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Background Systemic inflammation due to cardiogenic shock is associated with vasoplegia leading to organ hypoperfusion, right heart failure, and poor clinical outcome. Extracorporeal cytokine hemoadsorption emerged to attenuate excessive levels of inflammatory cytokines, potentially improving patient outcomes. Nevertheless, its prognostic impact during high-risk left ventricular assist device (LVAD) implantation remains unknown. Methods In total, 40 consecutive patients with advanced heart failure underwent continuous-flow LVAD implantation at our institution between 2018 and 2020. Out of 25 high-risk patients in cardiogenic shock (Interagency Registry for Mechanically Assisted Circulatory Support profile 1 and 2), 9 patients (CytoSorb group) underwent LVAD implantation with and 16 patients (control group) without simultaneous cytokine hemoadsorption during cardiopulmonary bypass. Besides preoperative patient characteristics, postoperative lactate clearance, vasopressor administration and mean arterial pressure, perioperative complication, and 30-day mortality rates were retrospectively analyzed. Results Apart from an increased rate of reoperations within the CytoSorb group, baseline characteristics including the severity of ventricular dysfunction and consecutive signs of end-organ failure were similar in both groups. Preoperative short-term mechanical circulatory support bridging was comparable (66.7 vs. 75%; p = 0.66) prior to LVAD implantation. Procedural characteristics including intraoperative volume management and postoperative vasopressor administration were similar in both groups. There was no difference regarding postoperative lactate clearance, although postoperative mean arterial pressure was significantly higher in the control group (71.3 vs. 57.4 mm Hg; p < 0.01). Furthermore, the 30-day mortality rate was significantly higher in the CytoSorb group (33.3 vs. 0.0%; p = 0.01). Conclusion Extracorporeal cytokine hemoadsorption during high-risk LVAD implantation was not associated with a decrease of postoperative vasopressor support, improved hemodynamics, or an accelerated lactate clearance. [ABSTRACT FROM AUTHOR]

Aims: Whether sex affects selection for and outcomes after heart transplantation (HTx) remains unclear. We aimed to show sex differences in pre‐transplant characteristics and outcomes after HTx. Methods and results: From 1995 to 2019, 49 200 HTx recipients were prospectively enrolled in the Organ Procurement and Transplantation Network. Logistic regression models were used to evaluate clinical characteristics by sex. Multivariable Cox regression models were fitted to assess sex differences in all‐cause mortality, cardiovascular mortality, graft failure, cardiac allograft vasculopathy (CAV), and malignancy. In 49 200 patients (median age 55 years, interquartile range 46–62; 24.6% women), 49 732 events occurred during a median follow‐up of 8.1 years. Men were older than women, had more often ischaemic cardiomyopathy (odds ratio [OR] 3.26, 95% confidence interval [CI] 3.11–3.42; P < 0.001), and a higher burden of cardiovascular risk factors, whereas women had less malignancies (OR 0.47, CI 0.44–0.51; P < 0.001). Men were more often treated in intensive care unit (OR 1.24, CI 1.12–1.37; P < 0.001) with a higher need for ventilatory (OR 1.24, CI 1.17–1.32; P < 0.001) or VAD (OR 1.53, CI 1.45–1.63; P < 0.001) support. After multivariable adjustment, men had a higher risk for CAV (hazard ratio [HR] 1.21, CI 1.13–1.29; P < 0.001) and malignancy (HR 1.80, CI 1.62–2.00; P < 0.001). There were no differences in all‐cause mortality, cardiovascular mortality, and graft failure between sexes. Conclusions: In this US transplant registry, men and women differed in pre‐transplant characteristics. Male sex was independently associated with incident CAV and malignancy even after multivariable adjustment. Our results underline the need for better personalized post‐HTx management and care. [ABSTRACT FROM AUTHOR]

Globalization in Asia and consequent strengthening of healthcare economic factors in tandem with an increasing heart failure (HF) population have enhanced potential for development and progress in the fields of HF medicine and mechanical circulatory support (MCS). In Japan, there are unique opportunities to investigate the outcome of acute and chronic MCS and a national registry for percutaneous and implantable left ventricular assist device (LVAD) including Impella pumps has been established. A Peripheral extracorporeal membrane oxygenation (ECMO) for acute MCS has been used in more than 7000 patients annually and Impella usage in more than 4000 patients over the past 4 years was noted. Recently, a novel centrifugal pump with hydrodynamically levitated impeller was developed and approved for mid‐term extracorporeal circulatory support. In terms of chronic MCS more than 1200 continuous flow LVADs have been implanted during the past decade, and 2‐year survival rate after primary LVAD implantation is 91%. Because of donor organ shortage, more than 70% of heart transplant recipients required LVAD support for more than 3 years and prevention and treatment of complications during long‐term LVAD support have become important. Five important topics including hemocompatibility‐related complications, LVAD infections, aortic valve insufficiency, right ventricular failure and cardiac recovery during LVAD support are discussed in this review for improving clinical outcomes. Findings from Japan will continue to provide useful information regarding MCS for the Asia‐Pacific region and beyond. [ABSTRACT FROM AUTHOR]

Background: Functional mitral regurgitation (FMR) is a common finding of advanced heart failure with detrimental effects. The prognostic impact of uncorrected FMR prior to left ventricular assist device (LVAD) implantation remains controversial.Methods: Between 2016 and 2019 77 patients underwent continuous-flow LVAD implantation at our institution. 34 patients showed FMR ≥ 2 (MR-group), whereas 43 patients showed FMR < 2 (Control-group). Data was retrospectively analyzed. Primary composite endpoint comprised freedom from death, stroke, pump-thrombosis, major bleeding and right heart failure (RHF) after 1 year.Results: Baseline characteristics, including the severity of left and right ventricular dysfunction, and periprocedural results were comparable. The overall survival during a mean follow up of 24.9 months was 55.9% in the MR-group versus 58.1% in the Control-group (p = 0.963), whereas 1-year event-free survival was 35.3% in the MR-group compared to 44.2% in the Control-group (p = 0.404). RHF within the first postoperative year occurred more frequently in the MR-group (35.3% vs. 11.6%; p = 0.017). Furthermore, RV function was significantly reduced in comparison to baseline values in the MR-group. 12 months after surgery, 74% of patients in the MR-group were classified as NYHA III in comparison to 24% of patients in the Control-group (p < 0.001).Conclusions: Preoperative uncorrected FMR prior to LVAD implantation did not affect overall survival, nevertheless it was associated with an impaired RV function and increased incidence of right heart failure during follow-up. Furthermore, preoperative FMR ≥ 2 was associated with persistent symptoms of heart failure. [ABSTRACT FROM AUTHOR]

The Abiomed Impella 5.5 (Danvers, MA) is a newly developed axial flow transaortic cardiac support device mounted on a 9 Fr steering catheter with a 21 Fr pump cannula. Impella 5.5 is intended for longer use and was approved for 30 days in 2018. This study evaluated the first-in-man series at six high-volume mechanical circulatory support centers in Germany after CE approval. The first 46 consecutive patients worldwide underwent implantation in six German centers between March 2018 and September 2019 for post-CE approval evaluation. The primary end-point was 30 days and 90 days all-cause mortality. The mean age of patients was 59.0 ± 11.5 years , and 43 (93.4%) were men. Half of the patients had acute on chronic heart failure. The main indication for Impella 5.5 implantation was ischemic cardiomyopathy and acute myocardial infarction (47.8%). The mean support time was 15.5 ± 24.2 days (range 0-164, median 10 days (IQR = 7-19)) with a total of 712 patient-days on support. The 30 days and 90 days survival rates were 73.9% (95% CI: 63.3–88.9%) and 71.7% (95% CI: 60.7-87.1%), respectively. Additionally, 16 patients (34.8%) were weaned from the device for native heart recovery, and 19 (41.3%) were bridged to a durable device. Fifteen patients (32.6%) were mobilized to a chair, and 15 (32.6%) were ambulatory. We only noted one stroke and found no other thromboembolic complications. No aortic valve damage was observed in the study cohort. Finally, seven patients (15.2 %) had pump thrombosis, and nine (19.6 %) underwent device exchange. Sixteen patients (34.8 %) suffered from bleeding requiring transfusions during the whole treatment course. In ten patients (21.7%), the inflow cannula dislocated into the aortic root. The first version of the Impella 5.5 presents promising early outcomes for patients with acute heart failure and expands the spectrum of available devices. The adverse event profile is favorable for short-term devices. Dislocations have been addressed by design changes. With increasing experience with this device, our study suggests that the indications for use will expand to other cardiac shock etiologies and may improve myocardial recovery and survival in patients with cardiogenic shock. [ABSTRACT FROM AUTHOR]

Objective: Left ventricular assist device (LVAD) implantation with concomitant Dor plasty is only reported anecdotally. We herein aimed to describe our experience with LVAD and concomitant Dor procedures and describe long-term outcomes of this special subset of heart failure patients. Methods: Between January/2010 and December/2018, 144 patients received LVAD therapy at our institution. Of those, five patients (80% male, 60.4±7.2 years) presented with an apical aneurysm and received concomitant Dor plasty. Apical aneurysms presented diameter between 75 and 98 mm, with one impending rupture. Results: Procedural success was achieved in all patients. No unplanned right ventricular assist device implantation occurred. Furthermore, no acute 30-day mortality was seen. In follow-up, one patient was lost due to intentional disconnection of the driveline. One patient underwent heart transplantation on postoperative day 630. The remaining three patients are still on device with sufficient flow; pump thromboses were successfully managed by lysis therapy in one patient. Conclusion: LVAD implantation with concomitant Dor procedure is feasible, safe, and occasionally performed in patients with ischemic cardiomyopathy. Major advantages are prevention of thromboembolism and facilitation of LVAD placement by improving pump stability and warranting midventricular, coaxial alignment of the inflow cannula. In long-term follow-up, no adverse event associated with Dor plasty was observed. [ABSTRACT FROM AUTHOR]

Background: Right heart failure (RHF) after left ventricular assist device (LVAD) implantation is common and associated with worse outcome. Prediction of RHF remains challenging. Our study aims to assess predictors of RHF focusing on clinical manifestations.Methods: We retrospectively analyzed clinical, echocardiographic and hemodynamic parameters of 112 patients undergoing LVAD implantation. Pre-operative, early (ERHF, day 7 and 14) and late postoperative RHF (LRHF, after 1, 3, 6 and 12 months) were assessed.Results: In the total study population (87.5% men, mean age 55 years), early RHF was frequent (47% on day 7 and 30% on day 14). Prevalence of late RHF and death from RHF was high after 3, 6 and 12 months (23, 24 and 17%). Pre-existing RHF was only associated with early RHF and persistent, but not for new onset late RHF. Early RHF was associated with lower INTERMACS level (p < 0.001), higher pulmonary vascular resistance (p = 0.046) and CVP/PAWP quotient (p = 0.011), higher bilirubin (p = 0.038) and creatinine (p = 0.013). LRHF was associated with creatinine (p = 0.006), urea (p = 0.012) and load adaption index (p = 0.007). Binary logistic regression models identified no single risk factors. Comparing the predictive value of regression models with a model of three clinical findings (INTERMACS level, age and pre-operative RHF) did not reveal differences in RHF.Conclusions: RHF before LVAD implantation enhances the risk of early RHF and persistent late RHF, but not for new onset late RHF, supporting the hypothesis of differences in the etiology. Echocardiographic or hemodynamic parameters did not show a predictive value for new onset late RHF. Similar predictive value of clinical findings and statistic models of risk factors suggest that a clinical evaluation is equally matched to predict RHF. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide Open in new tab Download slide OBJECTIVES Peripheral venoarterial extracorporeal life support (ECLS) for the treatment of cardiogenic shock has shown to improve survival but is associated with complications. However, if the patient cannot be weaned from ECLS, their therapy options are limited. Although durable left ventricular assist device implantation might be an option in such cases, an unclear neurological outcome is often a contraindication. We hypothesize that Impella 5.0 therapy provides sufficient circulatory support while avoiding ECLS-related complications, thereby allowing for an adequate evaluation of a patient's neurological state and facilitating further treatment options. METHODS We retrospectively reviewed data from 22 ECLS patients (mean age 56.5 ± 10.7 years) with an unclear neurological status who underwent Impella 5.0 implantation between January 2016 and July 2018 in our institution. Neurological status was evaluated on a daily basis using the cerebral performance category score and the modified Rankin scale. RESULTS Sixteen patients (72.7%) were resuscitated before ECLS implantation and 13 patients (59.1%) had acute myocardial infarction. The mean duration on ECLS before Impella 5.0 implantation was 9.3 ± 1.7 days. All patients were successfully weaned from ECLS by Impella 5.0 implantation via the axillary artery. The mean duration on Impella 5.0 was 16.3 ± 4.7 days. In surviving patients, both quantitative measurements of cerebral performance improved after 30 days compared to the baseline (P  < 0.01). Six patients (27.3%) were bridged to a durable left ventricular assist device. In 9 patients (40.9%), myocardial function recovered during Impella 5.0 support and the device was successfully explanted. The 30-day survival rate was 68.2%. CONCLUSIONS Impella 5.0 support provides a bridge-to-decision option for patients following ECLS implantation and leads to left ventricular unloading. It allows further evaluation of a patient's neurological situation and facilitates further therapy. About two-thirds of patients survived with acceptable neurological outcomes. [ABSTRACT FROM AUTHOR]

Background Despite the increasing use of ventricular assist devices (VADs), gender differences in indications, hemodynamics, and outcome are not well understood. We examined gender differences and gender-specific predictors for perioperative outcome in patients on ventricular support. Methods Multicenter data of 966 patients (median age 55 years, 151 women) from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) were analyzed. Median follow-up was 1.26 years. Results At the time of VAD implantation, women were more often in an unstable condition (Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS] profile 1 and 2) (51.7% vs 41.6% in men), experiencing significantly more often major bleeding ( p = 0.0012), arrhythmias ( p = 0.022), and right ventricular (RV) failure ( p < 0.001) with need for additional RV support. The survival of women on isolated LVAD support was significantly worse (1-year survival 75.5% vs 83.2% in men). Age-adjusted Cox regression analyses showed significant associations with mortality for preoperative inotropic therapy, percutaneous mechanical support, INTERMACS profile 1 and 2, RV dysfunction, major bleeding, cerebral bleeding, ischemic stroke, and RV failure. In women, pump thrombosis was more strongly related with mortality compared to men, while the direction of the association of renal dysfunction with mortality was different for women and men ( p -value interaction 0.028 and 0.023, respectively). Conclusions Women and men differ in perioperative hemodynamics, adverse events, and mortality after VAD implantation. A gender-dependent association of pump thrombosis with mortality was seen. The impact on treatment practice needs to be shown. [ABSTRACT FROM AUTHOR]

BACKGROUND: Infections are major complications in patients with ventricular assist devices (VAD). Positron emission tomography with deoxyglucose marked by fluorine-18 (18F-FDG PET/CT) is a diagnostic tool to scan for tissue with high metabolism as present in infections. The specificity of 18F-FDG PET/CT to discriminate between infection and an aseptic reaction of the implanted device is not defined and its evaluation is the aim of this retrospective analysis. METHODS: Until September 2015 a total of 100 patients underwent VAD implantations in our institution. Twenty-one patients (mean age 53.7 ± 14.3 years) had 29 PET-CT examinations for a suspected infection. All radiology reports were compared to clinical and intraoperative parameters. Infections were reported according to the guidelines of the International Society of Heart and Lung Transplantation. Followup was 222 days (range 107-484 days) after PET-CT scans and was complete in all patients. RESULTS: In 7 patients PET-CT scan ruled out any VAD associated infection. Sixteen patients had a VAD specific infection. Two patients had false negative PET-CT scan results. The sensitivity of VAD-specific infections was 87.5%, the specificity 100%, the positive predictive value was 100% and the negative predictive value 86.7%. Seven patients had more than one PET-CT scans at different time points. CONCLUSIONS: PET-CT scan findings showed a high specificity and positive predictive value for VAD-specific infections. Therefore, it may have the potential to guide the clinician in handling patients with infectious complications after VAD implantation. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Isolated right ventricular (RV) dysfunction with preserved left ventricular function is difficult to treat and associated with high mortality. Temporary devices for right ventricular support [right ventricular assist device (RVAD)] are available and have been used for short-term right heart assistance. In some patients, RV function does not recover and long-term devices are needed. Recently, isolated RVAD implantation with a permanent HeartWare HeartWare ventricular assist device (HVAD) device has been reported in patients with acute RV infarction and chronic graft failure. However, isolated implantation on the right side remains rare and is still an off-label use for this pump. To gather European data, we queried the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) database, in which procedures and outcome data for patients receiving mechanical circulatory support are registered. METHODS: Until May 2014, data of 8 patients (mean age 55.0 ± 17.3 years, 100% males) with an isolated HVAD for RV support were submitted to the EUROMACS registry. All patients were in INTERMACS classes 1-3. Device strategy was rescue therapy in 6 patients (75.0%) and destination therapy in 2 patients (25.0%). Indications for RVAD placement were acute myocardial infarction in 4 (50.0%), failure to wean from cardiopulmonary bypass in 2 (25.0%) and post-cardiotomy RV failure in another 2 patients (25.0%). Intra- and postoperative results of the EUROMACS registry were analysed. RESULTS: Inflow cannulas were implanted into the right atrium (RA) in 6 patients (75.0%) and into the RV in 2 patients (25.0%). CPB was used in 6 patients (75.0%). Four patients (50.0%) survived the first 30 days. During follow-up, 1 patient died after 44 days due to multiorgan failure. In the surviving three patients, 2 patients were transplanted after 29 and 419 days, respectively, and, in 1 patient, the device was explanted for pump thrombosis and recovered RV function. CONCLUSION: In this very specific and sick patient cohort within the EUROMACS registry, isolated permanent RVAD implantation is a novel and promising strategy for patients with isolated right heart failure. However, more experience is needed to identify patients who benefit from this technology. [ABSTRACT FROM AUTHOR]