranexamic acid) and serine protease inhibitors (aprotinin) were recommended. In 2008, the U.S. Food and Drug Administration prohibited aprotinin use because of associated postoperative complications, including cerebrovascular accidents and renal failure. This work aimed at reevaluating the efficacy and safety of aprotinin versus tranexamic acid in patients undergoing elective coronary artery bypass surgery. Methods Two groups were enrolled in this study. Group A (n = 256), operated from January 2005 to August 2007, was treated with the half-Hammersmith aprotinin regime whereas group B (n = 104), operated after 2008, was treated with the full-dose tranexamic acid regime. All patients were of low-risk profile, and underwent an elective, on-pump coronary artery bypass surgery. The main outcome measures were safety, assessed in relation to thrombosis-related cardiac, cerebral, and renal events; and efficacy, investigated in terms of postoperative bleeding and infusions of blood products. Results Postoperatively, group B demonstrated greater bleeding during the operative and first postoperative days, and total bleeding ( P values ≤ .001); a greater requirement of blood and/or blood products infusions ( P = .024); higher postoperative acute renal failure rates ( P = .028); lower platelet count ( P = .002); and a higher postoperative increase in troponin levels ( P Conclusions Among low-risk patients undergoing coronary artery bypass surgery, the half-Hammersmith aprotinin-based antifibrinolytic management proved to be more efficacious in terms of bleeding and consumption of blood products, with no evidence of associated increased rates of postoperative complications. Accordingly, the usage of aprotinin should be reconsidered for treatment among cohorts of low-risk cardiac patients.

Massive pulmonary embolism (MPE) is a life-threatening condition. The management of MPE has changed over the course of the last few years. Since the emergence of thrombolytic therapy, only a few patients remain amenable for surgical treatment. Currently, surgical embolectomy is advised only in very specific indications. This chapter will review the background, history, indications, surgical technique and results of surgical pulmonary embolectomy in patients with MPE.

Undernourished patients treated in general surgery departments suffer from prolonged and complicated hospitalizations, and higher mortality rates compared with well nourished patients. Pivotal information regarding patients' nutritional status and its effect on clinical outcome is lacking for cardiac surgery patients. We investigated the prevalence of malnutrition risk and its association with 30-day hospital mortality and postoperative complications.Four hundred and three patients who underwent cardiac surgery during 2008 and were screened with the Malnutrition Universal Screening Tool (MUST) on admission were enrolled. Univariate and multivariate logistic regression analyses compared the association of high and low risk for malnutrition with length of hospitalization (LOS), in-hospital and 30-day mortality, and postoperative complications. Almost 20% of the patients were found to be at high risk for malnutrition. Univariate analyses revealed higher in-hospital mortality rates (p = 0.03) and greater incidence of LOS and antibiotic treatment longer than 21 days (p = 0.002 and p = 0.04, respectively), vasopressor treatment longer than 11 days (p = 0.02), and positive blood cultures (p = 0.02) in patients belonging to the high-risk MUST group. Incorporation of the MUST in a multivariate model with the European System for Cardiac Operative Risk Evaluation (EuroSCORE) significantly improved postoperative complications prediction, as well as in-hospital and 30-day mortality, compared with the EuroSCORE alone.Malnutrition is prevalent in patients undergoing cardiac surgery, associated with higher postoperative mortality and morbidity. Preoperative MUST screening has emerged as highly relevant for enabling early diagnosis of patients at malnutrition risk, predicting postoperative mortality and morbidity, thus promoting well timed treatment. Prospective studies are needed to explore whether intervention can decrease malnutrition risk.

Evaluation of aortic proximal anastomoses in patients who have undergone coronary artery bypass surgery poses a special challenge to the interventional cardiologist during follow-up angiography procedures. We present a simple, safe, and fast technique for proximal anastomoses marking using hemostatic clips. Successful visualization of the graft marker was achieved using medium-sized hemoclips during fluoroscopy. The use of hemoclips for this procedure proved to be straightforward and required no additional surgical training.

Purpose Perioperative cerebral microemboli in cardiac surgery are associated with postoperative neurologic complications. The EmBlocker (Neurosonix Ltd, Rehovot, Israel), a newly developed device should be positioned against the ascending aorta, and it produces an ultrasonic force expected to divert microemboli away from the cerebral vasculature and reduce cerebral emboli. Description Twenty-one consecutive patients, undergoing a valve procedure, were enrolled into this nonrandomized pilot study. The EmBlocker (Neurosonix Ltd) was positioned in 11 consecutive patients and activated for 1 minute (1.5 W/cm 2 ) during seven selected aortic manipulations and for 10 minutes (0.5 W/cm 2 ) intermittently after cross-clamp removal. Transcranial Doppler-based quantification of microembolic signals was performed in all patients. Evaluation The use of the EmBlocker showed a significant overall reduction of the cerebral microembolic signals of 53%. Conclusions The use of the EmBlocker during valve surgeries is associated with a reduction of perioperative cerebral microembolic signals. This new technology holds the potential to lower the risk of postoperative neurologic complications.

Objective: The development of a novel surgical tool or technique for mitral valve repair can be hampered by cost, complexity, and time associated with performing animal trials. A dynamically pressurized model was developed to control pressure and flowrate profiles in intact porcine hearts in order to quantify mitral regurgitation and evaluate the quality of mitral valve repair. Methods: A pulse duplication system was designed to replicate physiological conditions in explanted hearts. To test the capabilities of this system in measuring varying degrees of mitral regurgitation, the output of eight porcine hearts was measured for two different pressure waveforms before and after induced mitral valve failure. Four hearts were further repaired and tested. Measurements were compared with echocardiographic images. Results: For all trials, cardiac output decreased as left ventricular pressure was increased. After induction of mitral valve insufficiencies, cardiac output decreased, with a peak regurgitant fraction of 71.8%. Echocardiography clearly showed increases in regurgitant severity from post-valve failure and with increased pressure. Conclusions: The dynamic heart model consistently and reliably quantifies mitral regurgitation across a range of severities. Advantages include low experimental cost and time associated with each trial, while still allowing for surgical evaluations in an intact heart.

International audience; OBJECTIVE: To verify the rate of thromboembolic and hemorrhagic complications during the first 6 months after mitral valve repair and to assess whether the type of antithrombotic therapy influenced clinical outcome. METHODS: Retrospective data were retrieved from 19 centers. Inclusion criteria were isolated mitral valve repair with ring implantation. Exclusion criteria were ongoing or past atrial fibrillation and any combined intraoperative surgical procedures. The study cohort consisted of 1882 patients (aged 58 +/- 15 years; 36% women), and included 1517 treated with an oral anticoagulant (VKA group) and 365 with antiplatelet drugs (APLT group). Primary efficacy outcome was the incidence of arterial thromboembolic events within 6 months and primary safety outcome was the incidence of major bleeding within 6 months. Propensity matching was performed to obtain 2 comparable cohorts (858 vs 286). RESULTS: No differences were detected for arterial embolic complications in matched cohort (1.6% VKA vs 2.1% APLT; P = .50). Conversely, patients in the APLT group showed lower incidence of major bleeding complications (3.9% vs 0.7%; P = .01). Six-month mortality rate was significantly higher in the VKA group (2.7% vs 0.3%; P = .02). Multivariable analysis in the matched cohort found VKA as independent predictor of major bleeding complications and mortality at 6 months. CONCLUSIONS: Vitamin K antagonist therapy was not superior to antiplatelet therapy to prevent thromboembolic complications after mitral valve repair. Our data suggest that oral anticoagulation may carry a higher bleeding risk compared with antiplatelet therapy, although these results should be confirmed in an adequately powered randomized controlled trial

Myocardial ischemia-reperfusion injury is common during cardiac procedures. Glutamine may protect the myocardium by preserving metabolic substrates. Glutamine (0.52 g·kg−1) or Ringer's lactate solution (control group) was administered intraperitoneally to 63 Sprague-Dawley rats at 4 or 18 hours prior to experimental ischemia and reperfusion. The hearts were excised and perfused on an isolated working heart model, exposed to global ischemia for 15 min and reperfusion for 1 hour. Left atrial pressure, mean aortic pressure, cardiac flow, coronary flow, and aortic output were measured 15 min before ischemia and every 15 min during reperfusion. There was significantly better cardiac output in the glutamine pretreated groups. Pretreatment at 4 hours before the experiment was superior to pretreatment at 18 hours, with better maintenance of cardiac output and coronary flow. The enhanced protective effect of pretreatment at 4 hours highlights the importance of timing, and suggests a potential clinical benefit.

Objective Acute and chronic pain after thoracotomy, post-thoracotomy pain syndrome, is well documented. The mechanical retractors used for the thoracotomy exert significant forces on the skeletal cage. Our hypothesis was that instrumented retractors could be developed to enable real-time monitoring and control of retraction forces. This would provide equivalent exposure with significantly reduced forces and tissue damage and thus less post-thoracotomy pain. Methods A novel instrumented retractor was designed and fabricated to enable real-time force monitoring during surgical retraction. Eight mature sheep underwent bilateral thoracotomy. One lateral thoracotomy was retracted at a standard clinical pace of 5.93 ± 0.80 minutes to 7.5 cm without real-time monitoring of retraction forces. The other lateral thoracotomy was retracted to the same exposure with real-time visual force feedback and a consequently more deliberate pace of 9.87 ± 1.89 minutes ( P = .006). Retraction forces, blood pressure, and heart rate were monitored throughout the procedure. Results Full lateral retraction resulted in an average force of 102.88 ± 50.36 N at the standard clinical pace, versus 77.88 ± 38.85 N with force feedback (a 24.3% reduction, P = .006). Standard retraction produced peak forces of 450.01 ± 129.58 N, whereas force feedback yielded peak forces of 323.99 ± 127.79 N (a 28.0% reduction, P = .009). Systolic blood pressure was significantly higher during standard clinical retraction ( P = .0097), and rib fracture occurrences were reduced from 5 to 1 with force feedback ( P = .04). Conclusions Use of the novel instrumented retractor resulted in significantly lower average and peak retraction forces during lateral thoracotomy. Moreover, these reduced retraction forces were correlated with reductions in animal stress and tissue damage, as documented by lower systolic blood pressures and fewer rib fractures.

Off-pump coronary artery bypass grafting (OPCAB) and complete arterial revascularization without proximal anastomosis to the aorta may decrease neurological events after open-heart surgery. Few reports exist regarding the combination of OPCAB and complete arterial revascularization exploring the theoretical advantage of avoiding manipulation of the aorta. We review our results in 110 patients who underwent multiple grafts off-pump complete arterial revascularization.110 patients underwent multiple grafts OPCAB complete arterial revascularization, and were compared to 216 patients who underwent traditional multiple grafts on pump CABG. Preoperative renal failure was 12.7% (n=14) as compared to 5.1%, (n=11, p=0.01) in the control group and 33.6% (n=37) of the patients were 75 years or older as compared to 19.0% (n=41, p=0.003) in the control group.The mean number of grafts per patient undergoing multiple OPCAB complete arterial revascularization was 2.3, as compared to 3.11 in the control group (p0.001). The mortality rate was 2.73% as compared to 1.85% (NS) in the control group. The incidence of CVA was 0% as compared to 2.31% (p=0.17) in the control group.Complete arterial OPCAB revascularization without manipulation of the aorta in high-risk patients can be performed with short-term similar results to conventional CABG and very low neurological complications.

Background: Complex ventricular reconstruction (CVR) is now being employed increasingly thanks to the pioneering work of Dor. However, little is known about the failure mode of CVR. We present experience from three centres with CVR and an analysis of the failure modes. Methods: Between January 1997 and February 2005, 284 patients underwent CVR in three centres in Australia and USA. All of the procedures were performed as adjuncts to coronary artery surgery and/or valvular surgery. Patients were followed-up clinically and/or echocardiographically. Failure modes were classified as fatal or non-fatal. Non-fatal failure mode (NFM) was defined as either persistent heart failure, recurrence of LV scar, need for ventricular assistance, persistent ventricular arrhythmia, or a combination. Results: Operative mortality rate (OMR) was 8% (23 deaths). This fatal failure mode was most related to urgency of surgery and cardiogenic shock in 15 patients (5.3% of OMR), stroke in 5 patients (1.8%) or postoperative bi-ventricular failure (1%). Non-fatal failure modes accounted for morbidity in 26 patients (9%). This was predominantly due to persistent septal dyskinesis in 7 patients (2.46%), persistent mitral regurgitation in 5 (1.8%), postoperative ventricular tachycardia in 4 (1.4%), sub-optimal myocardial protection in 4 (1.4%) use of a large, stiff patch in 4 (1.4%). One hundred and ninety-nine of the surviving 261 patients(76%) werein NYHAClassI.Conclusions:Complexventricular reconstruction isa robusttechniquethathaslasting benefit.Failuremodes have been identified and could be minimized by appropriate patient and procedure selection.

Increased Troponin I levels and pro-inflammatory cytokines have been reported in most patients undergoing cardiac surgery, ascribed to the type and extent of surgery, reperfusion injury, and the method of myocardial protection. We investigated their levels in patients undergoing on-pump (CCAB) or off-pump (OPCAB) coronary artery bypass surgery and whether these correlated with the extent of myocardial injury. One hundred twenty patients were prospectively randomized to undergo OPCAB (n = 60) or CCAB (n = 60). Hemodynamic and respiratory data, as well as serum CK-MB mass fraction, Troponin I, and interleukin (IL)-6, IL-8, and IL-10 levels, were collected perioperatively. Demographic, hemodynamic, and respiratory parameters were similar between the two groups. Troponin I was significantly lower in the OPCAB than in the CCAB group, either at the end of ischemia, end of surgery, 6-hour and 24-hour postoperatively (4 +/- 3, 5 +/- 3, 7 +/- 5, and 8 +/- 3 microg/L, vs. 19 +/- 18, 27 +/- 19, 28 +/- 13.5, and 33 +/- 8.5 microg/L, respectively, p0.05). Serum cytokine levels in the OPCAB patients were lower compared to the CCAB group at the end of surgery (32 +/- 35, 25 +/- 30, and 40 +/- 30 pg/ml for IL-6, IL-8, and IL-10 vs. 230 +/- 30, 140 +/- 70, and 125 +/- 50 pg/ml, respectively, p0.05). Plasma IL-6 levels correlated with the Troponin I levels at the end of surgery in both groups (r = 0.45, p = 0.01). Thus, OPCAB surgery is associated with reduced levels of Troponin I and activation of cytokines, compared to those in the CCAB group. High levels of these factors could correlate with myocardial damage during coronary artery bypass surgery. This finding warrants further laboratory and clinical confirmation in the future.

Sternal instability predisposes to post-operative mediastinitis. Biomechanical studies have shown the superiority of rigid plate fixation over wire circlage in sternal healing. We studied rigid plate fixation for sternotomies in high-risk patients. High-risk patients were identified as those having three or more historically established risk factors for post-operative mediastinitis, such as COPD, re-operative surgery, renal failure, diabetes, steroid use, obesity, existing infection, and immunosuppression. Three hundred and twenty high-risk patients had prophylactic rigid plate fixation (Group S) between July 2000 and Jan 2005. The control group (Group C) comprised 215 patients with similar risk profiles that were not plated during 2000 and 2001. Average age, male-female ratio, risk factors and type of procedures were similar in both groups. Follow up ranged from 4 to 200 weeks. There were 12 peri-operative deaths (3.75%) in group S and 8.6% (18 patients) in group C. There were no instances of deep mediastinitis in group S. Group C had mediastinitis in 28 (13%, P

ObjectivesWe tested the feasibility of real-time three-dimensional echocardiographic (RT3DE) perfusion imaging and developed and validated an algorithm for volumetric analysis of myocardial contrast inflow. The study included three protocols wherein perfusion was measured: 1) in an ex-vivo model of controlled global coronary flow, 2) in an in-vivo model during regional perfusion variations, and 3) in humans during pharmacologically induced hyperemia.BackgroundThe RT3DE technology offers an opportunity for myocardial perfusion imaging without multi-slice reconstruction and repeated contrast maneuvers.MethodsElectrocardiographically triggered harmonic RT3DE datasets were acquired (Philips 7500) while infusion of Definity was initiated and reached a steady state. Protocol 1 was performed in nine isolated rabbit hearts and included three coronary flow levels. In protocol 2, changes in regional perfusion caused by partial left anterior descending artery occlusion were measured in five pigs. In protocol 3, adenosine-induced changes in perfusion were measured in eight normal volunteers. Myocardial video-intensity (MVI) was measured over time in three-dimensional (3D) slices to calculate peak contrast inflow rate (PCIR). In pigs, PCIR was measured on a regional basis and validated against microspheres.ResultsThe RT3DE imaging allowed selection of slices for perfusion analysis in rabbit hearts, pigs, and humans. Administration of contrast resulted in clearly visible and quantifiable changes in MVI. In rabbits, The PCIR progressively decreased with coronary flow (p < 0.0001). In pigs, coronary occlusion caused a 59 ± 26% decrease in PCIR exclusively in the left anterior descending artery territory (p < 0.05) in agreement with microspheres. In humans, adenosine increased PCIR to 198 ± 57% of baseline (p < 0.05).ConclusionsContrast-enhanced RT3DE imaging provides the basis for volumetric imaging and quantification of myocardial perfusion.