Impella versus VA-ECMO for the treatment of patients with cardiogenic shock: the Impella Network Project - observational study protocol for cost-effectiveness and budget impact analyses.

INTRODUCTION: The treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. The aim of this study is, therefore, to collect and comparatively assess clinical and socioeconomic data of Impella versus VA-ECMO for the treatment of patients with severe CS, to ultimately conduct both a cost-effectiveness (CEA) and budget impact (BIA) analyses. METHODS AND ANALYSIS: This is a prospective plus retrospective, multicentre study conducted under the scientific coordination of the Center for Research on Health and Social Care Management of SDA Bocconi School of Management and clinical coordination of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute in Milan. The Impella Network stemmed for the purposes of this study and comprises 17 Italian clinical centres from Northern to Southern Regions in Italy. The Italian network qualifies as a subgroup of the international Impella Cardiac Surgery Registry. Patients with CS treated with Impella pumps (CP, 5.0 or 5.5) will be prospectively recruited, and information on clinical outcomes, resource use and QoL collected. Economic data will be retrospectively matched with data from comparable patients treated with VA-ECMO. Both CEA and BIA will be conducted adopting the societal perspective in Italy. This study will contribute to generate new socioeconomic evidence to inform future coverage decisions. ETHICS AND DISSEMINATION: As of May 2024, most of the clinical centres submitted the documentation to their ethical committee (N=13; 76%), six centres received ethical approval and two centres started to enrol patients. Study results will be published in peer-reviewed publications and disseminated through conference presentations.

Italian Association of Hospital Cardiologists Position Paper 'Gender discrepancy: time to implement gender-based clinical management'.

It has been well assessed that women have been widely under-represented in cardiovascular clinical trials. Moreover, a significant discrepancy in pharmacological and interventional strategies has been reported. Therefore, poor outcomes and more significant mortality have been shown in many diseases. Pharmacokinetic and pharmacodynamic differences in drug metabolism have also been described so that effectiveness could be different according to sex. However, awareness about the gender gap remains too scarce. Consequently, gender-specific guidelines are lacking, and the need for a sex-specific approach has become more evident in the last few years. This paper aims to evaluate different therapeutic approaches to managing the most common women's diseases.

[Gender discrepancy: time to implement gender-based clinical management]. / Position paper ANMCO: Differenze di genere nell'approccio farmacologico cardiovascolare.

It is well established that gender strongly influences cardiovascular risk factors, playing a crucial role in cardiovascular prevention, clinical pathways, diagnostic approach and treatment. Beyond the sex, which is a biological factor, gender entails a socio-cultural condition that impacts access and quality of care due to structural and institutional barriers. However, despite its great importance, this issue has not been adequately covered. Indeed sex and gender differences scarcely impact the clinical approach, creating a lot of disparities in care and outcomes of patients. Therefore, it becomes essential to increase the awareness of the importance of sex and gender influences on cardiovascular diseases. Moreover, new strategies for reducing disparities should be developed. Importantly, these differences should be taken into account in guideline recommendations. In this regard, it is crucial to include a greater number of women in clinical trials, since they are currently underrepresented. Furthermore, more women should be involved as member of international boards in order to develop recommendations and guidelines with more attention to this important topic.The aim of this ANMCO position paper is to shed light on gender differences concerning many cardiovascular drugs in order to encourage a more personalized therapeutic approach.

Cardiotoxicity, Cardioprotection, and Prognosis in Survivors of Anticancer Treatment Undergoing Cardiac Surgery: Unmet Needs.

BACKGROUND: Anticancer treatments are improving the prognosis of patients fighting cancer. However, anticancer treatments may also increase the cardiovascular (CV) risk by increasing metabolic disorders. Atherosclerosis and atherothrombosis related to anticancer treatments may lead to ischemic heart disease (IHD), while direct cardiac toxicity may induce non-ischemic heart disease. Moreover, valvular heart disease (VHD), aortic syndromes (AoS), and advanced heart failure (HF) associated with CV risk factors and preclinical CV disease as well as with chronic inflammation and endothelial dysfunction may also occur in survivors of anti-carcer treatments. METHODS: Public electronic libraries have been searched systematically looking at cardiotoxicity, cardioprotection, CV risk and disease, and prognosis after cardiac surgery in survivors of anticancer treatments. RESULTS: CV risk factors and disease may not be infrequent among survivors of anticancer treatments. As cardiotoxicity of established anticancer treatments has been investigated and is frequently irreversible, cardiotoxicity associated with novel treatments appears to be more frequently reversible, but also potentially synergic. Small reports suggest that drugs preventing HF in the general population may be effective also among survivors of anticancer treatments, so that CV risk factors and disease, and chronic inflammation, may lead to indication to cardiac surgery in survivors of anticancer treatments. There is a lack of substantial data on whether current risk scores are efficient to predict prognosis after cardiac surgery in survivors of anticancer treatments, and to guide tailored decision-making. IHD is the most common condition requiring cardiac surgery among survivors of anticancer treatments. Primary VHD is mostly related to a history of radiation therapy. No specific reports exist on AoS in survivors of anticancer treatments. CONCLUSIONS: It is unclear whether interventions to dominate cancer- and anticancer treatment-related metabolic syndromes, chronic inflammation, and endothelial dysfunction, leading to IHD, nonIHD, VHD, HF, and AoS, are as effective in survivors of anticancer treatments as in the general population. When CV diseases require cardiac surgery, survivors of anticancer treatments may be a population at specifically elevated risk, rather than affected by a specific risk factor.

Non-intrusive PODI-ROM for patient-specific aortic blood flow in presence of a LVAD device.

Left ventricular assist devices (LVADs) are used to provide haemodynamic support to patients with critical cardiac failure. Severe complications can occur because of the modifications of the blood flow in the aortic region. In this work, the effect of a continuous flow LVAD device on the aortic flow is investigated by means of a non-intrusive reduced order model (ROM) built using the proper orthogonal decomposition with interpolation (PODI) method based on radial basis functions (RBF). The full order model (FOM) is represented by the incompressible Navier-Stokes equations discretized by using a Finite Volume (FV) technique, coupled with three-element Windkessel models to enforce outlet boundary conditions in a multi-scale approach. A patient-specific framework is proposed: a personalized geometry reconstructed from Computed Tomography (CT) images is used and the individualization of the coefficients of the three-element Windkessel models is based on experimental data provided by the Right Heart Catheterization (RHC) and Echocardiography (ECHO) tests. At FOM level, we also consider the pre-surgery configuration in order to further validate the predictive capabilities of the model in several contexts. The ROM has been tested by considering a parametric setting with respect to the LVAD flow, which is a crucial parameter of the problem. We consider a parameter range that covers typical clinical values. The accuracy of the ROM is assessed against results obtained with the FOM both for primal, velocity and pressure, and derived quantities, wall shear stress (WSS). Finally, we briefly discuss the efficiency of our ROM approach.

A Case of Successful Use of the "Anchoring Technique" for Percutaneous Treatment of Left Ventricular Assist Device Graft Occlusion.

Left ventricular assist device (LVAD) obstruction can be a dramatic and life-threatening complication in patients with advanced heart failure (HF). Despite surgical redo is often required in these patients, it is associated with a high risk of periprocedural negative outcome. We report the case of a 68-year-old male with a thrombotic stenosis of the LVAD proximal outflow-graft. Following Heart Team debate, a percutaneous intervention was planned during veno-arterial Extra Corporeal Membrane Oxygenation (ECMO) assistance. To achieve the needed catheter support, we used the "distal balloon anchoring technique" through the outflow-graft and managed to implant a covered stent, rapidly restoring the flow through the LVAD. The patient was discharged without further complications. Our case shows that, in selected cases, percutaneous treatment of LVAD obstructions can be feasible, especially using advanced techniques derived from the experiences in coronary interventions and under ECMO assistance. More cases and prospective studies are mostly needed to explore long-term patency of the LVADs and clinical outcomes in these high-risk patients.

Comparative analysis of LVAD patients in regard of ischaemic or idiopathic cardiomyopathy: A propensity-score analysis of EUROMACS data.

BACKGROUND: Despite recent advances in management of patients with advanced heart failure, mortality remains high. Aim of this study was to compare impact of different aetiology of ischaemic and idiopathic cardiomyopathy on early outcomes and long-term survival of patients after left ventricular assist device implantation. METHODS: European Registry for Patients with Mechanical Circulatory Support (EUROMACS) gathers clinical data and follow-up parameters of LVAD recipients. Patients enrolled in the EUROMACS registry with primary diagnosis of either ischaemic (n = 1190) or idiopathic (n = 812) cardiomyopathy were included. Primary Endpoints were early mortality as well as long-term survival. Secondary endpoint were major postoperative adverse events, such as need for rethoracotomy. Additionally, a propensity-score matching analysis was performed for patients with ischaemic (n = 509) and idiopathic (n = 509) cardiomyopathy. RESULTS: In terms of basic demographics and baseline parameters the two groups significantly differed as expected before propensity-score matching due to different aetiology of cardiomyopathy. Seven-day (52 (4.4%) versus 18 (2.2%); p = 0.009), 30-day (153 (12.9%) versus 73 (9.0%); p = 0.008) and in-hospital mortality (253 (19.7%) versus 123 (15.1%); p = 0.009) were significantly lower in the idiopathic cardiomyopathy group compared to the ischaemic cardiomyopathy group, whereas after propensity-score matching 30-day (p = 0.169) was comparable and in-hospital mortality (p = 0.051) was almost significant. Kaplan-Meier survival analysis revealed no significant difference in regard of long-term survival after propensity-score matching (Breslow-test p = 0.161 and LogRank-test p = 0.113). CONCLUSION: Though patients with ischaemic and idiopathic cardiomyopathy suffer from different cardiomyopathy aetiologies, 30-day-mortality and long-term survival of both groups were similar leading to the conclusion that covariates predominately influence mortality and survival of ischaemic and idiopathic cardiomyopathies.

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.

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.

Extracorporeal Membrane Oxygenation for COVID-19 Respiratory Distress Syndrome: An Italian Society for Cardiac Surgery Report.

An increased need of extracorporeal membrane oxygenation (ECMO) support is going to become evident as treatment of SARS-CoV-2 respiratory distress syndrome. This is the first report of the Italian Society for Cardiac Surgery (SICCH) on preliminary experience with COVID-19 patients receiving ECMO support. Data from 12 Italian hospitals participating in SICCH were retrospectively analyzed. Between March 1 and September 15, 2020, a veno-venous (VV) ECMO system was installed in 67 patients (94%) and a veno-arterio-venous ECMO in four (6%). Five patients required VA ECMO after initial weaning from VV ECMO. Thirty (42.2%) patients were weaned from ECMO, while 39 (54.9%) died on ECMO, and six (8.5%) died after ECMO removal. Overall hospital survival was 36.6% (n = 26). Main causes of death were multiple organ failure (n = 14, 31.1%) and sepsis (n = 11, 24.4%). On multivariable analysis, predictors of death while on ECMO support were older age (p = 0.048), elevated pre-ECMO C-reactive protein level (p = 0.048), higher positive end-expiratory pressure on ventilator (p = 0.036) and lower lung compliance (p = 0.032). If the conservative treatment is not effective, ECMO support might be considered as life-saving rescue therapy for COVID-19 refractory respiratory failure. However warm caution and thoughtful approaches for timely detection and treatment should be taken for such a delicate patients population.

Extracorporeal membrane oxygenation-assisted emergency percutaneous treatment of left ventricular assist device graft occlusion.

End-stage heart failure is more often treated with Implantable left ventricular assist device (LVAD), even if the prolonged use may increase the risk of complications. In this case, a 51-year-old male patient presented to our emergency department showing acute heart failure signs and symptoms and a dramatic reduction of LVAD flow. Laboratory tests ruled out significant haemolysis, usually associated with pump thrombosis. The echocardiogram and the computed tomography were not able to clarify the correct diagnosis. We immediately placed a veno-arterial extracorporeal membrane oxygenation, followed by a selective retrograde angiography of the pump. The images showed stenosis of the LVAD-outflow graft, suggesting a twist. Through a hand-made J-tip guidewire, we performed multiple dilatations of the occlusion using peripheral balloons. Finally, we implanted an aortic coarctation covered-stent, re-establishing an adequate cardiac output to the patient. Our case indicates that catheter-based approach in extracorporeal membrane oxygenation assistance provides an important therapeutic alternative to treat outflow graft stenosis, especially in the case of acutely unstable patient.

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.

Hutchinson-Gilford Progeria Syndrome and Severe Aortic Stenosis: A New Hope for Treatment.

Hutchinson-Gilford progeria syndrome is an autosomal dominant, rare, fatal pediatric segmental premature aging disease. Cardiovascular and cerebrovascular diseases constitute the major cause of morbidity and mortality. Patients with the syndrome and severe aortic valve stenosis have been described in the literature, and for all of them a strategy of conservative management has been followed. We describe the first successful treatment of a 23-year-old Hutchinson-Gilford progeria syndrome patient with severe aortic stenosis who underwent transapical transcatheter aortic valve replacement.

A novel veno-arteriovenous extracorporeal membrane oxygenation with double pump for the treatment of Harlequin syndrome.

OBJECTIVES: The Harlequin syndrome is a complication observed in patients receiving peripheral venoarterial extracorporeal membrane oxygenation. This condition is defined as a critical variation in the oxygen saturation between the upper and the lower part of the body deriving from a poor lung function. METHODS: Between July 2018 and November 2019, a total of 60 patients (42 men and 18 women; mean age 57.4 ± 10.0 years; range = 28-71 years) underwent peripheral venoarterial extracorporeal membrane oxygenation in our center. Harlequin syndrome was identified in eight cases (six men and two women; 13.3%) of the 60 venoarterial extracorporeal membrane oxygenation-supported patients. As a result of the Harlequin syndrome, all these patients required conversion to veno-arteriovenous extracorporeal membrane oxygenation. Control and monitoring of the blood flows of the return cannulae were performed using two centrifugal pumps, one for each inlet line, according to the patient requirements to achieve optimum hemodynamic and oxygenation. RESULTS: Mean duration of veno-arteriovenous extracorporeal membrane oxygenation support was 5.3 ± 1.4 days. Seven patients (87.5%) were switched to venovenous extracorporeal membrane oxygenation, and after 13.5 ± 2.7 days, those patients were totally weaned from extracorporeal membrane oxygenation support. One patient (12.5%) had an improvement in the pulmonary function, but the cardiac function was poor. This patient was switched to venoarterial extracorporeal membrane oxygenation, and after 10 days, the patient was completely weaned from extracorporeal membrane oxygenation support. CONCLUSION: The use of a secondary centrifugal pump to manage the blood flow directed to the internal jugular vein, in the veno-arteriovenous extracorporeal membrane oxygenation setup, allows the reduction in the risk of blood clot formation, clotting factor consumption, and pulmonary embolism when compared to the use of an external clamp.

Percutaneous Aortic Valve Closure in Patient With Left Ventricular Assist Device and Dilated Aortic Annulus.

Percutaneous transcatheter intervention for aortic regurgitation secondary to implantation of a continuous-flow left ventricular assist device remains challenging, because of the minimal global experience with these procedures. Two treatment options are available: transcatheter aortic valve replacement, which is not always feasible when a dilated aortic annulus is present, and percutaneous aortic valve occlusion. We report a successful percutaneous closure of the aortic valve using an oversized Amplatzer patent foramen ovale multifenestrated device (St Jude Medical, Saint Paul, MN) to treat aortic regurgitation associated with dilated aortic annulus in a patient with a continuous-flow left ventricular assist device.

Minimally invasive treatment of multiple valve disease: A modified approach through a right lateral minithoracotomy.

BACKGROUND AND AIM OF THE STUDY: Today there is little experience with minimally invasive treatment of multiple valve disease and no standard techniques have been provided yet. We report our early experience with combined aortic and mitral valve surgery with or without tricuspid surgery through a right lateral minithoracotomy (RmT), describing the technical aspects of our approach. METHODS: From April 2017 to April 2019 thirty patients with mitro-aortic valve disease or with triple valve pathology underwent surgery through a 3 to 4 cm lateral RmT into the third intercostal space. Cardiopulmonary bypass was established through femoral vessels cannulation. Surgery on the mitral valve (MV) was performed first and sutures put into the mitral annulus. Aortic valve replacement (AVR) was performed next. Then, the selected ring or prosthetic valve was implanted in a mitral position throughout previously placed sutures. Finally, if required, tricuspid valve surgery was performed. RESULTS: In combined with AVR, MV replacement was performed in 20 patients (66%), and MV repair in 10 patients (34%). Concomitant tricuspid annuloplasty was performed in five patients (17%). There was no conversion to full sternotomy. Postoperatively, one patient died. Postoperative echocardiography showed no perivalvular leakage in aortic or in the mitral position. No residual mitral regurgitation was observed in patients who underwent MV repair. CONCLUSIONS: Minimally invasive surgery of double and triple valve disease is feasible. Our approach through a lateral RmT allows optimal visualization of the aortic, mitral, and tricuspid valves, simplifies the surgical procedure and allows excellent results also in complex MV repair procedures.

[Aortic valve repair: state of the art]. / Stato dell'arte della chirurgia riparativa della valvola aortica.

Mechanical or bioprosthetic aortic valve replacement has traditionally been the treatment of choice for patients with aortic valve insufficiency. However, prosthetic valve replacement has significant limitations being associated with a substantial cumulative risk of thromboembolism, anticoagulation-related hemorrhage, prosthetic valve endocarditis, and structural or non-structural valve dysfunction requiring reoperation. In this setting, aortic valve repair, by avoiding the long-term risks associated with prosthetic valve implantation, has emerged as a valid alternative treatment to conventional aortic valve replacement. In the last decade, improvements in the understanding of the mechanisms of valve disease, development of a classification system for aortic insufficiency and advances in surgical procedures have allowed for more effective and reproducible techniques for aortic valve repair. The aim of the present review is to assess the principles, the surgical techniques, and the role of echocardiographic imaging in the setting of aortic valve repair surgery.

[ANMCO/GISE/SICCH Inter-Society Consensus Document: Antithrombotic therapy after surgery or structural interventional procedures for valvular heart diseases: how to treat postoperative complications]. / Documento di consenso intersocietario ANMCO/GISE/SICCH: Terapia antitrombotica nei pazienti sottoposti a chirurgia e/o interventistica cardiaca valvolare: come trattare le complicanze.

Continuous improvement of technologies, devices and drugs needs a renewal and update of current recommendations and guidelines on antithrombotic strategies, especially in those fields where literature lacks of established scientific evidences. Accordingly, the aim of this consensus statement is to provide support for antithrombotic therapy based on current guidelines and the most recent scientific evidences.After an overview on the currently available devices, the appropriate therapy according to type of procedure and implanted device is discussed. The occurrence of postoperative thromboembolic and/or hemorrhagic complications is analyzed, along with the appropriate diagnostic tools and therapeutic approach. A section is dedicated to counseling to pregnancy in women with heart valve prosthesis. Finally, the role of novel oral anticoagulants is discussed, and indications are provided for the management of patients undergoing surgery or interventional procedures on oral anticoagulation therapy.