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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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Francica, Loforte, Attisani, Maiani, Iacovoni, Nisi, Comisso, Terzi, De Bonis, Vendramin, Boffini, Musumeci, Luciani, Rinaldi, Pacini and Onorati.)

Introduction: Heart transplant (HTx) recipients require continuous monitoring and care in order to prevent and treat possible complications related to the graft function or to the immunosuppressive treatment promptly. Since heart transplantation centers (HTC) are more experienced in managing HTx recipients than other healthcare facilities, the distance between patient residency and HTC could negatively affect the outcomes., Methods: Data of patients discharged after receiving HTx between 2000 and 2021, collected into our institutional database, were retrospectively analyzed. The population was divided into three groups: A (n = 180), B (n = 157), and C (n = 134), according to the distance tertiles between patient residency and HTC. The primary end-point was survival, secondary end-points were incidences of complications., Results: Recipient and donor characteristics did not differ between the three groups. Survival at 10 years was 66 ± 4%, 66 ± 4%, and 65 ± 5%, respectively, for groups A, B, and C (p = .34). Immunosuppressive regimen and rate of complications did not differ between groups. However, the rates of outpatient visits and of hospitalization performed at HTC were higher in group A than others., Conclusion: Distance from the HTC does not represent a barrier to a successful outcome for HTx recipients, as long as regular and continuous follow-up is provided., (© 2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

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., (© 2022 International Center for Artificial Organs and Transplantation and Wiley Periodicals LLC.)

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., (© 2022 International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Aims: We aimed to describe how treatment of patients in cardiogenic shock bridged to heart transplantation with mechanical circulatory support, using either biventricular assist devices (BVADs) or extracorporeal life support (ECLS), has evolved in the last 20 years in our centre., Methods: Since 1998, 72 patients with refractory heart failure and indication for heart transplantation have received mechanical circulatory support: 40 had an ECLS system and 32 a BVAD., Results: Early mortality was similar (17.5 vs. 9.4%, P = 0.25) regardless of the type of support. After a median support time of 8 (1-27) vs. 34 (0-385) days (P < 0.01), 70 vs. 65.6% (P = 0.69) of patients underwent transplantation in the two groups. Prior to transplantation, BVAD patients were more stable with lower need for mechanical ventilation (9 vs. 57%, P < 0.01) and dialysis (0 vs. 38%, P < 0.01). Thirty-day mortality after transplantation was similar (18 vs. 14%, P = 0.53). Patients with extracorporeal support had higher rates of renal (P = 0.02) and respiratory failure (P = 0.03), infections (P = 0.02), atrial fibrillation (P = 0.03) and longer ICU stay (P = 0.01). Late survival was similar, while 5-year freedom from coronary vasculopathy was higher in those with BVAD (P = 0.03)., Conclusion: Although ECLS provides faster and simpler assistance compared with BVADs, no differences in early and medium-term outcomes in the last 20 years were observed in patients with cardiogenic shock. However, BVADs provided longer duration of support, better multiorgan recovery allowing more adequate graft selection, resulting in a lower rate of posttransplant complications., (Copyright © 2020 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Objectives: Patients with mechanical circulatory support bridged to a heart transplant (HTx) are at higher risk of postoperative graft dysfunction. In this subset, a mode of graft preservation that shortens graft ischaemia should be beneficial., Methods: The outcomes of 38 patients on mechanical circulatory support (extracorporeal life support, left ventricular assist device and biventricular assist device) who received a HTx between 2015 and 2020 were analysed according to the method of graft preservation: cold storage (CS) group, 24 (63%) or ex vivo perfusion (EVP) group, 14 (37%)., Results: The median age was 57 (range 30-73) vs 64 (35-75) years (P = 0.10); 88% were men (P = 0.28); extracorporeal life support was more frequent in the CS group (54% vs 36%; P = 0.27) versus left ventricular and biventricular assist devices in the EVP group (46% vs 64%; P = 0.27). Clamping time was shorter in the EVP group (P < 0.001) and ischaemic time >4 h was higher in the CS group (P = 0.01). Thirty-day mortality was 13% (0-27%) in the CS group and 0% (P = 0.28) in the EVP group. A significantly lower primary graft failure [7% (0-23%) vs 42% (20-63%); P = 0.03] was observed in the EVP group. Survival at 1 year was 79 ± 8% (63-95%) in the CS group and 84 ± 10% (64-104%) in the EVP group (P = 0.95)., Conclusions: Our results support the use of ex vivo graft perfusion in patients on mechanical circulatory support as a bridge to a HTx. This technique, by shortening graft ischaemic time, seems to improve post-HTx outcomes., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

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., (© 2020 International Center for Artificial Organs and Transplantation and Wiley Periodicals LLC.)

Aim: Treatment efficacy is established via controlled research trials, but treatment in real-world clinical environments is typically highly variable and may differ from research protocols by necessity. Here, we examined provision of visual retraining for adults after neurological injury at an outpatient rehabilitation program in Calgary, Canada., Methods: Retrospective chart audits extracted demographic data, assessment outcomes, and details related to provision of training., Results: Treatment was provided to individuals with both visual field and visual-perceptual impairments due to neurological injury (mostly stroke). Tools and techniques of visual retraining at this program are discussed, the common denominator being repetitive practice of compensatory visual behaviors. Across this multisite program, there was significant variability in the number of treatment sessions, 13.00 (±10.21) sessions for those with visual-perceptual impairments and 14.41 (±9.63) sessions for those with field loss. Descriptive statistics and confidence intervals suggest improved outcomes on some measures for those with visual field and visual perceptual impairments., Conclusions: Our data suggest that visual retraining is feasible in this clinical outpatient setting. Implications for rehabilitation This program of visual retraining was provided to individuals with visual impairment (e.g., hemianopia) and visual perceptual impairment (e.g., unilateral spatial neglect) as a result of neurological injury. In this outpatient program, visual rehabilitation was feasible and appeared to improve outcomes among a heterogeneous clinical population. Fundamental characteristics of visual compensatory training at this program included repetitive practice of adaptive scanning behaviors across multiple contexts to promote automaticity and generalization of skills.

Bridge to heart transplantation (HTx) with ECMO is associated with poor outcome, but patient status, according to different levels of multiorgan compromise, is generally not considered. The aim of this study was to analyze the prognostic value of acute physiology, age, and chronic health evaluation IV (APACHE IV) score in this setting. Thirty-two patients underwent HTx bridged with ECMO at our institution between 2005 and 2017; they were divided into two groups, according to a cutoff value of APACHE IV score obtained by Receiver operating characteristic curve analysis for 30-day mortality. Kaplan-Meyer survival curves were plotted, and compared through the log-Rank test. Cox regression model was used to estimate which factors were associated with overall survival. The 30-day mortality prediction of the APACHE IV score showed an AUC of 0.98 [95% C.I. 0.84-0.99], with a cutoff value corresponding to a score value of 47 (specificity of 84.6% and sensitivity of 100%) in order to discriminate between a group with low probability (Group A, patients with an APACHE IV score <47), and a group with high probability (Group B, patients with an APACHE IV score ≥47) of 30-day mortality. Median follow up was 26.9 months (range: 0.03-143.8). On overall, patients bridged with ECMO showed a high early mortality (18.7% <30 days, n = 6). All deaths occurred in Group B, where 30-day mortality was 60%. Survival probability among Group B patients was 26.6% at both 1 and 5 years. Conversely, in Group A no early mortality was reported, and the estimated survival was 89.7% at 1 year and 81.5% at 5 years, respectively. Mortality correlated at univariate analysis with recipient age, APACHE IV score and female sex, while the multivariate Cox regression analysis showed that only an APACHE IV score (HR 1.23 [1.08-1.39, 95% C.I.]) and female sex (HR 6.68 [1.42-31.43, 95% C.I.]) had an adverse impact on survival. This study shows that the APACHE IV score could be considered a powerful predictor of survival in patients bridged by ECMO to HTx, and can account for a better selection of patients on ECMO support at time of listing., (© 2018 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.)

Background: Ceftolozane/tazobactam (C/T) is a novel antibiotic with enhanced microbiological activity against multidrug-resistant (MDR) gram-negative bacteria, including MDR Pseudomonas aeruginosa., Case Report: Five months after left ventricular assist device (LVAD) implantation, a 49-year old man developed fever and blood culture was positive for MDR P. aeruginosa, susceptible only to aminoglycosides, ciprofloxacin and colistin. A diagnosis of LVAD-related infection was made based on persistent bacteremia associated with moderate 18 F-fluorodeoxyglucose positron emission tomography/CT uptake in the left ventricular apex. Disk diffusion testing for C/T was performed (MIC 2 μg/mL) and intravenous antibiotic therapy with C/T and amikacin was started, with clinical and microbiological response. Initial conservative management with 6 weeks of systemic antibiotic therapy was attempted, but the patient relapsed one month after antibiotic discontinuation. Priority for transplantation was given and after 4 weeks of antibiotic therapy (C/T + amikacin), LVAD removal and heart transplant were performed, with no infection relapse., Conclusions: We reported the first off-label use of C/T in the management of MDR P. aeruginosa LVAD infection as a bridge to heart transplant. C/T has shown potent anti-pseudomonal activity and good safety profile making this drug as a good candidate for suppressive strategy in intravascular device-associated bloodstream infections caused by MDR P. aeruginosa.

Pharmacologic challenge with sodium channel blockers is part of the diagnostic workout in patients with suspected Brugada syndrome. The test is overall considered safe but both ajmaline and flecainide detain well known pro-arrhythmic properties. Moreover, the treatment of patients with life-threatening arrhythmias during these diagnostic procedures is not well defined. Current consensus guidelines suggest to adopt cautious protocols interrupting the sodium channel blockers as soon as any ECG alteration appears. Nevertheless, the risk of life-threatening arrhythmias persists, even adopting a safe and cautious protocol and in absence of major arrhythmic risk factors. The authors revise the main published case studies of sodium channel blockers challenge in adults and in children, and summarize three cases of untreatable ventricular arrhythmias discussing their management. In particular, the role of advanced cardiopulmonary resuscitation with extra-corporeal membrane oxygenation is stressed as it can reveal to be the only reliable lifesaving facility in prolonged cardiac arrest., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.)

Objective: In vitro tests demonstrated that the new cone-bearing configuration of the Jarvik 2000 (Jarvik Heart Inc, New York, NY) left ventricular assist device exhibits better hydraulic efficiency than the previous pin-bearing design. We investigated the long-term outcomes of patients who received the Jarvik 2000 left ventricular assist device, depending on bearing design., Methods: A retrospective review of prospectively collected data from 18 centers included in the Italian Registry was performed. From May 2008 to September 2013, 99 patients with end-stage heart failure were enrolled. Patients were divided into 2 groups according to their Jarvik 2000 suspending mechanism: Group pin included patients with pin bearings (May 2008 to June 2010), and group cone included patients with newer cone bearings (July 2010 to September 2013). The 2 groups did not differ significantly in terms of baseline characteristics., Results: A total of 30 of 39 patients (group pin) and 46 of 60 patients (group cone) were discharged. During follow-up, 6 patients underwent transplantation, and in 1 patient the left ventricular assist device was explanted. The cumulative incidence competing risk of the entire cohort for noncardiovascular-related death was 28% (20%-40%); the cumulative incidence competing risk for cardiovascular-related death was 56% (42%-73%): 71% in group pin versus 26% in group cone (P = .034). The multivariate analyses confirmed that the pin-bearing design was a risk factor for cardiovascular death, along with Interagency Registry for Mechanically Assisted Circulatory Support class. Right ventricular failures and ischemic and hemorrhagic strokes were significantly higher in group pin., Conclusions: Patients with the new pump configuration showed a better freedom from cardiovascular death and lower incidence of fatal stroke and right ventricular failure. Further studies are needed to prove the favorable impact of pump-enhanced fluid dynamics on long-term results., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Left ventricular assist device (LVAD) implantation improves survival and quality of life in patients with advanced heart failure (HF). Despite these advantages, LVADs are not free from risks. Among all adverse events (AE), pump thrombosis and bleeding, especially of the gastrointestinal (GI) tract, have been reported to occur with increasing frequency in some CF-LVADs. The INCOR LVAD system is a third-generation, continuous flow, axial pump with active magnetic levitation, avoiding the potential downsides of mechanical bearings., Methods: The aim of this retrospective study was to review the Italian clinical experience with the INCOR LVAD and to determine the prevalence of GI bleeding and pump thrombosis. All patients implanted between January 2006 and May 2012 were considered eligible., Results: The total population consisted of 42 patients. LVAD indication was BTT in 36 (86%) and DT in 6 (14%) patients; 31 patients (74%) were INTERMACS class 1 or 2. Mean support time was 525 ± 570 days. The 1-year and 2-year survival rates were 74% and 60%, respectively. The most frequent AE was driveline infection (0.33 events PPY) followed by stroke with consequence (0.17 events PPY), sepsis (0.07 events PPY), and right HF (0.05 events PPY). No episodes of pump thrombosis or GI bleeding were observed., Conclusions: In this cohort of high-risk, advanced HF patients, the INCOR LVAD provided effective support with improved survival. Moreover, the absence of GI bleeding and pump thrombosis demonstrates a favorable characteristic of this device. Further prospective studies are needed to confirm these data.

Although the myocardium contains progenitor cells potentially capable of regenerating tissue upon lethal ischaemic injury, their actual role in post-infarction heart healing is negligible. Therefore, transplantation of extra-cardiac stem cells is a promising therapeutic approach for post-infarction heart dysfunction. Paracrine cardiotropic factors released by the grafted cells, such as the cardiotropic hormone relaxin (RLX), may beneficially influence remodelling of recipient hearts. The current study was designed to address whether grafting of mouse C2C12 myoblasts, genetically engineered to express green fluorescent protein (C2C12/GFP) or GFP and RLX (C2C12/RLX), are capable of improving long-term heart remodelling in a rat model of surgically induced chronic myocardial infarction. One month after myocardial infarction, rats were treated with either culture medium (controls), or C2C12/GFP cells, or C2C12/RLX cells plus exogenous RLX, or exogenous RLX alone. The therapeutic effects were monitored for 2 further months. Cell transplantation and exogenous RLX improved the main echocardiographic parameters of cardiac function, increased myocardial viability (assessed by positron emission tomography), decreased cardiac sclerosis and myocardial cell apoptosis and increased microvascular density in the post-infarction scar tissue. These effects were maximal upon treatment with C2C12/RLX plus exogenous RLX. These functional and histopathological findings provide further experimental evidence that myoblast cell grafting can improve myocardial performance and survival during post-infarction heart remodelling and dysfunction. Further, this study provides a proof-of-principle to the novel concept that genetically engineered grafted cells can be effectively employed as cell-based vehicles for the local delivery of therapeutic cardiotropic substances, such as RLX, capable of improving adverse heart remodelling.