ECPELLA as a bridge-to-decision in refractory cardiogenic shock: a single-centre experience.

BACKGROUND: In refractory cardiogenic shock, temporary mechanical support (tMCS) may be crucial for maintaining tissue perfusion and oxygen delivery. tMCS can serve as a bridge-to-decision to assess eligibility for left ventricular assist device (LVAD) implantation or heart transplantation, or as a bridge-to-recovery. ECPELLA is a novel tMCS configuration combining venoarterial extracorporeal membrane oxygenation with Impella. The present study presents the clinical parameters, outcomes, and complications of patients supported with ECPELLA. METHODS: All patients supported with ECPELLA at University Medical Centre Utrecht between December 2020 and August 2023 were included. The primary outcome was 30-day mortality, and secondary outcomes were LVAD implantation/heart transplantation and safety outcomes. RESULTS: Twenty patients with an average age of 51 years, and of whom 70% were males, were included. Causes of cardiogenic shock were acute heart failure (due to acute coronary syndrome, myocarditis, or after cardiac surgery) or chronic heart failure, respectively 70 and 30% of cases. The median duration of ECPELLA support was 164 h (interquartile range 98-210). In 50% of cases, a permanent LVAD was implanted. Cardiac recovery within 30 days was seen in 30% of cases and 30-day mortality rate was 20%. ECPELLA support was associated with major bleeding (40%), haemolysis (25%), vascular complications (30%), kidney failure requiring replacement therapy (50%), and Impella failure requiring extraction (15%). CONCLUSION: ECPELLA can be successfully used as a bridge to LVAD implantation or as a bridge-to-recovery in patients with refractory cardiogenic shock. Despite a significant number of complications, 30-day mortality was lower than observed in previous cohorts.

Healthcare consumption of patients with left ventricular assist device: real-world data.

BACKGROUND: A left ventricular assist device (LVAD) is a life-saving but intensive therapy for patients with end-stage heart failure. We evaluated the healthcare consumption in a cohort of LVAD patients in our centre over 6 years. METHODS: All patients with a primary LVAD implantation at the University Medical Centre Utrecht in Utrecht, the Netherlands from 2016 through 2021 were included in this analysis. Subsequent hospital stay, outpatient clinic visits, emergency department visits and readmissions were recorded. RESULTS: During the investigated period, 226 LVADs were implanted, ranging from 32 in 2016 to 45 in 2020. Most LVADs were implanted in patients aged 40-60 years, while they were supported by or sliding on inotropes (Interagency Registry for Mechanically Assisted Circulatory Support class 2 or 3). Around the time of LVAD implantation, the median total hospital stay was 41 days. As the size of the LVAD cohort increased over time, the total annual number of outpatient clinic visits also increased, from 124 in 2016 to 812 in 2021 (p = 0.003). The numbers of emergency department visits and readmissions significantly increased in the 6­year period as well, with a total number of 553 emergency department visits and 614 readmissions. Over the years, the annual number of outpatient clinic visits decreased by 1 per patient-year follow-up, while the annual numbers of emergency department visits and readmissions per patient-year remained stable. CONCLUSION: The number of patients supported by an LVAD has grown steadily over the last years, requiring a more specialised healthcare in this particular population.

Incidence and risk factors of late right heart failure in chronic mechanical circulatory support.

BACKGROUND: Late right heart failure (LRHF) is a common complication during long-term left ventricular assist device (LVAD) support. We aimed to identify risk factors for LRHF after LVAD implantation. METHODS: Patients undergoing primary LVAD implantation between 2006 and 2019 and surviving the perioperative period were included for this study (n = 261). Univariate Cox proportional hazards analysis was used to assess the association of clinical covariates and LRHF, stratified for device type. Variables with p < 0.10 entered the multivariable model. In a subset of patients with complete echocardiography or right catheterization data, this multivariable model was extended. Postoperative cardiopulmonary exercise test data were compared in patients with and without LRHF. RESULTS: Nineteen percentage of patients suffered from LRHF after a median of 12 months, of which 67% required hospitalization. A history of atrial fibrillation (AF) (HR: 2.06 [1.08-3.93], p = 0.029), a higher preoperative body mass index (BMI) (HR: 1.07 [1.01-1.13], p = 0.023), and intensive care unit (ICU) duration (HR: 1.03 [1.00-1.06], p = 0.025) were independent predictors of LHRF in the multivariable model. A significant relation between the severity of tricuspid regurgitation (TR) and LRHF (HR: 1.91 [1.13-3.21], p = 0.016) was found in patients with echocardiographic data. Patients with LRHF demonstrated a lower maximal workload and peak VO2 at 6 months postoperatively. CONCLUSION: A history of AF, BMI, and longer ICU stay may help identify patients at high risk for LRHF. Severity of TR was significantly related to LRHF in a subset of patients.

Left ventricular assist device implantation and clinical outcomes in the Netherlands.

BACKGROUND: Left ventricular assist device (LVAD) therapy is an established treatment for advanced heart failure with reduced ejection fraction. We evaluated the characteristics and clinical outcomes of patients implanted with an LVAD in the Netherlands. METHODS: Patients implanted with an LVAD in the Netherlands between 2016 and 2020 were included in the analysis. Baseline characteristics entered into this registry, as well as clinical outcomes (death on device, heart transplantation) and major adverse events (device dysfunction, major bleeding, major infection and cerebrovascular event), were evaluated. RESULTS: A total of 430 patients were implanted with an LVAD; mean age was 55 ± 13 years and 27% were female. The initial device strategy was bridge to transplant (BTT) in 50%, destination therapy (DT) in 29% and bridge to decision (BTD) in the remaining 21%. After a follow-up of 17 months, 97 (23%) patients had died during active LVAD support. Survival was 83% at 1 year, 76% at 2 years and 54% at 5 years. Patients implanted with an LVAD as a BTT had better outcomes compared with DT at all time points (1 year 86% vs 72%, 2 years 83% vs 59% and 5 years 58% vs 33%). Major adverse events were frequently observed, most often major infection, major bleeding and cerebrovascular events (0.84, 0.33 and 0.09 per patient-year at risk, respectively) and were similar across device strategies. Patients supported with HeartMate 3 had a lower incidence of major adverse events. CONCLUSIONS: Long-term survival on durable LVAD support in the Netherlands is over 50% after 5 years. Major adverse events, especially infection and bleeding, are still frequently observed, but decreasing with the contemporary use of HeartMate 3 LVAD.

Validity and success rate of noninvasive mean arterial blood pressure measurements in cf-LVAD patients: A technical review.

BACKGROUND: The life expectancy of patients with a continuous flow left ventricular assist device (cf-LVAD) is increasing. Adequate determination and regulation of mean arterial pressure (MAP) is important to prevent adverse events. Given the low pulsatility characteristics in these patients, standard blood pressure equipment is inadequate to monitor MAP and not recommended. We provide an overview of currently available noninvasive techniques, using an extensive search strategy in three online databases (Pubmed, Scopus and Google Scholar) to find validation studies using invasive intra-arterial blood pressure measurement as a reference. Mean differences with the reference values smaller than 5 ± 8 mm Hg were considered acceptable. OBSERVATIONS: After deduplication, screening, and exclusion of incorrect sources, eleven studies remained with 3139 successful MAP measurements in 386 patients. Four noninvasive techniques, using Doppler, pulse oximetry, finger cuff volume clamp, or slow upper arm cuff deflation, were identified and evaluated for validity and success rate in cf-LVAD patients. Here, a comprehensive technical background of the blood pressure measurement methods is provided in combination with a clinical use comparison. Of the reported noninvasive techniques, slow cuff devices performed most optimally (mean difference 1.3 ± 5.2 mm Hg). CONCLUSIONS: Our results are encouraging and indicate that noninvasive blood pressure monitoring options with acceptable validity and success rate are available. Further technical development and validation is warranted for the growing population of patients on long-term cf-LVAD support.

Impact of a surgical approach for implantation of durable left ventricular assist devices in patients on extracorporeal life support.

BACKGROUND: The aim of this study was to evaluate the impact of the surgical approach on the postoperative outcome in patients who underwent left ventricular assist device (LVAD) implantation after having received veno-arterial extracorporeal life support (va-ECLS) using data from a European registry (ECLS-VAD). Five hundred and thirty-one patients were included. METHODS: A propensity score-adjusted outcome analysis was performed, resulting in 324 patients in the full sternotomy (FS) group and 39 in the less invasive surgery (LIS) group. RESULTS: The surgery lasted in median 236 min in the FS group versus 263 min in the LIS group (p = 0.289). The median chest tube output during the first 24 h was similar in both groups. Patients who underwent implantation with an FS required more blood products during the first 24 postoperative hours (median 16 vs. 12, p = 0.033). The incidence of revision due to bleeding was also higher (35.5 vs. 15.4%, p = 0.016). A temporary postoperative right ventricular assist device was necessary in 45.1 (FS) versus 23.1% (LIS) of patients, respectively (p = 0.067). No stroke occurred in the LIS group during the first 30 days after surgery (7.4% in the FS group). The incidence of stroke and of renal, hepatic, and respiratory failure during the follow-up was similar in both groups. The 30-day and one-year survival were similar in both groups. CONCLUSION: LIS for implantation of a durable LVAD in patients on va-ECLS implanted for cardiogenic shock is associated with less revision due to bleeding, less administration of blood products and absence of perioperative stroke, with no impact on survival.

Heart failure etiology and risk of right heart failure in adult left ventricular assist device support: the European Registry for Patients with Mechanical Circulatory Support (EUROMACS).

Objectives: Development of right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation remains a leading cause of perioperative morbidity, end-organ dysfunction and mortality. The objective of this study was to investigate whether the etiology of HF (ischemic HF versus non-ischemic HF) affects the risk of RVF within admission for LVAD implantation and during long-term follow-up. Methods: Between January 2011 and June 27, 2018, 3536 patients were prospectively enrolled into EUROMACS registry. Adult patients (>18 years) who received a first time LVAD were included. When excluding patients with congenital, restrictive, hypertrophic, valvular cardiomyopathies, and myocarditis the total population consisted of 2404 patients. Results: The total cohort consists of 2404 patients. Mean age were 55 years and predominantly male sex [2024 (84.2%)]. At the time of LVAD implantation 1355 (56.4%) patients had ischemic HF and 1049 (43.6%) patients had non-ischemic HF. The incidence of RVF was significantly increased in the non-ischemic HF group in the adjusted model (p = .026). The relative risk difference for RVF in patients with non-ischemic HF was in the adjusted model increased by an absolute value of 5.1% (95% CI: 0.61-9.6). In the ischemic HF group 76 patients (13.4%) developed late RVF and 62 patients (14.8%) in the non-ischemic HF group (p = .56). No differences in occurrence of RVF between HF etiology was observed after 2 and 4 years of follow-up, respectively (crude: p = .25, adjusted (sex and age) p = .2 and crude: p = .59, adjusted (sex and age) p = .44). Conclusions: Patients with non-ischemic HF undergoing LVAD had an increased incidence of early RVF compared to patients with ischemic HF in a large European population. During follow-up after discharge 14% patients developed RVF. We recommend HF etiology to be considered in identifying patients who are at risk for postoperative RVF after LVAD implantation.

The hemodynamic effect of different left ventricular unloading techniques during veno-arterial extracorporeal life support: a systematic review and meta-analysis.

BACKGROUND: Pulmonary edema and left ventricular thrombosis may arise during veno-arterial extracorporeal life support due to an increase in cardiac load. This mechanical stress can be reduced through different left ventricular unloading techniques. We set out to quantitatively summarize the hemodynamic effects of available methods in patients treated with veno-arterial extracorporeal life support. METHODS: Literature was systematically searched for studies reporting left ventricular unloading during veno-arterial extracorporeal life support as reflected by changes in left atrial pressure, pulmonary capillary wedge pressure, diastolic pulmonary artery pressure, or left ventricular end-diastolic pressure. For studies including ⩾10 patients per group, changes in these parameters were pooled using (1) standardized mean differences and (2) ratio of means. Assessment of potential bias was performed for all studies. RESULTS: Eight studies met the inclusion criteria. Reported techniques included use of intra-aortic balloon pump (n = 1), micro-axial blood pump (Impella®, n = 2), left ventricular venting (n = 1), and atrial septostomy (n = 4). Overall, left ventricular unloading was associated with a statistically significant reduction in preload parameters (standardized mean differences = -1.05 (95% confidence interval = -1.24 to -0.86) and ratio of means = 0.60 (0.47 to 0.76)). Effect sizes were strongest for micro-axial blood pump and atrial septostomy (standardized mean differences = -1.11 (-1.55 to -0.68) and -1.22 (-1.47 to -0.96), and ratio of means = 0.58 (0.39 to 0.86) and 0.54 (0.36 to 0.83), respectively). CONCLUSION: Left ventricular unloading was associated with a significant reduction in left ventricular preload parameters in the setting of veno-arterial extracorporeal life support. This effect may be most pronounced for micro-axial blood pump and atrial septostomy.

Soluble ST2 in end-stage heart failure, before and after support with a left ventricular assist device.

BACKGROUND: The interleukin-33 (IL-33)/suppressor of tumorigenicity 2 (ST2) pathway is suggested to play an important role in fibrosis, remodelling and the progression of heart failure (HF). Increased soluble (sST2) levels are associated with adverse outcome in the average HF population. Less is known about sST2 levels in end-stage HF. Therefore, we studied sST2 levels in end-stage HF and the effect of unloading by left ventricular assist device (LVAD) support on sST2 levels. METHOD AND RESULTS: Serial plasma measurements of sST2 were performed pre-implantation and 1, 3 and 6 months after (LVAD) implantation in 38 patients. sST2 levels were elevated in end-stage HF just prior to LVAD implantation (74.2 ng/mL [IQR 54.7-116.9]; normal <35 ng/mL) and decreased substantially during LVAD support, to 29.5 ng/mL [IQR 24.7-46.6](P < .001). Patients with INTERMACS profile I had significantly higher sST2 levels compared to patients in profile II and profile III. A moderate correlation was found between sST2 and C-reactive protein (r = .580, P < .010). CONCLUSION: Levels of sST2 are elevated in end-stage HF patients with variability that suggests multiple inputs to a pro-inflammatory and pro-fibrotic pathway. Cardiogenic shock and increased C-reactive protein levels are associated with higher sST2 levels. LVAD support results in a significant drop in sST2 levels with normalization within 3 months postimplantation. This suggests that LVAD support leads to lessening of fibrosis and inflammation, which might eventually be used to target medical policy: explantation of the LVAD versus permanent use or cardiac transplantation.

Therapy and Outcome of Staphylococcus aureus Infections of Intracorporeal Ventricular Assist Devices.

Infection of the driveline or pump pocket is a common complication in patients with ventricular assist devices (VADs) and Staphylococcus aureus is the main pathogen causing such infections. Limited evidence is currently available to guide the choice of antibiotic therapy and the duration of treatment in these patients. Patients at the University Medical Center Utrecht who developed a VAD-related S. aureus infection between 2007 and 2016 were retrospectively assessed. Blood culture isolates were typed by whole genome sequencing to differentiate between relapses and reinfections, and to determine whether antibiotic therapy had led to acquisition of resistance mutations. Twenty-eight patients had S. aureus VAD infections. Ten of these patients also suffered S. aureus bacteremia. Discontinuation of antibiotic therapy was followed by relapse in 50% of the patients without prior S. aureus bacteremia and in 80% of patients with bacteremia. Oral cephalexin could ultimately suppress the infection for the duration of follow-up in 8/8 patients without S. aureus bacteremia and in 3/6 patients with S. aureus bacteremia. Clindamycin failed as suppressive therapy in 4/4 patients. Cephalexin appears an adequate choice for antibiotic suppression of VAD infections with methicillin-susceptible S. aureus. In patients without systemic symptoms, it may be justified to attempt to stop therapy after treatment of the acute infection, but antibiotic suppression until heart transplant seems indicated in patients with S. aureus bacteremia.

Vasoplegia after implantation of a continuous flow left ventricular assist device: incidence, outcomes and predictors.

BACKGROUND: Vasoplegia after routine cardiac surgery is associated with severe postoperative complications and increased mortality. It is also prevalent in patients undergoing implantation of pulsatile flow left ventricular assist devices (LVAD). However, less is known regarding vasoplegia after implantation of newer generations of continuous flow LVADs (cfLVAD). We aim to report the incidence, impact on outcome and predictors of vasoplegia in these patients. METHODS: Adult patients scheduled for primary cfLVAD implantation were enrolled into a derivation cohort (n = 118, 2006-2013) and a temporal validation cohort (n = 73, 2014-2016). Vasoplegia was defined taking into consideration low mean arterial pressure and/or low systemic vascular resistance, preserved cardiac index and high vasopressor support. Vasoplegia was considered after bypass and the first 48 h of ICU stay lasting at least three consecutive hours. This concept of vasoplegia was compared to older definitions reported in the literature in terms of the incidence of postoperative vasoplegia and its association with adverse outcomes. Logistic regression was used to identify independent predictors. Their ability to discriminate patients with vasoplegia was quantified by the area under the receiver operating characteristic curve (AUC). RESULTS: The incidence of vasoplegia was 33.1% using the unified definition of vasoplegia. Vasoplegia was associated with increased ICU length-of-stay (10.5 [6.9-20.8] vs 6.1 [4.6-10.4] p = 0.002), increased ICU-mortality (OR 5.8, 95% CI 1.9-18.2) and one-year-mortality (OR 3.9, 95% CI 1.5-10.2), and a higher incidence of renal failure (OR 4.3, 95% CI 1.8-10.4). Multivariable analysis identified previous cardiothoracic surgery, preoperative dopamine administration, preoperative bilirubin levels and preoperative creatinine clearance as independent preoperative predictors of vasoplegia. The resultant prediction model exhibited a good discriminative ability (AUC 0.80, 95% CI 0.71-0.89, p <  0.01). Temporal validation resulted in an AUC of 0.74 (95% CI 0.61-0.87, p <  0.01). CONCLUSIONS: In the era of the new generation of cfLVADs, vasoplegia remains a prevalent (33%) and critical condition with worse short-term outcomes and survival. We identified previous cardiothoracic surgery, preoperative treatment with dopamine, preoperative bilirubin levels and preoperative creatinine clearance as independent predictors.

TriGuard™ HDH embolic deflection device for cerebral protection during transcatheter aortic valve replacement.

OBJECTIVES: This study aims to evaluate the safety and performance of the new embolic deflection device TriGuard™HDH in patients undergoing TAVR. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is associated with a high incidence of new cerebral ischemic lesions. The use of an embolic protection device may reduce the frequency of TAVR-related embolic events. METHODS: This prospective, single arm feasibility pilot study included 14 patients with severe symptomatic aortic stenosis scheduled for TAVR. Cerebral diffusion weighted magnetic resonance imaging (DWI) was planned in all patients one day before and at day 4 (±2) after the procedure. Major adverse cerebral and cardiac events (MACCEs) were recorded for all patients. Primary endpoints of this study were I) device performance success defined as coverage of the aortic arch takeoffs throughout the entire TAVR procedure and II) MACCE occurrence. Secondary endpoints included the number and the volume of new cerebral ischemic lesions on DWI. RESULTS: Thirteen patients underwent transfemoral TAVR and one patient a transapical procedure. Edwards SAPIEN valve prosthesis was implanted in 8 (57%) patients and Medtronic CoreValve prosthesis in the remaining 6 (43%). Predefined performance success of the TriGuard™HDH device was achieved in 9 (64%) patients. The composite endpoint MACCE occurred in none of the patients. Post-procedural DWI was performed in 11 patients. Comparing the DWI of these patients to a historical control group showed no reduction in number [median 5.5 vs. 5.0, P = 0.857], however there was a significant reduction in mean lesion volume per patient [median 13.8 vs. 25.1, P = 0.049]. CONCLUSION: This study showed the feasibility and safety of using the TriGuard™HDH for cerebral protection during TAVR. This device did not decrease the number of post-procedural new cerebral DWI lesions, however its use showed decreased lesion volume as compared to unprotected TAVR. © 2016 Wiley Periodicals, Inc.

Outcome after left ventricular assist device exchange.

OBJECTIVES: Left Ventricular Assist Device (LVAD) therapy has evolved from a short-term bridge-to-transplant strategy into a long-term and often chronic therapy due to long waiting times for heart transplantation and application as destination therapy. Consequently, patients are at risk of developing complications necessitating LVAD exchange. The aim of this study is to assess patient outcome after LVAD exchange. METHODS: Patients who underwent LVAD exchange between January 2010 and December 2022 were included. Logistic and cox regression analyses were used to identify potential risk factors for short and long-term adverse events, respectively. Survival after exchange was assessed using Kaplan-Meier estimates. RESULTS: Sixty-one patients underwent a total of 80 LVAD exchanges. Most frequently observed short-term complications were pulmonary infections (16.3%) and right heart failure (16.3%). Exit-site infections (34.7%) and device malfunctions (25.3%) were the most often observed long-term complications. HeartWare Ventricular Assist Device (HVAD) as index device was associated with a higher risk of right heart failure (HR 6.42, 95% CI 1.80-22.90) and respiratory failure (HR 7.81, 95% CI 1.95-31.23) compared to HeartMate II and HeartMate 3. Survival was 83% (95% CI 75.5%-95.3%) at one year and 67% (95% CI 53.9%-84.7%) at six years after exchange. After five years, 25.0% was transplanted, 23.8% had undergone a re-exchange and 32.5% was alive without new intervention. CONCLUSIONS: Although LVAD exchange can be performed with a relatively low mortality, other post-operative adverse events are common. Patients with the HVAD as index device may be at higher risk of developing right heart failure and respiratory failure after exchange.

[Lifestyle and the eligibility for left ventricular assist device implantation]. / Leefstijl en de indicatie voor een steunhart.

BACKGROUND: Advanced heart failure is defined as severe cardiac dysfunction combined with hospital admissions due to heart failure and major functional limitations. Selected patients with advanced heart failure can be treated with a left ventricular assist device. Patients with the newest generation of devices have a five-year survival of approximately 60%. CASE DESCRIPTION: We describe the case of a 54-year-old patient with advanced heart failure due to coronary artery disease, who was referred from a secondary to a tertiary care center to evaluate candidacy for LVAD therapy. Due to significant multimorbidity and unhealthy lifestyle (BMI 33 kg/m2, eGFR 29 ml/min/1.73m2, smoking, peripheral vascular disease, very poorly controlled diabetes mellitus), the patient was not considered a suitable candidate. Due to a rigorous change in his lifestyle, a number of (relative) contraindications changed in such a way that an LVAD was successfully implanted in the patient with a good functional status afterwards. CONCLUSION: Candidacy for LVAD therapy is determined on an individual basis through a vigilant screening process. Eligibility for this treatment can be positively influenced by a change in lifestyle. Intensive guidance of care providers is important in this respect.

Impairments identified by comprehensive geriatric assessment in potential candidates for left ventricular assist device and heart transplantation.

Background: The aim of this study was to assess the prevalence of frailty and other impairments in potential left ventricular assist device (LVAD) and heart transplantation (HTx) candidates by performing a preoperative comprehensive geriatric assessment (CGA) and reviewing the treatment recommendations resulting from the CGA. Methods and results: This cross-sectional study included 73 patients aged ≥40 years who received a CGA as part of the patient selection procedure for LVAD and HTx. In every patient, a conclusion comprising frailty and other impairments was formulated based on the medical, mental, functional, and social domains and recommendations were made. The mean age was 58 years (range 40-71) and 70 % were male. In 97 % of patients, at least one impairment was identified by the CGA. The most common impairments were polypharmacy, high morbidity burden, reduced renal function, osteopenia, depression, poor quality of life, reduced functionality, (risk of) malnutrition, reduced grip strength and high caregiver burden. A small proportion of the potential LVAD and HTx candidates were frail (7 % according to Fried's frailty criteria, 6 % according to the Edmonton Frail Scale) and 39 % were pre-frail. The domains for which most impairments were found and the domains for which most treatment recommendations were given matched well, with the functional domain as the frontrunner. Conclusion: This study showed that most of the potential candidates for LVAD or HTx have impairments on at least one domain of the CGA. Impairments and associated risks can contribute to the decision making process for candidacy for LVAD and HTx.

Soluble Suppression of Tumorigenicity-2 Predicts Mortality and Right Heart Failure in Patients With a Left Ventricular Assist Device.

BACKGROUND: Soluble suppression of tumorigenicity-2 (sST2) predicts mortality in patients with heart failure. The predictive value of sST2 in patients with a left ventricular assist device remains unknown. Therefore, we studied the relationship between sST2 and outcome after left ventricular assist device implantation. METHODS AND RESULTS: sST2 levels of patients with a left ventricular assist device implanted between January 2015 and December 2022 were included in this observational study. The median follow-up was 25 months, during which 1573 postoperative sST2 levels were measured in 199 patients, with a median of 29 ng/mL. Survival of patients with normal and elevated preoperative levels was compared using Kaplan-Meier analysis, which did not differ significantly (P=0.22) between both groups. The relationship between postoperative sST2, survival, and right heart failure was evaluated using a joint model, which showed a significant relationship between the absolute sST2 level and mortality, with a hazard ratio (HR) of 1.20 (95% CI, 1.10-1.130; P<0.01) and an HR of 1.22 (95% CI, 1.07-1.39; P=0.01) for right heart failure, both per 10-unit sST2 increase. The sST2 instantaneous change was not predictive for survival or right heart failure (P=0.99 and P=0.94, respectively). Multivariate joint model analysis showed a significant relationship between sST2 with mortality adjusted for NT-proBNP (N-terminal pro-B-type natriuretic peptide), with an HR of 1.19 (95% CI, 1.00-1.42; P=0.05), whereas the HR of right heart failure was not significant (1.22 [95% CI, 0.94-1.59]; P=0.14), both per 10-unit sST2 increase. CONCLUSIONS: Time-dependent postoperative sST2 predicts all-cause mortality after left ventricular assist device implantation after adjustment for NT-proBNP. Future research is warranted into possible target interventions and the optimal monitoring frequency.

FLAVOUR Study: FLow profiles And postoperative VasOplegia after continUous-flow left ventriculaR assist device implantation.

This study aims to associate the incidence of postoperative vasoplegia and short-term survival to the implantation of various left ventricular assist devices differing in hemocompatibility and flow profiles. The overall incidence of vasoplegia was 25.3% (73/289 patients) and 30.3% (37/122), 25.0% (18/72), and 18.9% (18/95) in the axial flow (AXF), centrifugal flow (CF), and centrifugal flow with artificial pulse (CFAP) group, respectively. Vasoplegia was associated with longer intensive care (ICU) and hospital length of stay (LOS) and mortality. ICU and in-hospital LOS and 1-year mortality were the lowest in the CFAP group. Post hoc analysis resulted in a p-value of 0.43 between AXF and CF; 0.35 between CF and CFAP; and 0.06 between AXF and CFAP. Although there is a trend in diminished incidence of vasoplegia, pooled logistic regression using flow profile and variables that remained after feature selection showed that flow profile was not an independent predictor for postoperative vasoplegia.

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): fourth Paediatric EUROMACS (Paedi-EUROMACS) report.

OBJECTIVES: The use of ventricular assist devices (VADs) in children is increasing. However, absolute numbers in individual centres and countries remain small. Collaborative efforts such as the Paedi-European Registry for Patients with Mechanical Circulatory Support (EUROMACS) are therefore essential for combining international experience with paediatric VADs. Our goal was to present the results from the fourth Paedi-EUROMACS report. METHODS: All paediatric (<19 years) patients from the EUROMACS database supported by a VAD were included. Patients were stratified into a congenital heart disease (CHD) group and a group with a non-congenital aetiology. End points included mortality, a transplant and recovery. Cox proportional hazard models were used to explore associated factors for mortality, cerebrovascular accident and pump thrombosis. RESULTS: A total of 590 primary implants were included. The congenital group was significantly younger (2.5 vs 8.0 years, respectively, P < 0.001) and was more commonly supported by a pulsatile flow device (73.5% vs 59.9%, P < 0.001). Mortality was significantly higher in the congenital group (30.8% vs 20.4%, P = 0.009) than in the non-congenital group. However, in multivariable analyses, CHD was not significantly associated with mortality [hazard ratio (HR) 1.285; confidence interval (CI) 0.8111-2.036, P = 0.740]. Pump thrombosis was the most frequently reported adverse event (377 events in 132 patients; 0.925 events per patient-year) and was significantly associated with body surface area (HR 0.524, CI 0.333-0.823, P = 0.005), CHD (HR 1.641, CI 1.054-2.555, P = 0.028) and pulsatile flow support (HR 2.345, CI 1.406-3.910, P = 0.001) in multivariable analyses. CONCLUSIONS: This fourth Paedi-EUROMACS report highlights the increasing use of paediatric VADs. The patient populations with congenital and non-congenital aetiologies exhibit distinct characteristics and clinical outcomes.

Clinical Outcome of Transcatheter Aortic Valve Replacement With TriGUARD 3™ Cerebral Embolic Protection Device.

OBJECTIVE: Periprocedural stroke during transcatheter aortic valve replacement (TAVR) is a highly feared adverse event. The TriGUARD 3 cerebral embolic protection device (CEPD) may have the potential benefit of reduction of embolic events, but it still remains unclear whether it reduces the incidence of periprocedural stroke or transient ischemic attack (TIA). We aimed to investigate whether the latest TriGUARD 3 CEPD reduces the incidence of clinically overt stroke within 72 h or at discharge after TAVR. METHODS: In this prospective single-center study 117 patients (mean age 80.3 years, 53.8 % male) were included from July 2020 to December 2021. RESULTS: The primary efficacy endpoint of this study, periprocedural clinically overt stroke or TIA, within 72 h or at discharge after TAVR with the TriGUARD 3 CEPD occurred in 1/117 pts (0.8 %). Secondary endpoints (device related issues such as life-threatening or disabling bleeding, acute kidney injury, major vascular complications) were reported in 4/117 pts (3.4 %). CONCLUSIONS: This study suggests that the use of the latest TriGUARD 3™ CEPD in transfemoral TAVR seems to be associated with a low rate of clinically overt stroke and a low rate of device related adverse events, reflecting "real world" TAVR practice. However these results should be hypothesis generating and confirmed in a large RCT.