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Background: Ventricular septal defect (VSD) is the most common congenital cardiac malformation, accounting for approximately 30% of congenital heart defects. Conventional surgical repair using cardiopulmonary bypass is invasive and associated with morbidities and prolonged hospital stay. With the advent of interventional approaches and availability of different occluding devices, the technique of perventricular device closure is evolving and being implemented successfully in larger groups of patients. We present herein, our initial experience of perventricular device closure for the ventricular septal defects in children to assess risks and benefits., Methods: From March, 2023 to February, 2024, we have performed perventricular closure of ventricular septal defects in 13 children, under guidance of transesophageal echocardiography without cardiopulmonary bypass support. The median age at operation was 2 year (range 1.3-10 years) with the median body weight 11 kg (range 8.7-16.6 kg). Sixty-nine percent were males. The ventricular septal defect sizes ranged from 2.7 to 6 mm (mean 4.7 mm). Seven defects were perimembranous, four sub-aortic and two were muscular. One patient also underwent pulmonary artery de-banding with pulmonary artery balloon angioplasty and other one patent ductus arteriosus ligation, concomitantly. For defect closure, we used ventricular septal defect occlusion device (MemoPart™, Lepu Medical Technology Company, China) through a 3-cm skin incision in the lower- third of the sternum. The device sizes ranged from 5 to 8 mm (mean 6.9+-1.8 mm) and all patients except for two required symmetrical devices., Results: All patients underwent device closure successfully. The procedural duration ranged between 32 and 52 min. None of the patients required cardiopulmonary bypass. The mean ventilation time and intensive care unit stay was 3 and 24 h, respectively. None of the patients required inotropic support or blood transfusions. Moreover, no patients developed any arrhythmias including heart block. The average length of hospital stay was 4.4 days. At the latest follow up, there were no residual shunts, conduction disturbances, device dislodgement or major aortic or tricuspid valve complications seen in any patients. There was no mortality., Conclusions: Perventricular device closure of ventricular septal defects is a less invasive, extremely safe and effective method in children. It is associated with very fast recovery, shorter hospitalization time and better cosmetic incision. Moreover, it avoids cardiopulmonary bypass. The modifications and refinements in the design, material and implantation techniques will help in expanding the indications and prevent complications in the long-term., (© 2024. The Author(s).)

Objective: Tracheal intubation in cardiac surgery patients has a higher incidence of difficult laryngoscopic views compared with patients undergoing other types of surgery. The authors hypothesized that using the McGrath Mac videolaryngoscope as the first intubation option for cardiac surgery patients improves the percentage of patients with "easy intubation" compared with using a direct Macintosh laryngoscope., Design: A prospective, observational, before-after study., Setting: At a tertiary-care hospital., Participants: One thousand one hundred nine patients undergoing cardiac surgery., Intervention: Consecutive patients undergoing cardiac surgery were intubated using, as the first option, a Macintosh laryngoscope (preinterventional phase) or a McGrath Mac videolaryngoscope (interventional phase)., Measurements and Main Results: The main objective was to assess whether the use of the McGrath videolaryngoscope, as the first intubation option, improves the percentage of patients with "easy intubation," defined as successful intubation on the first attempt, modified Cormack-Lehane grades of I or IIa, and the absence of the need for adjuvant airway devices. A total of 1,109 patients were included, 801 in the noninterventional phase and 308 in the interventional phase. The incidence of "easy intubation" was 93% in the interventional phase versus 78% in the noninterventional phase (p < 0.001). First-success-rate intubation was higher in the interventional phase (304/308; 98.7%) compared with the noninterventional phase (754/801, 94.1%; p = 0.005). Intubation in the interventional phase showed decreases in the incidence of difficult laryngoscopy (12/308 [3.9%] v 157/801 [19.6%]; p < 0.001), as well as moderate or difficult intubation (5/308 [1.6%] v 57/801 [7.1%]; p < 0.001)., Conclusions: The use of the McGrath videolaryngoscope as the first intubation option for tracheal intubation in cardiac surgery improves the percentage of patients with "easy" intubation," increasing glottic view and first-success-rate intubation and decreasing the incidence of moderate or difficult intubation., Competing Interests: Declaration of competing interest None., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

The implantation of electrodes for cardiac implantable electronic devices (CIED) requires profound technical understanding and precise execution. The positioning of electrodes in the right ventricle and atrium has significant implications for patient safety and the effectiveness of CIED therapy. Particular focus is given to the distinction between apical and septal stimulation in ventricular positioning. Based on current data, this article provides a practice-oriented guide that leads implanters through the individual steps of electrode positioning. The implantation of electrodes for physiological stimulation (cardiac resynchronization therapy, CRT, and conduction system pacing, CSP) is not addressed in this article., (© 2024. The Author(s).)

Objective: The technique for sternal closure has remained largely unchanged owing to the efficacy, simplicity, and low cost of stainless-steel sternal wires. Despite their ubiquity, several other closure devices designed to address the complications associated with sternal wires such as sternal bleeding and dehiscence have become popular. We have developed a novel sternal closure device that reduces sternal bleeding and dehiscence. This study quantifies the use of currently available sternal closure devices and determines predicted uptake of the novel device., Methods: An electronic survey, designed to determine practice patterns for sternal closure, was distributed to 70 US cardiac surgeons. The survey included a discrete choice section in which surgeons evaluated relative value of device attributes including cost, ease of emergent sternal reentry, and dehiscence risk., Results: There were 70 surgeons from 30 states who completed the survey. The most frequent means of sternal closure was straight sternal wires (35.8%), followed by straight sternal wires plus figure-of-8 sternal wires (18.1%), double wires (10.9%), plates (10.2%), and other (25%). The relative utilization shifted from sternal wires to sternal plates as the risk for dehiscence increased. The adoption of the novel closure device was estimated at 34.6%., Conclusions: The standard stainless-steel sternal wire remains the most common means of sternal reapproximation, but its utilization is lower in patients at high risk for sternal dehiscence. Based on this survey, there is acceptance in the community for a novel sternal closure device designed to address the limitations of traditional sternal closure methods., Competing Interests: Declaration of Conflicting InterestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: This work discusses a device designed and patented by the authors. The reference patent number is US20230107886A1. The authors have no conflicts of interest.

Background: Restoring adequate coaptation height is a key principle of mitral valve (MV) repair. This study aimed to evaluate the utility of fiberscope (FS) technology to assess MV coaptation height for intraoperative use., Methods: Ex-vivo testing was performed on five adult porcine hearts. The left atrium (LA) was resected, and the left ventricle (LV) was pressurized retrograde to 27 ± 1mm Hg. An endoscope was inserted into the LV apex, centered under the MV orifice. An FS system (Milliscope II camera, LED light source, and 0.7 mm diameter × 15 cm long) 90° semirigid scope with 1.2 mm focal length) was mounted above the MV annulus in a custom alignment and measuring fixture. Three blinded measurements were taken at two locations on each MV, A2 and P2 segment, from the top of coaptation to the leaflet edge identified by the FS. Accurate positioning was verified using the LV endoscope. A control (metal rod of similar thickness) was used for comparison, with coaptation height recorded when the control was seen via the endoscope., Results: Coaptation heights were similar for the control and FS methods across all hearts at A2 (11.6 ± 2.6 mm control vs 11.8 ± 2.2 mm FS) and P2 (13.3 ±   2.6 mm control vs 13.4 ±   2.9 mm FS) segments, with similar measurement variability (control SD 0.1-1.0 mm; FS SD 0.1-0.9 mm). One outlier was excluded from analysis (n = 19/20). The maximum absolute difference and percent error between measurement methods were less than 1.1 mm (median [IQR], 0.6 [0.3-0.9] mm) and less than 14% (4.1 [2.2-7.6]%)., Conclusions: Utilization of a miniaturized FS enabled precise and accurate quantification of MV coaptation. This technique is promising for evaluating post-repair valve competence and coaptation height.

Current catheter designs used for radiofrequency (RF) in cardiac tissue achieve limited ablation depth as lesion size is driven heavily by resistive heating at the tissue surface. A catheter with a truncated, dome-shaped tip with a toroidal surface designed for focal RF ablation was recently described. This in vivo study compares lesion characteristics between a second-generation focused electric field (FEF) catheter vs a standard irrigated catheter using RF energy in a beating heart model. We performed in vivo ablations using RF energy with the FEF ablation catheter tip (Focused Therapeutics) and an irrigated Blazer catheter (Boston Scientific) under identical power, duration, and irrigation rates. In addition, RF dosing at high power and duration was examined using the FEF catheter. Intracardiac echocardiography was used to evaluate steam pops and catheter tip angle relative to the tissue surface. Studies were terminal and lesion size was measured following 2,3,5-triphenyltetrazolium chloride staining. Ablations were performed in 6 swine (FEF, n = 31; control, n = 8). FEF ablation lesions (n = 7) were deeper (15.6 ± 2.6 mm vs 7.5 ± 1.9 mm; P < 0.001) and wider (18.4 ± 2.9 mm vs 12.6 ± 2.4 mm; P < 0.001) than lesions delivered with the control irrigated catheter (n = 8) under the same parameters. Thirty-two percent (n = 10 of 31) of lesions delivered from the left ventricle endocardial surface using the FEF catheter were transmural. No steam pops were observed with delivery of FEF lesions (n = 31). The angle of incidence did not significantly affect FEF lesion size. In this in vivo preclinical study, the FEF catheter, which provides focused energy delivery, resulted in significantly larger lesions than the irrigated control catheter without steam pops. Approximately one-third of ablations with the FEF catheter delivered from the endocardial left ventricular surface resulted in transmural lesions., Competing Interests: Funding Support and Author Disclosures Drs Paul Melman and Yonathan Melman have ownership interest in Focused Therapeutics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Several studies have reported that prophylactic dialysis can reduce the mortality of non-dialysis-dependent chronic kidney disease (CKD) patients after cardiac surgery. However, the results of complications in these randomized controlled trials (RCTs) were not consistent. We aimed to perform a meta-analysis to systematically evaluate the effect of prophylactic dialysis in these non-dialysis-dependent CKD patients., Methods: We systematically searched Medline, Embase, Cochrane's Library and other online sources for related RCTs. Effects of prophylactic dialysis on the incidence of 30 days' mortality and postoperative complications were analyzed., Results: Four RCTs comprising 395 patients were included, all of them treated by coronary artery bypass grafting. Treatment of preoperative and intraoperative prophylactic dialysis significantly reduced the rate of 30-day all-cause mortality (risk ratio [RR]: 0.27, 95% confidence interval [CI], 0.13-0.58, P < 0.001, I2 = 0%) and the incidence of pulmonary complications (RR: 0.39, 95% CI, 0.20-0.77, P = 0.007, I2 = 0%), low cardiac output (RR: 0.29, 95% CI, 0.09-0.99, P = 0.05, I2 = 0%), and acute kidney injury (RR: 0.19, 95% CI: 0.07-0.52, P = 0.001, I2 = 0%). However, there were no statistically significant differences between the dialysis group and the control group in gastrointestinal bleeding, sepsis or multiple organ failure, wound infection, arrhythmia, transient neurologic deficit, stroke and re-exploration for bleeding., Conclusion: Prophylactic dialysis can improve the 30-day clinical outcomes of non-dialysis-dependent CKD patients undergoing cardiac surgery, it was associated with the 30-day mortality benefit and led to a decrease in the incidence of pulmonary complications, as well as low cardiac output, and acute kidney injury., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

The efficacy of cardiac rehabilitation in heart-failure patients who received a left-ventricular assist device (LVAD) instead of heart transplantation (HTx) is still unclear. This study aims to evaluate whether cardiac rehabilitation is beneficial in LVAD as HTx patients in the short term and whether its effects in LVAD patients persist over time. Twenty-five LVAD patients were evaluated by functional and psychological tests at admission (T0) and discharge (T1) of a 4-week inpatient structured rehabilitation program, and follow-ups 3 (T2), 6 (T3), and 12 months (T4) after discharge. Twenty-five matched HTx patients were also studied from T0 to T1 to compare the improvements in the six-minute walk test (6MWT). The quality-of-life scores substantially improved in LVAD patients and the 6MWT showed the same functional recovery as in HTx patients from T0 to T1. After T1, numerous LVAD patients withdrew from the study. However, the 6MWT outcome increased further from T1 to T3, with a positive trend during the follow-ups. Hemoglobin and the ventilatory performance increased, and the psychological perception of heart-failure symptoms and pain further improved at T2. In conclusion, exercise-based rehabilitation programs provide similar beneficial effects in LVAD and HTx patients, without deterioration in LVAD patients up to 12 months after discharge., Competing Interests: The authors have declared that no competing interests exist.

Ischemic mitral regurgitation (IMR) is particularly challenging to repair with lasting durability due to the complex valvular and subvalvular pathologies resulting from left ventricular dysfunction. Ex vivo simulation is uniquely suited to quantitatively analyze the repair biomechanics, but advancements are needed to model the nuanced IMR disease state. Here we present a novel IMR model featuring a dilation device with precise dilatation control that preserves annular elasticity to enable accurate ex vivo analysis of surgical repair. Coupled with augmented papillary muscle head positioning, the enhanced heart simulator system successfully modeled IMR pre- and post-surgical intervention and enabled the analysis of adjunctive subvalvular papillary muscle repair to alleviate regurgitation recurrence. The model resulted in an increase in regurgitant fraction: 11.6 ± 1.7% to 36.1 ± 4.4% (p < 0.001). Adjunctive papillary muscle head fusion was analyzed relative to a simple restrictive ring annuloplasty repair and, while both repairs successfully eliminated regurgitation initially, the addition of the adjunctive subvalvular repair reduced regurgitation recurrence: 30.4 ± 5.7% vs. 12.5 ± 2.6% (p = 0.002). Ultimately, this system demonstrates the success of adjunctive papillary muscle head fusion in repairing IMR as well as provides a platform to optimize surgical techniques for increased repair durability., (© 2021. Biomedical Engineering Society.)

Background: Surgical transpleural minimally invasive occlusion of perimembranous and muscular ventral septal defects provides excellent results, but there is limited experience in outlet ventral septal defects (OVSDs) because of the specific anatomy and because OVSDs may occur with aortic valve prolapse., Methods: The procedure was performed in 84 children (mean age, 2.5 ± 2.3 years; mean weight, 12.1 ± 10.3 kg) between July 2014 and December 2018 at the Children's Heart Center of Henan Provincial People's Hospital. An approximately 2-cm right subaxillary incision was made, and the right ventricle was punctured under transesophageal echocardiographic guidance. The OVSD was occluded under transesophageal echocardiographic guidance with an asymmetric occluder., Results: Mean size of the OVSDs and the occluders was 4.6 ± 1.0 and 6.2 ± 1.2 mm, respectively. No patients died and no complications occurred, such as third-degree atrioventricular block, new aortic regurgitation, reoperation, or serious infection. All patients were observed for 32.1 ± 17.1 months. After surgery, there were 4 cases of residual shunt, which resolved spontaneously during follow-up. No complications, such as reoperation, aortic regurgitation, atrioventricular block, or occluder detachment, were observed during the follow-up period., Conclusions: Occluding OVSDs using an asymmetric occluder through the subaxillary approach was safe and effective, with satisfactory short-term and mid-term results. Further follow-up is required regarding the long-term results., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the midterm results of pulmonary valve leaflet augmentation in transannular repair of tetralogy of Fallot (TOF)., Methods: From 2007 to 2019, 131 patients underwent a transannular repair with pulmonary leaflet augmentation for TOF (n = 120) and double outlet right ventricle with pulmonary stenosis (n = 11). Patch material was expanded polytetrafluoroethylene (n = 76), glutaraldehyde-treated autologous pericardium (n = 47) and bovine pericardium (n = 8)., Results: Median age at repair was 8.9 months (interquartile range, 5.4-14.8). There was no operative mortality. Median follow-up was 6.25 years (interquartile range, 2.77-7.75). Freedom from severe pulmonary regurgitation (PR) was 85% (95% confidence interval [CI], 77%-90%) and 76% (95% CI, 66%-83%) at 1 and 5 years, respectively. Freedom from moderate or greater PR was 69% (95% CI, 60%-76%) and 30% (95% CI, 21%-39%) at 5 and 10 years, respectively. Three patients required pulmonary valve replacement for PR. Nine patients required pulmonary balloon valvuloplasty. Freedom from intervention for pulmonary valve stenosis was 98% (95% CI, 93%-99%) and 94% (95% CI, 87%-97%) at 1 and 5 years, respectively. One patient with severe PR had an indexed right ventricular volume >160 mL/m 2 . Use of expanded polytetrafluoroethylene resulted in a greater freedom from moderate or greater PR (log-rank test P < .001; Cox regression hazard ratio, 0.40; 95% CI, 0.25-0.63; P < .001)., Conclusions: At midterm follow-up of transannular repair with pulmonary valve leaflet augmentation, severe PR occurs in less than 50% of patients. The expanded polytetrafluoroethylene patch performs better than pericardium., (Copyright © 2021 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To investigate opportunities and limitations of using the Manufacturer and User Facility Device Experience (MAUDE) database for cardiovascular surgery research, we analyzed the quality of studies having ever used MAUDE, in the field of cardiovascular surgery., Methods: We systematically searched the Cochrane Library, PubMed, EMBASE, and Google Scholar for randomized and nonrandomized studies, from inception to July 2019. Two authors evaluated the quality of the retrieved observational studies, according to the National Institutes of Health quality assessment tool for either case series or cross-sectional studies. These tools quantify the quality of case series and cohorts/cross-sectional studies, respectively, with nine and 14 queries., Results: Fifty-eight studies were included in the final qualitative review. Of 58 identified studies, 32 were case series, 8 were abstracts of case series, and 13 were reviews or case discussion with an included series from MAUDE. Also, five articles were cross-sectional studies. Of the 32 formal case series, 26 (81%) were found to have poor quality. The most common reasons for a poor quality designation included a lack of consecutive participants, undetermined comparability of participants, and undetermined follow-up adequacy. Only one out of five cross-sectional studies had fair quality; four others were evaluated as poor quality studies., Conclusions: Cardiovascular surgery studies using the MAUDE database, whether case series or cross-sectional design, are mostly of poor quality. Their low quality is partly caused by poor study design, but mainly by intrinsic limitations to the MAUDE database: cases recruited are not consecutive; patient characteristics are not detailed enough to allow a meaningful comparison of patient characteristics between different patient entries; outcome measures are unclear; there is a limited follow-up; and time-to-event data are lacking. We conclude that the quality of cardiovascular surgery publications that rely on data from MAUDE could be improved if investigators were to extract all relevant data points from MAUDE entries, then apply standard quality assessment tools in compiling and reporting the data. MAUDE might be improved if it used medical case report standards during the process of reporting and indexing adverse events. To calculate the incidence rate of any adverse event, all event-free cases, as well as all adverse events in patients using a device, are required. Neither of these two variables is available in the MAUDE at the time of writing., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Cardiopulmonary bypass (CPB) is a standard technique for cardiac surgery, but comes with the risk of severe neurological complications (e.g. stroke) caused by embolisms and/or reduced cerebral perfusion. We report on an aortic cannula prototype design (optiCAN) with helical outflow and jet-splitting dispersion tip that could reduce the risk of embolic events and restores cerebral perfusion to 97.5% of physiological flow during CPB in vivo, whereas a commercial curved-tip cannula yields 74.6%. In further in vitro comparison, pressure loss and hemolysis parameters of optiCAN remain unaffected. Results are reproducibly confirmed in silico for an exemplary human aortic anatomy via computational fluid dynamics (CFD) simulations. Based on CFD simulations, we firstly show that optiCAN design improves aortic root washout, which reduces the risk of thromboembolism. Secondly, we identify regions of the aortic intima with increased risk of plaque release by correlating areas of enhanced plaque growth and high wall shear stresses (WSS). From this we propose another easy-to-manufacture cannula design (opti 2 CAN) that decreases areas burdened by high WSS, while preserving physiological cerebral flow and favorable hemodynamics. With this novel cannula design, we propose a cannulation option to reduce neurological complications and the prevalence of stroke in high-risk patients after CPB., (© 2021. The Author(s).)

During surgical procedures, cotton abdominal swabs with their high absorptive capacity and malleability are used to retain organs and absorb blood or other body fluids. Such properties of the natural material cotton are advantageous for most operations, but in cardiopulmonary bypass (CPB) surgery, a high blood volume can accumulate in the thoracic cavity that is quickly retransfused via the heart-lung machine (HLM). This common practice is supposed to be safe due to the high anticoagulation. However, in vitro analyses showed that blood cells and plasma proteins were activated despite a high anticoagulation, which can propagate especially an inflammatory response in the patient. Thus, we investigated patients' blood during CPB surgery for inflammatory and coagulation-associated activation after contact to the HLM and either cotton or synthetic abdominal swabs. Contact with cotton significantly increased thrombocyte and neutrophil activation measured as β-thromboglobulin and PMN-elastase secretion, respectively, compared to synthetic abdominal swabs. Both inflammatory cytokines, interleukin (IL) 1β and IL6, were also significantly increased in the cotton over the synthetic patient group, while SDF-1α was significantly lower in the synthetic group. Our data show for the first time that cotton materials can activate platelets and leukocytes despite a high anticoagulation and that this activation is lower with synthetic materials. This additional activation due to the material on top of the activation exerted by the tissue contact that blood is exposed to during CPB surgery can propagate further reactions in patients after surgery, which poses a risk for this already vulnerable patient group.

Atrial fibrillation (AF), the most common arrhythmia, is a major cause of stroke and systemic embolism. Patients with AF are at higher risk of stroke with the left atrial appendage (LAA) being the most common site for thrombus formation. Although oral anticoagulation (OAC) remains the standard of care for stroke prevention in AF patients, there are still several limitations, including increased risk of bleeding and noncompliance. LAA closure (LAAC) has been found to be non-inferior to OAC in preventing all-cause strokes and systemic embolisms in randomized clinical trials, and is increasingly performed for stroke prevention in patients with nonvalvular AF (NVAF). However, device-related thrombus (DRT) after LAAC and a potentially increased risk of stroke related to DRT were observed in several registered studies, and attract wide concern. This review provides a comprehensive update on the incidence, mechanism, risk factors, prevention, diagnosis, and treatment of DRT after LAAC in patients with NVAF., (© 2020 Wiley Periodicals LLC.)

Blood clots (90%) originate from the left atrial appendage (LAA) in non-valvular atrial fibrillation patients and are a major cause of embolic stroke. Long-term anticoagulation therapy has been used to prevent thrombus formation, but its use is limited in patients at a high risk for bleeding complications. Thus, left atrial appendage closure (LAAC) devices for LAA occlusion are well-established as an alternative to the anticoagulation therapy. However, the anticoagulation therapy is still required for at least 45 days post-implantation to bridge the time until complete LAA occlusion by neoendocardium coverage of the device. In this study, we applied an endothelium-mimicking nanomatrix to the LAAC device membrane for delivery of nitric oxide (NO) to enhance endothelialization, with the goal of possibly being able to reduce the duration of the anticoagulation therapy. The nanomatrix was uniformly coated on the LAAC device membranes and provided sustained release of NO for up to 1 month in vitro . In addition, the nanomatrix coating promoted endothelial cell proliferation and reduced platelet adhesion compared to the uncoated device membranes in vitro . The nanomatrix-coated and uncoated LAAC devices were then deployed in a canine LAA model for 22 days as a pilot study. All LAAC devices were not completely covered by neoendocardium 22 days post-implantation. However, histology image analysis showed that the nanomatrix-coated LAAC device had thicker neoendocardium coverage compared to the uncoated device. Therefore, our in vitro and in vivo results indicate that the nanomatrix coating has the potential to enhance endothelialization on the LAAC device membrane, which could improve patient outcomes by shortening the need for extended anticoagulation treatment.

Objective: The present study aimed to evaluate short- and middle-term results and postoperative anticoagulation of left atrial appendage (LAA) exclusion with an epicardial clip device., Materials and Methods: From September 2017 to August 2019, 102 patients at our institution underwent epicardial LAA exclusion using the AtriClip device. Anticoagulation therapy was resumed in the very early postoperative period and continued for at least three months after surgery. The patients' data were obtained by reviewing their medical records retrospectively., Results: The mean and median durations of follow-up was 510 ± 184 days and 482 days (range, 216-938 days), respectively. Successful LAA exclusion was confirmed in all but one patient. No device-related complications occurred during surgery. Postoperative computed tomography (CT) findings revealed no migration or displacement of the clips in any patient; however, small clots were observed at the LAA stump in seven patients. Stroke-free rate during the follow-up period was 98.9%., Conclusion: LAA exclusion using the AtriClip device was a feasible treatment method in terms of its early and middle-term safety and efficacy. In addition, our postoperative anticoagulation strategy could be optimal for maximizing the procedure's merits, although further studies, involving a larger number of patients and longer duration of follow-up, are needed.

Introduction: Ventricular septal defect (VSD) accounts for up to 40% of all congenital cardiac malformations. Transthoracic closure of VSDs has been well described in literature. In the current report, we described a procedure to successfully close a VSD with 2 occluders from different incisions simultaneously under the guidance of trans-esophageal echocardiography (TEE), to save the patient from undergoing another surgery., Patient Concerns: A 52-year-old man was referred to our clinic for repeating palpitations for 6 months without chest pain and polypnea after activity., Diagnosis: The diagnosis of VSD was established due to the findings of a juxtatricuspid VSD with a left-to-right shunt at ventricular level and mild mitral regurgitation by TTE., Interventions: A transcatheter VSD closure was firstly performed but failed to repair the VSD. After the failure of transcatheter VSD closure, the patient received transthoracic closure of VSD operated by a cardiac surgeon. The VSD was closed with 2 occluders from different incisions (median thoracic skin incision and subxiphoid incision) simultaneously under the TEE guidance., Outcomes: The patient was extubated in intensive care unit and was discharged 4 days after the operation. During the follow up, there were no significant clinical nor laboratory side-effects of the procedure found as compared to the patient's condition before the procedure., Conclusion: VSD can be closed with 2 occluders from different incisions simultaneously under the TEE guidance to save the patient from undergoing repeated surgeries. Meanwhile, TEE plays a significant role in cardiac surgery., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Extracorporeal circulation (ECC) is an integral part of cardiac surgery. Yet, the contact with artificial surfaces, mechanical stress, shear, and suction forces within the ECC pose a pronounced risk for damaging the corpuscular components of the blood. These suction forces may be reduced by a repositioning of the roller pumps employed below the reservoir. Furthermore, the repeated compression of the involved silicone tubing is likely to cause degradation. We present our observations regarding changes in the ECC performance following this degradation process. In vitro experiments were performed in a standard as well as a simplified ECC setup and included measurements of pressure, effective flow, and tubing restoring force over a time frame of 12 hours with two different pump positions utilizing transit time flow measurement. Suction forces within the tubing could be significantly reduced by shifting the pump position below the reservoir. Regardless of the setup, the tubing showed significant loss of restoring force as well as effective flow over time. A shift of the pump position within the ECC setup can be recommended to prevent blood damaging negative pressures. Further research is necessary to evaluate the exact cause of the reduction of restoring force overtime as well as its risks for the patients. Finally, our results underline the importance of transit time flow measurements to collect reliable flow data., (© 2020 The Authors. Artificial Organs published by International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Background: Diaphragm paralysis (DP) complicates the postoperative course of neonates and infants undergoing cardiac surgery. Events causing DP remain poorly understood, and preventive strategies remain elusive. This retrospective cohort analysis aims to test the hypothesis that chest tubes in contact with the phrenic nerve in the pleural apex may cause pressure palsy., Methods: In late 2018, the chest tube positioning strategy was changed so as to avoid a putative "danger zone" configuration, defined as (1) the chest tube looping apicomedially at the level of the second right intercostal space, and (2) wedging of chest tube tip against pericardium. A preintervention and postintervention analysis of 531 patients from 2012 to 2019 was performed to evaluate any association of chest tube position or duration in place with DP. Univariable and multivariable analyses were carried out, with significance set a priori at P < .05., Results: The preintervention group comprised 488 patients, of whom 32 (6.6%) had RDP. The postintervention group comprised 43 patients, none of whom had DP. Multivariable analysis of the entire cohort revealed chest tube positioning in the danger zone as the only significant association with RDP (odds ratio, 4.22; 95% confidence interval, 1.57-11.33; P < .05)., Conclusions: Chest tubes that occupy the right superior pleural space are associated with increased risk of DP., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

The field of transcatheter mitral valve repair (TMVr) for mitral regurgitation (MR) is rapidly evolving. Besides the well-established transcatheter mitral edge-to-edge repair approach, there is also growing evidence for therapeutic strategies targeting the mitral annulus and mitral valve chordae. A patient-tailored approach, careful patient selection and an experienced interventional team is crucial in order to optimise procedural and clinical outcomes. With further data from ongoing clinical trials to be expected, consensus in the Heart Team is needed to address these complexities and determine the most appropriate TMVr therapy, either single or combined, for patients with severe MR., Competing Interests: Competing interests: ODB received institutional research grants and consulting fees from Abbott and Boston Scientific. MT is a consultant for Abbott Vascular, Boston Scientific and 4tech; received personal fees from Edwards Lifesciences, Mitraltech, CoreMedic and Swissvortex; and is a shareholder of 4Tech. FM obtained grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, Terumo, Consulting fees, Honoraria personal and institutional from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, Occlufit; has Royalty Income/IP Rights Edwards Lifesciences; and is shareholder (including share options) of Cardiogard, Magenta, SwissVortex, Transseptal solutions, Occlufit, 4Tech, Perifect. LS received institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic and Edwards Lifesciences. All other coauthors have no conflict of interest to disclose concerning this manuscript., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Thrombus formation due to atrial fibrillation is the most common cause of embolic stroke. Anticoagulation offers an effective prophylaxis. However, anticoagulation in turn has an inherent increased risk of bleeding. Patients with non-valvular atrial fibrillation who have contraindications for anticoagulation may profit from a closure of the left atrial appendage. The most commonly and best studied devices for this are the WATCHMAN™ and the AMPLATZER Amulet™ Occluders.In this How-To article, the aim is to offer a general overview of the indications, contraindications and complications as well as the implantation and postoperative management of patients receiving LAA closure by example of the WATCHMAN FLX™ Occluder., Competing Interests: Die Autoren geben folgende potenzielle Interessenkonflikte an:Prof. Dr. Horst Sievert: 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Cardimed, Celonova, Comed B.V., Contego, CVRx, Dinova, Edwards, Endologix, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, Lifetech, Maquet Getinge Group, Medtronic, Mokita, Occlutech, Recor, Renal Guard, Terumo, Vascular Dynamics, Vectorious Medtech, Venock, Venus, Vivasure Medical.Dr. Stefan Bertog: Edwards Lifesciences, Ablative Solutions., (Thieme. All rights reserved.)

Mitral valve repair is typically performed by implanting a ring-like device at the valve annulus to reshape the annulus and to improve leaflet coaptation. In most cases, some additional procedures are needed, including leaflet resection and artificial chordae implantation. However, artificial chordae implantation could be technically challenging and postoperative left ventricular remodeling could increase the risk of recurrent mitral regurgitation. We propose an innovative annular device made of chromo-cobalt, finalized not only to reshape the annulus but also to enable anchoring of leaflets to a fixed intraventricular structure. Durability evaluation of the device was tested by applying eight radial force vectors equally spaced along the ring and related fatigue analysis. To evaluate the efficacy of the mitral valvuloplasty using the tested ring, the device was implanted in five adult swine hearts. Functional analysis of the ring was performed by measuring left ventricular pressure and fluid volume loss, following implantation in normal and dysfunctional mitral valve leaflets. Both fatigue and functional analysis showed satisfactory and promising results in terms of durability and efficacy of mitral valve repair. Because of its favorable durability and functional characteristics this device appears promising and provides good results in terms of valve competence, thus avoiding both manipulations of papillary muscles and interference in left ventricular hemodynamics. However, an in vivo test is mandatory to fully understand the impact of the device on subvalvular apparatus.

Purpose: A cutting stapler is a well-established instrument in many surgical fields. However, its efficacy and safety have not been proven yet in resecting a left atrial appendage (LAA) in minimally invasive cardiac surgery (MICS)., Methods: A cutting stapler was used to resect the LAA in 98 consecutive patients who underwent MICS. Of these, 26 patients underwent aortic valve replacement, 72 mitral valve repair/replacement, 25 tricuspid annuloplasty, 7 closure of atrial septal defect, and 26 the Maze procedure (contains overlapping). The ascending aorta was elevated using a retractor, and a 12-mm shaft motor-driven cutting stapler was inserted through the transverse sinus. As a control group, 150 patients who underwent suture resection/closure of the LAA either from inside or outside were compared., Results: There was one mortality in each group. They were not related to the LAA resection/closure. In the suture group, the LAA suture was taken down in one patient because of a suspected obstruction of the circumflex artery, and two patients had re-exploration for bleeding from the LAA. In the stapler group, there was no complication related with the LAA. The rate of complication did not reach a statistical difference., Conclusion: A cutting stapler is considered to be a useful instrument to resect the LAA in MICS.

Background: In specialized centers, percutaneous closure using specific occluders is the first-choice treatment in atrial septal defects (ASD). Late complications after this intervention, such as erosion of the aorta or the atria, are rare and have not been sufficiently approached and dealt with in literature. In our clinic we have been faced with the problematic situation of diagnosing and treating such cases. That is why, we have decided to share our experience with other colleagues., Case Presentation: We present two cases of severe late complications after percutaneous closure of atrial septal defects (ASD). In both cases, the atrial septal occluder (Amplatzer™ Atrial Septal Occluder Device, Abbott, Chicago USA) caused the erosion between the left atrium and the aortic root. The atrio-aortic erosion led to acute cardiac tamponade with upper venous congestion and shock. As the bleeding source remained undetectable for any imaging tools, a diagnostical sternotomy remained the only solution. The cause of the acute bleeding was discovered to be the erosion between the left atrium and the aortic root. The treatment consisted in the removal of the occluder, direct suturing of the perforated areas and the surgical closure of the remaining ASD. The patients fully recovered within the nine to fourteen days' hospital stay. Six months after surgery both patients were well and able to recover their daily routine., Conclusions: The atrio-aortic erosion after percutaneous closure of atrial septal defects is a surgical emergency. The more so, since it can be complicated by the absence of specific symptoms. A key-element in the diagnosis of this rare pathology remains the medical history of the patient, which the surgeon has to consider thoroughly and launch the diagnostic sternotomy without delay.

Despite advances in technologies for cardiac repair after myocardial infarction (MI), new integrated therapeutic approaches still need to be developed. In this study, we designed a perfusable, multifunctional epicardial device (PerMed) consisting of a biodegradable elastic patch (BEP), permeable hierarchical microchannel networks (PHMs) and a system to enable delivery of therapeutic agents from a subcutaneously implanted pump. After its implantation into the epicardium, the BEP is designed to provide mechanical cues for ventricular remodeling, and the PHMs are designed to facilitate angiogenesis and allow for infiltration of reparative cells. In a rat model of MI, implantation of the PerMed improved ventricular function. When connected to a pump, the PerMed enabled targeted, sustained and stable release of platelet-derived growth factor-BB, amplifying the efficacy of cardiac repair as compared to the device without a pump. We also demonstrated the feasibility of minimally invasive surgical PerMed implantation in pigs, demonstrating its promise for clinical translation to treat heart disease.

Novel interventional therapies for heart failure patients are emerging like atrial flow regulator (AFR). Our case showed that endocardial ventricular tachycardia (VT) ablation could be performed safely by passing through the AFR device lumen without additional transseptal puncture in these patients., (© 2020 Wiley Periodicals LLC.)

Background: The COVID-19 pandemic has compounded many existing healthcare delivery challenges including long waiting lists and cost containment. New challenges have arisen, such as demand on supply of personal protective equipment (PPE) and the implications of social distancing on staff, patients, and their families. Despite the pandemic, the need to deliver safe, urgent congenital cardiac surgery has remained., Objective: To demonstrate how Lean methodology can improve PPE supply chain demand and reduce staff exposure to children with unknown SARS-CoV-2 status undergoing congenital cardiac surgery, during the COVID-19 pandemic., Methods: We implemented the define, measure, analyze, improve, and control method (DMAIC) and Value Stream Maps to eliminate waste steps during testing for SARS-CoV-2 for children undergoing congenital cardiac surgery., Results: Following a 3-week period of implementation of this new value stream map, we reduced PPE set usage from 13 to 1 per patient, resulting in an annual saving of over €36,000 and reducing single-use plastic waste by nearly 70 000 pieces per annum. We reduced numbers of staff exposed to patients with an unknown SARS-CoV-2 status from 13 to 1., Conclusion: The use of Lean methodology can reduce waste of PPE and plastic, resulting in cost savings, while reducing staff exposure when testing patients with congenital cardiac disease for SARS-CoV-2. By preventing admission of SARS-CoV-2-positive patients, we can reduce use of isolation beds and prevent cancellation of surgery, improving patient flow and departmental efficiency. Other departments in our institution are implementing similar admission pathways to allow surgical services to restart during the ongoing pandemic., (© 2020 John Wiley & Sons Ltd.)

Our objective was to assess the effect of nitric oxide added to the sweep gas of the oxygenator during cardiopulmonary bypass (CPB) in infants on platelet count, platelet function, clinical outcomes, and safety. A randomized, double-blinded, placebo-controlled clinical trial in infants less than a year of age undergoing cardiac surgery requiring CPB was undertaken. Nitric oxide at a dose of 20 ppm was added to the sweep gas in the treatment group. Blood was collected at baseline and prior to separation from CPB to measure platelet count and function as determined by responsiveness to specific agonists. Clinical outcomes were observed through hospital discharge. Methemoglobin levels were measured preoperatively, at the conclusion of CPB, and upon admission to the ICU. Forty patients consented and were randomized in the trial. Eighteen patients were randomized to the treatment group and 22 were included in the placebo group. The groups were similar in terms of age, weight, gender, and surgical complexity. No significant differences were found in measures of platelet count, platelet response to agonist, or clinical outcomes. Patients in the treatment group had higher methemoglobin levels after receiving nitric oxide, but no levels approached toxicity (maximum 2.4%). Nitric oxide added to the sweep gas of the oxygenator during CPB in infants did not have an appreciable effect on the preservation of platelet count, platelet responsiveness to agonist, or clinical outcomes. Methemoglobin levels were increased after receiving nitric oxide but were far below a toxic level of 15%., (© 2020 International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Objectives: We aimed to explore the radiologic characteristics and interventional strategies for perimembranous ventricular septal defect (pmVSD) with aneurysm., Methods: 257 patients who underwent transcatheter closure of pmVSD with aneurysm were included in our study. We retrospectively reviewed the left ventricular opening of the aneurysm (a), diameter of the midsegment of the aneurysm (b), and diameter of the right ventricular opening of the aneurysm (c). If there were multiple defects within the aneurysm, the largest defect was denoted as c 1 and so forth. We developed a novel VSD classification method in which pmVSD with aneurysm was classified into three types (A, B, and C). When a  > b  ≥  c , it was classified as type A, when b  >  a  ≥  c , it was type B, and when c  >  a  ≥  b , it was type C; c / c 1 described the relationship among defects., Results: All of the 257 cases of pmVSD with aneurysm were defined using left ventriculography: type A, 60, type B, 58, and type C, 139. Transcatheter closure was attempted in 244 patients and succeeded in 227 cases (success rate was 93.0%; 227/244). Forty symmetric VSD occluders and 13 asymmetric VSD occluders were used for type A aneurysm occlusion; 31 symmetric VSD occluders, 19 asymmetric VSD occluders, and one Amplatzer duct occluder II (ADOII) were used for type B; 59 VSD symmetric occluders, 59 asymmetric VSD occluders, three eccentric VSD occluders, and two ADOII were used for type C. Within 24 hours after procedure, 2.2% patients had postprocedural residual shunt, and 2.2% experienced malignant arrhythmia (including type II second-degree AVB, cAVB, and CLBBB). Two hundred and twelve patients completed follow-up (93%, 212/227). No new severe complications were reported during follow-up, except in one patient who underwent surgery (removal of the device, VSD repair, and tricuspid valvuloplasty) due to severe postprocedural tricuspid regurgitation., Conclusions: It is safe and effective to apply this method for the classification of pmVSD with aneurysm and its interventional strategy., Competing Interests: The authors declare that there are no conflicts of interest regarding the publication of this paper., (Copyright © 2020 Weibing Guo et al.)

Background: Left atrial appendage closure (LAAC) using the LAmbre device has been associated with prevention of stroke in patients with nonvalvular atrial fibrillation (AF). Here, we interrogated the long-term safety and efficacy of using the LAmbre device in percutaneous LAAC., Methods: We analyzed 56 records of patients with nonvalvular AF undergoing LAAC procedures with the LAmbre device. We collected and analyzed the data to define the safety and efficacy of the LAmbre device implantation., Result: The LAAC was successfully occluded in the 56 patients. Our data showed no serious residual leak or pericardial effusion occurred during the perioperative period. At a mean follow-up of 37.8 ± 23.5 months, there were 7.1%, 3.6%, and 3.6% rates of death, stroke, and device-related thrombus, respectively. There were no cases of severe residual leak or systemic embolism., Conclusion: Taken together, we demonstrate that execution of LAAC with the LAmbre device has high procedural success and prevents AF-related stroke. However, further large-scale trials might be required to confirm our findings., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2020 Guangji Wang et al.)

The aim of this study was to investigate the prognostic role of heart failure (HF) history in patients with secondary mitral regurgitation (SMR) underwent MitraClip. We retrospectively analyzed 186 patients with SMR undergoing MitraClip at 4 centres. HF history was defined as number or days of HF hospitalizations in the 12-month before MitraClip, or as time from last HF hospitalization to MitraClip, or time between first SMR diagnosis and MitraClip. More severe symptoms were observed in patients with >1 HF hospitalization compared with those with ≤1 HF hospitalizations, in those with ≥10 days versus <10 days of HF hospitalization and in those with shortest time from the last HF hospitalization. No significant differences were observed for procedural data in the population stratified according to the different definitions. In variables related with HF history, only the number of HF hospitalizations before MitraClip was associated with an increased risk of clinical events (hazard ratio 1.59; 95% confidence interval [1.09 to 2.12]; p = 0.015), whereas days of previous HF hospitalization, time from last HF hospitalization and from first diagnosis of SMR do not impact on prognosis. A significant decrease in the number and days of HF hospitalizations was observed in the 12-month after MitraClip compared with the 12-month before. In conclusion, in variables related with HF history, recurrence (>1) of HF hospitalizations before MitraClip was the most powerful predictor of prognosis. Latency of intervention did not affect outcomes., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Left atrial appendage occlusion (LAAO) is performed in patients with nonvalvular atrial fibrillation to reduce the risk of ischemic stroke. The patients with a history of intracranial hemorrhage were excluded from the pioneer randomized controlled trials. The purpose of this systemic review was to evaluate the data from observational studies reporting the efficacy and safety of LAAO in patients with a history of intracranial hemorrhage., Methods: Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Web of Science Core Collection, Scopus, Global Index Medicus, and ClinicalTrials.gov data sources were utilized for data collection., Results: A total of 12 studies met the inclusion criteria that included seven retrospective observational and five prospective observational studies. A total of seven hundred and twenty-seven patients with a history of intracranial hemorrhage underwent percutaneous left atrial appendage occlusion. There were 11 events of recurrent intracranial hemorrhage, 12 ischemic strokes, 4 transient ischemic attacks, and 26 all-cause deaths. The duration of follow-up varied from 3 months to 3.6 years in the included studies., Conclusion: Left atrial appendage occlusion can potentially be an effective and relatively safe treatment option to reduce the risk of ischemic stroke in selected patients with nonvalvular atrial fibrillation patients and history of intracranial hemorrhage. Future prospective randomized trials are needed to validate this approach., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2020 Muhammad Ajmal et al.)

Objective: Patients with biventricular assist devices (BiVADs) have worse outcomes than those with left ventricular assist devices (LVADs). It is unclear whether these outcomes are due to device selection or patient factors. We used propensity score matching to reduce patient heterogeneity and compare outcomes in pediatric patients supported with BiVADs with a similar LVAD cohort., Methods: The Pedimacs registry was queried for patients who were supported with BiVAD or LVAD. Patients were analyzed by BiVAD or LVAD at primary implant and the 2 groups were compared before and after using propensity score matching., Results: Of 363 patients who met inclusion criteria, 63 (17%) underwent primary BiVAD support. After propensity score matching, differences between cohorts were reduced. Six months after implant, in the BiVAD cohort (LVAD cohort) 52.5% (42.5%) had been transplanted; 32.5% (40%) were alive with device, and 15% (10%) had died. Survival was similar between cohorts (P = .31, log-rank), but patients with BiVADs were more likely to experience a major adverse event in the form of bleeding (P = .04, log-rank). At 1 week and 1 and 3 months' postimplant, the percentage of patients on mechanical ventilation, on dialysis, or with elevated bilirubin was similar between the 2 groups., Conclusions: When propensity scores were used to reduce differences in patient characteristics, there were no differences in survival but more major adverse events in the patients with BiVADs, particularly bleeding. Differences in unmatched patient outcomes between LVAD and BiVAD cohorts likely represent differences in severity of illness rather than mode of support., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Neurological events after cardiac surgery or transcatheter aortic valve implantation (TAVI) have a dramatic effect on patients' prognosis. Recent development of transcatheter cerebral protection systems aims to reduce their incidence, even if their use is currently limited to TAVI. Here we report our initial experience with transcatheter cerebral protection devices used in patients at high brain embolic risk undergoing cardiac surgery., Methods: Between December 2018 and March 2020, at the Cardiac Surgery Unit of Lancisi Cardiovascular Center in Ancona, Italy, 9 patients (mean age 77 years; median EuroSCORE II: 2.2%) underwent cardiac surgery using a transcatheter cerebral protection system (Sentinel, Claret Medical, Santa Rosa, CA, USA). In all cases, a preoperative computed tomography scan highlighted the presence of severely calcified ascending aorta., Results: The brain protection system was successfully implanted in all patients. Total time for device implantation and removal was less than 10 min in all cases. Four patients underwent aortic valve replacement, 2 mitral surgery, whereas 3 received combined valve surgery. Calcified debris were found within filters in 100% of patients. Postoperatively, there were neither neurological events nor major complications., Conclusions: In our experience, transferring transcatheter brain protection techniques and technologies to cardiac surgery allowed us (with excellent results) to avoid palliative percutaneous or medical management in patients with severe aortic calcifications. Waiting for more solid evidence, we believe that our example supports the concept of hybrid surgery as a therapeutic approach capable of extending traditional surgical indications with improved patients' outcomes.

Background: Ensuring that lung-protective ventilation is achieved at scale is challenging in perioperative practice. Fully automated ventilation may be more effective in delivering lung-protective ventilation. Here, we compared automated lung-protective ventilation with conventional ventilation after elective cardiac surgery in haemodynamically stable patients., Methods: In this single-centre investigator-led study, patients were randomly assigned at the end of cardiac surgery to receive either automated (adaptive support ventilation) or conventional ventilation. The primary endpoint was the proportion of postoperative ventilation time characterised by exposure to predefined optimal, acceptable, and critical (injurious) ventilatory parameters in the first three postoperative hours. Secondary outcomes included severe hypoxaemia (Spo 2 <85%) and resumption of spontaneous breathing. Data are presented as mean (95% confidence intervals [CIs])., Results: We randomised 220 patients (30.4% females; age: 62-76 yr). Subjects randomised to automated ventilation (n=109) spent a 29.7% (95% CI: 22.1-37.4) higher mean proportion of postoperative ventilation time receiving optimal postoperative ventilation after surgery (P<0.001) compared with subjects receiving conventional postoperative ventilation (n=111). Automated ventilation also reduced the proportion of postoperative ventilation time that subjects were exposed to injurious ventilatory settings by 2.5% (95% CI: 1-4; P=0.003). Severe hypoxaemia was less likely in subjects randomised to automated ventilation (risk ratio: 0.26 [0.22-0.31]; P<0.01). Subjects resumed spontaneous breathing more rapidly when randomised to automated ventilation (hazard ratio: 1.38 [1.05-1.83]; P=0.03)., Conclusions: Fully automated ventilation in haemodynamically stable patients after cardiac surgery optimised lung-protective ventilation during postoperative ventilation, with fewer episodes of severe hypoxaemia and an accelerated resumption of spontaneous breathing., Clinical Trial Registration: NCT03180203., (Copyright © 2020 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)

Mitraclip corrects mitral regurgitation in a less invasive way than cardiac surgery. These procedures are becoming widespread with the emergence of new complications. We report a rare case of mitral stenosis associated with acute hemolytic anemia after mitraclip treatment in an 82-year-old patient. The cause of this stenosis in our case is linked to the placement of two clips and an increase gradient in post-procedure. The mechanism of hemolysis could be due to the persistence of mitral leaks resulting in strong collisions against the clip., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Background: Heater-cooler units (HCUs) used during cardiopulmonary bypass may become colonized with non-tuberculous mycobacteria (NTM), including Mycobacterium chimaera. Recently, a worldwide investigation conducted in hospitalized infected patients has detected M. chimaera in several Stockert 3T HCUs manufactured by LivaNova., Aim: Microbiological surveillance on Stockert 3T (LivaNova) and Maquet HCU40 (Getinge) devices as well as an evaluation of the efficacy of their recommended decontamination protocols., Methods: A total of 308 water samples were collected from 29 HCUs: 264 samples were collected from 17 Stockert 3T HCUs and 44 samples from 12 Maquet HCU40 devices. Samples were tested for total viable counts (TVCs) at both 22 and 36°C, Pseudomonas aeruginosa, coliform bacteria, and NTM. The microbiological surveillance began in June 2017 and ran until October 2019., Findings: A total of 308 HCU water samples were analysed, 65.5% of which yielded NTM. The most frequently colonized device with NTM was the Stockert 3T (88.2%), with a frequency of positive samples of 59.5% (157/264). The Maquet HCU40 devices less frequently yielded NTM (33.3%), with a frequency of positive water samples of 13.6% (6/44). Disinfection procedures were effective in reducing TVCs of bacteria with the exception of NTM species. NTM were detected in both pre-disinfection (50.1%) and post-disinfection (55.7%) samples, and no significant association was found between disinfection and NTM results both in Stockert 3T and Maquet HCU40 devices., Conclusion: This study suggests that manufacturers' procedures for disinfection are ineffective and/or inadequate. Until effective disinfection protocols become available, the only way to minimize the risk of NTM contamination is to closely monitor the water quality in the HCU, keep it as clean as possible, and treat it like any other biohazardous material., (Copyright © 2020 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.)

Objective: The Cor-Knot automated fastener has been used to eliminate the need for manual knot-tying in cardiac valve surgery for over a decade. We review the current literature pertaining to Cor-Knot and discuss its benefits and shortcomings with respect to cardiac valve surgery., Methods: A comprehensive literature search was conducted to identify articles discussing the use of automated fasteners and manually tied knots in the setting of cardiac valve surgery. The search terms used were "heart", "valve surgery", "cardiac", "Cor-Knot", "fastener", "automated fastener", "aortic valve", "mitral valve", "minimally invasive", and "titanium". These terms were used as keywords and, in combination, as MeSH terms to maximize the output of literature searches. Twenty-four relevant articles were identified and reviewed., Results: Current literature provides evidence to support the role of Cor-Knot in facilitating enhanced intraoperative efficacy by reducing total operation times as compared with manual knot-tying. However, studies to date fail to provide evidence for the translation of these intraoperative advantages into improved patient outcomes. Moreover, Cor-Knot is associated with a significant financial burden., Conclusion: A plethora of evidence exists to support the intraoperative advantages provided by Cor-Knot. However, the literature is yet to support its role in facilitating superior clinical outcomes as compared with manual knot tying. Larger high-quality trials and studies are required to provide evidence supporting the ongoing use of Cor-Knot in valve surgery., (© 2020 Wiley Periodicals LLC.)

The left atrial appendage is thought to be responsible for the majority of embolic strokes, and has become an important target in the surgical management of atrial fibrillation. We present an original clip-and-loop technique using an AtriClip via a left minithoracotomy for post-stroke patients with atrial fibrillation. This procedure was performed in 43 cases between March 2018 and January 2020. No patient had a thrombus at the edge of the clip or communication into the left atrial appendage 3 months after surgery. Anticoagulant could be discontinued in all patients. Follow-up at 23 ± 10 months showed no recurrence of stroke.

A dual-loop controller permits the automated titration of propofol and remifentanil during anesthesia; it has never been used in intensive care after cardiac surgery. The goal of this preliminary study was to determine the efficacy of this controller to provide postoperative sedation in 19 adult cardiac surgery patients with a Bispectral Index target of 50. Results are presented as numbers (percentages) or medians [25th-75th percentiles]. The sedation period lasted 139 min [89-205] during which the Richmond Agitation Sedation Scale was at - 5 and the Behavioral Pain Scale score at three points for all patients and observation times but one (82 out of 83 assessments). Sedation time in the range 40-60 for the Bispectral Index was 87% [57-95]; one patient had a period of electrical silence defined as Suppression Ratio at least > 10% for more than 60 s. The time between the end of infusions and tracheal extubation was 84 min [63-129]. The Richmond Agitation Sedation Scale was 0 [0-0], 0 [- 1 to 0], and 0 [0-0] respectively during the 3 h following extubation while the verbal numerical pain scores were 6 [4.5-7], 5 [4-6], and 2 [0-5]. Mean arterial pressure decreased during sedation requiring therapeutic interventions, mainly vascular filling in 15 (79%) patients. Automated sedation device was discontinued in two patients for hemodynamic instability. No patient had awareness of the postoperative sedation period. Dual closed-loop can provide postoperative sedation after cardiac surgery but the choice of the depth of sedation should take into account the risk of hypotension.

This article provides a detailed review of the current practices and future directions of transcatheter interventions in adults with congenital heart disease. This includes indications for intervention, risks, and potential complications, as well as a review of available devices and their performance., Competing Interests: Disclosure Dr Aboulhosn is a consultant and proctor for Edwards Lifesciences, a consultant for Medtronic Inc and Abbott Pharmaceuticals. Dr Hijazi is a consultant for Occlutech and Numed, he is a speaker for Venus and Medtech., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: The objective of our study was to investigate the feasibility of reconstructing the entire mitral valvular and subvalvular apparatus in pigs using a modified tube graft design made of 2-ply small intestinal submucosa extracellular matrix., Methods: The reconstructions were performed in an acute 80-kg porcine model with 8 pigs, each acting as its own control. A modified tube graft was designed from a sheet of 2-ply small intestinal submucosa extracellular matrix. Before and after mitral valve reconstruction, echocardiography was used to assess mitral regurgitation, left ventricular outflow tract obstruction due to systolic anterior motion, mitral stenosis, leaflet mobility, and leaflet geometry., Results: The reconstructed mitral valves were fully functional without any observable echocardiographic signs of regurgitation. We did not observe any left ventricular outflow tract obstruction due to systolic anterior motion nor any mitral valve stenosis, despite a diminished septal-lateral distance after reconstruction. The reconstruction had a reduced tenting area, a reduced coaptation length (9.6 ± 1.7 mm vs 7.9 ± 1.0 mm, P = .010, diff = -1.7 mm, 95% confidence interval, -3.1 to -0.4 mm), and atrial bending of both leaflets., Conclusions: In this acute porcine study, entire mitral valvular and subvalvular apparatus reconstruction using a modified tube graft design made from 2-ply small intestinal submucosal extracellular matrix was feasible. The 2-ply small intestinal submucosa extracellular matrix could withstand the pressure exerted by the left ventricle without any signs of tearing or rupture. These promising results warrant further assessment of both the annular geometry and the long-term durability., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)