Prognosticating Mortality of Primary Cardiogenic Shock Requiring Extracorporeal Life Support: The RESCUE Score.

We aimed to identify prognostic laboratory markers during extracorporeal life support (ECLS) in patients with primary refractory cardiogenic shock (RCS) and to create a preliminary specific mortality score. All 208 consecutive subjects admitted for primary RCS and treated with ECLS between January-2009 and December-2018 were retrospectively analyzed. Multivariate regression analysis on laboratory markers during the first nine days of ECLS was used to develop a "Refractory End-stage Shock CUred with Ecls" (RESCUE) score. Serum creatinine (OR = 3.72, 95%CI: 2.01-6.88), direct bilirubin (OR = 1.40, 95%CI: 1.05-1.8), and platelet count (OR = 0.62, 95%CI: 0.42-0.94) were independent predictors of in-hospital mortality and were included in the score. The mean AUC was 0.763 (95%CI: 0.698-0.828) in the development cohort and 0.729 (95%CI: 0.664-0.794) in the bootstrap internal validation cohort. The RESCUE score represents a novel promising instrument to predict early mortality during the first critical days of ECLS and to help in properly guiding the therapeutic decision-making process.

Anticoagulation alone as an effective and safe antithrombotic therapy in LVAD: When less is more.

To evaluate the safety and effectiveness of anticoagulation alone in HeartMate3 patients. According to antithrombotic regimen, patients were divided into 2 groups: Group-1(warfarin+aspirin) and Group-2(warfarin). A comparison of hemocompatibility-related adverse events (HRAEs), hemocompatibility score (HCS), and hemocoagulative laboratory markers, both qualitative and quantitative, between the 2 groups were performed. Fifty patients were enrolled, 28 (56%) in Group-1 and 22 in Group-2 (44%), without statistical differences at baseline. Median time of follow-up was 590 days (IQR: 410.25-1007.50). Eighteen HRAEs (36.0%) occurred: 17 in Group-1 (34%) and 1 in Group-2 (2%) (P < 0.001). The net HCS for Group-1 versus Group-2 was 24 points and 1 point (OR 12.116[2.034-233.226], P = 0.023), respectively. Hemocoagulative values turned into the normality and remained stable during follow-up, without differences between groups, except for ASPI-test (P = 0.003). HeartMate3 showed a high hemocompatibility independently from antithrombotic therapy. Aspirin avoidance resulted a safe and effective strategy since it reduced hemorrhagic events, without increasing thrombotic risk.

How to Optimize ECLS Results beyond Ventricular Unloading: From ECMO to CentriMag® eVAD.

CentriMag® extracorporeal VAD support could represent a more physiological choice than conventional ECMO in primary cardiogenic shock. We therefore evaluated the outcome of patients with primary cardiogenic shock who were supported with CentriMag® extracorporeal VAD implantation versus conventional ECMO. We retrospectively reviewed all extracorporeal life supports implanted for primary cardiogenic shock between January 2009 and December 2018 at our institution. Among 212 patients, 143 cases (67%) were treated exclusively with ECMO (Group 1) and 69 cases (33%) with extracorporeal VAD implantation (Group 2, 48 of whom as conversion of ECMO). ECLS mean duration was 8.37 ± 8.43 days in Group 1 and 14.25 ± 10.84 days in Group 2 (p = 0.001), while the mean rates of the highest predicted flow were 61.21 ± 16.01% and 79.49 ± 18.42% (p = 0.001), respectively. Increasing mechanical support flow was related to in-hospital mortality and overall mortality in Group 1 (HR 11.36, CI 95%: 2.19-44.20), but not in Group 2 (HR 1.48, CI 95%: 0.32-6.80). High-flow ECMO patients had lower survival with respect to high-flow extracorporeal VAD patients (p = 0.027). In the setting of high-flow mechanical circulatory support, CentriMag® extracorporeal VAD optimized patient survival, granting long-term assistance and physiological circulation patterns.

Technology and technique for left ventricular assist device optimization: A Bi-Tech solution.

BACKGROUND: We investigated the synergistic effect of the new cone-bearing design of Jarvik 2000 (Jarvik Heart Inc., NY) together with a minimally-invasive approach to outcomes of LVAD patients. METHODS: We retrospectively reviewed all patients from 5 institutions involved in the Jarvik 2000 Italian Registry, from October 2008 to October 2016. Patients were divided into three groups according to pump design and implantation technique: pin-bearing design and conventional approach (Group 1); cone-bearing and conventional approach (Group 2); cone-bearing and minimally-invasive implantation (Group 3). RESULTS: A total of 150 adult patients with end-stage heart failure were enrolled: 26 subjects in Group 1, 74 in Group 2, and 50 in Group 3. Nineteen patients (73%) in Group 1, 51 (69%) in Group 2, and 36 (72%) in Group 3 were discharged. During follow-up, 22 patients underwent transplantation, while in 3 patients the LVAD was explanted. The overall 1-year survival was 58 ± 10%, 64 ± 6%, and 74% ± 7% in Groups 1, 2, and 3, respectively (p = 0.034). The competing-risks-adjusted cumulative incidence rate for adverse events was 42.1 [27-62.7] per 100 patient-years in Group 1, 35.4 [25.3-48.2] in Group 2, and 22.1 [12.4-36.4] in Group 3 (p = 0.046 for Group 1 vs. 3). CONCLUSIONS: The association of the modern cone-bearing configuration of Jarvik 2000 and minimally invasive surgery improved survival and minimized the risk for cardiovascular events, as a result of combining technology and technique.

Totally peripheral approach for ICD lead vegetation removal in a GUCH patient.

AngioVac system (AngioDynamics) has already proved to be a useful tool in the treatment of thrombotic and endocarditic formations concerning the venous district. Herein, the AngioVac aspiration system combined with the bidirectional rotational Evolution mechanical sheath lead extraction was used for an effective and safety cardiac-device-related-infective-endocarditis removal in a grown-up congenital heart disease patient through a totally peripheral approach.

Proof of Concept: Microinvasive AngioVac Approach in Renal Cell Carcinoma With Atrial Thrombosis.

The AngioVac system (AngioDynamics, Latham, NY) has already been described for treatment of thrombotic formations concerning the venous district and the tricuspid valve. We describe an innovative application of the AngioVac system to treat the inferior vena cava thrombosis associated with renal cell carcinoma. In a high surgical risk patient, we utilized a microinvasive and a modified venoarterial AngioVac circuit to remove the atrial thrombus, ensure temporary circulatory support during abdominal surgery, and prevent pulmonary embolism.

Frozen Elephant Trunk to Exclude the Kommerell Diverticulum Associated with Double Aortic Arch in Adult Redo Patient.

Kommerell diverticulum can be associated to several types of vascular rings, including double aortic arch. Surgical indications for vascular rings and Kommerell diverticulum include bulging symptoms onto trachea and esophagus too. Moreover, the aneurysmal enlargement over time can eventually cause acute aortic syndromes. Management of this pathology in adulthood is challenging and many techniques have been proposed, notably hybrid solutions. Herein, we report the case of a patient, who underwent redo surgery with frozen elephant trunk technique, caused by persisting symptoms after a previous operation of vascular ring interruption.

Can Patients Be Transplanted or Undergo Ventricular Assist Device Placement During the COVID-19 Pandemic? Padova Perspective.

The SARS-CoV-2 pandemic is nowadays an international emergency and the North-Italian regions have faced a high rate of infection and case fatality. A logistic and structural rearrangement has been required to ensure COVID-19-free areas, to save human and economic resources, and to solve all incoming urgencies. Herein, we report the Padova experience in heart transplantation and mechanical circulatory support implantation for severe INTERMACS class patients with satisfactory results during COVID-19 pandemic.

Biological versus mechanical aortic valve replacement in non-elderly patients: a single-centre analysis of clinical outcomes and quality of life.

OBJECTIVES: The aim of this study was to evaluate short- and long-term clinical outcomes, including the perceived health-related quality of life, in patients younger than 65 years having undergone aortic valve replacement either with biological or mechanical valve prostheses. METHODS: Between 2002 and 2013, 242 consecutive patients <65 years of age underwent isolated aortic valve replacement at our institution, either with biological (n = 134, 55.4%) or mechanical (n = 108, 44.6%) prostheses. Survival, health-related quality of life, short- and long-term clinical outcomes and echocardiographic data were analysed with a retrospective, single-centre study. Propensity matching was performed. RESULTS: No significant difference in survival was found between the 2 groups (mechanical versus biological: 100% vs 96.6% at 1 year, 98.2% vs 93.1% at 5 years and 92.3% vs 83.4% at 10 years after surgery, P = 0.091). For all the interviewed patients (n = 161, 66.5%), perceived quality of life at the latest follow-up was excellent. Need for reoperation was higher in the bioprosthetic group (8% vs 0%, P = 0.995), whereas the rate of major bleedings was higher in the mechanical valve group (3% vs 20%, P = 0.094). The mean and maximum transvalvular pressure gradients were 20.5 ± 9.7 and 37.4 ± 17.5 mmHg in the biological group and 14.8 ± 4.8 and 26.6 ± 9.2 mmHg in the mechanical group (P = 0.014). CONCLUSIONS: No significant differences were found between biological and mechanical valves in terms of patients' survival, clinical outcomes and quality of life. Mean and maximum transvalvular pressure gradients were significantly higher in the biological group. The majority of patients would opt for the same prosthesis type, if asked to choose again.

From bench to bedside: Impact of left ventricular assist device outflow conduit anastomosis position on outcome.

Continuous flow left ventricular assist devices (LVADs) have become a valuable therapy for end-stage heart failure. In vitro research highlighted a role of outflow cannula position on the pattern of blood flow in the aorta. However, the clinical effects of the alterations of flow remain unclear. We investigate short- and long-term outcomes of patients implanted with Jarvik 2000 LVAD, according to the ascending (Group 1) versus descending (Group 2) outflow graft connection to the aorta in a multicenter study. From May 2008 to October 2014, 140 consecutive end-stage heart failure patients underwent Jarvik 2000 LVAD implantation in 17 Italian centers. According with a preliminary multivariate analysis, we selected the 90 patients implanted in the four high-volume centers to avoid bias (Group 1 n = 39, Group 2 n = 51). Among the groups, no differences were recorded in the hospital mortality and the main complications occurring after LVAD implantation were similar. In multivariable analysis, the ascending aorta outflow cannula position and higher creatinine at discharge were significant predictors for long-term survival. Postimplant hemolysis was more pronounced in descending aorta outflow graft anastomosis. Outflow graft anastomosis to the ascending aorta is associated with better long-term survival, independent of age and perfusion techniques, reflecting the previous in vitro results.

COVID-19 in Heart Transplant Recipients: A Multicenter Analysis of the Northern Italian Outbreak.

OBJECTIVES: The aim of this study was to assess the clinical course and outcomes of all heart transplant recipients affected by coronavirus disease-2019 (COVID-19) who were followed at the leading heart transplant centers of Northern Italy. BACKGROUND: The worldwide severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) pandemic has created unprecedented challenges for public health, demanding exceptional efforts for the successful management and treatment of affected patients. Heart transplant patients represent a unique cohort of chronically immunosuppressed subjects in which SARS-CoV-2 may stimulate an unpredictable clinical course of infection. METHODS: Since February 2020, we enrolled all 47 cases (79% male) in a first cohort of patients, with a mean age of 61.8 ± 14.5 years, who tested positive for SARS-CoV-2, out of 2,676 heart transplant recipients alive before the onset of the COVID-19 pandemic at 7 heart transplant centers in Northern Italy. RESULTS: To date, 38 patients required hospitalization while 9 remained self-home quarantined and 14 died. Compared to the general population, prevalence (18 vs. 7 cases per 1,000) and related case fatality rate (29.7% vs. 15.4%) in heart transplant recipients were doubled. Univariable analysis showed older age (p = 0.002), diabetes mellitus (p = 0.040), extracardiac arteriopathy (p = 0.040), previous PCI (p = 0.040), CAV score (p = 0.039), lower GFR (p = 0.004), and higher NYHA functional classes (p = 0.023) were all significantly associated with in-hospital mortality. During the follow-up two patients died and a third patient has prolonged viral-shedding alternating positive and negative swabs. Since July 1st, 2020, we had 6 new patients who tested positive for SARS-CoV-2, 5 patients asymptomatic were self-quarantined, while 1 is still hospitalized for pneumonia. A standard therapy was maintained for all, except for the hospitalized patient. CONCLUSIONS: The prevalence and mortality of SARS-CoV-2 should spur clinicians to immediately refer heart transplant recipients suspected as having SARS-CoV2 infection to centers specializing in the care of this vulnerable population.

Recurrent autoimmune myocarditis in a young woman during the coronavirus disease 2019 pandemic.

We report a unique case of a young woman with recurrent immune-mediated (virus-negative) lymphocytic fulminant myocarditis during the coronavirus disease 2019 pandemic. At the first endomyocardial biopsy (EMB)-proven episode, she had concomitant pneumonia, and a temporary biventricular assist device implant was followed by complete and long-lasting cardiac recovery. Five years later, she was re-admitted for relapsing cardiogenic shock with a recent history of pneumonia. She was treated with extracorporeal life support with apical venting for left ventricular unloading, and full recovery was achieved. Despite negative seriate nasopharyngeal swabs and EMB during hospitalization, an antibody positivity for severe acute respiratory syndrome coronavirus 2 was discovered after 4 weeks from discharge. This is the first report of an EMB-proven, immune-mediated (virus-negative) recurrence of fulminant myocarditis. We hypothesize that in patients with a predisposing immunogenetic background, autoimmune disease may be triggered or reactivated by major infections, for example, pneumonia, that may act as adjuvants leading to an immune-mediated hyper-response.

Conduction disorders after aortic valve replacement with rapid-deployment bioprostheses: early occurrence and one-year evolution.

BACKGROUND: Rapid-deployment bioprostheses represent one of the newest aortic valve substitutes introduced into clinical practice. The aim of this retrospective single-center study was to evaluate the occurrence of conduction disorders (CDs) after rapid-deployment aortic valve implantation at discharge and at 1-year follow-up, and to identify risk factors for CDs and permanent pacemaker implantation (PPI). METHODS: All patients who reached 1-year follow-up after isolated or combined aortic valve replacement (AVR) with rapid-deployment bioprostheses (Intuity Elite, Edwards Lifesciences, Irvine, CA) at our institution were included in this study. Standard 12-lead electrocardiograms (ECGs) were recorded before the procedure (within 24 hours), after the procedure as soon as the patient was moved to the intensive care unit (ICU), every day during in-hospital stay and at 1-year follow-up. The primary endpoint was the incidence of postoperative CDs at discharge and at 1-year follow up. Patients were divided in two groups: those who developed the primary endpoint (Group CD) and those who didn't (Group Non-CD). RESULTS: A total of 98 consecutive patients were included in the study. At discharge, the primary endpoint occurred in 40 patients (40.8%). In particular, new CDs and PPI occurred in 33 (33.7%) and in 7 (7.1%) patients, respectively. Valve size was the only independent predictor of primary endpoint at discharge. At 1-year, 30 patients (31.3%) presented with CDs or pacemaker-induced rhythm. In particular, in 25 patients of Group CD (64.1%), 1-year follow-up ECG revealed the persistence of the same CD as at discharge or pacemaker-induced rhythm, while 14 patients (35.9%) showed recovery of their CD. Age and prosthesis size were identified as independent predictors of CDs/pacemaker-induced rhythm at 1-year follow-up. CONCLUSIONS: According to our data, nearly 40% of patients develop a new CD after rapid-deployment aortic valve implantation. Of these, one third recover after one year. Bioprosthesis size and age were identified as independent risk factors for occurrence of CD after surgery.

Coronavirus disease 2019 (COVID-19) in the heart transplant population: a single-centre experience.

OBJECTIVES: Few anecdotal cases have been reported in the literature regarding heart transplant recipients and infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report our experience with 6 patients hospitalized in Northern Italy during the outbreak. METHODS: Of the 396 living heart transplant recipients from 1985 to 2020 included in the study, 6 patients developed the novel 2019 coronavirus disease. Risk factors, last follow-up characteristics, onset presentation, in-hospital course of disease and blood examinations data were collected for these patients. RESULTS: All patients were symptomatic and had positive results from a nasopharyngeal swab test for SARS-CoV-2. Of the 6 patients, 5 were hospitalized and 1 remained self-quarantined at home. Two patients died and 3 were discharged home. Two patients were admittted to the intensive care unit . Immunosuppressive therapy was modified with a median reduction comprising doses that were 50% cyclosporine and 50% mycophenolate. All patients received a medium-dose of corticosteroids as a bolus medication in addition to their therapy. All hospitalized patients received hydroxychloroquine; 2 patients received ritonavir/lopinavir. Broad-spectrum antibiotics for prophylaxis were administered to all. One patient had an ischaemic stroke and died of sepsis. CONCLUSIONS: In the absence of any strong evidence regarding the treatment of heart transplant recipients infected with SARS-CoV-2, we faced a new challenge in managing viral infection in an immunosuppressed population. Because immunomodulation interaction with the infection seems to be crucial for developing severe forms of the disease, we managed to reduce immunosuppressive therapy by adding medium doses of corticosteroids. Despite the limited number of affected patients, this report suggests that special considerations should be given to treating coronavirus disease in the heart transplant recipient population.

Transapical Aspiration of a Mitral Mass With the AngioVac System on a Beating Heart.

The AngioVac System has already proved to be effective and safe in the treatment of thrombotic and endocarditic formations concerning the venous district and the tricuspid valve. We describe an innovative use of the AngioVac System to treat a left-sided heart mass. In a high-surgical-risk patient, we used a micro-invasive transapical access and a modified extracorporeal membrane oxygenation circuit to remove the mass from the mitral bioprosthesis without having to replace it. Further experiences are required to confirm the safety of this technique in high-risk patients.

Surgical aortic valve replacement with new-generation bioprostheses: Sutureless versus rapid-deployment.

OBJECTIVES: The aim of this retrospective multicenter study was to compare early clinical and hemodynamic outcomes of Perceval-S sutureless (Livanova, London, United Kingdom) and Intuity rapid-deployment (Edwards Lifesciences, Irvine, Calif) bioprostheses. METHODS: Data from patients who underwent isolated or combined aortic valve replacement with Perceval-S and with Intuity bioprostheses at 18 cardiac surgical institutions were analyzed. Propensity matching was performed to identify similar patient cohorts. RESULTS: We included 911 patients from March 2011 until May 2017. Perceval-S and Intuity valves were implanted in 349 (38.3%) and in 562 (61.7%) patients, respectively. Propensity score identified 117 matched pairs. In the matched cohort, device success was 99.1% and 100% in Perceval-S and Intuity group, respectively (P = 1.000). Thirty-day Valve Academic Research Consortium mortality occurred in 2 (1.7%) and 4 (3.4%) patients in the Perceval-S and in Intuity group, respectively (P = .6834). The rate of postoperative new permanent pacemaker implantation was 6% (7 patients) and 6.8% (8 patients) in the Perceval-S and in Intuity group, respectively (P = .7896). Perceval-S valve implantation requires significantly shorter aortic crossclamp and cardiopulmonary bypass times than Intuity valve implantation (aortic crossclamp time for isolated, 52 ± 14 minutes vs 62 ± 24 minutes; P < .0001). Peak transaortic gradients were 22.4 ± 8.1 mm Hg and 19.6 ± 6.7 mm Hg (P = .0144), whereas mean gradients were 11.8 ± 4.7 mm Hg and 10.5 ± 3.9 mm Hg (P = .0388) in the Perceval-S and Intuity groups, respectively. CONCLUSIONS: Sutureless Perceval-S and rapid-deployment Intuity bioprostheses provide good and similar early clinical and hemodynamic outcomes. Perceval-S valve implantation requires shorter crossclamp and cardiopulmonary bypass times, whereas Intuity valve implantation provides lower transaortic peak and mean gradients.

Endomyocardial fibrosis and myocardial infarction leading to diastolic and systolic dysfunction requiring transplantation.

Endomyocardial fibrosis (EMF) is an endemic disease in tropical areas, characterized by restrictive physiology due to endocardial fibrous thickening of the ventricular chambers. We report the case of a 25-year-old man of African origin who presented with end-stage heart failure due to both diastolic and systolic dysfunction and extensive endocavitary thrombosis as proven by echocardiography and cardiac magnetic resonance. EMF diagnosis was confirmed by endomyocardial biopsy and the patient had eventually cardiac transplantation. The explanted heart revealed, besides features consistent with EMF, transmural post- myocardial infarction scarring, in the absence of significant coronary artery disease, most probably thromboembolic in origin.