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The definition of mechanical circulatory support (MCS) refers to a group of mechanical devices which can be added to the physiological circulation providing support or replacement of the heart and/or the lungs. This allows adequate blood flow and oxygenation in situations where pharmaceutical support is insufficient. To establish MCS we have several devices at our disposal which can be used as a stand-alone therapy or supplement each other depending on the clinical need. The ongoing technological development and especially radical miniaturization changes the playing field continuously. This article will briefly discuss some of the currently most used devices. [ABSTRACT FROM AUTHOR]

Objective: The present study assessed agreement between resting cardiac output estimated by inert gas rebreathing (IGR) and thermodilution methods in patients with heart failure and those implanted with a left ventricular assist device (LVAD).Methods and Results: Hemodynamic measurements were obtained in 42 patients, 22 with chronic heart failure and 20 with implanted continuous flow LVAD (34 males, aged 50 ± 11 years). Measurements were performed at rest using thermodilution and IGR methods. Cardiac output derived by thermodilution and IGR were not significantly different in LVAD (4.4 ± 0.9 L/min vs 4.7 ± 0.8 L/min, P = .27) or patients with heart failure (4.4 ± 1.4 L/min vs 4.5 ± 1.3 L/min, P = .75). There was a strong relationship between thermodilution and IGR cardiac index (r = 0.81, P = .001) and stroke volume index (r = 0.75, P = .001). Bland-Altman analysis showed acceptable limits of agreement for cardiac index derived by thermodilution and IGR, namely, the mean difference (lower and upper limits of agreement) for patients with heart failure -0.002 L/min/m2 (-0.65 to 0.66 L/min/m2), and -0.14 L/min/m2 (-0.78 to 0.49 L/min/m2) for patients with LVAD.Conclusions: IGR is a valid method for estimating cardiac output and should be used in clinical practice to complement the evaluation and management of chronic heart failure and patients with an LVAD. [ABSTRACT FROM AUTHOR]

The definition of mechanical circulatory support (MCS) refers to a group of mechanical devices which can be added to the physiological circulation providing support or replacement of the heart and/or the lungs. This allows adequate blood flow and oxygenation in situations where pharmaceutical support is insufficient. To establish MCS we have several devices to our disposal which can be used as a stand-alone therapy or supplement each other depending on the clinical need. The ongoing technological development and especially radical miniaturization changes the playing field continuously. This article will briefly discuss some of the currently most used devices. [ABSTRACT FROM AUTHOR]

The use of continuous-flow mechanical circulatory support in preschool children remains anecdotal. This case report describes the sequel to the implantation with a HeartWare HVAD system (Medtronic, Minneapolis, MN) in a 3-year old child. A 3-year-old boy with myocarditis-related cardiomyopathy underwent implantation with a HeartWare device. After an uncomplicated postoperative course, the patient was discharged home. Serial echocardiography showed progressive left ventricular recovery. After 6 months, the device was decommissioned, and the outflow graft was tied off. Six years after insertion, the device was explanted uneventfully. The HeartWare ventricular assist device offers viable long-term mechanical circulatory support in selected children that results in sustainable care and good quality of life. [ABSTRACT FROM AUTHOR]

Due to severely limited donor heart availability, durable mechanical circulatory support remains the only treatment option for many patients with end-stage heart failure. However, treatment complexity persists due to its univentricular support modality and continuous contact with blood. We investigated the function and safety of reBEAT (AdjuCor GmbH), a novel, minimal invasive mechanical circulatory support device that completely avoids blood contact and provides pulsatile, biventricular support. For each animal tested, an accurately sized cardiac implant was manufactured from computed tomography scan analyses. The implant consists of a cardiac sleeve with three inflatable cushions, 6 epicardial electrodes and driveline connecting to an electro-pneumatic, extracorporeal portable driver. Continuous epicardial electrocardiogram signal analysis allows for systolic and diastolic synchronization of biventricular mechanical support. In 7 pigs (weight, 50-80 kg), data were analyzed acutely (under beta-blockade, n = 5) and in a 30-day long-term survival model (n = 2). Acquisition of intracardiac pressures and aortic and pulmonary flow data were used to determine left ventricle and right ventricle stroke work and stroke volume, respectively. Each implant was successfully positioned around the ventricles. Automatic algorithm electrocardiogram signal annotations resulted in precise, real-time mechanical support synchronization with each cardiac cycle. Consequently, progressive improvements in cardiac hemodynamic parameters in acute animals were achieved. Long-term survival demonstrated safe device integration, and clear and stable electrocardiogram signal detection over time. The present study demonstrates biventricular cardiac support with reBEAT. Various demonstrated features are essential for realistic translation into the clinical setting, including safe implantation, anatomical fit, safe device–tissue integration, and real-time electrocardiogram synchronized mechanical support, result in effective device function and long-term safety. reBEAT, a novel, biventricular mechanical circulatory support device that avoids blood contact was studied in pigs. Cardiac function parameters (acute, n = 5) of the left ventricle and right ventricle were significantly improved. In addition, chronic survival of 30 days was achieved with correct positioning and normal tissue morphology. [Display omitted] [ABSTRACT FROM AUTHOR]

Background Mechanical circulatory support in the pediatric population is currently limited to pulsatile ventricular assist devices (VAD). In recent years, the use of durable, newer generation, continuous flow devices have increased substantially among adults with end-stage heart failure. We examined the extended role of this device in the pediatric population (aged less than 18 years). Methods Between 2010 and 2015, 12 patients (median age 7.1 years; range, 3.7 to 17.0; one third of patients were aged 5 years or less) received a HeartWare ventricular assist device (HVAD; HeartWare, Framingham, MA), 11 for cardiomyopathy and 1 for posttransplant rejection. Right VAD support (n = 5; 42%) was provided by a short-term device (Levitronix, Zurich, Switzerland). Results Overall, 1 patient died (day 638), 8 patients (67%) underwent transplantation, 1 patient (8.3%) recovered, and 2 patients (17%) remain on HVAD. The mean length of support was 150 days (range, 16 to 638). Four patients (33.3%) were discharged home (all left VAD). In the left VAD group (n = 7), 3 patients subsequently received transplants (days 185, 201, and 234, respectively), 1 recovered (day 149), 1 died (day 638), 1 remained on HVAD (day 198), and 1 needed conversion to biventricular assist device (BIVAD [day 73]). In the BIVAD group (n = 5), right VAD was weaned in 3 (60%), all subsequently received transplants, and 2 remained on BIVAD support until transplant (days 16 and 17, respectively). One BIVAD patient required conversion to central cannulation for longer-term support. Four BIVAD patients (80%) were in Interagency Registry for Mechanically Assisted Circulatory Support level 1 before VAD compared with 2 (29%) in the left VAD group ( p = not significant). The actuarial survival rate was 100% at 1 year with no neurologic events. Conclusions The third-generation, continuous flow device can provide durable support in the pediatric population. The selection strategy for patients who benefit most from the device continues to evolve. It is anticipated that a smaller design in the future will benefit an even wider pediatric population with heart failure. [ABSTRACT FROM AUTHOR]

Background The systemic morphologic right ventricle (RV) in congenitally corrected transposition of the great arteries or after atrial switch for transposition of the great arteries is associated with late ventricular failure. Although the role of the left ventricular assist device (LVAD) in supporting the failing LV is established, the indications and outcomes of using LVAD in a systemic RV remain unclear. We assessed the role of a third-generation LVAD for systemic RV support. Methods Seven patients (mean age, 36 years) received the HeartWare (HeartWare International Inc, Framingham, MA) VAD for systemic RV failure (congenitally corrected transposition of the great arteries in 1 and after atrial switch in 6). Four patients (57%) had severe subpulmonic LV failure, and aggressive perioperative diuresis with or without hemofiltration was used to offload the subpulmonic LV. The indications of VAD were (1) bridge to transplant in 3 and (2) bridge to decision for a high transpulmonary gradient in 4. Transplantation outcome was compared with systemic RV failure without VAD bridge in 19 patients (years 1989 to 2013). Results Systemic RV support alone was achieved in all patients, with no early deaths (≤30 days). Overall, 6 (86%) returned home, 3 (44%) received a transplant, 2 (28%) died of noncardiac causes, and 2 (28%) continue on VAD support (median support, 232 days). Repeat catheterization (n = 4) showed an improved median transpulmonary gradient in 3 patients (median 18.5 mm Hg pre-VAD vs 8.0 mm Hg post-VAD). Two bridge-to-decision patients received transplants at 640 and 685 days. The stroke rate on VAD support was 43% (2 thromboembolic and 1 hemorrhagic; 3 with satisfactory recovery). De novo aortic regurgitation was 29% (n = 2; 1 valve replacement). All patients (n = 3) survived transplantation (vs 10.5% early mortality without VAD bridge; p = 1.00) and were well at follow-up (range, 53 to 700 days). Conclusions The third-generation VAD provides durable support for systemic RV failure as a bridge to transplant and as a strategy to reduce pulmonary vascular resistance. Although concomitant subpulmonic LV failure is common, systemic RV support alone was achieved in all patients. [ABSTRACT FROM AUTHOR]

Background: Donor arterial blood gas measurements correlate poorly with lung allograft function in the recipient. We assessed the utility of reduced pulmonary vein gas (PVG) partial pressure of oxygen (Po 2) in predicting the incidence of primary graft dysfunction. Methods: While the donor was ventilated with 100% oxygen, superior and inferior pulmonary veins were directly aspirated bilaterally and pulmonary venous Po 2 measured. A Po 2 of less than 300 mm Hg was considered subnormal. These values were assessed for predictive value in terms of primary graft dysfunction in univariate and multivariate analysis. Results: In 112 of the 201 lung and heart-lung transplants performed during the period January 2000 to December 2004, full PVGs were available for analysis. The number of pulmonary veins with sub-normal PVG correlated significantly with the incidence of severe primary graft dysfunction posttransplant in univariate (p = 0.01) and multivariate analysis (hazard ratio 2.35, p = 0.016). When analyzed separately, this correlation remained significant for recipients of single or bilateral transplants alone. No correlation existed between arterial Po 2 at donor referral and incidence of primary graft dysfunction. Median duration of ventilation, intensive care unit stay, and 30-day and 90-day mortality were not significantly different for those with any subnormal PVG compared with those with all values in the normal range. Conclusions: Differential PVGs are a useful tool in the assessment of donor lung function before procurement. It is a helpful indicator of whether preischemic dysfunction is localized or diffuse, and can be used to predict the extent to which ischemia and reperfusion will exacerbate any existing abnormality. [Copyright &y& Elsevier]

Background. We established an in vivo pig model of standardized lung ischemia to analyze pulmonary reperfusion injury. Enhanced chemiluminescence measurement (CM) allowed immediate quantification of reactive oxygen species (ROS) and subsequent lipid peroxidation. In such model we analyzed efficacy of vitamins C and E to prevent reperfusion injury.Methods. After left lateral thoracotomy in group I (n = 6), normothermic lung ischemia was maintained for 90 minutes followed by a 5-hour reperfusion period. In group II, animals (n = 6) underwent ischemia as in group I, but received vitamins (preoperative IV bolus C = 1 g, E = 0.75 g, then continuous infusion (125 mg/h) each throughout the study). In Group III, animals (n = 6) underwent sham surgery and served as controls. Hemodynamic variables and gas exchange were assessed. The CM was performed for injury quantification in blood samples and to determine activation of isolated PMNs. The Wilcox rank test was used for statistical analysis.Results. During reperfusion, all animals in group I developed significant pulmonary edema with significant loss of pulmonary function. The addition of vitamins (group II) improved oxygenation and almost abolished pulmonary inflammatory cell infiltration; however, as in group I, pulmonary compliance still tended to decline and the number of circulating leucocytes increased. The CM showed that, compared with group I, vitamins reduced O2− basic release by PMNs significantly (460% to 170%, p < 0.05; control 165%), but could not prevent an increase of free ROS in whole blood similar to group I (443% to 270%, p = ns, control 207%). With regard to lipid peroxidation only a trend of reduction was observed (117% to 105%, p = ns, control 100%).Conclusions. Differentiated analysis by CM demonstrated that vitamins C and E inhibited PMN activation but were not able to prevent radical production by other sources. This offers a potential explanation why radical scavengers like vitamins only attenuate but ultimately do not prevent reperfusion injury. [Copyright &y& Elsevier]

LVADs through mechanical unloading can lead to reverse remodeling and may culminate in myocardial recovery permitting LVAD deactivation. Minimally invasive LVAD discontinuation with device left in-situ has been reported by our groups to be safe with respect to risk of TE or infection post-discontinuation. Whether this approach reduces long-term safety or recovery sustainability is unknown. This is a dual-center retrospective analysis from May 2010 to January 2020 of 17 patients who had elective minimally invasive LVAD discontinuation for myocardial recovery. All patients had outflow graft surgical ligation and driveline discontinuation with device left in-situ. LVAD discontinuations for infection or device thrombosis were excluded. Patients were followed with serial echocardiography or cardiac CT to monitor for cardiac remodeling. Primary composite endpoint was survival free of HF hospitalization, LVAD reimplantation or transplant after discontinuation. Median age of patients at VAD implantation was 42 years (IQR: 25 to 54) years, all had a nonischemic cardiomyopathy (100%), and 5 (29%) were female. At VAD implantation, median EF was 10.0% (5.0 to 15.0) and LVIDD 6.6cm (5.8 to 7.1). With 11 HVAD (65%) and 6 HeartMate II patients (35%), median duration of LVAD support was 28.7 months (13.5 to 36.2). During LVAD weaning study, median LVEF was 55% (50 to 60), LVIDD 4.8cm (4.3 to 5.1), PCWP 8mmHg (8 to 12), CI 2.4 L/m2 (2.0 to 2.7) and peak VO 2 21.2 mL/kg/min (15.7 to 23.8). Median follow-up time after discontinuation was 28.0 months (13.9 to 49.1). One month post-discontinuation, median EF decreased to 50% (49 to 55, p =0.04) and LVIDD increased to 5.2 cm (4.6 to 5.8, p =0.10). By 4 years, median EF was 40% (19 to 50, p =0.014) and LVIDD 6.0cm (5.5 to 6.3, p =0.001). Post-discontinuation, 1 (6%) patient required transplantation and 3 (18%) died, all from infection related causes. Probability of survival free of primary composite endpoint at 1, 2 and 4 years after discontinuation was 94, 87 and 62%, respectively (Figure). In this analysis, we found LVAD discontinuation with device left in-situ for myocardial recovery is associated with long-term cardiac remodeling. Importantly, probability of survival free of primary composite endpoint was 87% at 2 and 62% at 4 years post-discontinuation. These data show LVAD discontinuation without device explant for myocardial remission appears to be safe with low risk of recurrent HF, though infection may be an important cause of mortality. Factors leading to long-term remodeling must be elucidated. [ABSTRACT FROM AUTHOR]

Left ventricular assist devices (LVADs) mechanically unload the heart and coupled with neurohormonal therapy can promote reverse cardiac remodeling and myocardial recovery. Minimally invasive LVAD decommissioning with the device left in place has been reported to be safe over short-term follow-up. Whether device retention reduces long-term safety, or sustainability of recovery is unknown. This is a dual-center retrospective analysis of patients who had achieved responder status (left ventricular ejection fraction, LVEF ≥40% and left ventricular internal diastolic diameter, LVIDd ≤6.0 cm) and underwent elective LVAD decommissioning for myocardial recovery from May 2010 to January 2020. All patients had outflow graft closure and driveline resection with the LVAD left in place. Emergent LVAD decommissioning for an infection or device thrombosis was excluded. Patients were followed with serial echocardiography for up to 3-years. The primary clinical outcome was survival free of heart failure hospitalization, LVAD reimplantation, or transplant. During the study period 515 patients received an LVAD and 29 (5.6%) achieved myocardial recovery, 12 patients underwent total device explantation or urgent device decommissioning, 17 patients underwent elective LVAD decommissioning, and were included in the analysis. Median age of patients at LVAD implantation was 42 years (interquartile range, IQR: 25-54 years), all had a nonischemic cardiomyopathy, and 5 (29%) were female. At LVAD implantation, median LVEF was 10% (IQR: 5%-15%), and LVIDd 6.6 cm (IQR: 5.8-7.1 cm). There were 11 hydrodynamically levitated centrifugal-flow (65%), and 6 axial-flow LVADs (35%). The median duration of LVAD support before decommissioning was 28.7 months (range 13.5-36.2 months). As compared to the turndown study parameters, 1-month post-decommissioning, median LVEF decreased from 55% to 48% (p = 0.03), and LVIDd increased from 4.8 cm to 5.2 cm (p = 0.10). There was gradual remodeling until 6 months, after which there was no statistical difference on follow-up through 3-years (LVEF 42%, LVIDd 5.6 cm). Recurrent infections affected 41% of patients leading to 3 deaths and 1 complete device explant. Recurrent HF occurred in 1 patient who required a transplant. Probability of survival free of HF, LVAD, or transplant was 94% at 1-year, and 78% at 3-years. LVAD decommissioning for myocardial recovery was associated with excellent long-term survival free from recurrent heart failure and preservation of ventricular size and function up to 3-years. Reducing the risk of recurrent infections, remains an important therapeutic goal for this management strategy. [ABSTRACT FROM AUTHOR]

The HeartWare left ventricular assist device has been in use for over 12 years. We sought to determine how outcomes at our centre have improved over time. Review of electronic hospital records at the Freeman Hospital, Newcastle upon Tyne, United Kingdom. A total of 255 first time adult implants were divided into 2 eras: Era 1: 2009–2015 (N = 154) and Era 2: 2016–2020 (N = 101). We prospectively aimed to avoid higher risk Intermacs Classifications in Era 2, which resulted in significant changes in Intermacs class to lower risk in Era 2 (P < 0.001). There was a significant improvement in survival in Era 2, with 1 year survival increasing from 70 to 80% (P < 0.05). This was particularly associated with lower 30 day mortality in Era 2 (1.7 ± 2.3 vs 15.5 ± 7%, P < 0.005). This was associated with better right ventricular function in Era 2, and there was a trend to more temporary right ventricular assist devices used in Era 2 (28 ± 13 vs 12 ± 14%, P = 0.06). Deaths from intracranial haemorrhage, sepsis and right heart failure were unchanged between eras, though there was a trend towards less deaths in Era 2 from combined thromboses deaths (stroke and device thrombosis; 3.3 ± 5.4 vs 11.1 ± 7.4%, P = 0.07). Better patient selection in association with more use of temporary right ventricular assist support has resulted in a significant improvement in survival. Intracranial haemorrhage, sepsis and right heart failure remain significant problems. [ABSTRACT FROM AUTHOR]

The drive-line to power contemporary ventricular assist devices exiting the skin is associated with infection, and requires a holstered performance of the cardiac pump, which reduces overall quality of life. Attempts to eliminate the drive-line using transcutaneous energy transfer systems have been explored but have not succeeded in viable widespread application. The unique engineering of the coplanar energy transfer system is characterized by 2 large rings utilizing a coil-within-the-coil topology, ensuring robust resonance energy transfer while allowing for a substantial (>6 hours) unholstered circulatory support powered by an implantable battery source. Herein we report the first known human experience with this novel technology, coupled with a continuous-flow assist left ventricular assist device, in 2 consecutive patients evaluated with the primary end-point of system performance at 30 days post-implantation. [ABSTRACT FROM AUTHOR]

BACKGROUND Despite advances in device technology and treatment strategies, infection remains a major cause of adverse events (AEs) in mechanical circulatory support (MCS) patients. To characterize the epidemiology of MCS infection, we examined the type, location, and timing of infection in the International Society for Heart and Lung Transplantation Registry (ISHLT) for Mechanically Assisted Circulatory Support (IMACS) over 3 years, 2013 to 2015. METHODS Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definitions were used to categorize AE infections occurring in MCS patients within IMACS. The IMACS infection variables were mapped to ISHLT definitions for infection where feasible. Three categories of MCS infection were defined as ventricular assist device (VAD) specific, VAD related, and non-VAD. RESULTS There were 10,171 patients enrolled from January 2013 through December 2015. Infection was the most common AE, with 3,788 patients (37%) experiencing ≥ 1 infection, and 6,758 AE infections reported overall. Non-VAD infection was the largest category, 4,501: 34.0% pneumonias, 30.6% non-VAD-related bloodstream infections (BSIs), 24.15% urinary tract infections (UTIs), and 10.2% gastrointestinal infections. VAD-specific infection was the second largest category, 1,756: 82.9% driveline, 12.8% pocket, and 4.3% pump/or cannula infections. VAD-related infection was the smallest category, 501: 47.5% BSIs, 47.5% mediastinitis, and 5.0% mediastinitis/pocket infections. All 3 categories were more frequently reported ≤ 3 months after implant. CONCLUSIONS Non-VAD infection, including pneumonia, BSI, UTI, and gastrointestinal infection, was the leading category of infection in MCS patients and the most frequently reported ≤ 3 months after implant. These results provide evidence to support resourcing and strengthening infection prevention strategy early after implantation in MCS. [ABSTRACT FROM AUTHOR]

Background We used multicenter international data from the International Society of Heart and Lung Transplantation Mechanically Assisted Circulation Support (IMACS) registry to determine bloodstream infection (BSI) event rate, independent risk factors, and association with mortality. Methods Included were patients registered in IMACS from January 2013 through December 2015, assessed BSI event rate of mechanical circulatory support (MCS) and non–MCS-related BSIs, and conducted univariate and multivariate analyses between BSI with baseline characteristics and mortality. Results We documented 1,606 BSIs in 1,231 of 10,171 MCS recipients (12%), with an event rate of 2.43 BSIs/100 patient-months within 3 months after implant (early onset) and 1.03 BSIs/100 patient-months after 3 months (late onset). Of these episodes, 1,378 (85.8%) were non– MCS-related BSI. Increasing body mass index and bilirubin were independent correlates of MCS-related BSI. Independent correlates of non–MCS-related BSI included older age, higher body mass index, previous cardiac surgery, baseline chronic renal disease and dialysis, pre-implant frailty, presence of biventricular assist device, total artificial heart or right ventricular assist device, and Interagency Registry for Mechanically Assisted Circulatory Support category 1. Survival after 3 months after implant of patients who developed early-onset BSI was 56.9% at 24 months vs 77.4% in patients without early-onset BSI ( p < 0.001). Early-onset BSI was an independent correlate of mortality at 3 months after implantation (hazard ratio, 2.56; 95% confidence interval, 2.09-3.15; p < 0.001). Conclusions Early-onset BSI was associated with significantly increased 24-month mortality. More than 85% of these BSIs were not device related. There is an opportunity for infection prevention practices to decrease the BSI event rate, which may affect 24-month survival. These data can also serve as benchmarking for individual institutions. [ABSTRACT FROM AUTHOR]

The second annual IMACS registry report includes over 14, 000 patients from 35 countries. Survival, adverse events, and an updated risk model is presented. Continuous flow pumps continue to dominate the world’s experience. One and Two-year survival remains at 80% and 70%. Congenital heart disease and biventricular support are the most dominant risk factors. The database is poised for major novel analyses. [ABSTRACT FROM AUTHOR]

Background: Left ventricular assist devices (LVADs) have been used as an effective therapeutic option in patients with advanced heart failure, either as a bridge to transplantation, as destination therapy, or in some patients, as a bridge to recovery.Objectives: This study evaluated whether patients undergoing an LVAD bridge-to-recovery protocol can achieve cardiac and physical functional capacities equivalent to those of healthy controls.Methods: Fifty-eight male patients-18 implanted with a continuous-flow LVAD, 16 patients with LVAD explanted (recovered patients), and 24 heart transplant candidates (HTx)-and 97 healthy controls performed a maximal graded cardiopulmonary exercise test with continuous measurements of respiratory gas exchange and noninvasive (rebreathing) hemodynamic data. Cardiac function was represented by peak exercise cardiac power output (mean arterial blood pressure × cardiac output) and functional capacity by peak exercise O2 consumption.Results: All patients demonstrated a significant exertional effort as demonstrated with the mean peak exercise respiratory exchange ratio >1.10. Peak exercise cardiac power output was significantly higher in healthy controls and explanted LVAD patients compared with other patients (healthy 5.35 ± 0.95 W; explanted 3.45 ± 0.72 W; LVAD implanted 2.37 ± 0.68 W; and HTx 1.31 ± 0.31 W; p < 0.05), as was peak O2 consumption (healthy 36.4 ± 10.3 ml/kg/min; explanted 29.8 ± 5.9 ml/kg/min; implanted 20.5 ± 4.3 ml/kg/min; and HTx 12.0 ± 2.2 ml/kg/min; p < 0.05). In the LVAD explanted group, 38% of the patients achieved peak cardiac power output and 69% achieved peak O2 consumption within the ranges of healthy controls.Conclusions: The authors have shown that a substantial number of patients who recovered sufficiently to allow explantation of their LVAD can even achieve cardiac and physical functional capacities nearly equivalent to those of healthy controls. [ABSTRACT FROM AUTHOR]

Background This study examined whether aortic valve opening (AVO) and other echocardiographic parameters influence outcomes in patients on left ventricular (LV) assist device (LVAD) support. Pump thrombosis (PT) and ischemic stroke (IS) are known complications of LVAD, but mechanisms that could influence them are not completely understood. Methods This was a retrospective analysis of 147 patients who received a HeartWare Ventricular Assist Device ( HeartWare International) as a bridge to transplant or to candidacy between July 2009 and August 2015, of whom 126 had at least 30 days of follow-up before the first event (30-days-out cohort). Outcomes included survival, PT, IS, and PT+IS (combined thrombotic event; CTE). Results Median time on support was 518 days. Of the 30-days-out cohort, 29% had a first PT and 19% a first IS. AVO was associated with longer survival on device (1,081 vs 723 days; p = 0.01) in the entire cohort. In the 30-days-out cohort, the aortic valve was more frequently closed in patients with lower ejection fractions on support (14% ± 6% vs 18% ± 9%; p = 0.009), more dilated pre-event echocardiogram (LV end-diastolic diameter, 66 ± 12 mm vs 62 ± 10 mm; p = 0.04), and pre-implant LV end-diastolic diameter (70 ± 10 mm vs 66 ± 9 mm; p = 0.06). CTE-free survival on the device was lower with a closed aortic valve (897 vs 1,314 days; p = 0.003) as was PT-free survival on the device (1,070 vs 1,457 days; p = 0.02). Cox regression analysis showed that AVO was an independent predictor of CTE ( p = 0.03) Conclusions Thrombotic events are relatively frequent in patients on long-term LVAD support. A closed aortic valve was associated with decreased overall survival, thrombosis-free survival, and poorer LV function on support. These are high-risk patients, so whether they require more intense anti-coagulation or prioritizing for transplantation requires further research. [ABSTRACT FROM AUTHOR]

The first annual report of the International Society for Heart and Lung Transplantation (ISHLT) Mechanically Assisted Circulatory Support (IMACS) registry provides global data on 5,942 patients from 31 countries. This initial report focuses on patient demographics, survival, device types, adverse events, competing outcomes, and a risk factor analysis. [ABSTRACT FROM AUTHOR]

Background In this study we investigated the development of aortic incompetence (AI) and change in aortic root and left ventricular dimensions after implantation of the continuous-flow HeartWare ventricular assist device (HVAD) in our adult patient cohort. Methods A retrospective analysis of serial echocardiograms was performed on patients implanted with an HVAD between July 2009 and July 2013. Data from echocardiograms performed before and at 1 and 2 years (±3 months) were analyzed. Patients with native aortic valves (AoVs) with no previous intervention and HVAD in situ for ≥6 months were included. Results A total of 73 HVADs in 71 patients with a mean duration of support of 624 ± 359 days were included in our study. One patient developed moderate AI at 1 year (1.9%). Mild or greater AI was more likely in those with a closed or intermittently opening AoV at 1 year ( p = 0.005). Aortic annulus dimensions increased significantly at 1 and 2 years, regardless of extent of AI. At 2 years, in those with mild or worse AI, the sinuses of Valsalva were also larger ( p = 0.002). Left ventricular end-diastolic dimension (LVEDD) was significantly reduced in those with no or trace AI at 1 and 2 years ( p = 0.012 and p = 0.008, respectively), but remained unchanged in those with AI at both time-points. Conclusions The development of more than mild AI is rare in HVAD patients at our center. When encountered, it is more common with a closed AoV. Dilation of the aortic annulus, and root dilation in those with mild or more AI, is seen with HVAD support over time. [ABSTRACT FROM AUTHOR]

The present study defined the short- and long-term effects of left ventricular assist device (LVAD) implantation and heart transplantation (HT) on physical activity and quality of life (QoL). Forty patients (LVAD, n = 14; HT, n = 12; and heart failure [HF], n = 14) and 14 matched healthy subjects were assessed for physical activity, energy expenditure, and QoL. The LVAD and HT groups were assessed postoperatively at 4 to 6 weeks (baseline) and 3, 6, and 12 months. At baseline, LVAD, HT, and HF patients demonstrated low physical activity, reaching only 15%, 28%, and 51% of that of healthy subjects (1,603 ± 302 vs 3,036 - 439 vs 5,490 ± 1,058 vs 10,756 ± 568 steps/day, respectively, p <0.01). This was associated with reduced energy expenditure and increased sedentary time (p <0.01). Baseline QoL was not different among LVAD, HT, and HF groups (p = 0.44). LVAD implantation and HT significantly increased daily physical activity by 60% and 52%, respectively, from baseline to 3 months (p <0.05), but the level of activity remained unchanged at 3, 6, and 12 months. The QoL improved from baseline to 3 months in LVAD implantation and HT groups (p <0.01) but remained unchanged afterward. At any time point, HT demonstrated higher activity level than LVAD implantation (p <0.05), and this was associated with better QoL. In contrast, physical activity and QoL decreased at 12 months in patients with HF (p <0.05). In conclusion, patients in LVAD and HT patients demonstrate improved physical activity and QoL within the first 3 months after surgery, but physical activity and QoL remain unchanged afterward and well below that of healthy subjects. Strategies targeting low levels of physical activity should now be explored to improve recovery of these patients. [ABSTRACT FROM AUTHOR]

Background: The post-market Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) is an investigator-initiated registry established to collect post–CE Mark Trial clinical data on patients receiving a HeartWare ventricular assist device (HVAD) in the European Union and Australia. Methods: The ReVOLVE is a multi-center, prospective, single-arm registry performed at seven centers in Europe and two in Australia. Herein we describe a total of 254 commercial HVAD implants according to labeled indications between February 2009 and November 2012. Summary statistics included patients’ demographics, adverse events, length of support and outcomes. Results: Compared with the clinical trial supporting the CE Mark of the HeartWare system, patient selection differed in that patients were older, and there were higher proportions of females and patients with idiopathic cardiomyopathies in the ReVOLVE cohort. Duration of support ranged from 1 to 1,057 days, with a mean of 363 ± 280 days (median 299.5 days). Transplantation was done in 56 patients (22%), explant for recovery was performed in 3 patients (1%), 43 died while on support (17%), and 152 (60%) remain on the device. Success in patients with the HeartWare system was 87% at 6 months, 85% at 1 year, 79% at 2 years and 73% at 3 years. Adverse event rates were low, comparable or improved when compared to the CE Mark Trial. Conclusion: Real-world use of the HeartWare system continues to demonstrate excellent clinical outcomes in patients supported with the device. [ABSTRACT FROM AUTHOR]

Background: Pre-operative infection with organisms from the Burkholderia cepacia complex (BCC), particularly B cenocepacia, has been linked with a poorer prognosis after transplantation compared to patients with cystic fibrosis (CF) without this infection. Therefore, many transplant centers do not list these patients for transplantation. Methods: We report the early and long-term results of a cohort of lung transplant recipients with CF and pre-operative BCC infection. Patients with pre-transplantation BCC infection were identified by case-note review. BCC species status was assigned by polymerase chain reaction (PCR)-based techniques. Survival rates were compared to recipients with CF without BCC infection. Survival rates in BCC subgroups were also compared, and then further analyzed pre- and post-2001, when a new immunosuppressive and antibiotic regime was introduced for such patients. Results: Two hundred sixteen patients with CF underwent lung transplantation and 22 had confirmed pre-operative BCC infection, with 12 of these being B cenocepacia. Nine B cenocepacia–infected recipients died within the first year, and in 8 BCC sepsis was considered to be the cause of death. Despite instituting a tailored peri-operative immunosuppressive and microbiologic care approach for such patients, post-transplantation BCC septic deaths occurred frequently in those with pre-transplantation B cenocepacia infection. In contrast, recipients infected with other BCC species had significantly better outcomes, with post-transplantation survival comparable to other recipients with CF. Conclusions: Mortality in patients with B cenocepacia infection was unacceptably high and has led to our center no longer accepting patients with this condition onto the lung transplant waiting list. Long-term survival in the non–B cenocepacia BCC group was excellent, without high rates of acute rejection or bronchiolitis obliterans syndrome (BOS) longer term, and these patients continue to be considered for lung transplantation. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to determine whether thoracic endovascular aortic repair (TEVAR) reduces death and morbidity compared with open surgical repair for descending thoracic aortic disease. Background: The role of TEVAR versus open surgery remains unclear. Metaregression can be used to maximally inform adoption of new technologies by utilizing evidence from existing trials. Methods: Data from comparative studies of TEVAR versus open repair of the descending aorta were combined through meta-analysis. Metaregression was performed to account for baseline risk factor imbalances, study design, and thoracic pathology. Due to significant heterogeneity, registry data were analyzed separately from comparative studies. Results: Forty-two nonrandomized studies involving 5,888 patients were included (38 comparative studies, 4 registries). Patient characteristics were balanced except for age, as TEVAR patients were usually older than open surgery patients (p = 0.001). Registry data suggested overall perioperative complications were reduced. In comparative studies, all-cause mortality at 30 days (odds ratio [OR]: 0.44, 95% confidence interval [CI]: 0.33 to 0.59) and paraplegia (OR: 0.42, 95% CI: 0.28 to 0.63) were reduced for TEVAR versus open surgery. In addition, cardiac complications, transfusions, reoperation for bleeding, renal dysfunction, pneumonia, and length of stay were reduced. There was no significant difference in stroke, myocardial infarction, aortic reintervention, and mortality beyond 1 year. Metaregression to adjust for age imbalance, study design, and pathology did not materially change the results. Conclusions: Current data from nonrandomized studies suggest that TEVAR may reduce early death, paraplegia, renal insufficiency, transfusions, reoperation for bleeding, cardiac complications, pneumonia, and length of stay compared with open surgery. Sustained benefits on survival have not been proven. [Copyright &y& Elsevier]