Corrigendum: Five-Year Outcome After Continuous Flow LVAD With Full-Magnetic (HeartMate 3) Versus Hybrid Levitation System (HeartWare): A Propensity-Score Matched Study From an All-Comers Multicentre Registry.

[This corrects the article DOI: 10.3389/ti.2023.11675.].

Five-Year Outcome After Continuous Flow LVAD With Full-Magnetic (HeartMate 3) Versus Hybrid Levitation System (HeartWare): A Propensity-Score Matched Study From an All-Comers Multicentre Registry.

Despite the withdrawal of the HeartWare Ventricular Assist Device (HVAD), hundreds of patients are still supported with this continuous-flow pump, and the long-term management of these patients is still under debate. This study aims to analyse 5 years survival and freedom from major adverse events in patients supported by HVAD and HeartMate3 (HM3). From 2010 to 2022, the MIRAMACS Italian Registry enrolled all-comer patients receiving a LVAD support at seven Cardiac Surgery Centres. Out of 447 LVAD implantation, 214 (47.9%) received HM3 and 233 (52.1%) received HVAD. Cox-regression analysis adjusted for major confounders showed an increased risk for mortality (HR 1.5 [1.2-1.9]; p = 0.031), for both ischemic stroke (HR 2.08 [1.06-4.08]; p = 0.033) and haemorrhagic stroke (HR 2.6 [1.3-4.9]; p = 0.005), and for pump thrombosis (HR 25.7 [3.5-188.9]; p < 0.001) in HVAD patients. The propensity-score matching analysis (130 pairs of HVAD vs. HM3) confirmed a significantly lower 5 years survival (81.25% vs. 64.1%; p 0.02), freedom from haemorrhagic stroke (90.5% vs. 70.1%; p < 0.001) and from pump thrombosis (98.5% vs. 74.7%; p < 0.001) in HVAD cohort. Although similar perioperative outcome, patients implanted with HVAD developed a higher risk for mortality, haemorrhagic stroke and thrombosis during 5 years of follow-up compared to HM3 patients.

Hyperacute Sapien Aortic Valve thrombosis in a patient with Antiphospholipid Syndrome (APS).

In this case we briefly describe the case of an old woman presenting with acute exertional dyspnea due to hyperacute Sapien Valve thrombosis.

Impact of Surgeon Experience and Centre Volume on Outcome After Off-Pump Coronary Artery Bypass Surgery: Results From the European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG) Registry.

AIM: The aim of this study was to assess the impact of surgeon experience and centre volume on early operative outcomes in patients undergoing off-pump coronary artery bypass (OPCAB) surgery. METHOD: Of 7,352 patients in the European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG) registry, 1,549 underwent OPCAB and were included in the present analysis. Using adjusted regression analysis, we compared major early adverse events after procedures performed by experienced OPCAB surgeons (i.e., ≥20 cases per year; n=1,201) to those performed by non-OPCAB surgeons (n=348). Furthermore, the same end points were compared between procedures performed by OPCAB surgeons in high OPCAB volume centres (off-pump technique used in >50% of cases; n=894) and low OPCAB volume centres (n=307). RESULTS: In the experienced OPCAB surgeon group, we observed shorter procedure times (ß -43.858, 95% confidence interval [CI] -53.322 to -34.393; p<0.001), a lower rate of conversion to cardiopulmonary bypass (odds ratio [OR] 0.284, 95% CI 0.147-0.551; p<0.001), a lower rate of prolonged inotrope or vasoconstrictor use (OR 0.492, 95% CI 0.371-0.653; p<0.001), a lower rate of early postprocedural percutaneous coronary interventions (OR 0.335, 95% CI 0.169-0.663; p=0.002), and lower 30-day mortality (OR 0.423, 95% CI 0.194-0.924; p=0.031). In high OPCAB volume centres, we found a lower rate of prolonged inotrope use (OR 0.584, 95% CI 0.419-0.814; p=0.002), a lower rate of postprocedural acute kidney injury (OR 0.382, 95% CI 0.198-0.738; p=0.004), shorter duration of intensive care unit (ß -1.752, 95% CI -2.240 to -1.264; p<0.001) and hospital (ß -1.967; 95% CI -2.717 to -1.216; p<0.001) stays, and lower 30-day mortality (OR 0.316, 95% CI 0.114-0.881; p=0.028). CONCLUSIONS: Surgeon experience and centre volume may play an important role on the early outcomes after OPCAB surgery.

One-year clinical outcome of patients with left ventricular thrombus after acute myocardial infarction discharged on triple or dual antithrombotic therapy.

In patients with left ventricular thrombus (LVT) after acute myocardial infarction (MI), both anticoagulant and antiplatelet therapies are needed. It is unknown whether dual antithrombotic therapy (DAT) is able to reduce the incidence of bleeding complications without significantly increasing the number of thromboembolic events, compared to triple antithrombotic therapy (TAT). We retrospectively evaluated all post-MI patients with LVT discharged on TAT or DAT from our tertiary hospital in the last decade. The primary outcome was the occurrence of all-cause mortality, thromboembolic events, hospitalizations for re-MI or heart failure and any bleeding at 1 year. A propensity-score matching was performed in order to compare the primary outcome between TAT and DAT. Out of 2564 acute MI patients, 83 (3.2%) had an LVT at echocardiography: 51 (61.4%) discharged on TAT and 32 (38.6%) on DAT. At clinical follow-up, completed in 93% of cases, the incidence of the primary outcome was 18.2% (25.5% in TAT and 6.7% in DAT group; p = 0.04). More than 2/3 of the events included in the primary outcome were related to bleeding complications and occurred during the first month from hospital discharge. In the matched cohort of 42 patients with follow-up data available, the primary outcome occurred in 9 (42.9%) patients in the TAT and 2 (9.5%) in the DAT group (p = 0.03). In post-MI patients with LVT, DAT seems more effective than TAT in reducing clinical outcome, especially early bleeding complications. A randomized study is warranted to confirm this hypothesis.

Does the distance between residency and implanting center affect the outcome of patients supported by left ventricular assist devices? A multicenter Italian study on radial mechanically assisted circulatory support (MIRAMACS) analysis.

BACKGROUND: Patients with LVAD require continuous monitoring and care, and since Implanting Centers (ICs) are more experienced in managing LVAD patients than other healthcare facilities, the distance between patient residency and IC could negatively affect the outcomes. METHODS: Data of patients discharged after receiving an LVAD implantation between 2010 and 2021 collected from the MIRAMACS database were retrospectively analyzed. The population was divided into two groups: A (n = 175) and B (n = 141), according to the distance between patient residency and IC ≤ or >90 miles. The primary endpoint was freedom from Adverse Events (AEs), a composite outcome composed of death, cerebrovascular accident, hospital admission because of GI bleeding, infection, pump thrombosis, and right ventricular failure. Secondary endpoints were incidences of mortality and complications. All patients were followed-up regularly, according to participating center protocols. RESULTS: Baseline clinical characteristics and indications for LVAD did not differ between the two groups. The mean duration of support was 25.5 ± 21 months for Group A and 25.7 ± 20 months for Group B (p = 0.79). At 3 years, freedom from AEs was similar between Group A and Group B (p = 0.36), and there were no differences in rates of mortality and LVAD-related complications. CONCLUSIONS: Distance from the IC does not represent a barrier to successful outcomes as long as regular and continuous follow-up is provided.

Prediction of mortality in isolated tricuspid surgery.

BACKGROUND: Isolated tricuspid surgery is a rarely performed procedure considered at high risk for mortality. Preoperative risk estimation is still a s missing process and currently used risk score system are not validated for this procedures. AIM: To discuss the external validation of the EuroSCORE II and STS-TVS score in the setting of isolated tricuspid valve surgery. DISCUSSION: The stratification of the patient profile and risk estimation are still lacking in isolated tricuspid surgery. MELD Score, EuroSCORE II and STS-TVS score may help in the preoperative evaluation. Recently a dedicated score called TRI-SCORE has been introduced. We believe that the combination of these scores may determine a range of expected mortality rate and it could be an interesting approach to define the preoperative risk-profile of a patient planned for isolated tricuspid disease. Conclusion Further studies are needed to define the optimal risk stratification of patient affected by isolated tricuspid disease.

Single access transfemoral transcatheter aortic valve implantation for challenging iliofemoral route.

BACKGROUND: Optimal access for transcatheter aortic valve implantation is still a matter of debate. A tailored approach for patient anatomy is mandatory to reduce vascular complications and improve outcomes. AIMS: To optimize surgical technique in challenge scenario. MATERIAL AND METHODS: Here, we present a case of transfemoral transcatheter aortic valve replacement performed using single arterial access. RESULTS: A 92 years old patients affected by severe aortic stenosis showed no secondary arterial access. A single access approach was performed using the aortic valve calcification and the inferior margin of the second rib as lankdmarks for valve implantation. DISCUSSION AND CONCLUSIONS: Alternative options for TAVR are mandatory to deal with complex cases. The described technique is a simple and reproducible approach.

3D mitral annulus echocardiography assessment in patients affected by degenerative mitral regurgitation who underwent mitral valve repair with flexible band.

BACKGROUND: Degenerative mitral valve (MV) regurgitation (DMR) shows significative mitral annulus (MA) alterations; mitral valve repair (MVR) seeks to restore annular geometry and function, and the current use of flexible band seams to respect most annular mobility reducing parietal stress. Parameters of MV geometry obtained by 3D transesophageal echocardiography (3D-TTE) analysis are crucial for surgical planning and postoperative success. The aim of this study was to assess, by means of a dedicated software, the variations of MA geometry and function in patients affected by DMR compared to controls and after MVR with flexible band. METHODS: We enrolled 32 patients (cases) with severe DMR who underwent MVR using flexible band; we compare this group with 20 controls. The TEE with 3D MV images acquisition was performed in both groups and then analyzed in postprocessing by using a dedicated software. RESULTS: There were no anthropometrics differences between cases and controls, both presented normal left ventricular ejection fraction. DMR group showed a significant increase of annulus dimensional parameters (p = .001) and alteration of nonplanarity comparing to controls (p < .05). The annuloplasty with flexible band induces a considerable reduction of MV dimensions comparing to preoperative data and restores physiological mobility and nonplanarity. There were no statistical differences between postoperative DMR and controls data, except for nonplanarity parameters (p ~.05), maybe influenced by hemodynamic settings. CONCLUSIONS: MVR with annuloplasty using flexible band appears able to reinstate a more physiological anatomic conformation of the MA, without compromising its dynamic properties.

Observed versus predicted mortality after isolated tricuspid valve surgery.

BACKGROUND: Aim of this study is to analyse the performances of Clinical Risk Score (CRS) and European System for Cardiac Operative Risk Evaluation (EuroSCORE)-II in isolated tricuspid surgery. METHODS: Three hundred and eighty-three patients (54 ± 16 year; 54% female) were enrolled. Receiver operating characteristic analysis was performed to evaluate the relationship between the true positive fraction of test results and the false-positive fraction for a procedure. RESULTS: Considering the 30-day mortality the area under the curve was 0.6 (95% confidence interval [CI] 0.50-0.72) for EuroSCORE II and 0.7 (95% CI 0.56-0.84) for CRS-score. The ratio of expected/observed mortality showed underestimation when considering EuroSCORE-II (min. 0.46-max. 0.6). At multivariate analysis, the CRS score (p = .005) was predictor of late cardiac death. CONCLUSION: We suggest using both scores to obtain a range of expected mortality. CRS to speculate on late survival.

Prognostic value of SARS-CoV-2 on patients undergoing cardiac surgery.

OBJECTIVE: To analyze Italian Cardiac Surgery experience during the pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) identifying risk factors for overall mortality according to coronavirus disease 2019 (COVID-19) status. METHODS: From February 20 to May 31, 2020, 1354 consecutive adult patients underwent cardiac surgery at 22 Italian Centers; 589 (43.5%), patients came from the red zone. Based on COVID-19 status, 1306 (96.5%) were negative to SARS-CoV-2 (COVID-N), and 48 (3.5%) were positive to SARS-CoV-2 (COVID-P); among the COVID-P 11 (22.9%) and 37 (77.1%) become positive, before and after surgery, respectively. Surgical procedures were as follows: 396 (29.2%) isolated coronary artery bypass grafting (CABG), 714 (52.7%) isolated non-CABG procedures, 207 (15.3%) two associate procedures, and three or more procedures in 37 (2.7%). Heart failure was significantly predominant in group COVID-N (10.4% vs. 2.5%, p = .01). RESULTS: Overall in-hospital mortality was 1.6% (22 cases), being significantly higher in COVID-P group (10 cases, 20.8% vs. 12, 0.9%, p < .001). Multivariable analysis identified COVID-P condition as a predictor of in-hospital mortality together with emergency status. In the COVID-P subgroup, the multivariable analysis identified increasing age and low oxygen saturation at admission as risk factors for in-hospital mortality. CONCLUSION: As expected, SARS-CoV-2 infection, either before or soon after cardiac surgery significantly increases in-hospital mortality. Moreover, among COVID-19-positive patients, older age and poor oxygenation upon admission seem to be associated with worse outcomes.

Coronary Artery Bypass Grafting in Patients With High Risk of Bleeding.

BACKGROUND: Postoperative bleeding after cardiac surgery is associated with increased morbidity and mortality. We tested the hypothesis that patients with a preoperatively estimated high risk of severe perioperative bleeding may have impaired early outcome after on-pump versus off-pump coronary artery bypass grafting (CABG). METHOD: Data from 7,352 consecutive patients who underwent isolated CABG from January 2015 to May 2017 were included in the multicentre European Coronary Artery Bypass Grafting registry. The postoperative bleeding risk was estimated using the WILL-BLEED risk score. Of all included patients, 3,548 had an increased risk of severe perioperative bleeding (defined as a WILL-BLEED score ≥4) and were the subjects of this analysis. We compared the early outcomes between patients who underwent on-pump or off-pump CABG using a multivariate mixed model for risk-adjusted analysis. RESULTS: Off-pump surgery was performed in 721 patients (20.3%). On-pump patients received more packed red blood cell units (on-pump: 1.41 [95% confidence interval {CI} 0.99-1.86]; off-pump: 0.86 [95% CI 0.64-1.08]; p<0.001), had a longer stay in the intensive care unit (on-pump: 4.4 [95% CI 3.6-8.1] days; off-pump: 3.2 [95% CI 2.0-4.4] days; p=0.049), and a higher rate of postoperative atrial fibrillation (on-pump: 46.5% [95% CI 34.9-58.1]; off-pump: 31.3% [95% CI 21.7-40.9]; p=0.025). Furthermore, on-pump patients showed a trend towards a higher rate of postoperative stroke (on-pump: 2.4% [95% CI 0.9-4.1]; off-pump: 1.1 [95% CI 0.2-2.7]; p=0.094). CONCLUSION: Our data suggest that in patients with an increased risk of bleeding, the use of cardiopulmonary bypass is associated with higher morbidity. These patients may benefit from off-pump surgery if complete revascularisation can be ensured.

Current management and prognosis of patients with recurrent myocardial infarction.

Recurrent myocardial infarction (re-MI) is a common event following acute coronary syndrome (ACS), especially during the first year. According to epidemiological studies, patients who experience re-MI are at higher risk of all-cause cardiovascular events and mortality. The cornerstones of re-MI prevention include complete functional coronary revascularization, effective dual antiplatelet therapy and secondary prevention strategies. Notwithstanding this, some controversy still exists on the definition and management of re-MI, and no dedicated studies have been designed or conducted so far in this setting. We here provide an overview of epidemiological and prognostic data on ACS patients experiencing re-MI, along with current available treatment and preventive options.

Effectiveness of fondaparinux vs unfractionated heparin following percutaneous coronary intervention in survivors of out-of-hospital cardiac arrest due to acute myocardial infarction.

AIM: There is no specific evidence on the antithrombotic management of survivors of out-of-hospital cardiac arrest (OHCA) due to acute myocardial infarction (AMI). We sought to compare the short-term outcome of unfractioned heparin (UFH) vs fondaparinux in OHCA survivors due to AMI admitted in our Institution in the last decade. METHODS: We performed a retrospective cohort study on survivors of OHCA due to AMI managed with UFH or fondaparinux during the hospitalization. The primary outcome was the occurrence of any bleeding, all-cause mortality, cerebrovascular accidents, re-MI, and unplanned revascularization at 1 month. A propensity-score matching was performed to compare the outcome between UFH and fondaparinux. RESULTS: Out of 2083 AMI patients undergoing successful PCI, OHCA was present in 94 (4.5%): 41 (43.6%) treated with UFH and 53 (56.4%) with fondaparinux. At clinical follow-up, the incidence of the primary outcome was 65.9% in UFH and 35.8% in fondaparinux group (p = 0.007). More than half of the events included in the primary outcome were related to bleeding complications. In the matched cohort of 56 patients, the primary outcome occurred in 46.4% and 25.0% (p = 0.16), while bleeding was present in 32.1% and 7.1% (p = 0.04), in the UFH and fondaparinux group, respectively. CONCLUSIONS: The present analysis suggests that fondaparinux is safer than UFH in the management of OHCA due to AMI by reducing early bleeding complications at one month.

A new hemodynamic index to predict late right failure in patients implanted with last generation centrifugal pump.

BACKGROUND: Right ventricular failure (RVF) is a severe event that increases perioperative mortality after left ventricle assist device (LVAD) implantation. Right ventricular (RV) function is particularly affected by the LVAD speed by altering RV preload and afterload as well as the position of the interventricular septum. However, there are no studies focusing on the relationship between pump speed optimization and risk factors for the development of late RVF. METHODS: Between 2015 and 2019, 50 patients received LVAD implantation at San Camillo Hospital in Rome. Of these, 38 who underwent pump speed optimization were included. Post-optimization hemodynamic data were collected. We assessed a new Hemodynamic Index (HI), calculated as follows:  HI = MAP × PCWP CVP × RPM set RPM max , to determine the risk of late RVF, which was defined as the requirement for rehospitalization and inotropic support. RESULTS: Ten patients had late RVF after LVAD implantation. Five patients required diuretic therapy and speed optimization. Three patients required inotropic support with adrenaline 0.05 µg/kg/min. Two patients needed prolonged continuous venovenous hemofiltration and high dose inotropic support. Multivariate analysis revealed that a low HI (odds ratio 11.5, 95% confidence interval, 1.85-65.5, p [.003]) was an independent risk factor for late RVF after LVAD implantation. CONCLUSION: We demonstrated a low HI being a significant risk factor for the development of RVF after LVAD implantation. We suggest implementing HI as a decision support tool for goal-direct optimization of the device aiming to reduce the burden of late-onset RVF during the follow-up.

Fondaparinux During Intra-Aortic Balloon Pump Counterpulsation in Acute Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention.

BACKGROUND: Although anticoagulation with unfractionated heparin (UFH) is commonly used during intra-aortic balloon pump (IABP) counterpulsation to prevent thromboembolic events, no data or guidelines exist to support this strategy, especially in the setting of acute myocardial infarction (AMI). This study sought to compare the short-term outcome of UFH vs fondaparinux in AMI patients who underwent successful percutaneous coronary intervention (PCI) and IABP insertion. METHODS: The anticoagulation therapy of revascularised AMI patients who received IABP counterpulsation and admitted to a tertiary hospital in the last decade was retrospectively evaluated. The primary outcome was the occurrence of all-cause mortality, stroke or transient ischaemic attack, reinfarction, unplanned revascularisation, major or minor limb ischaemia, and any bleeding at 1 month. Propensity score matching was performed to compare the primary outcome between UFH and fondaparinux. RESULTS: Of 1,355 AMI survivors at 2 days after hospital admission and who underwent successful PCI, an IABP was inserted in 197 (14.5%): 72 (36.5%) were treated with UFH and 125 (63.5%) with fondaparinux (2.5 mg o.d.). At clinical follow-up, completed in 98.5% of cases, the incidence of the primary outcome was 22.5% in UFH and 5.7% in fondaparinux groups (p=0.0009). More than two-thirds of the events included in the primary outcome were related to early bleeding complications. In the matched cohort of 62 patients, the primary outcome occurred in 14 (45.2%) patients in the UFH and two (6.5%) in the fondaparinux group (p=0.01). CONCLUSIONS: This study suggested that fondaparinux is safer, by reducing early bleeding complications at one month, than UFH in the management of IABP.

Dynamic changes in cytoskeleton proteins of olfactory ensheathing cells induced by radiofrequency electromagnetic fields.

Several evidences have suggested the ability of radiofrequency electromagnetic fields to influence biological systems, even if the action mechanisms are not well understood. There are few data on the effect of radiofrequency electromagnetic fields on self-renewal of neural progenitor cells. A particular glial type that shows characteristics of stem cells is olfactory ensheathing cells (OECs). Herein, we assessed the non-thermal effects induced on OECs through radiofrequency electromagnetic fields changing the envelope of the electromagnetic wave. Primary OEC cultures were exposed to continuous or amplitude-modulated 900 MHz electromagnetic fields, in the far-field condition and at different exposure times (10, 15, 20 min). The expression of OEC markers (S-100 and nestin), cytoskeletal proteins (GFAP and vimentin), apoptotic pathway activation by caspase-3 cleavage and cell viability were evaluated. Our results highlight that 20 min of exposure to continuous or amplitude-modulated 900 MHz electromagnetic fields induced a different and significant decrease in cell viability. In addition, according to the electromagnetic field waveform, diverse dynamic changes in the expression of the analysed markers in OECs and activation of the apoptotic pathway were observed. The data suggest that radiofrequency electromagnetic fields might play different and important roles in the self-renewal of OEC stem cells, which are involved in nervous system repair.

Critical subaortic stenosis due to fibromuscular ridge in a 66-year-old woman: 2D-3D echocardiography findings.

Subvalvular aortic stenosis (SAS) can be either a fixed stenosis resulting from subaortic anatomical obstacle or a dynamic stenosis because of hypertrophic cardiomyopathy. Here, we report a patient with a rare subaortic circumferential fibromuscular tunnel who became unusually symptomatic in her sixth decade of life. Transthoracic and mostly transesophageal echocardiography with 3D application is the preferred diagnostic modality. Indications for surgery include symptoms and LVOT gradient of 50 mm Hg. Our purpose is an image focus on this infrequent case.

Fast myocardial recovery ensured by the combined use of V-A ECMO and IMPELLA CP in cardiogenic shock related to a pheochromocytoma crisis.

BACKGROUND: Pheochromocytoma is a rare catecholamine-secreting tumor derived from chromaffin cells in the adrenal glands. An excessive stimulation of cardiac myocytes, when pheochromocytoma 'crisis' occurs, lead to myocardial damage with cardiogenic shock. AIM OF THE STUDY: We present the case of a A 28-year old female patient admitted with signs of severe cardiogenic shock. She was successfully supported with extracorporeal membrane oxygenation (ECMO) combined with IMPELLA CP heart pump (Abiomed Danvers, MA), for left ventricular unloading. Mechanical circulatory support (MCS) was used to favour myocardial recovery and avoid cardiac remodeling. RESULTS: A very fast recovery was observed. The ECMO was discontinued after four days. The IMPELLA-CP was safely removed after six days. A completely myocardial recovery was observed. CONCLUSIONS: Use of MCS might find an indication in case of PCC as a bridge to myocardial recovery.

Minimally invasive implantation of a Sapien 3 Ultra Valve in a degenerated tricuspid bioprosthesis.

Surgical management of patients affected by structural valve deterioration of bioprostheses in tricuspid valve position represents a challenge. Furthermore, transcatheter valve-in-valve implantation (TVIVI) recently emerged as an interesting option in high-risk surgical patients. When surgery is performed, replacement of the dysfunctional tricuspid bioprosthesis could be a difficult procedure due to the risk of heart rupture during the prosthesis removal. Herein we report the case of a 52-year-old female patient in which a transcatheter TVIVI was successfully performed under direct vision as a bailout strategy due to the impossibility of bioprosthesis removal.