Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS).

INTRODUCTION: The trial hypothesized that minimally invasive extra-corporeal circulation (MiECC) reduces the risk of serious adverse events (SAEs) after cardiac surgery operations requiring extra-corporeal circulation without circulatory arrest. METHODS: This is a multicentre, international randomized controlled trial across fourteen cardiac surgery centres including patients aged ≥18 and <85 years undergoing elective or urgent isolated coronary artery bypass grafting (CABG), isolated aortic valve replacement (AVR) surgery, or CABG + AVR surgery. Participants were randomized to MiECC or conventional extra-corporeal circulation (CECC), stratified by centre and operation. The primary outcome was a composite of 12 post-operative SAEs up to 30 days after surgery, the risk of which MiECC was hypothesized to reduce. Secondary outcomes comprised: other SAEs; all-cause mortality; transfusion of blood products; time to discharge from intensive care and hospital; health-related quality-of-life. Analyses were performed on a modified intention-to-treat basis. RESULTS: The trial terminated early due to the COVID-19 pandemic; 1071 participants (896 isolated CABG, 97 isolated AVR, 69 CABG + AVR) with median age 66 years and median EuroSCORE II 1.24 were randomized (535 to MiECC, 536 to CECC). Twenty-six participants withdrew after randomization, 22 before and four after intervention. Fifty of 517 (9.7%) randomized to MiECC and 69/522 (13.2%) randomized to CECC group experienced the primary outcome (risk ratio = 0.732, 95% confidence interval (95% CI) = 0.556 to 0.962, p = 0.025). The risk of any SAE not contributing to the primary outcome was similarly reduced (risk ratio = 0.791, 95% CI 0.530 to 1.179, p = 0.250). CONCLUSIONS: MiECC reduces the relative risk of primary outcome events by about 25%. The risk of other SAEs was similarly reduced. Because the trial terminated early without achieving the target sample size, these potential benefits of MiECC are uncertain.

Corrigendum: Patterns of cytokine release and association with new onset of post-cardiac surgery atrial fibrillation.

[This corrects the article DOI: 10.3389/fsurg.2023.1205396.].

Evaluation of the anatomic sinus after transcatheter aortic valve replacement.

BACKGROUND: Following transcatheter aortic valve replacement (TAVI), the newly formed 'anatomic sinus'. may contribute to the formation of subclinical leaflet thrombosis (SLT).The evaluation of root geometry after TAVI is generally performed using multi-detector computed tomography (MDCT), and the role of transthoracic echocardiography (2D TTE) requires further validation. Thus, we aimed to test the reproducibility of 2D TTE assessment of the anatomic sinus with MDCT as a reference and its association with SLT. METHODS: 2D TTE was performed in 90 patients, and the echocardiograms were analyzed offline. Both sinus of Valsalva (SOV) and prosthesis diameters were assessed in the long- and short-axis parasternal views (PLAX/PSAX), and the anatomic sinus area was calculated. Inter- and intra-observer reproducibility were assessed using the interclass correlation coefficient (ICC). MDCT was performed in 50 individuals to evaluate concordance with 2D TTE and to detect SLT. RESULTS: There was excellent correlation regarding the diameter of the SOV and the prosthesis in PLAX (ICC: 0.93 (95% CI: 0.76,0.97); ICC: 0.80 (95% CI: 0.63,0.96)) and PSAX view (ICC: 0.90 (95% CI: 0.68,0.97); ICC: 0.88 (95% CI: 0.63,0.96)). Bland-Altman analysis of 2D TTE and MDCT anatomic sinus areas indicated a high level of agreement. SLT was detected in 8 individuals (16%); 3 patients had severe SLT at the level of 1 cusp. CONCLUSIONS: 2D TTE might play a role in the evaluation of the anatomic sinus after TAVI. The importance of this space and its effects on the SLT remain uncertain.

About different localization of hypoattenuated lesions following transcatheter aortic valve replacement.

BACKGROUND: Subclinical leaflet thrombosis is diagnosed using multidetector computed tomography (MDCT) and is characterised by a meniscal-shaped hypoattenuated lesion of one or more leaflets. Transcatheter aortic self-expandable valves are commonly manufactured with pliable pericardium over a nitinol frame that forms leaflet and extra-leaflet components such as the valve skirt. Little is known about extra-leaflet hypoattenuated lesion localisation, including that at the anatomical sinus level. Thus, the main aim of this study was to describe leaflet and extra-leaflet (anatomic sinus and subvalvular level) hypoattenuated lesions following transcatheter aortic valve replacement with a self-expandable prosthesis. As a secondary aim, we sought to investigate predictors of hypoattenuated lesions. METHODS: Fifty patients underwent MDCT at the follow-up. RESULTS: At a follow-up of 12 months, hypoattenuated leaflet lesions with mild to severe restricted movement were detected in eight individuals (16%), anatomic sinus lesions were identified in nine patients (18%), with higher prevalence in the non-coronary sinus (16%), and subvalvular lesions with variable extension toward the valve inflow were diagnosed in eight patients (16%). In 4 patients (8%) the anatomic sinus thrombus was 'in overlap' with leaflet thrombus; in 3 patients (6%) was in continuity with subvalvular frame thrombus. Bicuspid valve was the only independent predictor associated with hypoattenuated lesions (adj OR 8.25 (95% CI: 1.38, 49.21), p = 0.02)). CONCLUSIONS: This study demonstrated that hypoattenuated lesions could be identified not only at the leaflet but also at the subvalvular and anatomic sinus levels. The clinical relevance of such lesions remains unclear.

Emergent Conversion to Open Heart Surgery during Transcatheter Aortic Valve Implantation: The Presence of a Rescue Team Improves Outcomes.

OBJECTIVE: Transcatheter aortic valve implant (TAVI) is the gold standard for the high-surgical-risk group of patients with aortic valve disease and it is an alternative to surgery in patients at intermediate risk. Lethal complications can occur, and many of these are manageable only with emergent conversion to open heart surgery. We retrospectively evaluate the outcome of all patients undergoing TAVI in our departments and the impact of a complete cardiac rescue team to reduce 30-day mortality. METHODS: Data from all patients undergoing TAVI between January 2020 and August 2023 in our center were analyzed. An expert complete rescue was present in catheter laboratory. Primary outcomes were in-hospital and at 30-day mortality and evaluation of all cases needed for emergent conversion to open heart surgery. RESULTS: 825 patients were enrolled. The total mortality was 19/825 (2.3%). Eleven of the total patients (1.3%) required emergent conversion to open heart surgery. Among them, eight were alive (73%), with a theoretical decrease of 0.98% in overall mortality. CONCLUSIONS: surgical treatment is rare during TAVI. The presence of an expert complete rescue team as support means an increase in survival. Surgery must be used only to restore circulatory and to treat complication while percutaneous approaches should complete the procedure.

Self-Expandable Prosthesis Valve Adaptation: Non-Uniform Expansion and Stent Frame Decoupling.

The incidence of non-uniform expansion in the context of the self-expandable transcatheter heart valve (THV) is little investigated, along with stent-frame decoupling, which is a form of stent adaptation, in which the lower part of the THV stent conforms to both the ellipticity of the left ventricle outflow tract and the native annulus while maintaining the higher part of the valve more circular. We analyzed post-implant multi-detector computed tomography scans in 50 patients. Prosthesis non-uniform expansion was assessed by computing the prosthesis eccentricity on 6 prespecified levels: (1) frame inflow, (2) native annulus, (3) leaflet inflow, (4) prosthesis waist, (5) leaflet outflow, and (6) frame outflow. Stent-frame decoupling was assessed by comparing the mean eccentricity on 6 different prosthesis levels. Implantation depth, leaflet expansion and alignment, and residual anatomic sinus area ratios were also calculated. Subclinical leaflet thrombosis was defined as hypoattenuated lesion of a meniscal shape. At a 12-month follow-up, non-uniform expansion was consistently detected at each valvular level. Highest eccentricity was measured at the native annulus level (eccentricity: 0.54 ±  0.12), while the lowest index at the frame outflow level (0.23 ± 0.11). Similar results were observed in the subgroup analyses of sizes 23, 26, 29, and 34. Eccentricity significantly decreased from the annulus level to the prosthesis frame outflow (p <0.001). Notably, the incidence of mild-to-severe subclinical leaflet thrombosis was relevant (16%). In conclusion, prosthesis non-uniform expansion and stent frame decoupling frequently occur after self-expandable THV replacement. The clinical and hemodynamic implications remain uncertain.

Subclinical Leaflet Thrombosis Following Surgical and Transcatheter Aortic Valve Replacement: A Meta-Analysis.

Subclinical leaflets valve thrombosis (SLT) is a recently identified phenomenon with multidetector computer tomography after tissue aortic valve replacement. Whether SLT is more frequent after transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) is currently not known. Thus, the aim of this pairwise meta-analysis was to investigate the incidence of SLT after both TAVR and SAVR, the association with anticoagulation therapy, and the risk for neurological events. We searched PubMed, Google Scholar, and Ovid MEDLINE/Embase (January 02, 2023, last update) (PROSPERO registration: CRD42022383295). Statistical analysis was performed according to a prespecified statistical analysis plan. Time-to-event outcomes were summarized as incidence rate ratios (IRR). Pooled estimates were calculated using inverse variance method and random effect model. Overall, 2 registries, 2 randomized trials, and 1 observational study (1,593 patients) were included in this meta-analysis. There was a statistically significant difference in the incidence rate at follow-up of SLT between patients who underwent TAVR and SAVR (IRR 2.07, 95% confidence interval [CI]: [1.06; 4.03], I2 79%, 95% CI: [44; 92], p = 0.03). Oral anticoagulation therapy was associated with a reduced incidence of SLT (IRR 7.51, 95% CI: [3.24; 17.37], I2 62%, 95% CI: [0; 87], p <0.001). However, the incidence of later neurological events did not differ between patients with or without SLT (IRR 1.05, 95% CI: [0.32; 3.47], p = 0.93). In conclusion, SLT was more frequently detected after TAVR than SAVR. However, it was not associated with an increased risk for neurological events. Oral anticoagulation therapy seemed to reduce the incidence of SLT.

Patterns of cytokine release and association with new onset of post-cardiac surgery atrial fibrillation.

Introduction: Postoperative Atrial Fibrillation (POAF) is a common complication of cardiac surgery, associated with increased mortality, stroke risk, cardiac failure and prolonged hospital stay. Our study aimed to assess the patterns of release of systemic cytokines in patients with and without POAF. Methods: A post-hoc analysis of the Remote Ischemic Preconditioning (RIPC) trial, including 121 patients (93 males and 28 females, mean age of 68 years old) who underwent isolated coronary artery bypass grafting (CABG) and aortic valve replacement (AVR). Mixed-effect models were used to analyze patterns of release of cytokines in POAF and non-AF patients. A logistic regression model was used to assess the effect of peak cytokine concentration (6 h after the aortic cross-clamp release) alongside other clinical predictors on the development of POAF. Results: We found no significant difference in the patterns of release of IL-6 (p = 0.52), IL-10 (p = 0.39), IL-8 (p = 0.20) and TNF-α (p = 0.55) between POAF and non-AF patients. Also, we found no significant predictive value in peak concentrations of IL-6 (p = 0.2), IL-8 (p = >0.9), IL-10 (p = >0.9) and Tumour Necrosis Factor Alpha (TNF-α)(p = 0.6), however age and aortic cross-clamp time were significant predictors of POAF development across all models. Conclusions: Our study suggests no significant association exists between cytokine release patterns and the development of POAF. Age and Aortic Cross-clamp time were found to be significant predictors of POAF.

Role of pre-operative embolization in carotid body tumor surgery according to Shamblin classification: A systematic review and meta-analysis.

BACKGROUND: Pre-operative embolization prior to surgical resection of carotid body tumors was meant to decrease intraoperative blood loss and operative time. Yet, potential confounders such as different Shamblin classes have never been analyzed. Aim of our meta-analysis was to investigate effectiveness of a pre-operative embolization according to different Shamblin classes. METHODS: Five studies comprising 245 patients were included. A random effects model meta-analysis was conducted, and the I2 statistic was used to assessment for heterogeneity. RESULTS: Pre-operative embolization was associated with a significant reduction in blood loss (WM: 276.4 mL; 95% CI, 201.9-378.3, p < 0.01); an absolute mean reduction, though not statistically significant, was observed in both Shamblin 2 and 3 classes. No difference in operative time was found between the two strategies (WM: 192.0 min; 95% CI, 157.7-234.1, p = 1.0). CONCLUSIONS: Embolization proved an overall significant reduction in perioperative bleeding, which did not reach threshold for statistical significance when Shamblin classes were singularly considered.

Cardiac Surgery in Nonagenarians Following the TAVI/TMVI Era: A Multicenter 23-Year Comparative Analysis.

BACKGROUND: Studies reporting on the outcome of 90-year-old patients undergoing cardiac surgery are scant in literature; and currently, those regarding the implementation of trans-catheter techniques number even fewer. METHODS: We compared patients aged >89 years operated on between 1998 and 2008 at 8 Italian cardiac surgery centers, with patients of the same age operated on between 2009 and 2021. All of the patients were operated on with "open" surgery, with the exclusion of percutaneous valve repair/implantation procedures. RESULTS: The patients of the two groups (group 98-08-127 patients, and group 09-21-101 patients) had comparable preoperative risk factors in terms of the LogEuroSCORE (98-08: 21.3 ± 6.1 vs. 09-21: 20.9 ± 11.1, p = 0.12). There was a considerable difference in the type of surgery (isolated valve, isolated coronary, and combined surgery, 46.5, 38.5, and 15% vs. 52, 13, and 35% in 98-08 and 09-21, respectively, p = 0.01). Analogous operating durations were recorded (cross-clamp time: 98-08: 46 ± 28 min vs. 09-21: 51 ± 28 min, p = 0.06). The number of packed bypasses was lower in 09-21 (1.3 ± 0.6 vs. 2.4 ± 1.2, p = 0.001). In the postoperative period, there was a statistically significant difference in the 30-day survival in favor of the "more recent" patients (98-08: 17 deaths (13.4%) versus 09-21: 6(5.9%); p = 0.001), also confirmed in the subgroups (12.2% vs. 0% in isolated coronary surgery, p < 0.001; and 12.3% vs. 0% in isolated valve surgery, p < 0.001). CONCLUSIONS: Accurate pre-, intra-, and post-operative evaluation/management to reduce biological impacts facilitate significant improvements in the outcomes in nonagenarian patients when compared to the results recorded in previous years.

Efficacy of treatments tested in COVID-19 patients with cardiovascular disease. A meta-analysis.

BACKGROUND: The COVID-19 pandemic has spread globally infecting and killing millions. Those with cardiovascular disease (CVD) are at higher risk of increased disease severity and mortality. We performed a systematic review and meta-analysis to estimate the rate of in-hospital mortality following different treatments on COVID-19 in patients with CVD. METHODS: Pertinent articles were identified from the PubMed, Google Scholar, Ovid MEDLINE, and Ovid EMBASE databases. This study protocol was registered under PROSPERO with the identifier CRD42020183057. RESULTS: Of the 1673 papers scrutinized, 46 were included in the review. Of the 2553 patients (mean age 63.9 ± 2.7 years/o; 57.2% male), the most frequent CVDs were coronary artery disease (9.09%) and peripheral arterial disease (5.4%) and the most frequent cardiovascular risk factors were hypertension (86.7%) and diabetes (23.7%). Most patients were on multiple treatments. 14 COVID-19 treatments were compared with controls. The pooled event rate for in-hospital mortality was 20% (95% confidence interval (CI): 11-33%); certain heterogeneity was observed across studies. CONCLUSIONS: COVID-19 is associated with a high in-hospital mortality rate in patients with CVD. This study shows that previous CVD determines mortality, regardless of the type of COVID-19 administered therapy. Treatments for at-risk patients should be administered carefully and monitored closely until further data are available.

'Goal-directed extracorporeal circulation: transferring the knowledge and experience from daily cardiac surgery to extracorporeal membrane oxygenation'.

Metabolism management plays an essential role in extracorporeal technologies. There are different metabolic management devices integrated to extracorporeal devices; the most commonly used and accepted metabolic target in adult patients is indexed oxygen delivery (280 mL/min/m2) and cardiac index (2.4 L/min/m2), which can be managed independently or according to other metabolic parameters. Extracorporeal membrane oxygenation (ECMO) is a temporary form of life support providing a prolonged biventricular circulatory and pulmonary support for patients experiencing both pulmonary and cardiac failure unresponsive to conventional therapy. The goal-directed perfusion initiative during cardiopulmonary bypass (CPB) reduced the incidence of acute kidney injury after cardiac surgery. On the basis of the available literature, the identified goals to achieve during CPB include maintenance of oxygen delivery > 300 mL O2/min/m2 and reduction in vasopressor use. ECMO and CPB are conceptually similar but differ in many aspects and finality; in particular, they differ in the scientific evidence for metabolic management nadirs. As for CPB, predictive target parameters have been found and consolidated, particularly in terms of acute renal injury and the prevention of anaerobic metabolism, while for ECMO management, a blurred path remains. In this context, we review the strategies for optimal goal-directed therapy during CPB and ECMO, trying to transfer the knowledge and experience from daily cardiac surgery to veno-arterial ECMO.

2021 MiECTiS focused update on the 2016 position paper for the use of minimal invasive extracorporeal circulation in cardiac surgery.

The landmark 2016 Minimal Invasive Extracorporeal Technologies International Society (MiECTiS) position paper promoted the creation of a common language between cardiac surgeons, anesthesiologists and perfusionists which led to the development of a stable framework that paved the way for the advancement of minimal invasive perfusion and related technologies. The current expert consensus document offers an update in areas for which new evidence has emerged. In the light of published literature, modular minimal invasive extracorporeal circulation (MiECC) has been established as a safe and effective perfusion technique that increases biocompatibility and ultimately ensures perfusion safety in all adult cardiac surgical procedures, including re-operations, aortic arch and emergency surgery. Moreover, it was recognized that incorporation of MiECC strategies advances minimal invasive cardiac surgery (MICS) by combining reduced surgical trauma with minimal physiologic derangements. Minimal Invasive Extracorporeal Technologies International Society considers MiECC as a physiologically-based multidisciplinary strategy for performing cardiac surgery that is associated with significant evidence-based clinical benefit that has accrued over the years. Widespread adoption of this technology is thus strongly advocated to obtain additional healthcare benefit while advancing patient care.

The influence of metabolic syndrome in heart valve intervention. A multi-centric study.

BACKGROUND: The effect of metabolic syndrome (MetS), defined as insulin resistance along with two or more of: obesity, atherogenic dyslipidaemia and elevated blood pressure, on postoperative complications after isolated heart valve intervention remains controversial. We hypothesized that MetS may negatively influence the postoperative course in these patients. METHODS: Patients from 10 cardiac units who underwent isolated valve intervention (mitral ± $\pm $ tricuspid repair/replacement (mitral valve surgery [MVS]) or surgical aortic valve replacement (SAVR), or transcatheter aortic valve replacement (TAVR) were included. MetS was defined according to the World Health Organization criteria. Primary outcome was in-hospital mortality and overall postoperative length of stay (LOS). Relevant postoperative complications were also recorded. RESULTS: From 2010 to 2019, 17,283 patients underwent valve intervention. The MVS, SVAR, and TAVR accounted for the 39.4%, 48.2%, and 12.3% respectively of the whole. MetS compared to no-MetS was associated to higher mortality in the MVS group (6.5% vs. 2%, p < .001), but not in the SAVR and TAVR group. In both surgical cohorts, MetS was associated with increased complications including red blood cells transfusion, renal failure, mechanical ventilation time, intensive care and overall postoperative LOS (11 (9) vs. 10 (6), p < .001 and 10 (6) versus 10 (5) days, p = .002, MVS and [SAVR]). No differences were found in the TAVR cohort, with similar mortality and complications. CONCLUSION: MetS was associated to more postoperative complications, with higher mortality in the MVS group. In the TAVR cohort, postoperative complications and mortality rate did not differ between patients with and without MetS, however LOS was longer in the MetS group.

Continuous field flooding versus final one-shot CO2 insufflation in minimally invasive mitral valve repair.

BACKGROUND: Insufflation of carbon dioxide (CO2) into the operative field to prevent cerebral or myocardial damage by air embolism is a well known strategy in open-heart surgery. However, here is no general consensus on the best delivery approach. METHODS: From January 2018 to November 2021, we retrospectively collected data of one hundred consecutive patients undergoing minimally invasive mitral valve repair (MIMVR). Of these, fifty patients were insufflated with continuous CO2 1 min before opening the left atrium and ended after its closure, and fifty patients were insufflated with one shot CO2 10 min before the start of left atrium closure. The primary outcome of the study was the incidence of transient post-operative cognitive disorder, in particular agitation and delirium at discontinuation of anesthesia, mechanical ventilation (MV) duration and intensive care unit (ICU) length of stay. RESULTS: In all patients that received continuous field flooding CO2, correction of ventilation for hypercapnia during cardiopulmonary bypass (CPB) was applied with an increase of mean sweep gas air (2.5 L) and monitoring of VCO2 changes. One patient vs. 9 patients of control group reported agitation at discontinuation of anesthesia (p = 0.022). MV duration was 14 ± 3 h vs. 27 ± 4 h (p = 0.016) and ICU length of stay was 33 ± 4 h vs. 42 ± 5 h (p = 0.029). A significant difference was found in the median number of total micro-emboli recorded from release of cross-clamp until 20 min after end of CPB (154 in the continuous CO2 group vs. 261 in the one-shot CO2 control group; p < 0.001). Total micro-emboli from the first 15 min after the release of cross-clamp was 113 in the continuous CO2 group vs. 310 in the control group (p < 0.001). In the continuous CO2 group, the median number of detectable micro-emboli after CPB fell to zero 9 ± 5 min after CPB vs. 19 ± 3 min in the control group (p = 0.85). CONCLUSION: Continuous field flooding insufflation of CO2 in MIMVR is associated with a lower incidence of micro-emboli and of agitation at discontinuation of anesthesia, along with improved MV duration and ICU length of stay.