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BACKGROUND: Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with COVID-19, but uncertainty remains about the determinants of in-hospital mortality and data on post-discharge outcomes are scarce. The aims of this study were to investigate the variables associated with in-hospital outcomes in patients who received ECMO during the first wave of COVID-19 and to describe the status of patients 6 months after ECMO initiation.METHODS: EuroECMO-COVID is a prospective, multicentre, observational study developed by the European Extracorporeal Life Support Organization. This study was based on data from patients aged 16 years or older who received ECMO support for refractory COVID-19 during the first wave of the pandemic-from March 1 to Sept 13, 2020-at 133 centres in 21 countries. In-hospital mortality and mortality 6 months after ECMO initiation were the primary outcomes. Mixed-Cox proportional hazards models were used to investigate associations between patient and management-related variables (eg, patient demographics, comorbidities, pre-ECMO status, and ECMO characteristics and complications) and in-hospital deaths. Survival status at 6 months was established through patient contact or institutional charts review. This study is registered with ClinicalTrials.gov, NCT04366921, and is ongoing.FINDINGS: Between March 1 and Sept 13, 2020, 1215 patients (942 [78%] men and 267 [22%] women; median age 53 years [IQR 46-60]) were included in the study. Median ECMO duration was 15 days (IQR 8-27). 602 (50%) of 1215 patients died in hospital, and 852 (74%) patients had at least one complication. Multiorgan failure was the leading cause of death (192 [36%] of 528 patients who died with available data). In mixed-Cox analyses, age of 60 years or older, use of inotropes and vasopressors before ECMO initiation, chronic renal failure, and time from intubation to ECMO initiation of 4 days or more were associated with higher in-hospital mortality. 613 patients did not die in hospital, and 547 (95%) of 577 patients for whom data were available were alive at 6 months. 102 (24%) of 431 patients had returned to full-time work at 6 months, and 57 (13%) of 428 patients had returned to part-time work. At 6 months, respiratory rehabilitation was required in 88 (17%) of 522 patients with available data, and the most common residual symptoms included dyspnoea (185 [35%] of 523 patients) and cardiac (52 [10%] of 514 patients) or neurocognitive (66 [13%] of 512 patients) symptoms.INTERPRETATION: Patient's age, timing of cannulation (FUNDING: None.

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.

This study deals with the development of a new power supply system implanted in the human body to feed several implantable medical devices (IMDs). The power system is energized from outside the human body via a transcutaneous wireless power transfer (WPT) link implanted in a subcutaneous pocket. The internal power system is equipped with a backup battery and can continuously power multiple IMDs for a maximum power of 25 W. As a demonstration of the proposed solution, different IMDs are considered. An experimental setup was carried out and laboratory tests were performed on real devices to demonstrate the feasibility and efficiency of the proposed solution.

Background. Right ventricular failure (RVF) is a severe event that increases perioperative mortality after Left Ventricle Assist Device (LVAD) implantation. RV function is particularly affected by the LVAD speed by changing 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 development of lateRVF. Methods. Between 2015 and 2019,50 consecutive 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 x PCWP/CVP x RPM set/RPM max; risk factors for late RVF, which was defined as the requirement for 7 days or more of inotropic support. Results 10 patients had late RVF after LVAD implantation. 5 patients required diuretic therapy and speed optimization. In 3 patients inotropic support with adrenaline 0.05 g/kg/min was started. 2 patients required prolonged continuous veno-venous hemofiltration and high dosage 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 A low HI, according to our study, is a significant risk factor for the development of RVF after LVAD implantation. We suggest adopting this index during the follow-up to stratify the different hemodynamic profiles and modify the therapeutic strategies according to the different HI levels obtained for every single patient.

This article deals with the design of a wireless powering system for a left ventricular assist device (LVAD). The modern LVAD is mainly a miniaturized blood pump attached to the heart and is driven by an electric motor powered by a cable driveline that exits the patient's body through the skin to be connected with an external battery. The driveline is a portal to the exterior environment and this can cause frequent and severe infections. The goal of this article is the elimination of the cable link between the interior and the exterior of the human body. To this aim, an innovative powering design of the LVAD is proposed adopting the wireless power transfer (WPT) technology based on magnetic resonant coupling. The main challenges in the design of a WPT system for LVAD application are the considerable implantation depth (5-10 cm) and the relatively high power (≈5 W) required by the device to operate continuously. Two different design solutions are proposed: 1) a subcutaneous receiving coil connected to the LVAD by a short driveline completely inside the human body and 2) an LVAD with a receiving circuit and coil, both integrated on it.

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.

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

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.

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.

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.

Significant advancements have been made in Cardiac surgery during the last decades, thanks to technological evolution. The enormous progress achieved has led to a relevant improvement in terms of surgical results, and at the same time, new ethical dilemmas have been addressed. Until the 90’s ethics in cardiac surgery mainly concerned significant moral problems caused by the introduction of extremely innovative techniques. However, today’s ethical issue focuses essentially on the doctor-patient relationship, other aspects of doctor’s practice concern relevant ethical perspectives. Ethics affects today the activity of the surgeon and the doctor in general. It is possible to distinguish clinical ethics, an ethics of health policies, and scientific research ethics. In the following chapter, we try to analyze the main ethical aspects concerning the application of cardiac surgical procedures.

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.

An uninterruptable wireless power supply is developed for a left ventricular assist device (LVAD), which is an implanted, electrically driven centrifugal pump used to treat advanced heart failure pathologies. The LVADs are currently powered through a cable driveline (DL) that exits the patient's body through the skin. Here, an innovative uninterruptable power supply is presented, based on a hybrid wireless/wired architecture: the electric power of 10 W is transferred by the near field wireless power transfer technology operating at 300 kHz, from outside the human body to an implanted subcutaneous receiver, and then by an internal cable to the LVAD. A significant improvement of the subcutaneous receiver is here proposed, based on the integration in the receiving coil of a battery pack providing the following benefits: no-break power supply for the LVAD; peak load management; enhanced system reliability; elimination of DL infection; enhancement of patient's quality of life. The proposed system is first designed and optimized, then a demonstrator is made and tested in a laboratory using the latest LVAD generation. The measured coil currents are used as sources for dosimetric analysis to assess the compliance of the system with the electromagnetic field safety and thermal regulations.

This article deals with the electromagnetic interference (EMI) in a cardiac implantable electronic device (e.g., implantable cardioverter-defibrillator or cardiac resynchronization therapy) generated by a left ventricular assisted device (LVAD) powered by a wireless power transfer (WPT) system. Wireless LVAD, not yet available in the market, is currently being investigated for many aspects spanning from electronics, hydraulic, electrical feeding, mechanical, and its possible impact on other implanted devices, such as a cardiac implantable electronic device (CIED). No results are yet published on possible EMI effects produced by the WPT coil currents in the pacing leads of a CIED implanted in the same patient with the LVAD. To this aim, the next generation of wireless LVADs with transcutaneous WPT system is first described, and, then, used to predict the induced voltage by the WPT system on a CIED lead. The obtained results demonstrate as the proposed WPT system, tested in accordance with the ISO 14117 standard, does not interfere with other CIEDs.

This study deals with the analysis of an optimum configuration for a wireless powering system applied to a left ventricular assisted device (LVAD). The current models of LVAD are miniaturized pump that are attached directly to heart by mini-invasive technique and can be used to treat advanced heart pathologies. The pump is electrically driven by a DC brushless motor powered by an external battery connected to the motor by percutaneous driveline cable. This last is cause of many infections and should be eliminated. Aim of this work is the study of a wireless power transfer (WPT) system used to power the motor replacing the percutaneous driveline. Electrical performances, safety aspects and reliability of the system are all aspects of paramount importance. A backup battery integrated with the implanted secondary coil is also proposed. This solution permits to improve the system reliability with a minimum number of components that must be subcutaneously implanted.

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 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.

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.

Purpose The Multicenter Italian study on RAdial Mechanically Assisted Circulatory Support (MIRAMACS) represent the first national observational registry, gathering continuous-flow (CF) left ventricular (LVAD) and biventricular assist device (BiVAD) implantation performed in adult patients by high-volume, mechanical circulatory support (MCS) dedicated, Italian centres. Methods Seven participating hospitals contributed pre-, peri- and long-term postoperative data on LVAD implants to the registry. Data for all implants in adult patients (>18 years of age) performed between January 2000 to September 2020 were analysed. BiVADs were excluded in this preliminary analysis. This initial report focuses on patient demographics, survival, device types, adverse events and competing outcomes. Results A total of 515 patients received a CF LVAD. The mean age of LVAD recipients was 60±10 years. The majority of patients were male (89.3%). The adopted systems were: HeartWare HVAD (n=213), HeartMate III (n=140), HeartMate II (n=89), Jarvik 2000 (n=50), Berlin Heart Incor (n=19) and other brands (n=4). In 6.6% of patients the LVAD implantation was performed by usage of less invasive surgical approaches. Mortality at 30- and 90-days was 6.1% and 11.1%, respectively. A temporary right ventricular assist device (RVAD) support was necessary in 3.1% of patients. Mean follow-up time was 57±15 months. Heart transplantation was performed in 99 patients (19.2%). Survival at 1-year, 3-years, and 5-years of BTT cohort was 82.1%, 60.4% and 41.8%, respectively. Survival at 1-year, 3-years, and 5-years of DT cohort was 69.8%, 45.6% and 30.1%, respectively. Major bleeding, major infection, neurological events and device malfunction were reported in 40 (7.7%), 143 (27.7%), 97 (18.8%) and 36 (6.9%) patients, respectively. Conclusion This first MIRAMACS report reveals frequencies and results comparable with other registries. Overall success rate of CF LVAD patients seems to be satisfactory. Detailed prospective data collection, additional participating centres and further analyses may provide additional robust scientific contributions.

Left ventricular assist device (LVAD) management is very challenging since many adverse events can occur in ongoing patients. Inadequate anticoagulation treatment can lead to life-threatening situations like ischemic stroke or pump thrombosis. The main intention of our study was to investigate if early identification of aspirin nonresponders by using aggregometry can improve anticoagulation management, reducing the risk of pump thrombosis. Methods From December 2010 to May 2018, 24 patients were implanted with a HeartMate II (HMII), 6 received a HeartWare HVAD system--full support VAD (HVAD), and 22 received a HeartMate III (HMIII). All patients were maintained with a target INR of 2.0 to 3.0. When the aggregometry test revealed a normal platelet function, 100 mg of aspirin were initiated. Only aspirin nonresponders were early identified by repeating the aggregometry after 7 days of aspirin administration. In acetylsalicylic acid nonresponder patients, 75 mg of clopidogrel was used, and the patients were tested again. Ticlopidine (250 mg) was used when clopidogrel was unsuccessful. Results Four patients required modification in antiplatelet therapy. Three patients (5%), 2 HVAD and 1 HMII, suffered from pump thrombosis. One patient died as a consequence of a large intracranial hemorrhagic event following thrombolytic treatment. One patient required a pump exchange; in 1 patient, thrombolytic infusion was conducted successfully. Conclusion Reported rates of pump thrombosis at 12 months for patients implanted with commonly used LVADs were 6% to 12% for axial-flow pumps and 8% with centrifugal-flow devices. In our series, the reported 5% overall incidence of pump thrombosis encourages the routine use of an aggregometry test for early identification of aspirin nonresponders.

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.

Right ventricular failure after continuous-flow left ventricular assist device (LVAD) implantation is still an unsolved issue and remains a life-threatening event for patients. We undertook this study to determine predictors of the patients who are candidates for isolated LVAD therapy as opposed to biventricular support (BVAD). We reviewed demographic, echocardiographic, hemodynamic, and laboratory variables for 258 patients who underwent both isolated LVAD implantation and unplanned BVAD because of early right ventricular failure after LVAD insertion, between 2006 and 2017 (LVAD = 170 and BVAD = 88). The final study patients were randomly divided into derivation (79.8%, n = 206) and validation (20.1%, n = 52) cohorts. Fifty-seven preoperative risk factors were compared between patients who were successfully managed with an LVAD and those who required a BVAD. Nineteen variables demonstrated statistical significance on univariable analysis. Multivariable logistic regression analysis identified destination therapy (odds ratio [OR] 2.0 [1.7-3.9], p = 0.003), a pulmonary artery pulsatility index2 (OR 3.3 [1.7-6.1], p = 0.001), a right ventricle/left ventricle end-diastolic diameter ratio0.75 (OR 2.7 [1.5-5.5], p = 0.001), an right ventricle stroke work index300 mm Hg/ml/m (OR 4.3 [2.5-7.3], p0.001), and a United Network for Organ Sharing modified Model for End-Stage Liver Disease Excluding INR score17 (OR 3.5 [1.9-6.9], p0.001) as the major predictors of the need for BVAD. Using these data, we propose a simple risk calculator to determine the suitability of patients for isolated LVAD support in the era of continuous-flow mechanical circulatory support devices.

Background Mechanical circulatory support (MCS) is the standard therapy for the management of acute or chronic end-stage heart failure. We report on our two-center experience with MCS therapy. Methods Between January 2000 and December 2012, 116 adult patients (mean age 56.8 ± 9.9 years, range: 31 to 76 years) were primarily supported on temporary or long-term ventricular assist devices (VADs) or total artificial hearts (TAHs) at our institutions. Temporary extracorporeal radial VAD support was established in 50 patients (43.1%) (Group A) whereas 66 (56.8%) patients received long-term paracorporeal and intracorporeal VAD or TAH (Group B). LVAD support was established in 63 patients (54.3%), with BVAD/TAH support in 29 (25%). A temporary CentriMag was the only device adopted as an isolated RVAD support, being placed in 24 patients (20.6%). Results In Group A, the overall mean support time was 10.2 ± 6.6 days (range: 3 to 43 days) and the overall success rate was 55.1% (27 patients). The mean LVAD support time was 357 ± 352.3 days (range: 1 to 902 days) in Group B and 98 ± 82.6 days (range: 8 to 832 days) in BVAD/TAH patients, with success rates of 72.5% (37 patients) and 46.6% (seven patients), respectively. The heart transplantation (Htx) rate for both groups combined was 25.8% (n = 30). The overall one- and five-year survival rates after Htx were 73.3% and 60%, respectively. Conclusions When a decision to treat with VAD or TAH is made early, either modality can be used as an alternative to Htx, affording comparable early to mid-term outcomes. doi: 10.1111/jocs.12402 (J Card Surg 2014;29:717–722)

Background Currently, ventricular assist device (VAD) or total artificial heart (TAH) mechanical support provides an effective treatment of unstable patients with advanced heart failure. We report our single-center experience with mechanical circulatory support therapy. Methods From March 2002 to December 2012, 107 adult patients (mean age, 56.8 ± 9.9 y; range, 31–76 y) were primarly supported on temporary or long-term VAD or TAH support as treatment for refractory heart failure at our institution. Temporary extracorporeal radial VAD support (group A) was established in 49 patients (45.7%), and long-term paracorporeal and intracorporeal VAD or TAH (group B) in 58 patients (54.2%). Left ventricular (LVAD) support was established in 55 patients (51.4%; n = 33, Heartmate II; n = 6, Heartmate I XVE; n = 4, Heartware HVAD; and n = 12, Centrimag) and biventricular (BVAD/TAH) support (group B) in 28 patients (26.1%; n = 10, Thoratec paracorporeal; n = 2, Heartware HVAD, n = 1, Thoratec implantable; n = 1, Syncardia TAH; and n = 14, Centrimag). The temporary Centrimag was the only device adopted as isolated right ventricular (RVAD) support, and it was inserted in 24 patients (22.4%). Results In group A, overall mean support time was 10.2 ± 6.6 days (range, 3–43 d). In group B, LVAD mean support time was 357 ± 352.3 days (range, 1–902 d) and BVAD/TAH support time was 98 ± 82.6 days (range, 8–832 d). In group A, the overall success rate was 55.1% (27 patients). In group B, LVAD overall success rate was 74.4% (32 patients) and BVAD/TAH success rate was 50% (7 patients). Overall heart transplantation rate for both groups was 27.1% ( n = 2, group A; n = 27, group B). Overall 1-year and 5-year survivals after heart transplantation were 72.4% ( n = 21) and 58.6% ( n = 17), respectively. Conclusions Mechanical circulatory support is an effective strategy even in cases of end-stage heart failure according to our experience. Further improvement of VAD and TAH technologies may support their adoption as an encouraging alternative to heart transplantation in the near future.

Two centrifugal pumps, the RotaFlow (Maquet, Jostra Medizintechnik AG, Hirrlingen, Germany) and Levitronix CentriMag (Levitronix LCC, Waltham, MA, USA), used in central or peripheral veno-arterial extracorporeal membrane oxygenation (ECMO) support systems have been investigated, in terms of double-center experience, as treatment for patients with refractory cardiogenic shock (CS). Between January 2006 and December 2012, 228 consecutive adult patients were supported on RotaFlow (n = 213) or CentriMag (n = 15) ECMO, at our institutions (155 men; age 58.3 ± 10.5 years, range: 19–84 years). Indications for support were: failure to wean from cardiopulmonary bypass in the setting of postcardiotomy (n = 118) and primary donor graft failure (n = 37); postacute myocardial infarction CS (n = 27); acute myocarditis (n = 6); and CS on chronic heart failure (n = 40). A peripheral ECMO setting was established in 126 (55.2%) patients while it was established centrally in 102 (44.7%). Overall mean support time was 10.9 ± 9.7 days (range: 1–43 days). Eighty-four (36.8%) patients died on ECMO. Overall success rate, in terms of survival on ECMO (n = 144), weaning from mechanical support (n = 107; 46.9%), bridge to mid-long-term ventricular assist device (n = 6; 2.6%), and bridge to heart transplantation (n = 31; 13.5%), was 63.1%. One hundred twenty-two (53.5%) patients were successfully discharged. Stepwise logistic regression identified blood lactate level and MB isoenzyme of creatine kinase (CK-MB) relative index at 72 h after ECMO initiation, and number of packed red blood cells (PRBCs) transfused on ECMO as significant predictors of mortality on ECMO (P = 0.010, odds ratio [OR] = 2.94; 95% confidence interval [CI] = 1.10–3.14; P = 0.010, OR = 2.82, 95% CI = 1.014–3.721; and P = 0.011, OR = 2.69; 95% CI = 1.06–4.16, respectively). Central ECMO population had significantly higher rate of continuous veno-venous hemofiltration need and bleeding requiring surgery events compared with the peripheral ECMO setting population. No significant differences were seen by comparing the RotaFlow and CentriMag populations in terms of device performance. At follow-up, persistent heart failure with left ventricle ejection fraction (LVEF) ≤40% was a risk factor after hospital discharge. Patients with a poor hemodynamic status may benefit from rapid central or peripheral insertion of ECMO. The blood lactate level, CK-MB relative index, and PRBCs transfused should be strictly monitored during ECMO support. In addition, early ventricular assist device placement or urgent listing for heart transplant should be considered in patients with persistent impaired LVEF after ECMO.

Early planned institution of temporary right ventricular assist device (RVAD) support with the CentriMag (Levitronix LLC, Waltham, MA, USA) in left ventricular assist device (LVAD) recipients was compared with permanent biventricular assist device (BVAD) or total artificial heart (TAH) support. Between 2007 and 2011, 77 patients (age range: 25-70 years) with preoperative evidence of biventricular dysfunction (University of Pennsylvania score >50; University of Michigan score >5) were included. Forty-six patients (38 men; median age 54.5 years, range: 25-70 years) underwent LVAD placement combined with temporary RVAD support (group A); in 31 patients (25 men; median age 56.7 years, range: 28-68 years), a permanent BVAD or TAH implantation (group B) was performed. Within 30 days, 12 patients from group A (26.08%) and 14 patients from group B (45.1%) died on mechanical support (P = 0.02). Thirty patients (65.2%) in group A were weaned from temporary RVAD support and three (6.5%) underwent permanent RVAD (HeartWare, Inc., Framingham, MA, USA) placement. A total of 26 patients (56.5%) were discharged home in group A versus 17 (54.8%) in group B (P = 0.56). Three patients (8.5%) received heart transplantation in group A and six (19.3%) in group B (P = 0.04). In group A, 90-day and 6-month survival was 54.3% (n = 25) versus 51.6% (n = 16) in group B (P = 0.66). In group A, 1-year survival was 45.6% (n = 21) versus 45.1% (n = 14) in group B (P = 0.81). The strategy of planned temporary RVAD support in LVAD recipients showed encouraging results if compared with those of a similar permanent BVAD/TAH population. Weaning from and removal of the temporary RVAD support may allow patients to be on LVAD support only despite preoperative biventricular dysfunction.

Nowadays, approximately every patient affected from end-stage acute or chronic heart failure may be a potential candidate for MCS; therefore, a careful patient selection for MCS is crucial to establish an effective MCS program, having an impact on both the number of patient treated and the outcomes and the costs of the entire program.

Objectives: To examine the surgical treatment and mortality rate of valvular infective endocarditis complicated by an abscess in patients at a major tertiary care center. Background: Infective endocarditis (IE) involving a heart valve is fatal if left untreated. The appearance of a comorbid abscess impacts the choice of treatment and surgical technique and, in some instances, may present unique technical challenges. Methods: Departmental data from all patients who underwent surgery for IE at a single major tertiary care center from July 2007 to January 2016 were retrospectively screened for the presence of an intracardiac abscess. Patients with at least one confirmed abscess were examined further with respect to the surgical procedures completed and 30-day mortality rate. Results: Over the almost nine years of data collection, we identified 14 patients (9 males, 5 females) with at least one confirmed cardiac abscess. Patients ranged in age from 28 to 77 years old (mean 57.8 ± 14 years). Various surgical procedures were performed, including aortic or/and mitral valve replacement, mitral or/and tricuspid valve repair, and a freestyle prosthetic valve implant in the pulmonary position. In two patients, surgery was extended to include the ascending aorta; while two patients underwent coronary artery bypass grafting. A patch technique was adopted whenever necessary. Overall, 12 patients survived, while one died from septic shock and another from pneumonia. Conclusions: An abscess is a serious complication of valvular infective endocarditis that can appreciably increase the complexity of surgical intervention. In our experience, however, this seemed not to directly affect the 30-day mortality-rate, with both deaths ascribed to disseminated infection.

Heart failure is a clinical syndrome with different etiologies and quite variable presentation. The acute onset can be due to exacerbation of signs and symptoms of known HF (acute decompensated heart failure) or to the sudden appearance of HF in a patient with previous normal cardiac function (new-onset or de novo HF), as it happens after myocardial infarction or myocarditis. In chronic HF symptoms of ventricular dysfunction occur in a time span of weeks or months, generally caused by long-lasting ischemic heart disease, dilated cardiomyopathies, and hypertensive and valvular disease. With the advent of echocardiography, HF has been classified into two major subclasses: (1) heart failure with reduced ejection fraction (HFrEF), also called systolic heart failure, and (2) heart failure with preserved ejection fraction (HFpEF), also known as diastolic heart failure. The prevalence of heart failure increases rapidly with age. The Framingham Heart Study showed a prevalence of 8/1000 and up to 66/100 in 50–59 and 80–89 aged men, respectively [1]. In women, the prevalence of cardiac insufficiency was 8/1000 for the age group of 50–59 years and 7/1000 for age between 80 and 89 years. The incidence has similar trends, doubling for each subsequent decade of life. There are several reasons for this increase: the aging of the population, the improved efficacy of treatment of acute coronary syndromes with prolonged life span expectancy, and the significant increase of diabetes and obesity. As consequence the hospitalizations are progressively raising, due not only to the occurrence of worsening symptoms but also to comorbidities such as renal failure, electrolyte abnormalities, and multiorgan dysfunction. Risk factors for heart failure are age, sex, hypertension, diabetes, obesity, coronary artery disease, insulin resistance, genetic factors, and use of cardiotoxic drugs. In the SOLVD registry, 70% of patients suffering from heart failure had coronary heart disease and 7% hypertensive disease [2].

Two centrifugal pumps, the RotaFlow (Maquet, Jostra Medizintechnik AG, Hirrlingen, Germany) and Levitronix CentriMag (Levitronix LCC, Waltham, MA, USA), used in central or peripheral veno-arterial extracorporeal membrane oxygenation (ECMO) support systems have been investigated, in terms of double-center experience, as treatment for patients with refractory cardiogenic shock (CS). Between January 2006 and December 2012, 228 consecutive adult patients were supported on RotaFlow (n=213) or CentriMag (n=15) ECMO, at our institutions (155 men; age 58.3±10.5 years, range: 19-84 years). Indications for support were: failure to wean from cardiopulmonary bypass in the setting of postcardiotomy (n=118) and primary donor graft failure (n=37); postacute myocardial infarction CS (n=27); acute myocarditis (n=6); and CS on chronic heart failure (n=40). A peripheral ECMO setting was established in 126 (55.2%) patients while it was established centrally in 102 (44.7%). Overall mean support time was 10.9±9.7 days (range: 1-43 days). Eighty-four (36.8%) patients died on ECMO. Overall success rate, in terms of survival on ECMO (n=144), weaning from mechanical support (n=107; 46.9%), bridge to mid-long-term ventricular assist device (n=6; 2.6%), and bridge to heart transplantation (n=31; 13.5%), was 63.1%. One hundred twenty-two (53.5%) patients were successfully discharged. Stepwise logistic regression identified blood lactate level and MB isoenzyme of creatine kinase (CK-MB) relative index at 72 h after ECMO initiation, and number of packed red blood cells (PRBCs) transfused on ECMO as significant predictors of mortality on ECMO (P=0.010, odds ratio [OR]=2.94; 95% confidence interval [CI]=1.10-3.14; P=0.010, OR=2.82, 95% CI=1.014-3.721; and P=0.011, OR=2.69; 95% CI=1.06-4.16, respectively). Central ECMO population had significantly higher rate of continuous veno-venous hemofiltration need and bleeding requiring surgery events compared with the peripheral ECMO setting population. No significant differences were seen by comparing the RotaFlow and CentriMag populations in terms of device performance. At follow-up, persistent heart failure with left ventricle ejection fraction (LVEF)≤40% was a risk factor after hospital discharge. Patients with a poor hemodynamic status may benefit from rapid central or peripheral insertion of ECMO. The blood lactate level, CK-MB relative index, and PRBCs transfused should be strictly monitored during ECMO support. In addition, early ventricular assist device placement or urgent listing for heart transplant should be considered in patients with persistent impaired LVEF after ECMO.