Ventricular Assist Device Implantation Research Articles

Outflow graft stenosis after left ventricular assist device implantation: the rotterdam experience

Abstract Introduction Outflow graft stenosis (OGS) has been reported in patients with the HeartMate 3 left ventricular assist device (LVAD) as a result of biodebris accumulation outside the graft. As a result, patients may experience unexpected low-flow alarms, relapse of heart failure symptoms, cardiogenic shock, or even death. Different cutoff values are used to define OGS, and the literature also lacks clarity regarding how the severity of OGS relates to potential clinical outcomes. Purpose The purpose of this study is to describe the prevalence, clinical presentation, outcomes, and treatments associated with different degrees of HeartMate 3 LVAD OGS. Methods In this single-centre retrospective cohort study, we reviewed all HeartMate 3 patients between March 2016 and December 2023 with an available computed tomographic angiogram (CTA) sufficient to assess the outflow graft lumen. Before 2022, CTAs were conducted only at baseline after LVAD implantation and on specific indications, such as low-flow alarms. However, since 2022, routine biennial CTAs have been performed for all patients, starting 2 years post-LVAD implantation, reflecting increased awareness of LVAD OGS. We determined the percentage of lumen narrowing by measuring perpendicular to the outflow graft in different axes, categorizing as: no stenosis (0-25%), mild stenosis (25-50%), moderate stenosis (50-75%), and severe stenosis (>75%). Results We included 135 patients (median age: 53 years, 63% male), with a total of 330 available CTA scans. Throughout the study period (median FU of 31.8 months, IQR:11-43), evidence of OGS was observed in 16 (11.8%) patients: 8 (5.9%) with mild stenosis, 6 (4.4%) with moderate stenosis, and 2 (1.5%) with severe stenosis. The median time to mild stenosis, moderate stenosis, and severe stenosis was 2.5, 3.9, and 4.9 years respectively. Figure illustrates the prevalence, clinical presentation and treatment of various degrees of OGS. Among patients with mild stenosis, 75% (6/8) were detected incidentally during routine CTA scans, while 50% (3/6) of those with moderate stenosis presented with low-flow alarms. Only 7.6% (9/119) of patients with no stenosis experienced low-flow alarms. Mild and moderate stenosis were not associated with mortality compared to no stenosis (p>0.05), but severe stenosis was (p<0.05). Five patients underwent stenting, and one patient underwent surgery for outflow graft stenosis. Conclusions LVAD OGS is a significant late complication affecting approximately one in eight patients, with potentially severe consequences. Severe stenosis is associated with higher mortality compared to no stenosis. The true prevalence may be underestimated due to delayed radiological surveillance initiation. CTA plays a pivotal role as a non-invasive diagnostic step to identify OGS and systematic screening may be warranted. Endovascular stenting or surgery can effectively treat patients with OGS.

Prognostic implications of right and left atrial strain in diabetes mellitus without coronary artery diseases

Abstract Background 2D- speckle-tracking echocardiography (2D-STE) has recently be used to assess subclinical myocardial dysfunction, however its utility in diabetes mellitus (DM) has been specifically focusing on the longitudinal systolic function of the left ventricle (LV). Aim To assess the prognostic relation between left (LA) and right (RA) systolic and diastolic strain parameters with clinical outcome in patients with DM. Methods Of the initial 1721 diabetic patients screened for this study only 502 consecutive patients with DM were eligible and retrospectively enrolled, and 2D-STE strain parameters assessed on the 2D-TTE images. All patients were prospectively followed for development of new outcome/cardiac events which included hospitalization for acute HF, CVS-related death, new onset AF/AFI, stroke, heart transplantation, or need for ventricular assist device implantation. The 2D-STE analysis was used to measure the peak LA (longitudinal, radial and circumferential) and RA (longitudinal) strain. The long-term outcomes were evaluated for all-cause CVS outcomes and recurrent hospitalization. Results For the 502 eligible patients [mean age:58±4; 58 % male sex], 221 reached the combined endpoint. Mean follow-up was 1.1±0.6years. Both LA and RA strain parameters were significantly impaired compared to normal standard references (p<.0001), the RA was more impaired than LA strain parameters. The best performance parameters predictive of CVS (combined outcomes) events were for LA>RA systolic and diastolic strain, global RA systolic and diastolic strain (AUC: 0.74 and 70) and global LA longitudinal systolic and diastolic strain (AUC: 0.86 and 0.77). The strongest association between the degree of atrial myocardial mechanical dysfunction and risk of cardiovascular events was more evident for LA strain (free wall > global strain) and lesser extend to RA strain. More myocardial mechanical strain impairments were demonstrated in those with higher left atrial volume index (LAVI), NYHA ≥II class, significantly impaired diastolic function, lower strain values (LA, LV, RV), and tricuspid annular plane systolic excursion (TAPSE), p<.001). The LA (free wall) strain impairment was the independent predictors of combined outcome (including survival) after multiple adjustments using different models. Conclusion Patients with DM, LA strain parameters are stronger predictors of outcome than RA and other conventional parameters and should be included for regular clinical screening DM patients as these parameters provide a stronger prognostic stratification.

Ringlike late gadolinium enhancement: prevalence, association with cardiac phenotype, and patient outcome in an unselected cohort referred for cardiovascular magnetic resonance imaging

Abstract Background The identification of a non-ischemic ringlike enhancement in the left ventricular (LV) myocardium by cardiac magnetic resonance imaging (CMR) has emerged as a significant biomarker associated with arrhythmogenic cardiomyopathy (CMP) and adverse patient outcomes. Recently, the term "scarring CMP" has been also proposed to encompass various conditions characterized by a high burden of non-ischemic, often ring-like, myocardial scarring, including both genetic and acquired etiologies. Purpose To systematically evaluate CMR phenotypic traits and etiologic backgrounds in patients with ringlike enhancement and to assess the burden of adverse outcomes during follow-up (FU). Methods This is a single-center, retrospective analysis of prospectively enrolled patients undergoing CMR (from 2002 to 2024). Ringlike late gadolinium enhancement (LGE) was defined as continuous enhancement in three or more adjacent segments based on the AHA 17 segment model. Patients records were reviewed for etiologic classification and FU assessment. Results Among 23.472 patients, 19.696 (84%) underwent LGE assessment. In 152 patients (0.77%; 73% male; mean age 48.5 ± 17 years) a ringlike LGE was identified. The mean number of LV segments with LGE was 10 ± 3. Right ventricular (RV) LGE was present in 23% of subjects. LV fatty metaplasia was detected in 22%. Infero-lateral segments were most frequently affected. CMR showed the following morpho-functional features: LV dilatation (53%), LV hypokinesia (69%), LV hypertrophy (10.5%), LV non-compaction (11%), RV dilation (26%), and RV ejection fraction < 40% (21%). Phenotypic classification according to 2023 ESC guidelines identified dilated CMP phenotype (43%), non-dilated LV CMP phenotype (39%), predominant arrhythmogenic right ventricular phenotype (6%), hypertrophic phenotype (7%). 5% of cases remained unclassified, all of them showing LV dilated non-hypokinetic phenotype. Genetic analysis was performed in 101 patients (66%). Etiologic classification revealed non-desmosomal gene related CMP (24%), desmosomal gene related CMP (8%), inflammatory CMP (16%), genetic neuromuscular diseases (5%), congenital metabolic errors (3%), familiar gene elusive CMP (2%) and unknown etiology (45%). Notably, only 17% of patients classified as having inflammatory CMP and 66% of those with unknown etiology underwent genetic testing, with negative results. The median follow-up duration was 3 (IQR: 1-7) years. All-cause mortality occurred in 10.5% of patients, while 17% experienced sustained ventricular tachycardia, appropriate implantable cardioverter-defibrillator therapies, or sudden cardiac death. Heart transplantation or left ventricular assist device implantation was required in 8% of cases. Conclusion Ringlike LGE is a rare, non-disease-specific feature that can be found in different morpho-functional CMP phenotypes. It is associated with frequent genetic-determined etiology and high burden of arrhythmic and non-arrhythmic outcomes.

Genotype predicts heart failure independent of left ventricular ejection fraction and NT-proBNP levels in hypertrophic cardiomyopathy

Abstract Background/Introduction Hypertrophic cardiomyopathy (HCM) is a myocardial disease associated with progression to heart failure. In around 40% of cases, the disease is caused by variants in genes encoding sarcomere proteins. Purpose To evaluate the role of genotype in predicting heart failure (HF) outcomes. Methods In this observational single-centre cohort study, consecutive patients with HCM were assessed for heart failure clinically stratified by genetic status into genotype-elusive which included those with no significant variants (G-) or variants of unknown significance (VUS) and genotype-positive (G+) with pathogenic/likely pathogenic (LP/P) variants. Heart failure endpoint was defined as left ventricular assist device implantation, heart transplantation or heart-failure-related death. The incidence of HF endpoint was compared between genotypes during follow-up using a time-to-event analysis. Results 474 patients (50.9 ±14.5 years, 67.3 males) with HCM (25% with left ventricular (LV) outflow obstruction) were followed for 10.9 years (IQR 5.1-13.5). G+ LP/P patients (201/474 (42.4%)) were younger (45.8. ±14.0 years) compared to G- (225/474 (47.5%), 55.2 ±13.4 years) and VUS (48/474 (10.1%), 52.0 ± 15 years); 29/474 (6.1%) reached the heart failure endpoint. The incidence of heart failure endpoints was 12.4% (25/201) in the G+ LP/P group compared to 1.5% (4/273) in the gene elusive group. A multivariate Cox proportional hazards model including NT-proBNP and LV ejection fraction (LVEF) and genetic status showed that G+ LP/P was associated with increased risk of heart failure outcomes (HR: 5.11, 95% CI: 1.43–18.25, p=0.012). Every 100-unit rise in NT-proBNP was associated with a 41% increase in risk (HR: 1.41, 95% CI: 1.20–1.66, p<0.0001). A one-unit (1%) reduction in LVEF correlated with a 10% increase in heart failure risk (HR: -0.90, 95% CI: 0.87–0.93, p<0.0001). Conclusion(s) Genetic status is a predictor of heart failure outcomes independent of LVEF and NT-proBNP levels in HCM. This underscores the importance of genetic testing in the clinical management of HCM.

Organ perfusion pressure: a significant predictor of outcomes in cardiogenic shock

Abstract Background Cardiogenic shock (CS) is an ominous condition with a high mortality rate. The diagnosis of CS relies upon signs and/or symptoms of end-organ hypoperfusion. However, the combination of hypoperfusion and systemic congestion poses a serious risk and significantly increases mortality rates in critically ill patients. Purpose This study evaluated organ perfusion pressure (OPP), calculated as mean arterial pressure (MAP) minus central venous pressure (CVP), as a predictor of outcomes in CS. Methods All consecutive patients with CS related to acute myocardial infarction (AMI-CS) or acutely decompensated heart failure (ADHF-CS) enrolled in the multicenter Altshock-2 registry between January 2020 and November 2023 were selected. Only patients with both OPP and primary endpoint data available were included in the analysis. The primary outcome was in-hospital all-cause mortality. Results 316 patients fulfilled the inclusion criteria (mean age: 64±13 years, 62 [20%] females, mean left ventricular ejection fraction: 24%±10%, mean MAP: 71±16 mmHg, mean CVP: 12±6 mmHg). Mean OPP was 59.1±17.3 mmHg. In-hospital all-cause death occurred in 117 (37%) patients. In univariable analysis, higher OPP was associated with a significantly lower risk of in-hospital all-cause death both as a continuous variable (HR 0.981 per mmHg [95%CI 0.969-0.993], p-value=0.003) and dichotomized (HR 0.522 [95%CI 0.354-0.770], p-value=0.001) according to the optimal cut-off value of 59.5 mmHg identified by receiver operating characteristic curve analysis (specificity 66.4%, sensitivity 53.8%, area under the curve 0.61). OPP greater than 59.5 mmHg predicted significantly reduced risk of in-hospital all-cause death among ADHF-CS patients (HR 0.315 [95%CI 0.151-0.660], p-value=0.002), but not among AMI-CS patients (HR 0.628 [95%CI 0.392-1.007], p-value=0.054). After multivariable adjustment for significant clinical data available at first bedside assessment, namely age and Sequential Organ Failure Assessment score, higher OPP still predicted significantly lower risk of in-hospital all-cause death (HR 0.984 [95%CI 0.972-0.996], p-value=0.010). In univariable analysis, OPP was also associated with significantly increased long-term overall survival (p-value<0.001), but not with worsening renal function at 24 hours after CS onset, in-hospital length of stay or the composite of left ventricular assist device implantation or heart transplantation. Conclusions In this multicenter, observational, prospective study of patients hospitalized for CS, higher OPP on admission was associated with a significantly reduced risk of in-hospital all-cause death.

What is the true normal: comparison of different equations for estimating peak oxygen uptake for outcome prediction in heart failure

Abstract Background and Objectives One of the strongest prognostic parameters obtained during Cardiopulmonary exercise testing (CPET) in patients with heart failure (HF) is the peak oxygen uptake (pVO2), as a standalone or as a percentage of the predicted peak oxygen uptake (ppVO2) reached. However, traditional standards by which ppVO2 is calculated have limitations, having been derived from small cohorts, lacking portability and poorly represented by women. Thus, we aim to compare the FRIEND Registry equation to previously used methods of calculating ppVO2 as it relates to prognostic value imparted by the percentage of ppVO2 (%ppVO2) reached during CPET and portability to the Portuguese HF population. Methods Single centre retrospective study of patients with HF with LVEF < 50% who underwent CPET between 2015-2021. Patients who did not reach RER≥ 1.05 were excluded from our analysis. All tests were evaluated and ventilatory thresholds determined by 3 independent, experienced operators. ppVO2 was calculated according to 1) the Wasserman equation; 2) the Wasserman equation using ideal body weight; 3) the Neder equation, 4) the SHIP equation and 5) the FRIEND equation. Our primary endpoint was a composite of CV death, urgent transplant or left ventricular assist device implantation and HF hospitalization. Results We included 238 patients (mean age 59 ± 11 years, 83% males). The HF aetiology was mostly ischemic in nature (68%), with LVEF of 34 ± 9% and median NTproBNP of 776 (2566 – 2342) pg/mL. Most patients (67%) were in class NYHA I-II and with high prevalence of GDMT (93% ACEi/ARB; 97% beta-blockers and 64% on MRA). Mean BMI in this group was 27.3 ± 4.7 kg/min. Patients performed CPET on a treadmill with a protocol adjusted to their predicted exercise capacity. Mean pVO2 was 18.1 ± 6.2mL/kg/min, corresponding to a median %ppVO2 that ranges from 51 ± 16% to 71 ± 22%, depending on the equation that is used. Mean VE/VCO2 Slope was 42 ± 13 and 48 % (n = 98) of patients showed exercise oscillatory ventilation (EOV). Mean ppVO2 as per the FRIEND and Wasserman equations was 18.9 ± 6.6 and 21.2 ± 4.5 mL/kg/min, with no statistically significant difference between both. %ppVO2 as calculated through all equations was an independent predictor of prognosis on multivariate analysis adjusted for LVEF, NTproBNP and VE/VCO2 Slope (p < 0.001 for values derived from all equations). However, the FRIEND and Wasserman equations showed a slight advantage over the remaining 2 equations, with higher AUC on ROC curve analysis (see figure). Conclusions In our population of Portuguese patients with HF, both the FRIEND registry and Wasserman equations for predicting pVO2 yielded strong prognostic power. However, these equations provide different absolute predicted VO2 values for the same patients and thus should not be used interchangeably. Standardisation of the type ppVO2 equation used should be recommended by local scientific societies.

Comparison between invasive cardiac output and left ventricular assist device flow parameter.

To evaluate the correlation between left ventricular assist device flow parameter and invasive cardiac output measurements. We retrospectively evaluated right heart catheterization examinations performed in left ventricular assist device patients from 2 tertiary medical centres. We evaluated the correlation between cardiac output measurement methods (indirect Fick and thermodilution) and pump flow parameter using linear regression, and the agreement was graphically displayed using Bland-Altman plot technique. Clinical, echocardiographic, pump and haemodynamic parameters were compared between patients with and without discordance, defined as at least a 20% difference between measurements. The study population consisted of 102 patients [median age 58 (51-64), 86% males, 17 ± 12 months post left ventricular assist device implantation] with a total of 544 measurements compared. Discordance between measurements was present in 102 of 226 (45%) comparisons between indirect Fick and pump flow and in 72 of 161 (48%) between thermodilution and pump flow. A comparison of indirect Fick and left ventricular assist device exhibited a statistical correlation of R = 0.751, and that of thermodilution and left ventricular assist device of R = 0.789. Parameters associated with the presence of discordance between cardiac output measurements included a higher rate of aortic valve opening, lower indirect Fick and higher thermodilution cardiac output. After excluding the lowest tertile of indirect Fick cardiac output values, the correlation between measurements improved (thermodilution: R = 0.879 and indirect Fick: R = 0.843, P < 0.001). The current left ventricular assist device flow parameter provides an estimation of cardiac output that correlates well with indirect Fick and exhibits the strongest correlation with thermodilution. This correlation was stronger after excluding lower cardiac output values.

Effects of atrial fibrillation ablation on arrhythmia burden and ventricular function in end-stage heart failure: Lessons from CASTLE-HTx.

The CASTLE-HTx trial showed the benefit of atrial fibrillation (AF) ablation compared to medical therapy in decreasing mortality, need for left ventricular assist device implantation or heart transplantation (HTx) in patients with end-stage heart failure (HF). Herein we describe the effects of catheter ablation on AF burden, arrhythmia recurrences, and ventricular function in end-stage HF. The CASTLE-HTx protocol randomized 194 patients in end-stage HF with AF to catheter ablation and medical therapy or medical therapy alone. AF burden, left ventricular ejection fraction (LVEF), and type of AF were assessed at baseline and at each follow-up visit. Overall, 97 patients received ablation; 66 patients (68%) underwent pulmonary vein isolation (PVI) and 31 patients (32%) were treated with PVI and additional ablation. Electroanatomic mapping showed the extent of left atrial low voltage (cardiomyopathy) >10% in 31 (31.9%) patients. At 12 months post-ablation, persistent AF was present in 31/89 patients (34.8%), which was significantly less frequent compared to baseline (p = 0.0001). Median AF burden reduction was 36.3 (interquartile range 13.6-63.3) percentage points at 12 months and LVEF improved from 29.2 ± 6.2% to 39.1 ± 8.3% (p < 0.001) following ablation. AF burden reduction <50% was significantly associated with LVEF improvement ≥5% at 12 months after ablation (p = 0.017). Atrial fibrillation ablation in end-stage HF leads to a substantial decrease in AF burden, a regression from persistent to paroxysmal AF and notably improved LVEF. Favourable ablation outcomes were observed in patients regardless of the presence or absence of signs indicating left atrial cardiomyopathy.

Left ventricular unloading to facilitate ventricular remodelling in heart failure: A narrative review of mechanical circulatory support.

Heart failure represents a dynamic clinical challenge with the continuous rise of a multi-morbid and ageing population. Yet, the evolving nature of mechanical circulatory support offers a variety of means to manage candidates who might benefit from such interventions. This narrative review focuses on the role of the main mechanical circulatory support devices, such as ventricular assist device, extracorporeal membrane oxygenation, Impella and TandemHeart, in the physiological process of ventricular unloading and remodelling in heart failure, highlighting their characteristics, mechanism and clinical outcomes. The outcome measures described include physiological changes (i.e., stroke volume or preload and afterload), intracardiac pressure (i.e., end-diastolic pressure) and extracardiac pressure (i.e., pulmonary capillary wedge pressure). Overall, all the above mechanical circulatory support strategies can facilitate the unloading of the ventricular failure through different mechanisms, which subsequently affects the ventricular remodelling process. These physiological changes start immediately after ventricular assist device implantation. The devices are indicated in different but overlapping populations and operate in distinctive ways; yet, they have evidenced performance to a favourable standard to improve cardiac function in heart failure, although this proved variable for different devices, and further high-quality trials are vital to assess their clinical outcomes further. Both Impella and TandemHeart are indicated mainly in cardiogenic shock and high-risk percutaneous coronary intervention patients; at the time the literature was evaluated, both devices were found to yield a significant improvement in haemodynamics but not in survival. Nevertheless, the choice of device strategy should be based on individual patient factors, including indication, to optimize clinical outcomes.

Patient selection for left ventricular assist device implantation. The main problems

To analyze the experience of Chazov National Medical Research Center of Cardiology in patient selection for left ventricular assist device (LVAD) implantation. 901 patients, whose documents were sent to Chazov National Medical Research Center of Cardiology from regional medical and prophylactic institutions, were screened as selection for LVAD implantation. Firstly, all patients underwent transthoracic echocardiography performed according to the extended protocol with a comprehensive assessment of the left and right ventricle size and function. Patients who underwent the screening procedure underwent further examination including both laboratory and instrumental diagnostic methods. In addition, the polyclinic database of patients diagnosed with chronic heart failure (CHF) and dilated cardiomyopathy was also analyzed. Among 901 screened patients 7.9% were suitable candidates for LVAD implantation and only 23 (2.6%) patients underwent surgery. Among those not eligible for surgery: 208 (29%) patients were not on optimal medical therapy, 15% of patients had indications for other surgical treatment of CHF, 12% of patients had severe right ventricular failure, 9.8% had severe comorbidities, 6.8% of patients refused surgery. The main problems of selection for LVAD implantation were: low awareness of doctors about the introduction of new treatment methods, poor quality of transthoracic echocardiography, a large percentage of patients not receiving basic therapy for CHF, untimely referral of patients for other types of surgical treatment.

ABLE-SCORE, a simplified risk score for major adverse cardiovascular outcomes in left ventricular hypertrabeculation: a multicenter longitudinal cohort study.

Left ventricular hypertrabeculation (LVHT) is a heterogeneous entity with life-threatening complications and variable prognosis. However, there are limited prediction models available to identify individuals at high risk of adverse outcomes, and the current risk score in LVHT is comparatively complex for clinical practice. This study aimed to develop and validate a simplified risk score to predict major adverse cardiovascular events (MACE) in LVHT. This multicenter longitudinal cohort study consecutively enrolled morphologically diagnosed LVHT patients between January 2009 and December 2020 at Fuwai Hospital (derivation cohort, n = 300; internal validation cohort, n = 129), and between January 2014 and December 2022 at two national-level medical centers (external validation cohort, n = 95). The derivation/internal validation cohorts and the external validation cohort were followed annually until December 2022 and December 2023, respectively. MACE was defined as a composite of all-cause mortality, heart transplantation/left ventricular assist device implantation, cardiac resynchronization therapy, malignant ventricular arrhythmia, and thromboembolism. A simplified risk score, the ABLE-SCORE, was developed based on independent risk factors in the multivariable Cox regression predictive model for MACE, and underwent both internal and external validations to confirm its discrimination, calibration, and clinical applicability. A total of 524 LVHT patients (43.5 ± 16.6years, 65.8% male) were included in the study. The ABLE-SCORE was established using four easily accessible clinical variables: age at diagnosis, N-terminal pro-brain natriuretic peptide levels, left atrium enlargement, and left ventricular ejection fraction ≤ 40% measured by echocardiography. The risk score showed excellent performance in discrimination, with Harrell's C-index of 0.821 [95% confidence interval (CI), 0.772-0.869], 0.786 (95%CI, 0.703-0.869), and 0.750 (95%CI, 0.644-0.856) in the derivation, internal validation, and external validation cohort, respectively. Calibration plots of the three datasets suggested accurate agreement between the predicted and observed 5-year risk of MACE in LVHT. According to decision curve analysis, the ABLE-SCORE displayed greater net benefits than the existing risk score for LVHT, indicating its strength in clinical applicability. A simplified and efficient risk score for MACE was developed and validated using a large LVHT cohort, making it a reliable and convenient tool for the risk stratification and clinical management of patients with LVHT.

Potential of plasma biomarkers for heart failure prediction, management, and prognosis: A multiomics perspective.

Heart failure (HF) remains a major global health challenge, and more effective and comprehensive plasma biomarkers are needed to effectively treat HF patients. Multiomics studies have shown that DNA fragments, noncoding RNAs, proteins, and metabolites may be potential plasma biomarkers for HF. However, comprehensive reviews that focus on research on plasma biomarkers for HF from an omics perspective are lacking. This review summarizes the applications of various omics approaches in the exploration of biomarkers related to the risk assessment, diagnosis, subtype classification, medical management, and prognosis prediction of HF. Moreover, as heart transplantation and left ventricular assistant device (LVAD) implantation are terminal therapies for end-stage HF patients, this review also discusses the role of cell-free DNA as a biomarker for cardiac transplant rejection and omics studies of plasma biomarkers in patients who respond to LVAD therapy. Our findings suggest that future omics research on HF biomarkers should employ integrated multiomics methods and expand the sample size to increase the robustness of the results and that the identified biomarkers should be further validated in large cohorts.

Anti-factor Xa and activated partial thromboplastin time strategies for unfractionated heparin dosing after HeartMate 3 left ventricular assist device implantation.

No clear guidelines exist for perioperative anticoagulation management after durable left ventricular assist device insertion. In this study, we sought to compare outcomes between anti-factor Xa (FXa) and activated partial thromboplastin time (aPTT) in monitoring unfractionated heparin (UFH) dosing after HeartMate 3 (HM3) insertion. This is a single-center retrospective review of patients who received UFH after HM3 insertion between 01/2020-12/2022. Post-operative UFH dose was titrated by aPTT goal 45-60 sec (n = 53) or FXa goal 0.1-0.2 U/mL (n = 59). Baseline differences between cohorts were balanced by inverse probability treatment weighting. At baseline, unadjusted FXa patients were more likely to be white (47.5% vs. 35.8%, p < 0.001), INTERMACS 1-2 (69.5% vs. 47.2%, p = 0.013), have history of coronary artery disease (66.1% vs. 43.4%, p = 0.026), and lower eGFR (54.1 vs. 63.7 mL/min/1.73 m2, p = 0.029) compared to the aPTT group. After adjusting for several bleeding/thrombosis risk factors, 97.5% of FXa and 91.0% of aPTT patients reached therapeutic levels with comparable UFH duration and maximum dose. Moreover, in-hospital mortality (2.5% vs. 3.1%, p = 0.842), major bleeding events (4.2% vs. 9.2%, p = 0.360), and thromboembolic events (21.8% vs. 10.1%, p = 0.151) remained without significant differences between FXa and aPTT cohorts. There was a high degree of variability in FXa (r2 = 0.20) and aPTT (r2 = 0.22) values for any given UFH dose. No differences in frequency of bleeding or thromboembolic events were observed in this study between FXa versus aPTT cohorts after HM3 implantation. More longitudinal studies are warranted to determine whether or not one assay is superior to the other.

Lateral QRS amplitude is independently associated with outcome after cardiac resynchronization therapy: Advancing patient selection?

BackgroundCardiac resynchronization therapy (CRT) is a cornerstone in the treatment of selected heart failure patients. However, a relevant proportion of patients do not show beneficial response. Identification of simple, additive, and outcome-relevant selection criteria may improve selection of patients. ObjectiveWe sought to determine whether baseline QRS amplitude is associated with outcome in CRT. MethodsQuantification of intrinsic, pre–CRT implantation QRS amplitude was performed in an observational multinational 2-center retrospective cohort analysis (derivation cohort Zurich, n = 178, 2000–2015; validation cohort Leuven, n = 183, 1999–2016) with a composite end point of all-cause mortality, ventricular assist device implantation, or heart transplantation at 5 years. ResultsHigher baseline to peak amplitude in lateral leads (lead I and V6) was associated with a lower risk of reaching the composite end point (lead I: hazard ratio, 0.86 [95% confidence interval, 0.78–0.95] per millivolt, P = .002; lead V6: hazard ratio, 0.94 [95% confidence interval, 0.88–1.00] per millivolt, P = .043). Concordance index–based comparison of quartile, spline, and receiver operating characteristic curve analysis suggested cutoff values of 6 mV for lead I and 3 mV for V6 for optimal discrimination of outcome. External validation confirmed the cutoff of 3 mV in lead V6 as a highly significant discriminator of outcome (P < .001) associated with a risk reduction of 65%. ConclusionLow QRS amplitude in lateral electrocardiogram leads is associated with higher risk of poor outcome in CRT patients. A cutoff of 3 mV in lead V6 proved highly discriminative. Further studies need to confirm the additive value of QRS amplitude in selection of patients for CRT and to assess whether CRT may be made available to more patients.

Propensity score-based comparison of high-risk coronary artery bypass grafting vs. left ventricular assist device implantation in patients with coronary artery disease and advanced heart failure.

Revascularization in patients with severely reduced left ventricular function and coronary artery disease (CAD) is associated with a high perioperative risk. In this setting, implantation of a durable left ventricular assist device (LVAD) might be an alternative. We retrospectively compared the outcomes of adult patients with CAD and a left ventricular ejection fraction (LVEF) ≤ 25% who underwent coronary artery bypass grafting (CABG) vs. LVAD implantation. Propensity score (PS) matching was performed for statistical analysis, resulting in 168 pairs. In the PS-matched cohorts, the mean age was 62 years; one third had a history of myocardial infarction, 11% were resuscitated, half of the patients were on inotropic support, and 20% received preoperative mechanical circulatory support. LVAD patients required significantly longer ventilation (58 h [21, 256] vs. 16 h [9, 73], p < 0.001) and had a longer ICU stay (11d [7, 24] vs. 4d [2, 10], p ≤ 0.001) compared to CABG patients The incidence of postoperative renal replacement therapy (2 [1.2%] vs.15 [8.9%], p = 0.002) and temporary mechanical circulatory support was lower in the LVAD group (1 [0.6%] vs. 51 [30.4%], p ≤ 0.001). The in-hospital stroke rate was similar (LVAD 7 [5.4%] vs. CABG 8 [6.2%], p = 0.9). In-hospital survival, 1-year survival, and 3-year survival were 90.5% vs. 85.5% (p = 0.18), 77.4% vs. 68.9% (p = 0.10) and 69.6% vs. 45.9% (p < 0.001), for CABG and LVAD patients respectively. Patients with CAD and advanced HF demonstrate better mid-term survival if they undergo CABG rather than LVAD implantation.

Medium to long-term ventricular assist device support in adults with congenital heart disease

Heart failure is the leading cause of morbidity and mortality in adults with congenital heart disease. Though for many in this population, heart transplantation is not possible or requires longer wait times necessitating prolonged circulatory support. Medium to long-term durable ventricular assist device therapy provides a possible solution. We analyzed outcomes of nine patients with congenital heart disease and at least 3 years of durable mechanical support, all age 18 or older at time of ventricular assist device implantation at our affiliated pediatric and adult hospitals. Palliated congenital anatomies varied and included biventricular physiologies as well as single ventricle with Fontan circulation. Median duration of support was 4.2 years including three patients successfully bridged to transplant averaging 2.1 years on the waitlist. Device-related complications were infrequent with HeartMate 3, a feasible and sustainable option for either bridge to transplant or destination strategies in adults with congenital heart disease.

SOPRANO: Macitentan in patients with pulmonary hypertension following left ventricular assist device implantation.

Macitentan is a dual endothelin receptor antagonist (ERA) approved for treating pulmonary arterial hypertension (PAH). SOPRANO evaluated the efficacy and safety of macitentan versus placebo in pulmonary hypertension (PH) patients after left ventricular assist device (LVAD) implantation. SOPRANO was a phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group study. Patients with an LVAD implanted within the prior 90 days who had persistent PH (i.e., mean pulmonary arterial pressure ≥25 mmHg, pulmonary artery wedge pressure [PAWP] ≤18 mmHg, and pulmonary vascular resistance [PVR] >3 Wood units [WU]) were randomized (1:1) to macitentan 10 mg or placebo once daily for 12 weeks. The primary endpoint was change in PVR. Secondary endpoints included change in right-heart catheterization hemodynamic variables, N-terminal prohormone of brain natriuretic peptide levels, World Health Organization functional class, and safety/tolerability. Fifty-seven patients were randomized to macitentan (n = 28) or placebo (n = 29). A statistically significant reduction in PVR from baseline to Week 12 was observed with macitentan versus placebo (placebo-corrected geometric mean ratio, 0.74; 95% confidence interval, 0.58-0.94; p = .0158). No statistically significant differences were observed in secondary endpoints. In a post-hoc analysis, 66.7% of patients receiving macitentan achieved PVR <3 WU versus 40.0% receiving placebo (p = .0383). Macitentan was generally well tolerated; adverse events were consistent with those in previous PAH studies with macitentan. In conclusion, macitentan showed promising tolerability and significantly reduced PVR in PH patients with persistently elevated PVR after LVAD implantation. ClinicalTrials. gov identifier: NCT02554903.

Total Artificial Heart Implantation as a Bridge to Transplantation in Slovakia.

Although left ventricular assist device implantation represents the majority of durable mechanical circulatory support implants for patients with advanced heart failure, as many as 20 to 30% will subsequently have right heart failure requiring extended inotropic support or short-term mechanical circulatory support, and the total artificial heart is an established tool in the bridge to transplant armamentarium. The aim of this short report is to present our center's experience with the use of SynCardia total artificial heart. Between November 2017 and April 2021, 10 SynCardia total artificial heart devices were implanted. Of the 10 patients who underwent total artificial heart implantation, 6 (60%) were successfully bridged to transplant with a median time of 6.5 (interquartile range [IQR] 6-8) months, and 4 patients died on device support during the index hospitalization. The 30-day, 1-year, and 3-year survival rates after heart transplantation were the same at 66.7% (4/6). Despite the uncertain future of total artificial hearts, it remains a viable option for patients who require biventricular bridge to transplant or for a select subset of patients with advance heart failure who may not otherwise survive.

Nursing collaboration for minimally invasive left ventricular assist device implantation.

Nursing collaboration for minimally invasive left ventricular assist device implantation.

Ratio of pulmonary artery diameter to ascending aortic diameter and its association with right ventricular failure after left ventricular assist device implantation

BackgroundSeveral invasive hemodynamic parameters help predict right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation. However, prediction using non-invasive parameters alone has not been established. The ratio of the diameters of the pulmonary artery (PAD) to those of the ascending aorta (AoD) may indicate past hemodynamic load and cardiac dysfunction. We aimed to investigate a predictive model for RVF after LVAD implantation using non-invasive parameters including PAD/AoD ratio. MethodsWe studied 141 patients who underwent primary LVAD implantation and 117 healthy individuals with computed tomography (CT) data. RVF was defined as the need for a subsequent right ventricular assist device or intravenous inotrope administration for more than 30 days after LVAD implantation. The PAD/AoD ratio was measured at the level of the pulmonary artery bifurcation on the CT transaxial slices. ResultsRVF was observed in 29 patients. The correlation between PAD and AoD differed among healthy individuals, patients with and without RVF. Patients with RVF had higher total bilirubin and log brain natriuretic peptide (BNP) levels, a lower left ventricular end-diastolic diameter (LVDd) index, and a higher PAD/AoD ratio than those without RVF. Decision tree analysis indicated that the subgroup with a high PAD/AoD ratio (≥1.09) and a small LVDd index (<35.4 mm/m2) showed the highest probability of RVF (100 %), while the subgroup with a low PAD/AoD ratio (<1.09) and low log BNP (<2.79) showed the lowest probability of RVF (1 %). ConclusionCombining non-invasive parameters with the PAD/AoD ratio can predict RVF with high accuracy.