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Introduction Acute right ventricular failure (aRVF) is associated with high mortality and morbidity. Mechanical circulatory support (MCS) may be considered as an advanced treatment option. The ProtekDuo is a cannula that can be used to provide acute right ventricular support as part of a temporary percutaneous (tp) right ventricular assist device (RVAD) system. The primary objective of this systematic review is to describe patient survival and complications when the ProtekDuo cannula was used as part of an tpRVAD system. Methods MEDLINE, Embase, and Scopus were searched from database inception to August 26, 2022. Reference sections of studies were reviewed to screen for database omissions. Results Seven studies with 127 patients were eligible for inclusion. The studies included patients with aRVF from a variety of causes. Mean duration of support was between 10 and 58 days in five studies. Patient survival to discharge was between 60% and 85.2% in two studies. Four authors reported 30-day survival between 60% and 85.2%. Devicerelated and non-device related complications were low. Conclusions Patients treated with RVAD using the ProtekDuo cannula have comparable survival rates and complications to other tpRVAD systems. Several advantages exist compared to other RVAD systems.

Objectives Extracorporeal membrane oxygenation (ECMO) is used to support patients in severe cardiogenic shock. In the absence of recovery, these patients may need to be listed for heart transplant (HT), which offers the best long-term prognosis. However, posttransplantation mortality is significantly elevated in patients who receive ECMO. The objective of the present study was to describe and risk-stratify different profiles of patients listed for HT supported by ECMO. Methods Patients listed for HT in the United Network for Organ Sharing database were analyzed. The primary outcome was 1-year survival and was assessed in patients bridged to transplant with ECMO (ECMOBTT) and patients who were previously supported on ECMO but had it removed before HT (ECMOREMOVED). Results Among 65,636 adult candidates listed for HT (between 2001 and 2017), 712 were supported on ECMO, 292 of whom (41%) underwent HT (ECMOBTT, n = 202; ECMOREMOVED, n = 90). Most of the patients with ECMOREMOVED were transplanted with a ventricular assist device. In ECMOBTT, recipient age (each 10-year increase), time on the waitlist (both defined as minor risk factors), need for dialysis, and need for mechanical ventilation (both defined as major risk factors) were independent predictors of mortality. ECMOREMOVED and ECMOBTT with no risk factors showed 1-year survival comparable to that in patients who were never supported on ECMO. Compared with patients who were never on ECMO, patients in ECMOBTT group with minor risk factors, 1 major risk factor, and 2 major risk factors had ~2-, ~5-, and >10-fold greater 1-year mortality, respectively (P Conclusions The HT recipients in the ECMOREMOVED and ECMOBTT groups with no risk factors showed similar survival as the HT recipients who were never supported on ECMO. In the ECMOBTT group, posttransplantation mortality increased significantly with increasing risk factors.

Introduction Acute right ventricular failure (aRVF) is associated with high mortality and morbidity. Mechanical circulatory support (MCS) may be considered as an advanced treatment option. The ProtekDuo is a cannula that can be used to provide acute right ventricular support as part of a temporary percutaneous (tp) right ventricular assist device (RVAD) system. The primary objective of this systematic review is to describe patient survival and complications when the ProtekDuo cannula was used as part of an tpRVAD system. Methods MEDLINE, Embase, and Scopus were searched from database inception to August 26, 2022. Reference sections of studies were reviewed to screen for database omissions. Results Seven studies with 127 patients were eligible for inclusion. The studies included patients with aRVF from a variety of causes. Mean duration of support was between 10 and 58 days in five studies. Patient survival to discharge was between 60% and 85.2% in two studies. Four authors reported 30-day survival between 60% and 85.2%. Devicerelated and non-device related complications were low. Conclusions Patients treated with RVAD using the ProtekDuo cannula have comparable survival rates and complications to other tpRVAD systems. Several advantages exist compared to other RVAD systems.

Ventricular assist devices (VADs) provide an alternative solution to heart transplantation for patients with end-stage heart failure. Insufficient hemocompatibility of VAD components can result in severe adverse events, such as thromboembolic stroke, and readmissions. To enhance VAD hemocompatibility, and avoid thrombus formation, surface modification techniques and endothelialization strategies are employed. In this work, a free form patterning topography is selected to facilitate the endothelialization of the outer surface of the inflow cannula (IC) of a commercial VAD. An endothelialization protocol for convoluted surfaces such as the IC is produced, and the retainment of the endothelial cell (EC) monolayer is evaluated. To allow this evaluation, a dedicated experimental setup is developed to simulate realistic flow phenomena inside an artificial, beating heart phantom with a VAD implanted on its apex. The procedural steps of mounting the system result to the impairment of the EC monolayer, which is further compromised by the developed flow and pressure conditions, as well as by the contact with the moving inner structures of the heart phantom. Importantly, the EC monolayer is better maintained in the lower part of the IC, which is more susceptible to thrombus formation and may therefore aid in minimizing the hemocompatibility related adverse events after the VAD implantation., Biomaterials Advances, 152, ISSN:2772-9508, ISSN:2772-9516

Infection is a serious adverse event limiting left ventricular assist device (LVAD) therapy in advanced heart failure patients, but a reliable means to identify patients at increased risk of infection is still lacking. We hypothesized that preoperative elevated levels of plasma Oncostatin M (OSM), a cytokine marker of leukocyte activation and inflammation, would be predictive of subsequent infection. We measured plasma OSM in 41 LVAD patients one day before LVAD implantation and postoperatively over two months. Preoperative plasma OSM levels were normal in 27 patients (group A, 4.9 ± 3.2 pg/ml) but elevated in 14 patients (group B, 1649.0 ± 458.9 pg/ml) ( p = 0.003). Early postoperative levels rose in both groups and declined rapidly in group A, with group B declining slowly over two months. Significantly more infections developed in group B than group A patients over two months postimplantation ( p = 0.004). No other routine clinical assessment or laboratory testing afforded this differentiation. These findings suggest that preoperative plasma OSM levels may assist in identifying patients at increased risk of infections after LVAD implantation.

We are developing a universal, advanced ventricular assist device (AVAD) with automatic pressure regulation suitable for both left and right ventricular support. The primary goal of this computational fluid dynamics (CFD) study was to analyze the biventricular performance of the AVAD across its wide range of operating conditions. An AVAD CFD model was created and validated using in vitro hydraulic performance measurements taken over conditions spanning both left ventricular assist device (LVAD) and right ventricular assist device (RVAD) operation. Static pressure taps, placed throughout the pump, were used to validate the CFD results. The CFD model was then used to assess the change in hydraulic performance with varying rotor axial positions and identify potential design improvements. The hydraulic performance was simulated and measured at rotor speeds from 2,300 to 3,600 revolutions/min and flow rates from 2.0 to 8.0 L/min. The CFD-predicted hydraulic pressure rise agreed well with the in vitro measured data, within 6.5% at 2300 rpm and within 3.5% for the higher rotor speeds. The CFD successfully predicted wall static pressures, matching experimental values within 7%. High degree of similarity and circumferential uniformity in the pump's flow fields were observed over the pump operation as an LVAD and an RVAD. A secondary impeller axial clearance reduction resulted in a 10% decrease in peak flow residence time and lower static pressures on the secondary impeller. These lower static pressures suggest a reduction in the upwards rotor forces from the secondary impeller and a desired increase in the pressure sensitivity of the pump. The CFD analyses supported the feasibility of the proposed AVAD's use as an LVAD or an RVAD, over a wide range of operating conditions. The CFD results demonstrated the operability of the pump in providing the desired circumferential flow similarity over the intended range of flow/speed conditions and the intended functionality of the AVAD's automated pressure regulation.

OBJECTIVE: The objective of this study was to investigate variations across hospitals in infection rates and associated costs, the latter reflected in 90-day Medicare payments. Despite high rates and expenditures of healthcare-associated infections associated with durable ventricular assist device implant, few studies have examined inter-hospital variation and associated costs. METHODS: Clinical data on 8688 patients who received primary durable ventricular assist devices from July 2008 to July 2017 from The Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) hospitals (n=120) were merged with post-implant 90-day Medicare claims. Terciles of hospital-specific, risk-adjusted infection rates per 100 patient-months were estimated using Intermacs and associated with Medicare payments (among 5440 Medicare beneficiaries). Primary outcomes included infections within 90 days of implant and Medicare payments. RESULTS: There were 3982 infections identified among 27.8% (2,417/8,688) of patients developing an infection. The median (25(th), 75(th) percentile) adjusted incidence of infections (per 100 patient-months) across hospitals was 14.3 (9.3, 19.5) and varied by hospital (range 0.0 – 35.6). Total Medicare payments from implant to 90-days were 9.0% (absolute difference: $13,652) greater in high versus low infection tercile hospitals, p

On June 3, 2021 Medtronic, Inc announced discontinuation of the HVAD left ventricular assist device. The purpose of this analysis was to provide summary data on surgical risks of HVAD to HeartMate 3 exchange and compare survival after HVAD to HeartMate 3 exchange to survival after primary HVAD implantation.Three cohorts within The Society of Thoracic Surgeons Intermacs database were identified: primary HVAD implant cohort (January 2017 to March 2021, n = 3797), HVAD to HeartMate 3 exchange cohort (December 2017 to March 2021, n = 45), and HVAD to HVAD exchange cohort (January 2017 to March 2021, n = 234). Mortality after HVAD to HeartMate 3 exchange was modeled and compared with the constant hazard phase for risk of mortality while on continued HVAD support. As a secondary analysis outcomes and survival were compared between patients who underwent HVAD to HeartMate 3 and HVAD to HVAD exchange.HVAD to HeartMate 3 exchange was associated with significantly reduced survival compared with survival while remaining on HVAD support (6 months after exchange, 73.8% [70% confidence interval, 68.6-77.8] vs 79.0% [70% confidence interval, 78.3-79] for continued HVAD support). Compared with HVAD to HVAD exchange, survival was higher after replacement with HeartMate 3 (1 year: 85.9% [70% confidence interval, 79.5-90.5] vs 66.6% [70% confidence interval, 63.0-70.0], P = .009).Compared with continued support on HVAD, an exchange to HeartMate 3 was found to be associated with a significant increase in mortality. For patients who required pump exchange on HVAD support, exchange to HeartMate 3 demonstrated superior survival. Currently there is insufficient evidence to support elective exchange from an HVAD to HeartMate 3.

Background This report describes 9 high-risk neonates and infants with hypoplastic left heart syndrome (HLHS) who were stabilized with a combined hybrid approach and ventricular assist device (VAD) insertion (HYBRID+VAD) in preparation for heart transplantation. Methods A total of 9 patients with HLHS (7 neonates, 2 infants) presented with anatomic or physiologic features associated with an increased risk for conventional univentricular palliation with the Norwood operation (large coronary sinusoids or fistulas, severe tricuspid regurgitation, cardiogenic shock, restrictive atrial septum). These patients underwent combined VAD insertion (Berlin EXCOR, Berlin Heart, Inc, Berlin, Germany) and Stage 1 hybrid palliation (application of bilateral pulmonary bands, stent placement in the patent arterial duct, and atrial septectomy if needed). During this same era, at the Congenital Heart Center, University of Florida, Gainesville, Florida, 46 neonates underwent a Norwood operation, 4 neonates underwent a hybrid approach “Stage 1” without VAD, and 3 patients with HLHS were supported with prostaglandin while awaiting heart transplantation. Results At HYBRID+VAD insertion, the median age was 20 days (range, 13 to 143 days), and median weight was 3.25 kg (range, 2.43 to 4.2 kg). Six patients survive (67%), and 3 patients died (33%). Five survivors are at home doing well after successful heart transplantation, and 1 survivor is doing well in the intensive care unit on VAD support while awaiting transplantation. Only 1 of 6 survivors (16.7%) required intubation more than 10 days after HYBRID+VAD insertion. In 8 patients no longer undergoing VAD support, the median length of VAD support was 119.5 days (range, 56 to 196 days). Conclusions High-risk patients with HLHS who are suboptimal candidates for Norwood palliation can be successfully stabilized with pulsatile VAD insertion along with hybrid palliation while awaiting cardiac transplantation. These patients may be extubated and optimized for transplantation while undergoing VAD support.

Objectives Acute kidney injury (AKI) remains a leading source of morbidity and mortality after cardiothoracic surgery. Insulin-like growth factor-binding protein 7 (IGFBP7), and tissue inhibitor of metalloproteinases-2 (TIMP-2), are novel early-phase renal biomarkers that have been validated as sensitive predictors of AKI. Here the authors studied the efficacy of these biomarkers for predicting AKI after left ventricular assist device (LVAD) implantation and cardiac transplantation. Design/Setting/Participants/Interventions This was a prospective study of 73 patients undergoing LVAD implantation (n = 37) or heart transplant (n = 36) from 2016 to 2017 at the authors’ center. TIMP-2 and IGFBP7 were measured with the NephroCheck Test on urine samples before surgery and one-to-six hours after surgery. NephroCheck scores were assessed as predictors of moderate/severe AKI (Kidney Disease International Global Outcomes 2/3 creatinine criteria) within 48 hours of surgery, and the association with survival to one year was investigated. Measurements and Main Results The LVAD and transplant cohorts overall were similar in demographics and baseline creatinine (p > 0.05), with the exception of having more African-American patients in the LVAD arm (p = 0.003). Eleven (30%) LVAD and 16 (44%) transplant patients developed moderate/severe AKI. Overall, AKI was associated with postsurgery NephroCheck (odds ratio [95% confidence interval] for 0.1 mg/dL increase: 1.36 [1.04-1.79]; p = 0.03), but not with baseline NephroCheck (p = 0.92). When analyzed by cohort, this effect remained for LVAD (1.68 [1.05-2.71]; p = 0.03) but not for transplant (p = 0.15). Receiver operating characteristic analysis showed postoperative NephroCheck to be superior to baseline creatinine in LVAD (p = 0.046). Furthermore, an increase of 0.1 mg/dL in postoperative NephroCheck was associated with a 10% increase in the risk of mortality (adjusted hazard ratio: 1.11 [1.01-1.21]; p = 0.04) independent of age and body mass index. Conclusion Assessment of TIMP-2 and IGFBP7 within six hours after surgery appeared effective at predicting AKI in patients with LVADs. Larger studies are warranted to validate these findings.

INTRODUCTION AND OBJECTIVES The effect of a centrifugal continuous-flow left ventricular assist device (cfLVAD) on hemodynamic left ventricular unloading (HLVU) and the clinical conditions that interfere with hemodynamic optimization are not well defined. METHODS We retrospectively evaluated the likelihood of incomplete HLVU, defined as high pulmonary capillary wedge pressure (hPCWP)> 15mmHg in 104 ambulatory cfLVAD patients when the current standard recommendations for cfLVAD rotor speed setting were applied. We also evaluated the ability of clinical, hemodynamic and echocardiographic variables to predict hPCWP in ambulatory cfLVAD patients. RESULTS Twenty-eight percent of the patients showed hPCWP. The variables associated with a higher risk of hPCWP were age, central venous pressure, absence of treatment with renin-angiotensin-aldosterone system inhibitors, and brain natriuretic peptide levels. Patients with optimal HLVU had a 15.2±14.7% decrease in postoperative indexed left ventricular end-diastolic diameter compared with 8.9±11.8% in the group with hPCWP (P=.041). Independent predictors of hPCWP included brain natriuretic peptide and age. Brain natriuretic peptide

Refractory right ventricular failure at the time of left ventricular assist device implantation requires treatment with supplemental mechanical circulatory support. However, the optimal strategy for support remains unknown.All patients undergoing first-time durable left ventricular assist device implantation with a contemporary device were selected from The Society of Thoracic Surgeons National Database (2011 to 2019). Patients requiring right ventricular assist device (RVAD) or venoarterial extracorporeal membrane oxygenation (VA-ECMO) were included in the analysis. Patients were stratified by RVAD or VA-ECMO and by timing of placement (intraoperative vs postoperative).In all, 18 423 left ventricular assist device implants were identified, of which 940 (5.1%) required RVAD (n = 750) or VA-ECMO (n = 190) support. Patients receiving an RVAD more frequently had preoperative inotrope requirement (76% vs 62%, P.01) and severe tricuspid regurgitation (20% vs 13%, P.01). The RVAD patients had lower rates of postoperative renal failure (40% vs 51%, P = .02) and limb ischemia (4% vs 13%, P.01), as well as significantly less operative mortality (41% vs 54%, P.01). After risk adjustment with propensity score analysis, support with VA-ECMO was associated with a higher risk of mortality (risk ratio 1.46; 95% confidence interval, 1.21 to 1.77; P.01) compared with patients receiving an RVAD. Importantly, institution of right ventricular support postoperatively was associated with higher mortality (1.43, P.01) compared with intraoperative initiation.Patients with severe right ventricular failure in the setting of durable left ventricular assist device implantation may benefit from the use of RVAD over VA-ECMO. Regardless of the type of support, initiation at the index operation was associated with improved outcomes.

OBJECTIVES: To highlight the role of percutaneous left ventricular assist device (LVAD) decommissioning as a safe procedure after myocardial recovery in patients with advanced heart failure.BACKGROUND: The HeartMate3 LVAD (Abbott, Chicago, IL, USA) is designed to provide circulatory support with enhanced hemocompatibility for patients with advanced heart failure. Most VADs are used as a bridge to heart transplantation; however, in certain cases, myocardial function recovers, and VADs can be explanted after the patient is weaned. Although surgical explantation remains the gold standard, minimally invasive percutaneous decommissioning has been described as a successful alternative. In this study, we present our experience, one-year outcomes, and adverse events associated with percutaneous LVAD decommissioning.METHODS: We conducted a retrospective review of data from six consecutive patients who underwent percutaneous LVAD decommissioning.RESULTS: Six patients were enrolled in the study. For all six patients, HM3 decommissioning was completed at least 6 months ago. No technical complications were documented. No strokes were observed within the study period, and the ejection fraction improved. The mean follow-up duration was 18 ± 8.5 months, and the survival rate was 100%.CONCLUSION: Percutaneous HeartMate3 decommissioning appears to be safe. In particular, the survival after the procedure was 100%, and no events, especially thromboembolic ones, occurred.

Iron deficiency (ID) is a common comorbidity in heart failure (HF). In these patients, intravenous iron administration can improve clinical outcomes and quality of life (QoL). However, data on ID are lacking in patients who have transitioned toward left ventricular assist device (LVAD) or heart transplantation (HTx). All patients who underwent LVAD (n = 84) surgery or HTx (n = 67) at our center between 2012 and 2019, aged ≥18 years with a follow-up of ≥3 months, were included. Retrospectively, the prevalence of ID up to 1 year preoperatively, and up to February 2020 postoperatively, as well as all iron administrations were assessed during this period. Iron status was assessed in 61% and 51% of the LVAD and HTx patients preoperatively, and 81% and 84%, respectively, postoperatively. Of these patients, 53% and 71% of the LVAD and HTx patients preoperatively were diagnosed with ID preoperatively, and 71% and 77%, respectively, postoperatively. ID was more frequently diagnosed >3 months postoperatively. Sixty-three percent of the LVAD (mostly intravenous) and 63% of the HTx patients (mostly oral) received iron administration. ID is highly prevalent pre- and post-LVAD and HTx. It is plausible that substitution can have similar QoL gains as in regular HF patients.

OBJECTIVE: Myocardial damage occurs in up to 25% of coronavirus disease 2019 (COVID-19) cases. While veno-venous extracorporeal life support (V-V ECLS) is used as respiratory support, mechanical circulatory support (MCS) may be required for severe cardiac dysfunction. This systematic review summarizes the available literature regarding MCS use rates, disease drivers for MCS initiation, and MCS outcomes in COVID-19 patients.METHODS: PubMed/EMBASE were searched until October 14, 2021. Articles including adults receiving ECLS for COVID-19 were included. The primary outcome was the rate of MCS use. Secondary outcomes included mortality at follow-up, ECLS conversion rate, intubation-to-cannulation time, time on ECLS, cardiac diseases, use of inotropes, and vasopressors.RESULTS: Twenty-eight observational studies (comprising both ECLS-only populations and ECLS patients as part of larger populations) included 4218 COVID-19 patients (females: 28.8%; median age: 54.3 years, 95%CI: 50.7-57.8) of whom 2774 (65.8%) required ECLS with the majority (92.7%) on V-V ECLS, 4.7% on veno-arterial ECLS and/or Impella, and 2.6% on other ECLS. Acute heart failure, cardiogenic shock, and cardiac arrest were reported in 7.8%, 9.7%, and 6.6% of patients, respectively. Vasopressors were used in 37.2%. Overall, 3.1% of patients required an ECLS change from V-V ECLS to MCS for heart failure, myocarditis, or myocardial infarction. The median ECLS duration was 15.9 days (95%CI: 13.9-16.3), with an overall survival of 54.6% and 28.1% in V-V ECLS and MCS patients. One study reported 61.1% survival with oxy-right ventricular assist device.CONCLUSION: MCS use for cardiocirculatory compromise has been reported in 7.3% of COVID-19 patients requiring ECLS, which is a lower percentage compared to the incidence of any severe cardiocirculatory complication. Based on the poor survival rates, further investigations are warranted to establish the most appropriated indications and timing for MCS in COVID-19.

Background: Significant aortic regurgitation at the time of left ventricular assist device (LVAD) implantation, requires concomitant aortic valve (AoV) replacement or repair. However, the impact of concomitant AoV surgery on morbidity remains unknown. Therefore, our aim is to determine the impact of concomitant AoV surgery on thromboembolic and bleeding events. Methods: A retrospective IMACS registry study, including patients implanted from 2013 until September 2017. Differences between different concomitant AoV surgery modalities were analyzed. Results: In total, 785 (5.1%) out of 15.267 patients (median age 58 IQR 49-66 years, 79% male) underwent concomitant AoV surgery (median age 63 IQR 54-69 years, 84% male); 386 (49%) patients received biological prostheses, 71 (9%) mechanical prostheses and 328 (42%) AoV repairs. In total, 54 (8%) patients with AoV surgery experienced a thromboembolic event and 1016 (9%) patients with no AoV surgery. Only AoV repair surgery was associated with an increased rate of pump thrombosis (p=0.024). Furthermore, concomitant AoV surgery was associated with an increased rate of all and nonsurgical bleedings. Following a multivariable Cox regression, concomitant AoV surgery remained an independent predictor for bleeding events. Conclusions: In LVAD patients undergoing concomitant AoV surgery, thromboembolic event rates were not higher, however both all and nonsurgical bleeding event rates were higher. Furthermore, concomitant AoV repair surgery was associated with an increased rate of pump thrombosis.

Ventricular assist devices (VADs) are implantable turbomachines that save and improve the lives of patients with severe heart failure. In the preclinical evaluation, a VAD design must be experimentally or numerically tested regarding its pump characteristics, primarily for its pressure buildup (pressure head H) since it must provide the cardiovascular system with a sufficient blood flow rate Q. Those pump characteristics are determined on a test bench. Here, a glycerol-water mixture is almost exclusively used as blood-analogous fluid, which should reflect the properties (density, viscosity) of blood as close as possible. However, glycerol water has some disadvantages, such as a higher density compared to real blood and a relatively high cost. Therefore, the study aimed to analyze six different blood analogous fluids to select the most suitable one in consideration of fluid handling, costs, and, most importantly, fluid properties (material and rheological). First, all fluids were mixed to achieve reference values of blood density and viscosity from the literature. Afterwards, the pump characteristics (pressure heads and efficiencies via the VAD) were experimentally and numerically determined and compared among each other and with literature values. Of all six investigated fluids, only the aqueous–polyethylene glycol 200 (PEG 200) solution matches exactly the desired blood properties, and the pump characteristics of this fluid are in the expected range for the analyzed operation point of the VAD. Another advantage is that the cost of the mixture is 35% lower compared to glycerol water. Additionally, we demonstrate that non-Newtonian flow behavior has little effect on the pump characteristics in our VAD.

Long-term continuous-flow left ventricular assist device (CFLVAD) therapy is limited by complications. Compared with stroke and renal dysfunction, post-CFLVAD bowel ischemia is poorly characterized. Adult patients who underwent first-time durable CFLVAD implantation at our institution between 2008 and 2018 were identified and screened for bowel ischemia using Current Procedural Terminology codes for abdominal surgical exploration and International Classification of Disease codes for intestinal vascular insufficiency. Patients who developed biopsy-proven bowel ischemia (cases) were matched to controls (1:1, nearest neighbor, caliper = 0.29) based on preoperative characteristics. Incidences of postoperative right heart failure and renal replacement therapy were compared using McNemar's test. One year survival was estimated using the Kaplan-Meier method. Overall, 711 patients underwent CFLVAD implantation. Nineteen (2.7%) developed bowel ischemia (cases) median 17 days postimplantation (IQR 8-71). The majority of cases were male (78.9%), Black (63.2%), received HeartMate II (57.9%), treated as destination therapy (78.9%), and had a history of hypertension (89.5%), chronic kidney disease (84.2%), hyperlipidemia (84.2%), smoking (78.9%), and atrial fibrillation (57.9%). Post-LVAD, case patients were more likely to develop moderate-severe right heart failure (89.5% vs. 68.4%, p = 0.005), require renal replacement therapy (21.1% vs. 0%, p < 0.001), and less likely to survive to discharge (52.6% vs. 89.5%, p = 0.02) compared with controls. Case subjects demonstrated worse 1 year survival. While less common than stroke and renal dysfunction, post-CFLVAD bowel ischemia is associated with high 1 year mortality. Multi-institutional registries should consider reporting abdominal complications such as bowel ischemia as an adverse event to further investigate these trends and identify predictors of this complication to reduce patient mortality.

Current generation continuous flow assist devices to operate at a fixed speed, which limits preload response and exercise capacity in left ventricular assist device (LVAD) patients. A feedback control system was developed to automatically adjust pump speed based on direct measurements of ventricular loading using a custom cannula tip with an integrated pressure sensor and volume-sensing conductance electrodes. The input to the control system is the integral of the left ventricular (LV) pressure versus conductance loop (PGA) over each cardiac cycle. The feedback control system adjusts pump speed based on the difference between the measured PGA and the desired PGA. The control system and cannula tip were tested in acute ovine studies (n = 5) using the HeartMate II LVAD. The preload response of the control system was evaluated by partially occluding and releasing the inferior vena cava using a vessel loop snare. The cannula tip was integrated onto a custom centrifugal flow LVAD and tested in a 14-day bovine study. The control system adjusted pump support to maintain constant ventricular loading: pump speed increased (decreased) following an increase (decrease) in preload. This study demonstrated in vivo the Starling-like response of an automatic pump control system based on direct measurements of LV loading.

Some neonates with functionally univentricular hearts are extremely high risk for conventional surgical palliation. Primary cardiac transplantation offers the best option for survival of these challenging neonates; however, waitlist mortality must be minimized. We have developed a comprehensive strategy for the management of neonates with functionally univentricular hearts that includes the selective use of conventional neonatal palliation in standard risk patients, hybrid approaches in neonates with elevated risk secondary to noncardiac etiology, and neonatal palliation combined with insertion of a single ventricular assist device (VAD) in neonates with elevated risk secondary to cardiac etiology. The purpose of this manuscript is to describe our selection criteria, technical details, management strategies, pitfalls, and current outcomes for neonates with functionally univentricular hearts supported with VAD. Our experience documents that extremely high-risk patients with functionally univentricular hearts who are poor candidates for conventional palliation can be successfully stabilized with concomitant palliation and pulsatile VAD insertion while awaiting transplantation.

Heparin-induced thrombocytopenia (HIT) is a serious complication in patients exposed to heparin, leading to thrombocytopenia and, potentially, thrombosis. This disorder is challenging in cardiac surgery when anticoagulation for cardiopulmonary bypass is required. Herein a patient with HIT who had active thrombosis and successfully underwent urgent left ventricular assist device implantation managed with plasma exchange, intravenous immunoglobulin, and protamine infusion is described. These therapies reduce the immune response to heparin and minimize thrombosis when heparin reexposure is planned. These approaches to perioperative management of HIT represent an attractive alternative to the use of non-heparin anticoagulants in the cardiac and vascular surgical population.

Advances in surgical techniques and outpatient cardiac care have led to a growing population of pediatric patients surviving well into adulthood with previous single-ventricle palliation. Continued improvement in survival has resulted in subsequent increases in the number of patients with single-ventricle physiology listed for heart transplantations. Some of these patients require mechanical circulatory support as a bridge to transplantation, although establishing successful mechanical circulatory support in these complex patients remains challenging. Only limited published data exist describing the perioperative anesthetic management and key considerations dedicated to patients with failing single-ventricle physiology presenting for ventricular assist devices. This clinical review aims to provide a focused evaluation of the vital perioperative considerations encountered in this novel population.

Ventricular suction is a common adverse event in ventricular assist device (VAD) patients and can be due to multiple underlying causes. The aim of this study is to analyze the potential of different therapeutic interventions to mitigate suction events induced by different pathophysiological conditions. To do so, a suction module was embedded in a cardiovascular hybrid (hydraulic-computational) simulator reproducing the entire cardiovascular system. An HVAD system (Medtronic) was connected between a compliant ventricular apex and a simulated aorta. Starting from a patient profile with severe dilated cardiomyopathy, four different pathophysiological conditions leading to suction were simulated: hypovolemia (blood volume: -900 ml), right ventricular failure (contractility -70%), hypotension (systemic vascular resistance: 8.3 Wood Units), and tachycardia (heart rate:185 bpm). Different therapeutic interventions such as volume infusion, ventricular contractility increase, vasoconstriction, heart rate increase, and pump speed reduction were simulated. Their effects were compared in terms of general hemodynamics and suction mitigation. Each intervention elicited a different effect on the hemodynamics for every pathophysiological condition. Pump speed reduction mitigated suction but did not ameliorate the hemodynamics. Administering volume and inducing a systemic vasoconstriction were the most efficient interventions in both improving the hemodynamics and mitigating suction. When simulating volume infusion, the cardiac powers increased, respectively, by 38%, 25%, 42%, and 43% in the case of hypovolemia, right ventricular failure, hypotension, and tachycardia. Finally, a management algorithm is proposed to identify a therapeutic intervention suited for the underlying physiologic condition causing suction.

Continuous-flow left ventricular assist devices (CF-LVAD) have been shown to enhance reverse remodeling and myocardial recovery in certain patients allowing for device removal. We sought to analyze the characteristics and describe outcomes of patients who underwent CF-LVAD explantation at a large academic center. We retrospectively identified all patients who underwent CF-LVAD explants due to recovery from 2006 to 2019. Patient baseline characteristics and data on pre- and postexplant evaluation were collected and analyzed. Of 421 patients who underwent CF-LVAD implantation, 13 underwent explantation (3.1%). Twelve HeartMate II and one HeartWare LVAD were explanted. All patients had nonischemic cardiomyopathy. Median time from heart failure diagnosis to LVAD implant was 12 months (interquartile range [IQR], 2-44) and the median time supported on LVAD was 22 months (IQR, 11-28). Two patients died within 30 days of explant. Three additional patients died during the follow-up period and all were noted to be nonadherent to medical therapy. After a mean follow-up duration of 5 years, overall survival was 52%. Mean pre-explant ejection fraction was 49%, which decreased at most recent follow-up to 32%. Mean pre-explant left ventricular internal diameter in diastole (LVIDD) was 4.37 cm and increased to 5.52 cm at most recent follow-up. Continuous-flow left ventricular assist device explantation is feasible and safe in select patients.

OBJECTIVE: Myocardial damage occurs in up to 25% of coronavirus disease 2019 (COVID-19) cases. While veno-venous extracorporeal life support (V-V ECLS) is used as respiratory support, mechanical circulatory support (MCS) may be required for severe cardiac dysfunction. This systematic review summarizes the available literature regarding MCS use rates, disease drivers for MCS initiation, and MCS outcomes in COVID-19 patients. METHODS: PubMed/EMBASE were searched until October 14, 2021. Articles including adults receiving ECLS for COVID-19 were included. The primary outcome was the rate of MCS use. Secondary outcomes included mortality at follow-up, ECLS conversion rate, intubation-to-cannulation time, time on ECLS, cardiac diseases, use of inotropes, and vasopressors. RESULTS: Twenty-eight observational studies (comprising both ECLS-only populations and ECLS patients as part of larger populations) included 4218 COVID-19 patients (females: 28.8%; median age: 54.3 years, 95%CI: 50.7-57.8) of whom 2774 (65.8%) required ECLS with the majority (92.7%) on V-V ECLS, 4.7% on veno-arterial ECLS and/or Impella, and 2.6% on other ECLS. Acute heart failure, cardiogenic shock, and cardiac arrest were reported in 7.8%, 9.7%, and 6.6% of patients, respectively. Vasopressors were used in 37.2%. Overall, 3.1% of patients required an ECLS change from V-V ECLS to MCS for heart failure, myocarditis, or myocardial infarction. The median ECLS duration was 15.9 days (95%CI: 13.9-16.3), with an overall survival of 54.6% and 28.1% in V-V ECLS and MCS patients. One study reported 61.1% survival with oxy-right ventricular assist device. CONCLUSION: MCS use for cardiocirculatory compromise has been reported in 7.3% of COVID-19 patients requiring ECLS, which is a lower percentage compared to the incidence of any severe cardiocirculatory complication. Based on the poor survival rates, further investigations are warranted to establish the most appropriated indications and timing for MCS in COVID-19.

BackgroundRight Heart Failure (RHF) is a severe complication that can occur after left ventricular assist device (LVAD) implantation, increasing early and late mortality. Although numerous RHF predictive scores have been developed, limited data exist on the external validation of these models.We therefore aimed at comparing existent risk score models and identifying predictors of severe RHF at our center.MethodsIn this retrospective, single center analysis, clinical, biological and functional data were collected in patients implanted with a LVAD between 2011 and 2020. Early severe RHF was defined as use of inotropes for ≥14 days, nitric oxide use for ≥48 hours or unplanned right-sided circulatory support.Risk models were evaluated for the primary outcome of RHF or RVAD implantation by means of logistic regression and receiver operating characteristic curves. ResultsAmong 92 patients implanted, 24 (26%) developed early severe RHF. The EUROMACS-RHF risk score performed the best in predicting RHF (C=0.82 - 95% CI: 0.68-0.90), compared with the other scores (Michigan, CRITT). In addition, we developed a new model, based on four variables selected for the best reduced logistic model: the INTERMACS level, the number of inotropes used, the ratio of right atrial/pulmonary capillary wedge pressure and the ratio of right ventricle/left ventricle diameters by echocardiography. This model demonstrated significant discrimination of RHF (C=0.91 - 95% CI: 0.76-0.96).ConclusionAmongst available risk scores, EUROMACS-RHF performs best to predict the occurrence of RHF after LVAD implantation. Our model’s performance compares well to the EUROMACS-RHF score, adding a more objective parameter to RV function evaluation.

BACKGROUND The Society of Thoracic Surgeons (STS) Intermacs Registry represents a real-world data source of durable, left ventricular assist devices that can address knowledge gaps not informed through randomized clinical trials. We sought to compare survival with contemporary left ventricular assist device technologies using multiple analytic approaches to assess concordance of treatment effects and to validate prior STS Intermacs observations. METHODS Patients (≥19 years of age) enrolled into STS Intermacs between August 2017 and June 2019 were stratified by device type (continuous flow, centrifugal left ventricular assist device with hybrid levitation [CF-HL] or full magnetic levitation [CF-FML]). The primary outcome was 1-year survival assessed by 3 statistical methodologies (multivariable regression, propensity score matching, and instrumental variable analysis). RESULTS Of 4448 patients, 2012 (45.2%) received the CF-HL and 2436 (54.8%) received the CF-FML. One-year survival for the CF-FML was 88% vs 79% for the CF-HL (overall P < .001), with a hazard ratio for mortality of 3.18 for the CF-HL (P < .0001) after risk adjustment. With propensity score matching (n = 1400 each cohort), 1-year survival was 87% for the CF-FML vs 80% for the CF-HL, with a hazard ratio of 3.20 for mortality with the CF-HL (P < .0001) after risk adjustment. With an instrumental variable analysis, the probability of receiving the CF-HL was associated with a hazard ratio of 3.11 (P < .0001). CONCLUSIONS Statistical methodology using propensity score matching and instrumental variable analysis increased the robustness of observations derived from real-world data and demonstrates the feasibility of performing comparative effectiveness research using STS Intermacs. These analyses provide additional evidence supporting a survival benefit of the CF-FML vs CF-HL.

Pulmonary hypertension (PH) is a common complication of end-stage heart failure (ESHF) and associated with increased mortality. The definition of PH has recently been changed from a mean pulmonary arterial pressure (PAPm) ≥25 mmHg to a PAPm20 mmHg. Since this change, there are no data evaluating group 2 PH subgroups on outcomes. The purpose of this study was to determine the impact of updated group 2 PH subgroups on outcomes, as well as to evaluate the clinical, echocardiographic, and haemodynamic characteristics of subgroups, and determine predictors of PH in patients with ESHF.A total of 416 patients with ESHF with left ventricular ejection fraction (LVEF) ≤25% were divided into three groups. Pulmonary hypertension was defined as PAPm20 mmHg. Primary outcome was defined as left ventricular assist device (LVAD) implantation, urgent heart transplantation (HT), or death. Secondary outcome was defined as LVAD implantation and HT.Over a median follow-up of 503.5 days, combined pre- and postcapillary PH (Cpc-PH) displayed greater risk of primary outcome than those with isolated postcapillary (Ipc-PH) (hazard ratio [HR], 1.57; 95% confidence interval [CI], 1.29-1.91; p0.001) and those with no PH (HR, 2.47; 95% CI, 1.68-3.63; p0.001). Patients with Ipc-PH demonstrated greater risk than those with no PH (HR, 1.57; 95% CI, 1.57-1.90; p0.001). Likelihood ratios of updated PH criteria and old PH criteria (PAPm ≥25 mmHg) in identifying primary outcome were 75.6 (RPulmonary hypertension increases the risk of LVAD, urgent HT, or death, and Cpc-PH further increases risk in patients with ESHF. Compared to the previous definition, a new PH definition better discriminates death, going to urgent HT, or LVAD implantation for PH subgroups.

Heart transplant is in high demand, but the wait list exceeds 6 months in Turkey. Until a donor heart can be procured, venoarterial extracorporeal membrane oxygenation is an important support option to bridge patients on the wait list or as a rescue therapy for patients with right ventricular failure after implant of left ventricular assist device; it is less expensive than other options, provides benefits such as simple percutaneous insertion, and requires neither sternotomy nor biventricular and respiratory support. We present a case of a patient bridged to transplant with 5 months of extracorporeal membrane oxygenation support.

Background: The ideal timing of a durable assist device implantation in patients with end-stage heart failure presenting with INTERMACS profile I is still controversial. The data on extracorporeal life support (ECLS) bridge to durable left ventricular assist device (LVAD) in these patients is limited. Materials and methods: We retrospectively analyzed the outcomes of 35 patients in acute cardiogenic shock (CS) who, between December 2013 and September 2020, were bridged with ECLS to durable LVAD. The mean age was 52.3 ± 12.0 years. The primary endpoints of this study were in-hospital, 30-day, 6-month, and 1-year mortality. The secondary endpoint was the development of any postoperative adverse events and other characteristics during the follow-up period. We also assessed the impact of the rescue ECLS on the recovery of the end-organ function. Results: In-hospital, 30-day, 6-month, and 1-year survival was 65.6%, 75.9%, 69.2%, and 62.7% respectively. The median time on ECLS was 7 days (IQR 5.0–13.0). We observed a high incidence of a severe right heart failure (22.9%), acute kidney injury on dialysis (68.6%), and respiratory failure (77.1%). Bridge with ECLS provided a significant recovery of liver and kidney function prior to durable LVAD implantation. Conclusion: The concept of bridging patients presenting in end-stage heart failure and cardiogenic shock with ECLS prior to durable LVAD implantation is a feasible method to ensure acceptable survival rates and significant recovery of the end-organ function.

Ventricular assist devices have become a valuable tool in the treatment of heart failure in children. The use of ventricular assist devices has decreased mortality in children with end-stage heart failure awaiting transplant. It is not uncommon for children with end-stage heart failure associated with cardiomyopathy or congenital heart disease to have significant systemic semilunar and atrioventricular valve regurgitation, which can impact the efficiency and efficacy of hemodynamic support provided by a ventricular assist device. Therefore, implanting clinicians should carefully assess for valve abnormalities that may need repair and impact device selection and cannulation strategy to effectively support this diverse population. The purpose of this review is to provide an overview of this important and relevant topic and to discuss strategies for managing these patients.

Non-surgical bleeding (NSB) remains the most critical complication in patients under left ventricular assist device (LVAD) support. It is well known that blood exposed to high shear stress results in platelet dysfunction. Compared to patients without NSB, decreased surface expression of platelet receptor GPIbα was observed in LVAD patients with NSB. In this study, we aimed to compare the expression level of glycoprotein (GP)Ib-IX-V platelet receptor complex in HeartMate 3 (HM 3) patients with and without bleeding complications to investigate the alterations of the platelet transcriptomic profile on platelet damage and increased bleeding risk. Blood samples were obtained from HM 3 patients with NSB (bleeder group, n = 27) and without NSB (non-bleeder group, n = 55). The bleeder group was further divided into patients with early NSB (bleeder ≤ 3 mo, n = 19) and patients with late NSB (bleeder > 3 mo, n = 8). The mRNA and protein expression of GPIbα, GPIX and GPV were quantified for each patient. Non-bleeder, bleeder ≤ 3 mo and bleeder > 3 mo were comparable regarding the mRNA expression of GPIbα, GPIX and GPV (p > 0.05). The protein analysis revealed a significantly reduced expression level of the main receptor subunit GPIbα in bleeders ≤ 3 mo (p = 0.04). We suggest that the observed reduction of platelet receptor GPIbα protein expression in patients who experienced their first bleeding event within 3 months after LVAD implantation may influence platelet physiology. The alterations of functional GPIbα potentially reduce the platelet adhesion capacities, which may lead to an impaired hemostatic process and the elevated propensity of bleeding in HM 3 patients.

In recent times, wireless power transfer systems have been identified as a reliable option to supply power to medical implants. Up to now, Wireless Power Transfer Systems (WPTS) have only been used to charge batteries of low-power medical implants. However, for medical implants requiring a relatively higher power, such as a ventricular assist device, which is an implanted blood pump in the patient’s abdominal cavity, an external power supply has been used. When WPTS is used for medical implants, it increases the number of required power converter stages and hardware complexity along with the volume, which tends to reduce the overall efficiency. In addition, the existence of uncertainties in WPTS-based medical implants, such as load and mutual inductance variations, can lead to system instability or poor performance. The focus of this paper is to design a WPTS to supply power to the pump motor directly through its inverter based on the requirements of the motor drive system (MDS) without resorting to an additional DC-to-DC converter stage. To this end, the constraints that the drive system imposes upon WPTS have been identified. In addition, to make a reliable closed-loop operation, a µ-synthesis robust controller is designed to make sure the system maintains its stability and performance with respect to the system’s existing uncertainties. A number of experimental results are provided to verify the effectiveness of the adopted WPTS design approach and the corresponding closed-loop controller for WPTS. Furthermore, the experimental findings for the maximum efficiency tracking (MET) approach (to minimize WPTS coil losses) and constant DC link voltage control approach are shown and compared. According to experimental results and system efficiency analysis, the former appears to perform better. The system dynamic performance analysis, on the other hand, demonstrates the latter’s advantage.

Heart failure (HF) is one of the most prevalent life-threatening cardiovascular diseases in which 6.5 million people are suffering in the USA and more than 23 million worldwide. Mechanical circulatory support of HF patients can be achieved by implanting a left ventricular assist device (LVAD) into HF patients as a bridge to transplant, recovery or destination therapy and can be controlled by measurement of normal and abnormal pulmonary arterial wedge pressure (PAWP). While there are no commercial long-term implantable pressure sensors to measure PAWP, real-time non-invasive estimation of abnormal and normal PAWP becomes vital. In this work, first an improved Harris Hawks optimizer algorithm called HHO+ is presented and tested on 24 unimodal and multimodal benchmark functions. Second, a novel fully Elman neural network (FENN) is proposed to improve the classification performance. Finally, four novel 18-layer deep learning methods of convolutional neural networks (CNNs) with multi-layer perceptron (CNN-MLP), CNN with Elman neural networks (CNN-ENN), CNN with fully Elman neural networks (CNN-FENN), and CNN with fully Elman neural networks optimized by HHO+ algorithm (CNN-FENN-HHO+) for classification of abnormal and normal PAWP using estimated HVAD pump flow were developed and compared. The estimated pump flow was derived by a non-invasive method embedded into the commercial HVAD controller. The proposed methods are evaluated on an imbalanced clinical dataset using 5-fold cross-validation. The proposed CNN-FENN-HHO+ method outperforms the proposed CNN-MLP, CNN-ENN and CNN-FENN methods and improved the classification performance metrics across 5-fold cross-validation with an average sensitivity of 79%, accuracy of 78% and specificity of 76%. The proposed methods can reduce the likelihood of hazardous events like pulmonary congestion and ventricular suction for HF patients and notify identified abnormal cases to the hospital, clinician and cardiologist for emergency action, which can diminish the mortality rate of patients with HF.

Heart failure affects an estimated 26 million people worldwide, and at any one time 300,000 Australians. Whilst the gold standard treatment for heart failure is heart transplantation, a shortage of donor hearts limits the availability of this lifesaving intervention. Mechanical circulatory support devices offer a promising alternative treatment for not only patients on the transplantation waiting list, but also as a destination therapy for patients who are not eligible for transplantation. Ventricular assist devices (VADs) are a form of mechanical circulatory support used to support the function of the failing heart when the heart is unable to maintain adequate cardiac output. Most commonly a VAD will work in parallel with the native left ventricle (LV), with inflow cannula implantation performed through the apex of the LV and secured to the epicardium with a suture ring. Common complications of VAD implantation and support, such as surgical bleeding, can be attributed in part to inflow cannula design or placement. Extended time on cardiopulmonary bypass (utilised during VAD implantation) is also associated with inferior postoperative outcomes. To address the complications influenced by extended surgical time, and inflow cannula design and placement, Shaun Gregory developed a novel sutureless cannula through his doctoral research. The cannula was introduced in a chapter of his thesis and awarded a provisional patent (now lapsed). Gregory’s research involved the design and manufacture of a proof-of-concept device, and its implantation within cadaveric hearts connected to an ex-vivo mock circulation loop that evaluated the ability of the device to provide a blood-tight seal through the compression of the myocardium between the internal and external components. In 2016 a paper was published that evaluated different inflow cannula tip geometries for thrombus risk within an in-silico heart model, from the same research group. One of the five cannulae modelled had an inferiorly flared internal geometry, indicative of Gregory’s cannula, however it was only a representative model with an idealised internal geometric shape. Beyond this publication there has been no further research, device development, or device evaluation undertaken or published involving the sutureless inflow cannulae (SLIC) until this doctoral research. The doctoral research presented within this thesis aimed to continue the development beyond proof-of-concept and undertake a critical evaluation of the SLIC. To undertake further evaluation of the SLIC a critical review of the cannula developed by Gregory was undertaken, where the limitations of the design were addressed, and the device progressed through design changes. For development of an implantable medical device one of the evaluations conducted is implantation within an animal in the acute setting. To continue with its evaluation the SLIC was implanted in-vivo (within pigs) through an acute study and evaluated against parameters such as the ability of the SLIC to be implanted in under 2 minutes, for the SLIC to provide a secure haemostatic seal across the myocardial wall, and there to be no bleeding at the site of SLIC implantation. To investigate the impact the compressive seal of the SLIC had on the myocardium, histology review was conducted on sectioned cardiac tissue from all five animals against markers for myocardial injury. Whilst the initial two animals in the acute in-vivo study had successful outcomes across all areas evaluated, the following three animals all suffered adverse events due to internal cardiac geometry incompatible with SLIC implantation (hypertrophic cardiomyopathy), or surgical error (near-complete oversew of the outflow graft). The final animal implanted with the SLIC had undiagnosed severe hypertrophic cardiomyopathy that resulted, during attempted implantation, in critical breakage of the SLIC within the LV. Histological review against immunohistochemical markers for early onset myocardial injury also produced positive results, primarily seen at the site of implantation through expression of Tumor Necrosis Factor Alpha, and depletion of Cardiac Troponin T and Myoglobin. Haematoxylin and Eosin staining also revealed changers indicative of early onset damage such as wavy fibres, interstitial oedema, granulation formation, and hypereosinophilia of some cardiomyocytes. These results, in combination with the in-vitro testing determining forces applied by the SLIC onto the cardiac tissue, provide indication that the current implantation securement mechanism of the SLIC causes myocardial injury. The final research conducted and described in this doctoral thesis details the redesign process of the SLIC, that extracts the outcomes from the research and formulates new device development inputs. A proof-of-concept device is introduced in the final research chapter. The main finding of this doctoral research indicates that a SLIC that is capable of rapid implantation, without the reliance on suturing into place for secure fixation is feasible and capable of working in conjunction with a VAD to support cardiac function. However, the impact that the compressive locking mechanism has on the tissue it is implanted within requires attention and consideration in any future work design parameters to ensure development of an implantable medical device suitable for long-term implantation.

Postoperative bleeding is the most common complication after pediatric cardiac surgery. Up to 5 % of cardiac surgery will require re-exploration for major blood loss in the first 24 h after surgery. Uncontrolled bleeding if not addressed early could lead to hypovolemic shock, multi-organ failure, and eventually death. Concealed bleeding in the chest could also cause cardiac tamponade if the chest and mediastinum are not adequately drained. Blood product use is not devoid of complication, and strategies should be designed to minimize transfusion as much as possible. There are several known medical and surgical risk factors for postoperative bleeding. During the preoperative visit, the anesthesiologist should investigate for “red flags” for postoperative bleeding and address them. Unnecessary medications that could affect coagulation should be discontinued. Medical conditions that affected the coagulation system should be stabilized. Cardiopulmonary bypass (CPB) strategies and surgical plan should also consider the effect on bleeding and coagulation. Finally it is very important to plan for adequate intravenous access and use of prophylactic agents and to secure availability of blood, coagulation factors, and components.

Cardiogenic shock has a high mortality rate (up to 60%). Different respiratory and mechanical circulatory support (MCS) is sometimes needed in treating these critically ill patients. We present a young patient with severe acute myocarditis and cardiogenic shock successfully treated to full recovery which required different extracorporeal membrane oxygenation (ECMO) configurations and a percutaneous left ventricular assist device (LVAD).

We previously reported the first successful implantation of the Heartmate 3TM in a Fontan patient. We now report his successful transplantation after 1,104 days of support, the longest reported bridge to transplantation of a Fontan patient. We describe our operative technique complicated by not only the Fontan anatomy and ventricular assist device (VAD) explanation but also a >10cm ascending and aortic arch aneurysm. Additionally, the post-transplant hemodynamics of this patient appear to demonstrate that effective VAD support may induce reversal of chronic effects of the failing Fontan circulation, which in this case was the elimination of his aorto-pulmonary collateral burden.

Background Appropriate collection of quality of life (QOL) measurements for left ventricular assist device (LVAD) patients is challenging. Patient-Reported Outcomes Measurement Information System (PROMIS) is a popular tool that has been validated across multiple disciplines, but its applicability to the LVAD population remains unknown. Methods This single-center, retrospective review included LVAD patients that completed a PROMIS assessment and Kansas City Cardiomyopathy Questionnaire (KCCQ-12) survey at clinical encounters postoperatively. Patients completed computer adaptive PROMIS assessments for physical function, pain interference and depression. All PROMIS domains are designed to follow a normal distribution (mean T-score 50, standard deviation 10) in the general population. Assessments were aggregated over time and correlation between the KCCQ-12 summary score and each PROMIS domain was assessed individually. Results A total of 178 LVAD patients were included in the study. The median time between LVAD implantation and PRO collection was 16.5 [interquartile range, 7.9-37.8] months. Patients typically had worse physical function (T-score 38.8 [33.6-44.2]) but comparable pain (51.1 [38.7-59.2]) and depression (49.9 [41.7-57.5]) as the general population. The KCCQ-12 was more strongly correlated to PROMIS physical function (Spearman’s ρ = 0.746) than pain (ρ = -0.539) or depression (ρ = -0.591). Conclusions PROMIS provides a robust QOL data collection system that can be implemented in a clinical setting without imposing a significant burden. Using this more holistic system may allow for better patient-centered care in order to address QOL limitations imposed by LVAD support that are not directly related to heart failure symptoms.

Background: The Impella transaortic microaxial left ventricular assist device (MLVAD) bears the risk of severe ipsilateral limb ischemia due to its percutaneous insertion through the common femoral artery (CFA). As long as the MLVAD is required for cardio - circulatory support, treatment options are limited. Therefore, we developed a temporary extracorporeal femoral - femoral crossover bypass to restore and maintain perfusion of the affected leg. Methods: From October 2018, we treated all patients with severe limb ischemia due to the MLAVD with a femoral - femoral crossover bypass. For comparison, a consecutive cohort of patients undergoing placement of the MLAVD between January 2011 and October 2018 was identified. The primary outcome is the feasibility and safety of our percutaneously established extracorporeal femoral - femoral crossover bypass. Results: Between January 2011 and July 2019, 25 of 245 (10.3%) patients developed a severe ipsilateral limb ischemia following the MLVAD placement. Until October 2018, 20 patients were treated conventionally (C - cohort) and since October 2018, five (consecutive) patients have been treated by an extracorporeal femoral - femoral cross over bypass (BP - Cohort). Following the BP - procedure, an immediate improvement of the perfusion was seen in all patients. Limb salvage was documented in 100% of our patients and 30 - day mortality was 60% in both groups. Conclusion: This is the first case series reporting on this novel technique. We demonstrated that the percutaneous creation of an extracorporeal crossover bypass is feasible, safe and effective and should therefore be promoted.

BACKGROUND There is little insight into which patients can be weaned off right ventricular (RV) acute mechanical circulatory support (AMCS) after left ventricular assist device (LVAD) implantation. We hypothesize that concomitant RV AMCS insertion instead of postoperative implantation will improve 1-year survival and increase the likelihood of RV AMCS weaning. METHODS A multicenter retrospective database of 826 consecutive patients who received a HeartMate II or HVAD between January 2007 and December 2016 was analyzed. We identified 91 patients who had early RV AMCS on index admission. Cox proportional-hazards model was constructed to identify predictors of 1-year mortality post-RV AMCS implantation and competing risk modeling identified RV AMCS weaning predictors. RESULTS There were 91 of 826 patients (11%) who required RV AMCS after CF-LVAD implantation with 51 (56%) receiving a concomitant RV AMCS and 40 (44%) implanted with a postoperative RV AMCS during their ICU stay; 48 (53%) patients were weaned from RV AMCS support. Concomitant RV AMCS with CF-LVAD insertion was associated with lower mortality (HR 0.45 [95% CI 0.26-0.80], p = 0.01) in multivariable model (which included age, BMI, angiotensin-converting enzyme inhibitor use, and heart transplantation as a time-varying covariate). In the multivariate competing risk analysis, a TPG < 12 (SHR 2.19 [95% CI 1.02-4.70], p = 0.04) and concomitant RV AMCS insertion (SHR 3.35 [95% CI 1.73-6.48], p < 0.001) were associated with a successful wean. CONCLUSIONS In patients with RVF after LVAD implantation, concomitant RV AMCS insertion at the time of LVAD was associated with improved 1-year survival and increased chances of RV support weaning compared to postoperative insertion.

Preoperative variables can predict short term left ventricular assist device (LVAD) survival, but predictors of extended survival remain insufficiently characterized.Patients undergoing LVAD implant (2012-2018) in the Intermacs registry were grouped according to time on support: short-term (1 year, n = 7,483), mid-term (MT, 1-3 years, n = 5,976) and long-term (LT, ≥3 years, n = 3,015). Landmarked hazard analyses (adjusted hazard ratio, HR) were performed to identify correlates of survival after 1 and 3 years of support.After surviving 1 year of support, additional LVAD survival was less likely in older (HR 1.15 per decade), Caucasian (HR 1.22) and unmarried (HR 1.16) patients (p0.05). After 3 years of support, only 3 preoperative characteristics (age, race, and history of bypass surgery, p0.05) correlated with extended survival. Postoperative events most negatively influenced achieving LT survival. In those alive at 1 year or 3 years, the occurrence of postoperative renal (creatinine HR MT = 1.09; LT HR = 1.10 per mg/dl) and hepatic dysfunction (AST HR MT = 1.29; LT HR = 1.34 per 100 IU), stroke (MT HR = 1.24; LT HR = 1.42), infection (MT HR = 1.13; LT HR = 1.10), and/or device malfunction (MT HR = 1.22; LT HR = 1.46) reduced extended survival (all p ≤ 0.03).Success with LVAD therapy hinges on achieving long term survival in more recipients. After 1 year, extended survival is heavily constrained by the occurrence of adverse events and postoperative end-organ dysfunction. The growth of destination therapy intent mandates that future LVAD studies be designed with follow up sufficient for capturing outcomes beyond 24 months.

Document Reviewers: Rudolf A. de Boer (CPG Review Coordinator) (Netherlands), P. Christian Schulze (CPG Review Coordinator) (Germany), Magdy Abdelhamid (Egypt), Victor Aboyans (France), Stamatis Adamopoulos (Greece), Stefan D. Anker (Germany), Elena Arbelo (Spain), Riccardo Asteggiano (Italy), Johann Bauersachs (Germany), Antoni Bayes-Genis (Spain), Michael A. Borger (Germany), Werner Budts (Belgium), Maja Cikes (Croatia), Kevin Damman (Netherlands), Victoria Delgado (Netherlands), Paul Dendale (Belgium), Polychronis Dilaveris (Greece), Heinz Drexel (Austria), Justin Ezekowitz (Canada), Volkmar Falk (Germany), Laurent Fauchier (France), Gerasimos Filippatos (Greece), Alan Fraser (United Kingdom), Norbert Frey (Germany), Chris P. Gale (United Kingdom), Finn Gustafsson (Denmark), Julie Harris (United Kingdom), Bernard Iung (France), Stefan Janssens (Belgium), Mariell Jessup (United States of America), Aleksandra Konradi (Russia), Dipak Kotecha (United Kingdom), Ekaterini Lambrinou (Cyprus), Patrizio Lancellotti (Belgium), Ulf Landmesser (Germany), Christophe Leclercq (France), Basil S. Lewis (Israel), Francisco Leyva (United Kingdom), AleVs Linhart (Czech Republic), Maja-Lisa Løchen (Norway), Lars H. Lund (Sweden), Donna Mancini (United States of America), Josep Masip (Spain), Davor Milicic (Croatia), Christian Mueller (Switzerland), Holger Nef (Germany), Jens-Cosedis Nielsen (Denmark), Lis Neubeck (United Kingdom), Michel Noutsias (Germany), Steffen E. Petersen (United Kingdom), Anna Sonia Petronio (Italy), Piotr Ponikowski (Poland), Eva Prescott (Denmark), Amina Rakisheva (Kazakhstan), Dimitrios J. Richter (Greece), Evgeny Schlyakhto (Russia), Petar Seferovic (Serbia), Michele Senni (Italy), Marta Sitges (Spain), Miguel Sousa-Uva (Portugal), Carlo G. Tocchetti (Italy), Rhian M. Touyz (United Kingdom), Carsten Tschoepe (Germany), Johannes Waltenberger (Germany/Switzerland) All experts involved in the development of these guidelines have submitted declarations of interest. These have been compiled in a report and published in a supplementary document simultaneously to the guidelines. The report is also available on the ESC website www.escardio.org/guidelines For the Supplementary Data which include background information and detailed discussion of the data that have provided the basis for the guidelines see European Heart Journal online.

SUMMARY OBJECTIVE: We aimed to investigate whether sarcopenia measured from pectoralis muscles is a risk factor for long-term mortality in left ventricular assist device patients. METHODS: Patients aged >18 years implanted with a left ventricular assist device in a single center between 2013 and 2019 were retrospectively included. Patients without a thoracic computed tomography scan performed within 3 months of left ventricular assist device implantation and without computed tomography scans appropriate for pectoralis muscle measurement were excluded. Pectoralis muscle measurements were made on thoracic computed tomography slices, and pectoralis muscle indices were calculated for each patient. Sarcopenia was defined as being in the gender-specific lowest tertile of pectoralis muscle index. Survival was compared between patients with and without sarcopenia. RESULTS: The study was conducted on 64 left ventricular assist device patients who met the inclusion criteria. Notably, 21 (32.8%) of the study patients were sarcopenic. Diabetes mellitus and sarcopenia were more common in patients with 2-year mortality in our cohort. Patients with sarcopenia had a worse 2-year survival (p

Objectives This analysis sought to investigate the waitlist and post-transplant outcomes of individuals bridged to transplantation by using temporary percutaneous endovascular mechanical circulatory support (tMCS) through a status 2 designation (cardiogenic shock and exception). Background The 2018 donor heart allocation policy change granted a status 2 designation to patients supported with tMCS. Methods Adult patients in the United Network for Organ Sharing registry after October 18, 2018 who received a status 2 designation for tMCS were included and grouped by their status 2 criteria: cardiogenic shock with hemodynamic criteria (CS-HD), cardiogenic shock without hemodynamic criteria before tMCS (CS-woHD), and exception. Baseline characteristics, waitlist events (death and delisting), and post-transplant outcomes were compared. Results A total of 2,279 patients met inclusion criteria: 68.6% (n = 1,564) with CS-HD, 3.2% (n = 73) with CS-woHD, and 28.2% (n = 642) with exceptions. A total of 64.2% of patients underwent heart transplantation within 14 days of status 2 listing or upgrade, and 1.9% died or were delisted for worsening clinical condition. Among the 35.8% who did not undergo transplantation following 14 days, only 2.8% went on to receive a left ventricular assist device (LVAD). The 30-day transplantation likelihood was similar among groups: 80.1% for the CS-HD group vs 79.7% for the exception group vs 73.3% for the CS-woHD group; P = 0.31. However, patients who met criteria for CS-woHD had 2.3-fold greater risk of death or delisting (95% CI: 1.10-4.75; P = 0.03) compared with CS-HD patients after multivariable adjustment. Pre-tMCS hemodynamics were not associated with adverse waitlist events. Conclusions The use of tMCS is an efficient, safe, and effective strategy as a bridge to transplantation; however, patients with CS-woHD may represent a high-risk cohort. Transition to a durable LVAD was a rare event in this group.

Background Dilated cardiomyopathy (DCM) is a well-described entity for heart failure (HF) with reduced left ventricular ejection fraction (LVEF). Recently, drugs and other substance of abuse have been recognized as potential triggers for DCM. The aim of this study was to assess the survival in patients under 65 years old with toxic cardiomyopathy (TCM). Left ventricular remodeling and the potential usefulness of left ventricular assist device (LVAD) was also assessed. Methods Single center retrospective study from January 2003 to August 2019 at a tertiary care cardiology center identified 553 patients younger than 65 years old with LVEF Results Two hundred and one patients (36%) had a diagnosis of idiopathic DCM. Further analysis identified 38 patients (19%) for which a TCM was the most likely etiology (amphetamine [50%], cocaine [37%], anabolic steroids [8%], and energy drinks [5%]). Despite a mean LVEF of 17±8% at presentation, most patients (n=27, 71%) had an event-free survival with guideline-directed medical therapy, and 61% (n=23) recovered a LVEF ≥40% after a median follow-up of 21±23 months. Seven patients (18%) required a LVAD and 1 (3%) patient a transplantation. All LVAD were explanted or decommissioned after a median support time of 11±4 months following partial or complete LVEF recovery. Conclusion TCM induced by substance abuse is a frequent cause of HF accounting for almost 20% of all patients with DCM of unknown etiology under 65 years of age. Treatment must be tailored on an individual basis. Mechanical circulatory support demonstrated its usefulness in carefully selected patients.

The prevalence of sarcoidosis-related cardiomyopathy is increasing. Sarcoidosis impacts cardiac function through granulomatous infiltration of the heart, resulting in conduction disease, arrhythmia and/or heart failure. Diagnosis of cardiac sarcoidosis can be challenging and requires clinician awareness as well as differentiation from overlapping diagnostic phenotypes such as other forms of myocarditis and arrhythmogenic cardiomyopathy. Clinical manifestations, extracardiac involvement, histopathology, and advanced cardiac imaging can all lend support to a diagnosis of cardiac sarcoidosis. Mainstay therapy for cardiac sarcoidosis is immunosuppression, however no prospective clinical trials exist to guide management. Patients may progress to developing advanced heart failure or ventricular arrhythmia, for which ventricular assist device therapies or heart transplantation may be considered. The existing knowledge gaps in cardiac sarcoidosis call for an interdisciplinary approach to both patient care and future investigation to improve mechanistic understanding and therapeutic strategies.

Background Ventricular septal rupture (VSR) is a rare but severe complication of acute myocardial infarction (AMI). For such cases, surgical repair is recommended by major guidelines, but not always possible for such cases. Case presentation A 72-year-old man presented to the emergency room. ECG showed the ST-segment was elevated by 2–3 mm in lead II, III, and aVF, with Q-waves. Coronary angiography (CAG) showed multi-vessel disease with a total occlusion of the right coronary artery (RCA) and severe stenosis of the left anterior descending artery (LAD). A diagnosis of acute inferior myocardial infarction was made. VSR occurred immediately after percutaneous coronary intervention (a 2.5 × 20 mm drug-eluting stent implanted in RCA), and the patient developed cardiogenic shock. An intra-aortic balloon pump (IABP) was used to stabilize the hemodynamics. Transthoracic echocardiography (TTE) revealed an 11.4-mm left-to-right shunt in the interventricular septum. An attempt was made to reduce the IABP augmentation ratio for weaning on day 12 but failed. Transcatheter closure was conducted using a 24-mm double-umbrella occluder on day 28. The patient was weaned from IABP on day 31 and underwent secondary PCI for LAD lesions on day 35. The patient was discharged on day 41. Upon the last follow-up 6 years later, CAG and TTE revealed no in-stent restenosis, no left-to-right shunt, and 51% left ventricular ejection fraction. Conclusions Prolonged implementation of IABP can be a viable option to allow deferred closure of VSR in AMI patients, and transcatheter closure may be considered as a second choice for the selected senior and vulnerable patients, but the risk is still high.

A 55-year-old woman who had received an implantable left ventricular assist device 3 months earlier presented with dyspnea and a low-flow alarm of the device. Computed tomography and log-file analysis of the device system suggested inflow cannula obstruction. Since the patient had cardiogenic shock due to pump failure, venoarterial extracorporeal membrane oxygenation (ECMO) was initiated. With ECMO, surgical exchange of the pump was considered. However, the obstruction spontaneously resolved without surgical intervention. It turned out that an obstructive thrombus was washed out by rebooting the pump. Moreover, the thrombus was embolized in the patient’s left subclavian artery. The patient underwent heart transplantation 4 months after the pump obstruction accident and continued to do well.