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Objective: Congenital heart disease is a risk factor for mortality after orthotopic heart transplantation; however, the impact of preoperative circulation type and primary congenital heart disease diagnosis remains poorly delineated. Methods: We retrospectively reviewed patients with adult congenital heart disease aged 16 years or more who underwent orthotopic heart transplantation at our institution between 2008 and 2022. Patients were categorized as having single-ventricle or biventricular circulation. The primary end point was 5-year post-transplant survival. Results: Sixty-one patients with adult congenital heart disease (single-ventricle: n = 26 [42.6%], biventricular: n = 35 [57.4%]) underwent orthotopic heart transplantation at 33.7 [interquartile range, 19.1-48.7] years. The most common congenital heart disease diagnosis was hypoplastic left heart syndrome (n = 11, 42.3%) in the single-ventricle group and congenitally corrected transposition of the great arteries (n = 7, 20.0%) in the biventricular group. Twenty-four patients previously underwent Fontan palliation. At transplant, patients in the single-ventricle group were younger (18.5 [interquartile range, 17.6-32.3] years vs 45.0 [interquartile range, 33.0-52.2] years, P

Objective: This study assessed characteristics and outcomes of younger (18-65) versus older (>65) recipients of simultaneous heart–kidney (SHK) transplantation with varying functional dependence. Methods: This study retrospectively analyzed 1398 patients from the United Network for Organ Sharing database who received SHK between 2010 and 2021. Patients who were 65 years (n = 236), baseline characteristics were similar and well-balanced between the 2 cohorts. Between matched cohorts, older recipients did not have increased posttransplant mortality compared with younger recipients (90-day survival, P = .85; 7-year survival, P = .61). Multivariable Cox regression analysis found that age (hazard ratio [HR], 1.039 [0.975-1.106], P = .2415) and pretransplant functional status with interaction term for age (some assistance, HR, 0.965 [0.902-1.033], P = .3079; total assistance, HR, 0.976 [0.914-1.041], P = .4610) were not significant risk factors for 7-year post-SHK transplantation mortality. Conclusions: Older and more functionally dependent recipients in this study did not have increased post-SHK transplantation mortality. These findings have important implications for organ allocation among elderly patients, as they support the need for thorough assessment of SHK candidates in terms of comorbidities, rather than exclusion solely based on age and functional dependence.

Background Venoarterial extracorporeal membrane oxygenation (VA‐ECMO) is increasingly used for patients with cardiogenic shock. Although Impella or intra‐aortic balloon pump (IABP) is frequently used for left ventricular unloading (LVU) during VA‐ECMO treatment, there are limited data on comparative outcomes. We compared outcomes of Impella and IABP for LVU during VA‐ECMO. Methods and Results Using the Nationwide Readmissions Database between 2016 and 2020, we analyzed outcomes in 3 groups of patients with cardiogenic shock requiring VA‐ECMO based on LVU strategies: extracorporeal membrane oxygenation (ECMO) only, ECMO with IABP, and ECMO with Impella. Of 15 980 patients on VA‐ECMO, IABP and Impella were used in 19.4% and 16.4%, respectively. The proportion of patients receiving Impella significantly increased from 2016 to 2020 (6.5% versus 25.8%; P‐trend

Abstract Aims Acute heart failure (HF) is associated with muscle mass loss, potentially leading to overestimation of kidney function using serum creatinine‐based estimated glomerular filtration rate (eGFRsCr). Cystatin C‐based eGFR (eGFRCysC) is less muscle mass dependent. Changes in the difference between eGFRCysC and eGFRsCr may reflect muscle mass loss. We investigated the difference between eGFRCysC and eGFRsCr and its association with clinical outcomes in acute HF patients. Methods and results A post hoc analysis was performed in 841 patients enrolled in three trials: Diuretic Optimization Strategy Evaluation (DOSE), Renal Optimization Strategies Evaluation (ROSE), and Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARRESS‐HF). Intra‐individual differences between eGFRs (eGFRdiff) were calculated as eGFRCysC–eGFRsCr at serial time points during HF admission. We investigated associations of (i) change in eGFRdiff between baseline and day 3 or 4 with readmission‐free survival up to day 60; (ii) index hospitalization length of stay (LOS) and readmission with eGFRdiff at day 60. eGFRCysC reclassified 40% of samples to more advanced kidney dysfunction. Median eGFRdiff was −4 [−11 to 1.5] mL/min/1.73 m2 at baseline, became more negative during admission and remained significantly different at day 60. The change in eGFRdiff between baseline and day 3 or 4 was associated with readmission‐free survival (adjusted hazard ratio per standard deviation decrease in eGFRdiff: 1.14, P = 0.035). Longer index hospitalization LOS and readmission were associated with more negative eGFRdiff at day 60 (both P ≤ 0.026 in adjusted models). Conclusions In acute HF, a marked difference between eGFRCysC and eGFRsCr is present at baseline, becomes more pronounced during hospitalization, and is sustained at 60 day follow‐up. The change in eGFRdiff during HF admission and eGFRdiff at day 60 are associated with clinical outcomes.

Background: The integrated design of the HeartMate 3 (Abbott Laboratories, Chicago, IL, USA) affords flexibility to place the pump within the pericardium or thoracic cavity. We sought to determine whether the presence of a left ventricular assist device (LVAD) in either location has a meaningful impact on overall patient outcomes. Methods: A retrospective cohort study was conducted of all 165 patients who received a HeartMate 3 LVAD via a median sternotomy from November 2014 to August 2019 at our center. Based on operative reports and imaging, patients were divided into intrapleural (n=81) and intrapericardial (n=84) cohorts. The primary outcome of interest was in-hospital mortality, while secondary outcomes included postoperative complications, cumulative readmission incidence, and 3-year survival. Results: There were no significant between-group differences in baseline demographics, risk factors, or preoperative hemodynamics. The overall in-hospital mortality rate was 6%, with no significant difference between the cohorts (9% vs. 4%, p=0.20). There were no significant differences in the postoperative rates of right ventricular failure, kidney failure requiring hemodialysis, stroke, tracheostomy, or arrhythmias. Over 3 years, despite similar mortality rates, intrapleural patients had significantly more readmissions (n=180 vs. n=117, p

Abstract Aims We aimed to detail the early clinical experience with pVAD 5.5 at a large academic medical centre. Impella® 5.5 (Abiomed) is a temporary peripherally inserted left ventricular assist device (pVAD) used for the treatment of cardiogenic shock (CS). This system has several modifications aimed at improving deliverability and durability over the pVAD 5.0 system, but real‐world experience with this device remains limited. Methods and results We collected clinical and outcome data on all patients supported with pVAD 5.5 at our centre between February and December 2020, including procedural and device‐related complications. Fourteen patients with pVAD 5.5 were included. Aetiology of CS was acute myocardial infarction (n = 6), decompensated heart failure (n = 6), suspected myocarditis (n = 1), and post‐cardiotomy CS (n = 1). Four patients received pVAD 5.5 after being on inotropes alone, two were escalated from intra‐aortic balloon pump, two were escalated from pVAD CP, and six patients were transitioned to pVAD 5.5 from extracorporeal membrane oxygenation. Median duration of pVAD 5.5 support was 12 (interquartile range 7, 25) days. Complications included axillary insertion site haematoma (n = 3), acute kidney injury (n = 3), severe thrombocytopenia (n = 1), and stroke (n = 1). No valve injury or limb complications occurred. Survival to device explant for recovery or transition to another therapy was 11/14 (79%) patients. Conclusions In this early experience of the pVAD 5.5, procedural and device‐related complications were observed but were manageable, and overall survival was high in this critically ill cohort, particularly when the device was used as a bridge to other therapies.

Abstract Aims Allograft rejection following heart transplantation (HTx) is a serious complication even in the era of modern immunosuppressive regimens and causes up to a third of early deaths after HTx. Allograft rejection is mediated by a cascade of immune mechanisms leading to acute cellular rejection (ACR) and/or antibody‐mediated rejection (AMR). The gold standard for monitoring allograft rejection is invasive endomyocardial biopsy that exposes patients to complications. Little is known about the potential of circulating miRNAs as biomarkers to detect cardiac allograft rejection. We here present a systematic analysis of circulating miRNAs as biomarkers and predictors for allograft rejection after HTx using next‐generation small RNA sequencing. Methods and results We used next‐generation small RNA sequencing to investigate circulating miRNAs among HTx recipients (10 healthy controls, 10 heart failure patients, 13 ACR, and 10 AMR). MiRNA profiling was performed at different time points before, during, and after resolution of the rejection episode. We found three miRNAs with significantly increased serum levels in patients with biopsy‐proven cardiac rejection when compared with patients without rejection: hsa‐miR‐139‐5p, hsa‐miR‐151a‐5p, and hsa‐miR‐186‐5p. We identified miRNAs that may serve as potential predictors for the subsequent development of ACR: hsa‐miR‐29c‐3p (ACR) and hsa‐miR‐486‐5p (AMR). Overall, hsa‐miR‐486‐5p was most strongly associated with acute rejection episodes. Conclusions Monitoring cardiac allograft rejection using circulating miRNAs might represent an alternative strategy to invasive endomyocardial biopsy.

Right ventricular (RV) failure is associated with significant morbidity and mortality, with in-hospital mortality rates estimated as high as 70–75%. RV failure may occur following cardiac surgery in conjunction with left ventricular failure, or may be isolated in certain circumstances, such as inferior MI with RV infarction, pulmonary embolism or following left ventricular assist device placement. Medical management includes volume optimisation and inotropic and vasopressor support, and a subset of patients may benefit from mechanical circulatory support for persistent RV failure. Increasingly, percutaneous and surgical mechanical support devices are being used for RV failure. Devices for isolated RV support include percutaneous options, such as micro-axial flow pumps and extracorporeal centrifugal flow RV assist devices, surgically implanted RV assist devices and veno-arterial extracorporeal membrane oxygenation. In this review, the authors discuss the indications, candidate selection, strategies and outcomes of mechanical circulatory support for RV failure.

Background Functional tricuspid regurgitation (TR) can occur secondary to atrial fibrillation (AF). The impact of AF on functional TR and cardiovascular events is uncertain in patients with left ventricular assist devices. This study aimed to investigate the effect of AF on functional TR and cardiovascular events in patients with a HeartMate 3 left ventricular assist device. Methods and Results We retrospectively reviewed 133 patients who underwent HeartMate 3 implantation at our center between November 2014 and November 2018. We excluded patients who had undergone previous or concomitant tricuspid valve procedures and those whose echocardiographic images were of insufficient quality. The primary end point was death and the presence of a cardiovascular event at 1 year. We defined cardiovascular event as a composite of death, stroke, and hospital readmission due to recurrent heart failure and significant residual TR as vena contracta width ≥3 mm. In total, 110 patients were included in this analysis. Patients were divided into 3 groups: no AF (n=51), paroxysmal AF (n=40), and persistent AF (PeAF) (n=19). Kaplan‐Meier analysis showed that patients with PeAF had the worst survival (no AF 98%, paroxysmal AF 98%, PeAF 84%, log‐rank P=0.038) and event‐free rate (no AF 93%, paroxysmal AF 89%, PeAF 72%, log‐rank P=0.048) at 1 year. Thirty‐one (28%) patients had residual TR 1 month after left ventricular assist device implantation. Patients with residual TR had a significantly poor prognosis compared with those without residual TR (log‐rank P=0.014). Conclusions PeAF was associated with increased mortality, cardiovascular events, and residual TR compared with no AF and paroxysmal AF.

Abstract Background The MOMENTUM3 trial1 has revealed superiority of the novel HeartMate3 (HM3) left ventricular assist device (LVAD) compared with the HM2, with a significantly reduced occurrence of cerebrovascular accidents. Thus, cerebral autoregulation may be improved in HM3 compared with HM II patients, possibly because of altered microcirculatory haemodynamics associated with the in-built speed modulation (‘pulsatility’) of the HM3 device. Methods Angle-corrected Doppler ultrasound images of the middle cerebral artery (MCA) were recorded before and at the end of a 30s breathhold test in healthy controls (n = 17), heart failure (HF n = 18), HM2 (n = 10) and HM3 (n = 17) patients. Microcirculatory haemodynamics as represented by the central retinal artery (CRA) were also quantified (Controls = 33, HF = 27, HM2 = 23, HM3 = 31). Data were analysed for Time-Averaged Maximum flow velocity (TAMAX), peak flow velocity (Vmax), minimum flow velocity (Vmin), Pulsatility Index (PI) and Resistance Index (RI, Table 1). Results Breathhold significantly increased TAMAX, Vmax and Vmin in all groups except HM II patients (Figure 1A). Conversely, PI decreased slightly in all groups while RI was maintained. The greater breathhold response in HM3 compared with HM2 patients was not attributable to the in-built pump-speed modulation (Figure 1B), however, HM3 had a consistently lower RI in the MCA and CRA. Conclusion Although reduced compared with healthy controls, HF and HM3 patients have a significantly greater metabolic cerebral vasoreactivity compared with HM2 patients. The 60% greater diastolic flow velocity in the microcirculation of both LVAD groups compared to healthy controls may alter gas exchange in the microcirculation. Future studies should examine the role of altered RI in HM3 patients. Table 1 Haemodynamics in the middle cererbral artery (MCA) and the central retinal artery (CRA) between HeartMate2 and HeartMate3 patients Healthy controls (n = 33) Heart failure (n = 27) HeartMate II (n = 23) HeartMate3 (average) (n = 31) HeartMate3 (no speed modulation) (n = 31) HeartMate3 (with speed modulation) (n = 31) Middle cerebral artery TAMAX (cm/s) 58 ± 15 48 ± 13 45 ± 15 48 ± 19 48 ± 19 46 ± 18 Vmax (cm/s) 92 ± 22 78 ± 20 55 ± 19*# 55 ± 21*# 54 ± 21*# 55 ± 22*# Vmin (cm/s) 39 ± 12 29 ± 11 37 ± 16 39 ± 14 44 ± 16# 32 ± 13 Pulsatility index 0.88 ± 0.18 1.05 ± 0.31* 0.40 ± 0.24*# 0.34 ± 0.14*# 0.21 ± 0.12*#$ 0.56 ± 0.24*# Resistance index 0.57 ± 0.07 0.60 ± 0.11 0.29 ± 0.14*# 0.16 ± 0.09*#$ 0.17 ± 0.10*#$ 0.14 ± 0.09*#$ Central retinal artery TAMAX (cm/s) 6 ± 1 5 ± 2 6 ± 3 7 ± 3 7 ± 4 6 ± 4 Vmax (cm/s) 12 ± 3 11 ± 6 8 ± 4* 8 ± 4* 8 ± 4* 8 ± 4* Vmin (cm/s) 3 ± 1 3 ± 1 5 ± 2 5 ± 3 6 ± 3*# 4 ± 4 Pulsatility index 1.60 ± 0.45 1.42 ± 0.40 0.58 ± 0.26*# 0.49 ± 0.21*# 0.32 ± 0.17*# 0.79 ± 0.35*# Resistance index 0.75 ± 0.09 0.70 ± 0.11 0.38 ± 0.15*# 0.22 ± 0.11*#$ 0.24 ± 0.12*#$ 0.20 ± 0.13*#$ *p < 0.05 compared with healthy controls; #p < 0.05 compared with Heart Failure; $p < 0.05 compared with HeartMate II. Figure 1 (A) Time-averaged maximum flow velocity in the middle cerebral artery of healthy controls and patient groups in response to a 30-s breathhold test. (B) Breakdown of the responses in HM3 patients, comparing beats with and without added pulsatility.

IntroductionEffective tacrolimus (TAC) dosing is hampered by complex pharmacokinetics and significant patient variability. The gut microbiome, a key mediator of endotoxemia, inflammation and oxidative stress in advanced heart failure (HF) patients, is a possible contributor to interindividual variations in drug efficacy. The effect of alterations in the gut microbiome on TAC dosing requirements after heart transplant (HT) has not been explored.MethodsWe enrolled 24 patients (mean age = 55.8 ±2.3 years) within 3 months post-HT. Biomarkers of endotoxemia ((lipopolysaccharide (LPS)), inflammation (tumor necrosis factor-α (TNF-α)) and oxidative stress (8,12-iso-Isoprostane F-2alpha-VI) were measured in 16 blood samples. 22 stool samples were analyzed using 16S rRNA sequencing. TAC dose and serum trough level were measured at the time of stool and blood collection. TAC doses were reported in mg/kg/day and as level-to-dose (L/D) ratio, and categorized as ≤ vs. > median.ResultsThe median TAC dose was 0.1 mg/kg/day and L/D ratio was 100.01. Above the median daily weight-based TAC dose was associated with higher gut microbial alpha diversity (p = 0.03); similarly, TNF-α and 8,12-iso-Isoprostane F-2alpha-VI levels were lower and LPS levels were higher in the above median TAC group, although these findings were only marginally statistically significant and dependent on BMI adjustment. We observed n = 37 taxa to be significantly enriched among patients with > median TAC dose (all FDRConclusionsOur pilot study observed gut microbial alpha diversity to be increased while inflammation and oxidative stress were reduced among patients requiring higher TAC doses early after HT.

Background: In heart failure patients with continuous-flow left ventricular assist devices (CF-LVAD), arterial pulsatility in the brain is reduced and diastolic blood velocities (Vmin) are maintained. The effects of such altered hemodynamics on kinetic energy and, importantly, energy loss in the cerebral circulation have never been studied. Methods: Angle-corrected Doppler ultrasound movies of the middle cerebral artery (MCA) were recorded in 11 healthy volunteers, 5 patients with severe heart failure, and 4 patients with HM II. Data were analyzed offline using validated Vector Flow Mapping software (Cardio Flow Design, Tokyo, Japan). Vmin, pulsatility index (PI), total Energy Loss (ELAUC) and total Kinetic Energy (KEAUC) and both variables normalized for different heart rates (ELAUC/time & KEAUC/time) were calculated (Figure 1). Correlations between these energetic parameters and PI were determined. Results: PI, KEAUC and ELAUC were significantly lower in HM II (P < 0.0001 and P < 0.05) while Vmin was similar (Fig 1). Normalization of data for different heart rates (ELAUC/time & KEAUC/time) revealed the same results. PI correlated with KEAUC (logr2 = 0.33, P = 0.008) but not ELAUC (logr2 = 0.154, P = 0.087). Conclusions: ELAUC and KEAUC were significantly lower in HM II. The correlation between KEAUC and PI suggests that pulsatility may have an important impact not only on the stretch of arteries but also on the energetics of blood flow. Future studies should evaluate the clinical meaning of these observations.

Background Although implantation of a left ventricular assist device (LVAD) generally improves tricuspid regurgitation (TR) in short‐term follow‐up, the clinical significance of residual TR in patients with mid‐ to long‐term LVAD support is unknown. This study aimed to identify the prevalence, predictors, and prognostic value of residual TR in LVAD patients in association with tricuspid valve (TV) deformation. Methods and Results The study cohort consisted of 127 patients who underwent LVAD implantation without TV procedure and were supported with LVAD at least 1 year. All patients underwent echocardiographic examination preoperatively and 1 year after LVAD implantation. TR was quantitatively assessed by ratio of TR color jet area/right atrial area, and significant residual TR was defined as ≥20% of %TR at follow‐up echocardiographic examination. Detailed echocardiographic measurements were also performed, including TV annulus diameter, TV leaflet displacement, and left ventricular and right ventricular systolic function. LVAD implantation significantly improved ratio of TR color jet area/right atrial area as well as left ventricular and right ventricular systolic function and tethering distance (all P

BackgroundPredicting which patients are unlikely to benefit from continuous flow left ventricular assist device (LVAD) treatment is crucial for the identification of appropriate patients. Previously developed scoring systems are limited to past eras of device or restricted to specific devices. Our objective was to create a risk model for patients treated with continuous flow LVAD based on the preimplant variables. Methods and ResultsWe performed a retrospective analysis of all patients implanted with a continuous flow LVAD between 2006 and 2014 at the University of Pennsylvania and included a total of 210 patients (male 78%; mean age, 56±15; mean follow‐up, 465±486 days). From all plausible preoperative covariates, we performed univariate Cox regression analysis for covariates affecting the odds of 1‐year survival following implantation (P

Background: High pulsatility index (PI) in the cerebral circulation has been associated with increased prevalence of stroke (1). Interestingly, heart failure (HF) patients implanted with continuous-flow left ventricular assist devices (CF-LVADs) have increased rates of stroke despite presenting with dramatically lower pulse pressures compared with healthy individuals (20 mmHg vs. 30–40 mmHg). Characterising and understanding flow velocity profiles of the middle cerebral artery (MCA) may provide a useful and local marker of pulsatile energy transmitted into the brain of HF and CF-LVAD patients. Methods: PI and resistance index (RI) were quantified from Duplex ultrasound images (2D and pulsed-wave Doppler) of the MCA obtained in four heart failure patients (HF; 68 ± 7 yrs), eight CF-LVAD patients (59 ± 4 yrs) and 20 healthy controls (51 ± 7 yrs). Results: Compared with healthy controls, PI of the MCA was actually higher in the HF group (0.72 ± 0.16 vs. 1.32 ± 0.17, P < 0.0001), but markedly lower in patients on CF-LVAD (0.36 ± 0.21, P < 0.0001). However, RI was similar between healthy controls and HF patients (P > 0.05), and only lower in CF-LVAD patients (P < 0.0001). Conclusions: PI in the MCA is significantly higher in HF but markedly lower in CF-LVAD patients, relative to healthy controls. The higher PI in HF does not appear to be associated with an altered RI. Future work should examine the cerebrovascular outcomes associated with varying levels of pulsatility and resistance in both HF and CF-LVAD patients.

Heart transplantation alone has been recognized to be contraindicated when pulmonary hypertension (PH) and elevated pulmonary vascular resistance (PVR) are irreversible, irrespective of any medical intervention by the use of inotropic agents or pulmonary vasodilators, because such patients are at an increased risk of post-transplantation right ventricular failure and mortality. Therefore, end-stage heart failure patients with concomitant fixed PH and irreversibly high PVR are considered to be heart–lung transplant candidates. Recently, left ventricular assist device (LVAD) therapy has been reported to normalize PVR through persistent unloading of the left ventricle, even in patients with medically refractory PH. Therefore, LVAD therapy could make such patients suitable for “heart-only” transplants, which contributes to appropriate donor lung allocation for lung-only candidates. We review the literature regarding LVAD use for secondary PH and present a case with end-stage heart failure that could avoid a heart–lung transplant owing to LVAD therapy.

Staphylococcus epidermidis remains the predominant pathogen in prosthetic-device infections. Ventricular assist devices, a recently developed form of therapy for end-stage congestive heart failure, have had considerable success. However, infections, most often caused by Staphylococcus epidermidis, have limited their long-term use. The transcutaneous driveline entry site acts as a potential portal of entry for bacteria, allowing development of either localized or systemic infections. A novel in vitro binding assay using explanted drivelines obtained from patients undergoing transplantation and a heterologous lactococcal system of surface protein expression were used to identify S. epidermidis surface components involved in the pathogenesis of driveline infections. Of the four components tested, SdrF, SdrG, PIA, and GehD, SdrF was identified as the primary ligand. SdrF adherence was mediated via its B domain attaching to host collagen deposited on the surface of the driveline. Antibodies directed against SdrF reduced adherence of S. epidermidis to the drivelines. SdrF was also found to adhere with high affinity to Dacron, the hydrophobic polymeric outer surface of drivelines. Solid phase binding assays showed that SdrF was also able to adhere to other hydrophobic artificial materials such as polystyrene. A murine model of infection was developed and used to test the role of SdrF during in vivo driveline infection. SdrF alone was able to mediate bacterial adherence to implanted drivelines. Anti-SdrF antibodies reduced S. epidermidis colonization of implanted drivelines. SdrF appears to play a key role in the initiation of ventricular assist device driveline infections caused by S. epidermidis. This pluripotential adherence capacity provides a potential pathway to infection with SdrF-positive commensal staphylococci first adhering to the external Dacron-coated driveline at the transcutaneous entry site, then spreading along the collagen-coated internal portion of the driveline to establish a localized infection. This capacity may also have relevance for other prosthetic device-related infections.

Background The Clinical Frailty Scale (CFS) is a useful frailty marker for predicting clinical outcomes in patients undergoing invasive therapy. However, the clinical impact of CFS after transcatheter edge‐to‐edge repair in patients with mitral regurgitation (MR) remains unclear. This study aimed to elucidate the association between the baseline frail status defined by the CFS and clinical outcomes with or without postprocedural MR ≥2+ (post‐MR ≥2+) after transcatheter edge‐to‐edge repair. Methods and Results Based on a Japanese multicenter registry (OCEAN [Optimized Catheter Valvular Intervention]‐Mitral), data from 2078 patients with MR who underwent transcatheter edge‐to‐edge repair were analyzed. The patients were classified into 5 groups: CFS 1 to 3, 4, 5, 6, and ≥7. The procedural and clinical outcomes and post‐MR ≥2+ were compared among the groups. All‐cause mortality for up to 2 years was explored using Cox proportional hazards regression analysis. Although the rates of acute procedural success and post‐MR ≥2+ were similar, all‐cause mortality at 2 years was significantly increased across the 5 CFS categories (15.5%, 23.8%, 27.7%, 34.6%, and 48.8%, respectively, P

Abstract Background/Purpose Endoscopic biliary stenting (EBS) is commonly used for preoperative drainage of localized perihilar cholangiocarcinoma (LPHC). This study retrospectively compared the utility of inside stent (IS) and conventional stent (CS) for preoperative EBS in patients with LPHC. Methods EBS was performed in 56 patients with LPHC. EBS involved the placement of a CS (n = 32) or IS (n = 24). Treatment outcomes were compared between these two groups. Results Preoperative recurrent biliary obstruction (RBO) occurred in 23 patients (71.9%) in the CS group and 7 (29.2%) in the IS group, with a significant difference (p = 0.002). The time to RBO (TRBO) was significantly longer in IS than in CS (log-rank: p

Aims We aimed to detail the early clinical experience with pVAD 5.5 at a large academic medical centre. Impella® 5.5 (Abiomed) is a temporary peripherally inserted left ventricular assist device (pVAD) used for the treatment of cardiogenic shock (CS). This system has several modifications aimed at improving deliverability and durability over the pVAD 5.0 system, but real-world experience with this device remains limited. Methods and results We collected clinical and outcome data on all patients supported with pVAD 5.5 at our centre between February and December 2020, including procedural and device-related complications. Fourteen patients with pVAD 5.5 were included. Aetiology of CS was acute myocardial infarction (n = 6), decompensated heart failure (n = 6), suspected myocarditis (n = 1), and post-cardiotomy CS (n = 1). Four patients received pVAD 5.5 after being on inotropes alone, two were escalated from intra-aortic balloon pump, two were escalated from pVAD CP, and six patients were transitioned to pVAD 5.5 from extracorporeal membrane oxygenation. Median duration of pVAD 5.5 support was 12 (interquartile range 7, 25) days. Complications included axillary insertion site haematoma (n = 3), acute kidney injury (n = 3), severe thrombocytopenia (n = 1), and stroke (n = 1). No valve injury or limb complications occurred. Survival to device explant for recovery or transition to another therapy was 11/14 (79%) patients. Conclusions In this early experience of the pVAD 5.5, procedural and device-related complications were observed but were manageable, and overall survival was high in this critically ill cohort, particularly when the device was used as a bridge to other therapies. [ABSTRACT FROM AUTHOR]

One of the goals of the revised 6-tiered US adult heart allocation policy was to improve risk stratification of patients to lower exception status utilization for transplant listing. We sought to define the characteristics and outcomes of waitlisted patients using exception status and to examine region- and center-level differences in utilization of exception status in the new heart allocation system. METHODS: This retrospective cohort analysis of the United Network for Organ Sharing database included adult waitlisted patients for heart transplant between October 18, 2018, and June 30, 2020, in the United States, stratified by use of exception status versus standard criteria. RESULTS: Out of 6351 patients, 1907 (30.0%) were waitlisted under exception status. Patients using exception status were more likely to have a nonischemic cause of heart failure, blood type O, United Network for Organ Sharing status 2 at listing and were less likely to have a durable left ventricular assist device at listing. Exception status utilization varied significantly between and within United Network for Organ Sharing regions. Listing by exception criteria was associated with a significantly higher incidence of heart transplantation compared with listing by standard criteria (hazard ratio, 1.25 [1.15–1.38], P<0.001), without increased risk of death or delisting for worsening clinical status (hazard ratio, 0.83 [0.65–1.05], P=0.12) after multivariable adjustment. CONCLUSIONS: The status tiers of the new heart allocation system may not fully capture medical urgency and complexity of waitlisted patients as assessed by transplant physicians and review committees and may limit the ability to develop a heart allocation score. [ABSTRACT FROM AUTHOR]

Background Limited data are available about clinical outcomes and residual mitral regurgitation (MR) after transcatheter edge‐to‐edge repair in the large Asian‐Pacific cohort. Methods and Results From the Optimized Catheter Valvular Intervention (OCEAN‐Mitral) registry, a total of 2150 patients (primary cause of 34.6%) undergoing transcatheter edge‐to‐edge repair were analyzed and classified into 3 groups according to the residual MR severity at discharge: MR 0+/1+, 2+, and 3+/4+. The mortality and heart failure hospitalization rates at 1 year were 12.3% and 15.0%, respectively. Both MR and symptomatic improvement were sustained at 1 year with MR ≤2+ in 94.1% of patients and New York Heart Association functional class I/II in 95.0% of patients. Compared with residual MR 0+/1+ (20.4%) at discharge, both residual MR 2+ (30.2%; P

BACKGROUND: Continuous-flow left ventricular assist devices (CF-LVADs) have become a standard treatment choice in advanced heart failure patients. We hypothesized that practice patterns with regards to CF-LVAD utilization vary significantly among transplant centers and impact waitlist outcomes. METHODS AND RESULTS: The United Network for Organ Sharing registry was queried to identify adult patients who were waitlisted for heart transplantation (HT) between 2008 and 2015. Each patient was assigned a propensity score based on likelihood of receiving a durable CF-LVAD before or while waitlisted. The primary outcomes of interest were death or delisting for worsening status and HT at 1 year. A total of 22 863 patients from 92 centers were identified. Among these, 9013 (39.4%) were mechanically supported. CF-LVAD utilization varied significantly between and within United Network for Organ Sharing regions. Freedom from waitlist death or delisting was significantly lower in propensity-score--matched patients who were mechanically supported versus medically managed (83.5% versus 79.2%; P<0.001). However, cumulative incidence of HT was also lower in mechanically supported patients (53.3% versus 63.6%; P<0.001). Congruous mechanical and medical bridging strategies based on clinical risk profile were associated with lower risk of death or delisting (hazard ratio, 0.88; P=0.027) and higher likelihood of HT (hazard ratio, 1.14; P<0.001). CONCLUSIONS: CF-LVAD utilization may lower waitlist mortality at the expense of lower likelihood of HT. Decision to use CF-LVAD and timing of transition should be individualized based on patient-, center-, and regionlevel risk factors to achieve optimal outcomes. [ABSTRACT FROM AUTHOR]