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Background: During the height of the coronavirus disease 2019 (COVID-19) pandemic in New York City, COVID-19 hospitalization was associated with high mortality. It is unknown how palliative care wa...

Background Anticoagulation therapy management during venoarterial extracorporeal membrane oxygenation (ECMO) is particularly difficult in postcardiotomy shock patients given a significant bleeding risk. We sought to determine the effect of anticoagulation treatment on bleeding and thrombosis risk for postcardiotomy shock patients on ECMO. Methods We retrospectively reviewed patients who received ECMO for postcardiotomy shock from July 2007 through July 2019. Characteristics of patients who had bleeding and thrombosis were investigated, and risk factors were assessed by multilevel logistic regression. Results Of the 152 patients who received ECMO for postcardiotomy shock, 33 (23%) had 40 thrombotic events and 64 (45%) had 86 bleeding events. Predictors of bleeding were intraoperative packed red blood cell transfusion (odds ratio [OR] 1.05; 95% confidence interval [CI], 1.01 to 1.09), platelet transfusion (OR 1.10; 95% CI, 1.05 to 1.16), international normalized ratio (OR 1.18; 95% CI, 1.02 to 1.37), and activated partial thromboplastin time greater than 60 seconds (OR 2.32; 95% CI, 1.14 to 4.73). Predictors of thrombosis were anticoagulant use (OR 0.39; 95% CI, 0.19 to 0.79), surgical venting (OR 3.07; 95% CI, 1.29 to 7.31), hemoglobin (OR 1.38; 95% CI, 1.06 to 1.79), and central cannulation (OR 2.06; 95% CI, 1.03 to 4.11). The daily predicted probability of thrombosis was between 0.075 and 0.038 for patients who did not receive anticoagulation and decreased to between 0.030 and 0.013 for patients who received anticoagulation treatment at activated partial thromboplastin times between 25 and 80 seconds. Conclusions Anticoagulation therapy can reduce thromboembolic events in postcardiotomy shock patients on ECMO, but bleeding risk may outweigh this benefit at activated partial thromboplastin times greater than 60 seconds.

Objectives This analysis sought to investigate the waitlist and post-transplant outcomes of individuals bridged to transplantation by using temporary percutaneous endovascular mechanical circulatory support (tMCS) through a status 2 designation (cardiogenic shock and exception). Background The 2018 donor heart allocation policy change granted a status 2 designation to patients supported with tMCS. Methods Adult patients in the United Network for Organ Sharing registry after October 18, 2018 who received a status 2 designation for tMCS were included and grouped by their status 2 criteria: cardiogenic shock with hemodynamic criteria (CS-HD), cardiogenic shock without hemodynamic criteria before tMCS (CS-woHD), and exception. Baseline characteristics, waitlist events (death and delisting), and post-transplant outcomes were compared. Results A total of 2,279 patients met inclusion criteria: 68.6% (n = 1,564) with CS-HD, 3.2% (n = 73) with CS-woHD, and 28.2% (n = 642) with exceptions. A total of 64.2% of patients underwent heart transplantation within 14 days of status 2 listing or upgrade, and 1.9% died or were delisted for worsening clinical condition. Among the 35.8% who did not undergo transplantation following 14 days, only 2.8% went on to receive a left ventricular assist device (LVAD). The 30-day transplantation likelihood was similar among groups: 80.1% for the CS-HD group vs 79.7% for the exception group vs 73.3% for the CS-woHD group; P = 0.31. However, patients who met criteria for CS-woHD had 2.3-fold greater risk of death or delisting (95% CI: 1.10-4.75; P = 0.03) compared with CS-HD patients after multivariable adjustment. Pre-tMCS hemodynamics were not associated with adverse waitlist events. Conclusions The use of tMCS is an efficient, safe, and effective strategy as a bridge to transplantation; however, patients with CS-woHD may represent a high-risk cohort. Transition to a durable LVAD was a rare event in this group.

Background Heart failure predisposes to intracardiac thrombus (ICT) formation. There are limited data on the prevalence and impact of preexisting ICT on postoperative outcomes in left ventricular assist device patients. We examined the risk for stroke and death in this patient population. Methods and Results We retrospectively studied patients who were implanted with HeartMate (HM) II or HM3 between February 2009 and March 2019. Preoperative transthoracic echocardiograms, intraoperative transesophageal echocardiograms and operative reports were reviewed to identify ICT. There were 525 patients with a left ventricular assist device (median age 60.6 years, 81.8% male, 372 HMII and 151 HM3) included in this analysis. An ICT was identified in 44 patients (8.4%). During the follow-up, 43 patients experienced a stroke and 55 died. After multivariable adjustment, presence of ICT increased the risk for the composite of stroke or death at 6-month (hazard ratio [HR] 1.82, 95% confidence interval [CI] 1.00–3.33, P = .049). Patients with ICT were also at higher risk for stroke (HR 2.45, 95% CI 1.14–5.28, P = .021) and death (HR 2.36, 95% CI 1.17–4.79 P = .016) at 6 months of follow-up. Conclusions The presence of ICT is an independent predictor of stroke and death at 6 months after left ventricular assist device implantation. Additional studies are needed to help risk stratify and optimize the perioperative management of this patient population.

OBJECTIVES Left atrial appendage occlusion (LAAO) at the time of implantation may reduce thromboembolic events (TEs) during continuous-flow left ventricular assist device support. The HeartMate 3 (HM3) reduces TEs overall, but the efficacy of LAAO in HM3 is unknown. METHODS Adults receiving first HM3 implantation from November 2014 through December 2019 at a single, large medical centre were retrospectively reviewed. TEs included device thrombosis and ischaemic stroke. Patients were classified by whether they received LAAO or not. Incidence of TEs was compared between groups using cumulative incidence curves with competing risks (death and heart transplant) and risk factors for TEs were assessed with Fine and Gray competing risk regression. RESULTS A total of 182 patients received HM3, of whom 99 (54%) received LAAO versus 83 (46%) who did not. There were 14 TEs, including 13 strokes (7%) and 1 pump thrombosis (0.5%). No significant difference in the incidence of TEs in each group was found (Gray’s test: P = 0.35). LAAO was not associated with TEs in multivariable Fine–Gray analysis (P = 0.10) and no significant risk factors for TEs were found. There were zero disabling strokes in those who received LAAO compared to 6 (7%) in those who did not receive LAAO (P = 0.008). CONCLUSIONS A low number of TEs was observed in HM3 recipients. LAAO did not further reduce the overall rate of TEs in this patient population, though its use may be beneficial in preventing disabling ischaemic strokes after HM3 implantation.

BACKGROUND: Right heart catheterization for invasive hemodynamics has shown only modest correlation with clinical outcomes. We designed a novel hemodynamic variable that incorporates ventricular output and filling pressure. We anticipated that the aortic pulsatility index (API) would correlate with clinical outcomes in patients with heart failure. METHODS AND RESULTS: We retrospectively analyzed consecutive patients undergoing right heart catheterization with milrinone drug study at our institution (February 2013 to November 2019). The API was calculated as (systolic blood pressure – diastolic blood pressure)/pulmonary capillary wedge pressure. The primary outcome was freedom from advanced therapies, defined as the need for inotropes, temporary mechanical circulatory support, a left ventricular assist device, or orthotopic heart transplantation, or death at 30 days. A total of 224 patient encounters, age 57 years (48–66 years; 34% women; 31% ischemic cardiomyopathy) were included. In univariable analysis, lower baseline API was significantly associated with progression to advanced therapies or death at 30-days (odds ratio 0.43, 95% confidence interval 0.30–0.61; P < .001) compared with those on continued medical management. Receiver operator characteristic analysis specified an optimal cutpoint of 1.45 for API. A Kaplan–Meier analysis indicated an association of API with the primary outcome (79% for API ≥ 1.45 vs 48% for API < 1.45). In multivariable analysis, higher API was strongly associated with freedom from advanced therapies or death (odds ratio 0.38, 95% confidence interval 0.22–0.65, P ≤ .001), even when adjusted for baseline characteristics and routine right heart catheterization measurements. CONCLUSIONS: The API is a novel invasive hemodynamic measurement that is associated independently with freedom from advanced therapies or death at 30-day follow-up.

Objective The objective of this study was to describe the profiles and outcomes of a cohort of advanced heart failure patients on ambulatory inotropic therapy (AIT). Background With the growing burden of patients with end-stage heart failure, AIT is an increasingly common short or long-term option, for use as bridge to heart transplant (BTT), bridge to ventricular assist device (BTVAD), bridge to decision regarding advanced therapies (BTD) or as palliative care. AIT may be preferred by some patients and physicians to facilitate hospital discharge. However, counseling patients on risks and benefits is critically important in the modern era of defibrillators, durable mechanical support and palliative care. Methods We retrospectively studied a cohort of 241 patients on AIT. End points included transplant, VAD implantation, weaning of inotropes, or death. The primary outcomes were survival on AIT and ability to reach intended goal if planned as BTT or BTVAD. We also evaluated recurrent heart failure hospitalizations, incidence of ventricular arrhythmias (VT/VF) and indwelling line infections. Unintended consequences of AIT, such reaching unintended end point (e.g. VAD implantation in BTT patient) or worse than expected outcome after LVAD or HT, were recorded. Results Mean age of the cohort was 60.7 ± 13.2 years, 71% male, with Class III-IV heart failure (56% non-ischemic). Average ejection fraction was 19.4 ± 10.2%, pre-AIT cardiac index was 1.5 ± 0.4 L/min/m2 and 24% had prior ventricular arrhythmias. Overall on-AIT 1-year survival was 83%. Hospitalizations occurred in 51.9% (125) of patients a total of 174 times for worsening heart failure, line complication or ventricular arrhythmia. In the BTT cohort, only 42% were transplanted by the end of follow-up, with a 14.8% risk of death or delisting for clinical deterioration. For the patients who were transplanted, 1-year post HT survival was 96.7%. In the BTVAD cohort, 1-year survival after LVAD was 90%, but with 61.7% of patients undergoing LVAD as INTERMACS 1-2. In the palliative care cohort, only 24.5% of patients had a formal palliative care consult prior to AIT. Conclusions AIT is a strategy to discharge advanced heart failure patients from the hospital. It may be useful as bridge to transplant or ventricular assist device, but may be limited by complications such as hospitalizations, infections, and ventricular arrhythmias. Of particular note, it appears more challenging to bridge to transplant on AIT in the new allocation system. It is important to clarify the goals of AIT therapy upfront and continue to counsel patients on risks and benefits of the therapy itself and potential unintended consequences. Formalized, multi-disciplinary care planning is essential to clearly define individualized patient, as well as programmatic goals of AIT.

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.

AIMS Infections are common following left ventricular assist device (LVAD) implantation and predict adverse events. Infections are frequent prior to LVAD implantation although their impact on postoperative outcomes remains unknown. Gut and nasal microbial imbalance may predispose to mucosal colonization with pathogens. Herein, we investigated the predictive role of pre-LVAD infections, and explored the association of nasal Staphylococcus aureus (SA) colonization and gut microbiota, on postoperative outcomes. METHODS AND RESULTS Overall, 254 LVAD patients were retrospectively categorized based on pre-LVAD infection status: Group 1, bacterial/fungal bloodstream infection (BSI); Group 2, other bacterial/fungal; Group 3, viral; and Group 4, no infection. In a subset of patients, nasal SA colonization (n = 140) and pre-LVAD stool (n = 25) were analysed using 16S rRNA sequencing. A total of 75 (29%) patients had a pre-LVAD infection [Group 1: 22 (29%); Group 2: 41 (55%); Group 3: 12 (16%)]. Pre-LVAD BSIs were independent predictors of 1-year postoperative mortality and infections [Group 1 vs. 4: hazard ratio (HR) 2.70, P = 0.036 vs. HR 1.8, P = 0.046]. In an unadjusted analysis, pre-LVAD infections other than BSIs, INTERMACS profile ≤2, higher serum creatinine, lower serum albumin and nasal SA colonization were also significantly associated with postoperative infections. Patients with early post-LVAD infections exhibited decreased microbial diversity (P

There are limited safety data on reduced anti-thrombotic therapy (RT) in patients with HeartMate 3 (HM3) left ventricular assist device (LVAD). We conducted a single-center, retrospective study of patients with HM3 managed with RT from November 2014 through January 2020. We analyzed baseline characteristics, RT indications, and bleeding and thrombotic complications. We found that 50 of 161 patients with HM3 (31.1%) received RT starting at a median time of 90.5 days after LVAD implantation. Patients on RT were older and more likely to have ischemic heart failure than patients on standard anti-thrombotic therapy (ST). The most common indication for RT was gastrointestinal bleeding (29 patients [58.0%]). At 1-year follow-up, 5.0% of patients on RT developed a thrombotic event. Switching patients from ST to RT reduced the occurrence of major bleeding from 1.252 to 0.324 events per patient-year (p = 0.006). In our population of patients with HM3 LVAD, RT reduces bleeding without increasing the incidence of thrombosis. Our retrospective study suggests that an upfront RT strategy in patients with HM3 may be beneficial and should be prospectively studied.

Background Elevated lactic acid (LA) levels carry a poor prognosis in patients with shock. Data are lacking on the significance of LA levels in patients with acute decompensated heart failure (ADHF). Hypothesis This study assessed the relationship between LA levels, hemodynamics and clinical outcomes. Methods This was a retrospective analysis of registry data of 100 advanced heart failure patients presenting for right heart catheterization (RHC) for concern of ADHF. LA levels (normal ≤2.1 mmol/L) were obtained prior to RHC; no significant changes in therapy were made between LA collection and RHC. Results Median age was 58 (47.3, 64.8) years; 57% were receiving inotropes prior to RHC. Median pulmonary capillary wedge pressure (PCWP) and cardiac index (CI) were 28 (21, 35) mmHg and 2.0 (1.7, 2.5) L/min/m2, respectively. Eighty patients had normal LA prior to RHC. There was no correlation between LA levels and PCWP (R = 0.09, p = .38); 63% of the normal LA group had a PCWP >24 mmHg. There was a moderate inverse correlation between LA and CI (R = − 0.40; p

Background Hyperkalemia (HK) is a life-threatening complication following solid organ transplantation, and patients often need potassium-chelating agents and deviations from standard posttransplant protocols. This is the first study to report the incidence and clinical impact of hyperkalemia following heart transplantation. Methods We retrospectively included patients who underwent heart transplantation at our institution between April 2014 and December 2018. Patients with multiorgan transplantation were excluded. Clinical outcomes of patients who had serum potassium >5.5 mEq/L in the first year posttransplant (HK group) were compared to patients who did not have serum potassium >5.5 mEq/L in the first year posttransplant (non-HK group). Results A total of 143 patients were included in this study. During the first year posttransplant, cumulative incidence of serum potassium >5.0, >5.5, and >6.0 mEq/L was 96%, 63%, and 24%, respectively. Fifty-five percent of patients required treatment with potassium-chelating agents. Sulfamethoxazole-trimethoprim was discontinued because of HK in 39% of patients. Overall survival of patients in the HK group (n = 89) was comparable to that of patients in the non-HK group (n = 54, 91% vs 98% at 1 year, P = .19), whereas infection-free survival was significantly lower in the HK group (34% vs 53% at 1 year, P = .010). Multivariate analysis revealed pretransplant renal dysfunction (odds ratio = 2.62; 95% confidence interval, 1.18-5.80; P = .018) and use of mechanical circulatory support (odds ratio = 2.90; 95% confidence interval, 1.08-7.76; P = .035) as significant predictors of posttransplant hyperkalemia. Conclusions The incidence of HK following heart transplantation was high, with more than half of patients requiring any therapeutic interventions, and HK was related to an increase in infection events.

Reverse remodeling of the left ventricle has been reported following left ventricular assist device (LVAD) implantation. However, left ventricular (LV) and right ventricular (RV) volumetric and shape changes have not been described. Consecutive candidates for LVAD were prospectively enrolled. Comprehensive 2- and 3-dimensional echocardiographic (2DE, 3DE) images were acquired before and 1 to 2 months following LVAD implantation. 3D endocardial surfaces were analyzed to derive shape indices, including LV sphericity and conicity and RV septal and free-wall curvatures. Sixty patients were enrolled with a mean age 56 ± 13 years, 77% male, and 83% destination therapy. 3DE showed that LV end-diastolic volume (EDV) improved from 461 ± 182 to 287 ± 144 ml (p < 0.001) and RV EDV showed no change (p = 0.08). RV longitudinal strain (LS) worsened from -9.1 ± 3.1 to -5.9 ± 2.6% (p < 0.01). LV sphericity and conicity improved (p < 0.001 for both), whereas the curvature of the interventricular septum and RV free wall did not change (p = 0.79 and 0.26, respectively). At 1 month following LVAD implantation, LV volumes decrease dramatically, and there is a favorable LV shape improvement, indicating reverse remodeling. RV shape did not change, whereas RV LS worsened, indicating an absence of RV reverse remodeling.

Acute myocardial infarction with refractory cardiogenic shock (AMI-RCS) is associated with poor outcomes. Several percutaneous mechanical circulatory support devices exist; however, limitations exist regarding long-term use. Herein, we describe our experience with the temporary surgical CentriMag VAD. We reviewed 74 patients with AMI-RCS who underwent CentriMag VAD insertion as bridge-to-decision device from 2007 to 2020. Patients were divided into groups based on introduction of the “shock team” model: Era 1 (2007–2014, n = 51) and Era 2 (2015–2020, n = 23). Era 2 had higher proportion of patients with INTERMACS Profile I. The use of percutaneous MCS as bridge to VAD and the use of minimally invasive VAD were higher in Era 2. There were fewer postoperative bleeding events in Era 2 (80% vs 61%, p = .07). Thirty-day mortality was 23% and 1-year survival was 55%, which were no differences between eras. Destinations after CentriMag VAD included myocardial recovery (39%), durable LVAD (27%), and transplantation (5%). CentriMag VAD device represents a viable bridge-to-decision device with acceptable short- and long-term outcomes for patients with AMI-RCS. Stable outcomes in a progressively sicker population may be related to changes in practice patterns as well as introduction of the “shock team” concept.

Aortic insufficiency remains a difficult to treat and highly morbid condition even in the era of HeartMate 3 left ventricular assist devices (LVADs). The prognostic nature of the longitudinal progression of aortic insufficiency, however, remains unknown. We prospectively collected data on patients who received HeartMate 3 LVAD implantation, who had assessments of aortic insufficiency using a novel Doppler echocardiography obtained at outflow graft at three (baseline) and 6 months postimplant. Patients with moderate or greater aortic insufficiency at baseline were excluded. The risk of aortic insufficiency progression on 1-year death and readmission for heart failure was investigated. In total, 41 patients (median 51 years old and 29 males) were included. All patients had less than moderate aortic insufficiency at baseline. Of them, 22 patients had worsening aortic insufficiency for 3 months following baseline assessments, which was associated with a significantly higher risk of 1-year death or heart failure readmission rate (41% vs. 11%, P = .023) with a hazard ratio of 3.24 (95% confidence interval 1.02-18.5, P = .038) adjusted for device speed at baseline and destination therapy indication. In patients with HeartMate 3 LVADs, progressive aortic insufficiency may be associated with a higher risk of 1-year death or readmission for heart failure. Close monitoring of patients with baseline aortic insufficiency should be considered as a measure to risk-stratify those for future adverse events.

Background Late graft failure (LGF) is an unresolved issue after orthotopic heart transplant (OHT). In this study, we report characteristics and outcomes of severe LGF requiring mechanical circulatory support (MCS). Methods All patients undergoing OHT from 2000 to 2018 at our center were reviewed. Patients re-admitted to the hospital for late graft failure (>3 months after initial discharge) and developing cardiogenic shock requiring MCS were identified. Outcomes and mortality were evaluated. Results Twenty-six patients were identified. Median age was 37.3 years (interquartile range: 28.2-47.6) and 69% were male. Median time from initial transplant to MCS was 2.9 years. Etiology of graft failure was rejection in 19 patients (73%), transplant coronary artery disease (tCAD) in 3 (12%), with mixed tCAD or rejection in 4 (15%).

A 66-year-old woman with advanced diffuse large B-cell lymphoma (DLBCL) was referred for chimeric antigen receptor (CAR) T cell therapy. She was diagnosed with DLBCL 6 years prior to presentation and had no significant past medical history. She received a total of 10 cycles of rituximab

There are conflicting data regarding whether concomitant mitral valve surgery (MVS) at left ventricular assist device (LVAD) implantation is beneficial. This study aimed to assess the hemodynamic effects of concomitant MVS. Of all 73 enrolled patients, 44 patients had undergone concomitant MVS and 29 patients had not. Before LVAD implantation, MVS group had higher pulmonary capillary wedge pressure (p = 0.04). After LVAD implantation, MVS group had higher mean pulmonary artery pressure and cardiac output (CO). During the hemodynamic ramp study, MVS group had steeper CO slopes (0.18 [0.13 0.28] vs. 0.15 [0.08, 0.20] L/min/step; p = 0.04) at incremental LVAD speed and achieved a higher CO at the optimized set speed (5.5 [4.7, 6.9] vs. 4.9 [4.0, 5.7] L/min; p = 0.03). One-year freedom from death or heart failure readmission was statistically comparable between the two groups (61% vs. 80%, p = 0.20). Thus far, after LVAD implantation and concomitant MVS, patients had increased pulmonary hypertension, despite having higher CO and a better response of CO at incremental LVAD speed. The implication of hemodynamic features after concomitant MVS on clinical outcomes warrants further investigation.

Ventricular arrhythmias are common following left ventricular assist device implantation (LVAD), and the effects of ventricular tachycardia (VT) ablation on thrombosis and embolic events are unknown. We aimed to assess LVAD thrombosis, stroke, and embolic event rates after VT ablation. Left ventricular assist device implantation patients from two academic centers who underwent endocardial VT ablation between 2009 and 2016 were compared to a control group with VT who were not ablated and followed for one year. The primary composite outcome was confirmed or suspected LVAD thrombosis, stroke, or other embolic event. Survival analysis was conducted with Kaplan-Meier curves, log-rank tests, and Cox regression. Forty-three LVAD patients underwent VT ablation, and 73 LVAD patients had VT but were not ablated. Patients who were ablated were more likely have VT prior to LVAD (p = 0.04), monomorphic VT (p < 0.01), and to be on antiarrhythmics (p < 0.01). Fifty-eight percent of the patients in the ablation group experienced the primary composite outcome (11% had confirmed device thrombosis [DT], 41% suspected DT, 39% had a stroke or embolic event) compared to 30% in the control group (12% with confirmed DT, 11% with suspected DT, 14% with stroke or embolic event) (p = 0.002). In multivariable regression, ablation was an independent predictor of the primary composite outcome (hazard ratios, 2.24; 95% confidence interval, 1.09–4.61; p = 0.03). Patients with LVADs referred for endocardial VT ablation had elevated rates of DT and embolic events.

Purpose Aortic insufficiency (AI) significantly affects morbidity and mortality in patients with left ventricular assist devices. Although AI may be commonly assessed by echocardiography, expert techniques are required for accurate quantification of AI severity. Description In this prospective blinded study, screenshots from the HVAD (Medtronic, Framingham, MA) display and simultaneous echocardiographic measurements were obtained. Each screenshot was digitized and the early diastolic phase slope was calculated, with blinding to the echocardiographic results. The regurgitant fraction of AI was quantified by Doppler echocardiography of the outflow graft. Evaluation A total of 30 patients (median, 57 years old; 57% male) were enrolled. A cutoff of −17.6 L/min/s for the early diastolic phase slope had a sensitivity of 0.92 and a specificity of 0.53 to estimate significant AI with a regurgitant fraction of 30% or greater, and it significantly stratified patients into a low regurgitant faction group (0.3%) and a high regurgitant fraction group (33.0%) (P = .009). The early diastolic phase slope had a moderate correlation with the actually measured regurgitant fraction (r = .50). Conclusions The early diastolic phase slope of the HVAD flow waveform may be a parameter that can estimate the presence of clinically significant AI.

Tolvaptan is an effective therapy for heart failure patients with symptomatic congestion and hyponatremia. The efficacy of its use in patients with continuous-flow left ventricular assist devices (LVADs) is unknown. The aim of this study was to assess the clinical efficacy and safety of tolvaptan in LVAD patients. We retrospectively reviewed medical records of patients who underwent LVAD implantation between January 2014 and August 2018. Among 217 consecutive LVAD patients, tolvaptan was used in 20 patients. Mean age was 46 ± 14 years old and 14 patients were males. The duration of tolvaptan therapy was 4 (interquartile range 1–8) days. Urine volume significantly increased from 2,623 ± 1,109 ml/day before tolvaptan to 4,308 ± 1,432 ml/day during tolvaptan therapy (p < 0.001). Serum sodium increased from 127 ± 3 to 133 ± 3 mEq/L at the end of tolvaptan therapy (p < 0.001). No patients developed hypernatremia (serum sodium >150 mEq/L). The 90-day overall survival following tolvaptan therapy was 89% in both the tolvaptan group and a propensity score-matched non-tolvaptan group (p = 0.918). Survival free of heart failure readmissions was also comparable between the groups (p = 0.751). In conclusion, short-term use of tolvaptan following LVAD implantation is a safe and effective therapy to augment diuresis and improve hyponatremia.

Background: Development of aortic regurgitation (AR) following left ventricular assist device (LVAD) implantation is common, and it is associated with a poor prognosis. Transcatheter aortic valve r...

INTRODUCTION: Left ventricular assist device (LVAD) exchange has been historically associated with a significant risk of morbidity and mortality. It is unknown, however, whether these outcomes have improved. We aimed to compare clinical outcomes following LVAD exchange to those following initial LVAD implant in a contemporary patient cohort. METHODS: A total of 115 LVAD patients were enrolled between 2014 and 2017 and followed for 1 year. Of these, 15 patients (54.5 ± 13.3 years old, 87% male) underwent LVAD exchange at 277 (IQR 191-597) days following LVAD implantation and 100 patients (57.5 ± 12.3 years old, 76% male) did not undergo an LVAD exchange (non-exchange group). RESULTS: One-year survival rate following LVAD exchange tended to be higher than the non-exchange patients (93% vs 76%, P = .15). Readmission rates for each comorbidity did not significantly differ between the two groups (P > .05 for all) except for the higher rate of pump thrombosis in the LVAD exchange group (P < .05). DISCUSSION: LVAD exchange cohorts seem to have comparable clinical outcome with the non-exchange cohorts. CONCLUSION: LVAD exchange might be an increasingly appropriate therapeutic option for the management of pump thrombosis, although careful monitoring for recurrent pump thrombosis is required.

Mechanical unloading with left ventricular assist device (LVAD) support can lead to clinically meaningful reversal of stress-related compensatory mechanisms. However, true assessment of left ventricular ejection fraction (LVEF) is not possible, whereas the left ventricle is unloaded by LVAD therapy making identification of patients with myocardial recovery even more challenging. We introduce our new protocol, the "reverse ramp test" for HeartWare HVAD, HeartMate II, and HeartMate 3. The reverse ramp is transthoracic echo (TTE) and right heart catheterization (RHC)-based protocol with LVAD turn down steps to minimal support allowing for a more accurate assessment of myocardial function.

Background Little is known regarding the profile of patients with multiorgan failure listed for simultaneous cardiac transplantation and secondary organ. In addition, few studies have reported how these patients are bridged with mechanical circulatory support (MCS). In this study, we examined national data of patients listed for multiorgan transplantation and their outcomes after bridging with or without MCS. Methods United Network for Organ Sharing data were reviewed for adult multiorgan transplantations from 1986 to 2019. Post-transplant patients and total waitlist listings were examined and stratified according to MCS status. Survival was assessed via Cox regression in the post-transplant cohort and Fine–Gray competing risk regression with transplantation as a competing risk in the waitlist cohort. Results There were 4534 waitlist patients for multiorgan transplant during the study period, of whom 2117 received multiorgan transplants. There was no significant difference in post-transplant survival between the MCS types and those without MCS in the whole cohort and heart-kidney subgroup. Fine–Gray competing risk regression showed that patients bridged with extracorporeal membrane oxygenation had significantly greater waitlist mortality compared with those without MCS when controlling for preoperative characteristics (subdistribution hazard ratio, 2.27; 95% confidence interval, 1.48-3.47; P Conclusions MCS, as currently applied, does not appear to compromise the survival of multiorgan heart transplant patients. Waitlist data show that extracorporeal membrane oxygenation patients have profoundly worse survival irrespective of preoperative factors including organ type listed. Survival on the waitlist for multiorgan transplant has improved across device eras.

BACKGROUND: Hemocompatibility-related clinical adverse events (HRAEs) are major causes of readmission in patients with left ventricular assist devices (LVADs). Omega-3 is an unsaturated fatty acid that possesses anti-inflammatory and antiangiogenic properties. We aimed to investigate the impact of omega-3 therapy on HRAEs during LVAD support. METHODS: Consecutive LVAD patients who were followed for 6 months were enrolled, and stratified by the use of omega-3. Freedom from any HRAEs and net burden of HRAEs, which was calculated by using a hemocompatibility score (using 4 escalating tiers of hierarchal severity to derive a total score for events), were compared between those with and without omega-3 therapy. RESULTS: Among 169 LVAD patients (57 years old and 124 males), 31 patients received 4 g/d of omega-3 therapy and 138 patients were in the control group. During the 6-month observational period, freedom from any HRAEs was 90% in the omega-3 group compared with 70% in the control group with a hazard ratio of 0.35 (95% confidence interval 0.11–0.87 and P = .042). The average hemocompatibility score in the omega-3 group was significantly lower compared with the control group (0.23 vs 0.91; P = .042), due to reduced Tier I scores (mild HRAE; P = .003) and Tier IIIB scores (severe HRAE; P < .001). The similar trends remained at propensity-matched populations. CONCLUSIONS: Omega-3 therapy was associated with reduced HRAEs including both bleeding and thromboembolic events in LVAD patients.

The purpose of this study is to compare clinical outcomes of left ventricular assist device (LVAD) patients with device thrombosis who underwent device exchange (DE) or medical therapy (MT) alone. Consecutive patients undergoing LVAD implant between July 2008 and December 2017 were included. Device thrombosis was diagnosed with comprehensive assessments including ramp test, laboratory data, device parameters, and clinical presentations. First, MT was initiated in all patients. After MT, DE was considered if device thrombosis was refractory to initial MT, and it caused end-organ impairment and/or hemodynamic instability. Among 319 consecutive LVAD patients, 43 patients (13.5%) were diagnosed with device thrombosis. DE was performed in 28 patients (DE group); device explant was performed in 1 patient. MT was continued in 14 patients (MT group). In-hospital mortality was significantly lower in the DE group than the MT group (3.6% [1/28] vs. 28.6% [4/14], P = .0184). One-year survival was significantly better in the DE group (74.0% vs. 30.1%; log-rank = .001), and freedom from cerebrovascular accident (CVA) at 1 year was greater in the DE group (87.1% vs. 47.7%; log-rank = .004). DE was associated with improved 1-year survival and fewer CVAs. Surgical intervention, if feasible, is recommended for LVAD device thrombosis.

OBJECTIVE Intra-aortic balloon pump (IABP) support may improve the hemodynamic profiles of patients in cardiogenic shock and bridge patients to heart transplant. In 2018, the United Network for Organ Sharing (UNOS) introduced new heart allocation criteria that increased the waitlist status of patients with IABPs to Status 2. This study assesses the impact of this change on IABP use and outcomes of patients with IABPs. METHODS We queried the UNOS database for first adult heart transplant candidates with IABPs listed or transplanted before and after the UNOS policy changes (October 18, 2016-October 17, 2018, or October 18, 2018-September 4, 2020). We compared post-transplant survival and waitlist outcomes using Kaplan-Meier and Fine-Gray analyses. RESULTS Two thousand three hundred fifty-eight patients met inclusion criteria. Utilization of IABPs for hemodynamic support increased by 338% in the two years after the policy change. Patients with IABPs listed after the policy change were more likely to receive a transplant and were transplanted more quickly (p

Donor-specific antibodies (DSA) are associated with antibody-mediated rejection (AMR) and poor patient survival. In heart transplant, the efficacy of intermittent intravenous immunoglobulin (IVIg) in reducing de novo DSA levels and treating AMR has not been characterized. We retrospectively studied a cohort of 19 patients receiving intermittent IVIg for elevated DSA and examined changes in DSA levels and graft function. Intermittent IVIg infusions were generally safe and well tolerated. Overall, 23 of 62 total DSA (37%) were undetectable after treatment, 21 DSA (34%) had MFI decrease by more than 25%, and 18 (29%) had MFI decrease by less than 25% or increase. The average change in MFI was -51% ± 71% (P

Venoarterial extracorporeal membrane oxygenation (VA ECMO) is used to provide cardiopulmonary support in cardiogenic shock; however, high extracorporeal flow may increase left ventricular (LV) afterload leading to LV distention and intracardiac stasis. It is unclear how ECMO flow affects patient outcomes and complications related to ECMO. Retrospective review of patients at a single institution placed on VA ECMO from 2007 to 2018 was performed. Patients were divided into full flow (flow index > 2.2 L/min/m2) and partial flow (flow index < 2.2 L/min/m2) groups. In-hospital mortality and markers of end-organ perfusion were compared between groups balanced for risk factors using propensity score inverse probability of treatment weighting. ECMO-related complications such as LV distention, limb ischemia, and bleeding were recorded. There were 488 patients included, 405 (83%) in the partial flow group, and 83 (17%) in the full flow group. No major differences in age, gender, or comorbidities were found. There was no difference in in-hospital mortality between groups (51% vs. 55%, p = 0.59). At 72 hours post-ECMO initiation, there was no difference in the change in renal, hepatic function, or lactate from baseline nor in the rates of continuous venoveno hemofiltration initiation (p = 0.41). There was a trend towards the decreased incidence of LV distention requiring LV vent placement in the partial flow group (12% vs. 7%, p = 0.16). Compared with full flow VA ECMO, partial flow VA ECMO in carefully selected patients results in similar in-hospital mortality and provides similar end-organ perfusion for the treatment of refractory cardiogenic shock.

Current guidelines recommend serial right heart catheterization (RHC) to survey pulmonary hypertension in patients awaiting heart transplant. However, the role and impact of this surveillance is unclear in patients with a left ventricular assist device (LVAD). We reviewed our surveillance RHC protocol to determine whether useful data were obtained to justify the risks of serial invasive procedures (i.e., excessive bleeding). Between January 2015 and December 2018, 78 patients who received an LVAD as bridge-to-transplant (BTT) were included in this study. Routine RHC surveillance was performed every 6 months. Hemodynamic variables were retrospectively collected and reviewed. In 78 patients, 205 RHCs were analyzed. Median patient age was 54 years (IQR 46-61), and 64 (82%) were male. Thirty-six patients (46%) had pulmonary vascular resistance (PVR) ≤ 3 Wood units (WUs), and 42 patients (54%) had PVR3 WUs before LVAD. After LVAD implantation, mean PVR decreased by 36% from 3.8 ± 2.1 to 2.4 ± 1.1 WUs (p0.001) at 6 months and stabilized below 3 WUs at all post-LVAD time points. Four patients (11%) with pre-LVAD PVR ≤ 3 and 16 patients (38%) with a pre-LVAD PVR3 had PVR3 at least once during RHC survey. Of the 56 (76%) transplanted patients, six (40%) of 15 patients with a post-LVAD PVR3 at least once developed moderate-to-severe right ventricular dysfunction. Although PVR significantly decreased after LVAD implant, PVR values fluctuated, particularly for those with pre-LVAD PVR3.0 WUs. Routine RHC appears valid for all BTT patients.

BACKGROUND: Conditional survival (CS) is a dynamic method of survival analysis that provides an estimate of how an individual’s future survival probability changes based on time post-transplant, individual characteristics, and post-transplant events. This study sought to provide post-transplant CS probabilities for heart transplant recipients based on different prognostic variables and provide a discussion tool for the providers and the patients. METHODS: Adult heart transplant recipients from January 1(st), 2004 through October 18(th), 2018 were identified in the UNOS registry. CS probabilities were calculated using data from Kaplan-Meier survival estimates. RESULTS: CS probability exceeded actuarial survival probability at all times post-transplant. Women had similar short-term, but greater long-term CS than men at all times post-transplant (10-year CS 1.8%−11.5% greater [95% CI 1.2%−12.9%]). Patients with ECMO or a surgical BiVAD had decreased survival at the time of transplant, but their CS was indistinguishable from all others by one-year post-transplant. Rejection and infection requiring hospitalization during the first-year were associated with a persistently decreased CS probability. CONCLUSIONS: In this study, we report differential conditional survival outcomes based on time, patient characteristics, and clinical events post-transplant, providing a dynamic assessment of survival. The survival probabilities, will better inform patients and clinicians of future outcomes.

Background: Trimethylamine N-oxide (TMAO)—a gut-derived metabolite—is elevated in heart failure (HF) and linked to poor prognosis. We investigated variations in TMAO in HF, left ventricular assist device (LVAD), and heart transplant (HT) and assessed its relation with inflammation, endotoxemia, oxidative stress, and gut dysbiosis. Methods: We enrolled 341 patients. TMAO, CRP (C-reactive protein), IL (interleukin)-6, TNF-α (tumor necrosis factor alpha), ET-1 (endothelin-1), adiponectin, lipopolysaccharide, soluble CD14, and isoprostane were measured in 611 blood samples in HF (New York Heart Association class I–IV) and at multiple time points post-LVAD and post-HT. Gut microbiota were assessed via 16S rRNA sequencing among 327 stool samples. Multivariable regression models were used to assess the relationship between TMAO and (1) New York Heart Association class; (2) pre- versus post-LVAD or post-HT; (3) biomarkers of inflammation, endotoxemia, oxidative stress, and microbial diversity. Results: ln-TMAO was lower among HF New York Heart Association class I (1.23 [95% CI, 0.52–1.94] µM) versus either class II, III, or IV (1.99 [95% CI, 1.68–2.30], 1.97 [95% CI, 1.71–2.24], and 2.09 [95% CI, 1.83–2.34] µM, respectively; all P 6 months: 1.99 [95% CI, 1.76–2.22] µM) and HT (>6 months: 1.86 [95% CI, 1.66–2.05] µM) were not different from symptomatic HF. After multivariable adjustments, TMAO was not associated with biomarkers of inflammation, endotoxemia, oxidative stress, or microbial diversity. Conclusions: TMAO levels are increased in symptomatic HF patients and remain elevated long term after LVAD and HT. TMAO levels were independent from measures of inflammation, endotoxemia, oxidative stress, and gut dysbiosis.

Neurohormonal blockade (NHB) is the mainstay of therapy for patients with systolic heart failure (HF). However, the efficacy in patients with left ventricular assist devices (LVADs) remains unknown. Of all, 114 LVAD patients (57 [48, 65] years old and 78% male) were enrolled and followed during the early period (6 months after index discharge), and 98 were followed during the late period (6-12 months following index discharge). Of them, 46% were on beta-blocker (BB), 49% on angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin II receptor blocker (ARB), and 51% on aldosterone antagonist at baseline. Prevalence of BB and ACEi/ARB use increased during the study period. During the early period, similar event rates were found irrespective of the NHB uses. During the late period, BB was associated with reduced HF readmission, and ACEi/ARB was associated with reduced HF readmission and gastrointestinal bleeding (p < 0.05 for all). In conclusion, BB and ACEi/ARB use during the late period was associated with a reduction in HF recurrence in LVAD patients. Further prospective randomized control trials are warranted to clarify the utility of NHB therapy in LVAD patients.

BACKGROUND: Tricuspid regurgitation (TR) is common in patients receiving left ventricular assist device (LVAD) implantation. The current literature is conflicting regarding the effects of concomitant tricuspid valve repair (TVR) at LVAD implantation. We investigated the hemodynamic effects of concomitant TVR at LVAD implantation. METHODS: Consecutive clinically stable LVAD outpatients who underwent hemodynamic ramp testings were enrolled in this study, and they were stratified by concomitant TVR. Results of hemodynamic ramp tests were compared between the TVR group and the non-TVR group. RESULTS: Among 65 LVAD patients undergoing ramp tests, 34 patients had received TVR, and 31 had not. There were no significant differences in baseline characteristics between two groups except for higher degree of TR and lower pulmonary artery pulsatility index in the TVR group (P < .05 for both). Following LVAD implantation, the degree of TR improved significantly in the TVR group down to the comparable level with the non-TVR group. During ramp tests, the TVR group had steeper cardiac index slope (0.14 ± 0.12 vs 0.07 ± 0.07 L/min/m(2)/step, P = .002) and higher cardiac index at set LVAD speed (2.99 ± 0.84 vs 2.52 ± 0.42 L/min/m(2), P = .007). CONCLUSIONS: Concomitant TVR improves cardiac output and its response to LVAD speed change following LVAD implantation. Longitudinal clinical implications of such hemodynamic changes are unknown.

Increased vascular stiffness is known to be an independent predictor of mortality in patients with heart failure with reduced ejection fraction (HFrEF). The effects of sacubitril–valsartan on vascular structure and function have not been systematically studied in this patient population. We hypothesized that aortic distensibility (AD) and fractional area change (AFAC), as assessed by 2D transthoracic echocardiography (TTE), would improve over time in HFrEF patients on sacubitril–valsartan therapy, due to the vasodilatory properties of the medication. We prospectively studied 30 patients with HFrEF (25 < EF < 40%) on optimal guideline-directed medical therapy who were subsequently started on sacubitril–valsartan. Patients underwent serial 2D TTE imaging at baseline, 3 and 6 months following therapy initiation. Ascending aortic diameters were measured 3 cm above the aortic valve in the parasternal long-axis view and used to calculate AD and AFAC, two markers of vascular compliance. For reference, we also measured AD and AFAC in 30 healthy, age and gender-matched controls at a single time point. Normal controls had significantly higher values of AD and AFAC than HFrEF patients at baseline (AD: 4.0 ± 1.1 vs. 2.2 ± 0.9 c m(2)dyne(−1)10(−3), p < 0.0001 and AFAC: 18.8 ± 3.7% vs. 10.3 ± 4.3%, p < 0.0001). In HFrEF patients on sacubitril–valsartan, both indices of aortic compliance progressively improved towards normal from baseline to 6 months: AD from 2.2 ± 0.9 to 3.6 ± 1.5 cm(2)dyne(−1)10(−3) (p < 0.0001) and AFAC from 10.3 ± 4.3 to 13.7 ± 4.1% (p < 0.0001). In conclusion, AD and AFAC are decreased in patients with HFrEF and gradually improve with sacubitril–valsartan treatment. The echocardiographic markers used in this study may become a useful tool to assess the effectiveness of sacubitril–valsartan therapy in HFrEF patients.

In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device.We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years.This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group.Among patients with advanced heart failure, a fully magnetically levitated centrifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).

This is a single-center retrospective study to summarize clinical outcomes of patients requiring surgical continuous-flow left ventricular assist device (HeartMate II) exchange. The patients who underwent HeartMate II exchange were divided into two groups either via a subcostal approach (SC group) or a full sternotomy (FS group). The exclusion criteria of a subcostal approach for device exchange included the presence of outflow graft obstruction, and/or the need for concomitant cardiac procedures. Among 277 consecutive patients who underwent HeartMate II implantation from July 2008 to December 2015, 25 patients (9.0%) required device exchange (SC group; N = 13, FS group; N = 12). The SC group, compared to the FS group, had a shorter operative time (200.6 ± 31.4 min vs 534.2 ± 123.9 min; P 0.001), shorter cardiopulmonary bypass time (33.1 ± 22.0 min vs 151.5 ± 53.1 min; P 0.001), fewer blood transfusion (0.31 ± 0.48 units vs 4.67 ± 3.65 units; P = 0.002). The SC group had lower incidence of postoperative prolonged intubation ( 24 h) (7.7% vs 90.9%, P 0.001), tracheostomy (0.0% vs 41.7%, P = 0.015), acute kidney injury requiring dialysis (0.0% vs 33.3%, P = 0.039). In-hospital mortality was 0.0% (0/13) in the SC group and 16.7% (2/12) in the FS group (P = 0.220). In conclusion, a subcostal approach was associated with shorter operative time, fewer blood transfusions, and less postoperative complications, compared to full sternotomy. A subcostal approach, if feasible, is preferred for HeartMate II device exchange.

Background Thromboembolic events (TEs) are common adverse events with continuous-flow left ventricular assist devices (LVADs). Left atrial appendage occlusion (LAAO) is commonly performed at the time of a cardiac operation. The effect of LAAO on TEs in LVAD patients remains unknown. Methods All patients receiving a first LVAD implantation between January 2013 and January 2014 were reviewed. TEs included device thrombosis and ischemic cerebrovascular accidents. The incidence of TEs with respect to LAAO was evaluated using Kaplan-Meier and Cox proportional hazards analyses. Results The analysis included 102 patients, 36 of whom received LAAO and 66 did not. LAAO patients were an average age of 60 years, and 69.4% were men. Non-LAAO patients were an average age of 59.3 years, and 71.2% were men. There were no significant differences in characteristics other than history of coronary artery bypass grafting (8.3% of LAAO vs 44% of non-LAAO, p = 0.0005). Preoperative atrial fibrillation was present in 19 LAAO patients (52.7%) and in 36 non-LAAO patients (54.5%; p = 1.0). Patients were monitored for a median of 306 days. TEs occurred in 3 LAAO patients (1 device thrombosis and 2 cerebrovascular accidents) compared with 15 non-LAAO patients (5 device thromboses and 11 cerebrovascular accidents, p = 0.049). In a Cox hazards analysis including age, sex, hypertension, and atrial fibrillation, LAAO demonstrated a decreased risk of TE (hazard ratio, 0.27; 95% confidence interval, 0.08 to 0.95; p = 0.04). Conclusions In patients undergoing LVAD implantation, LAAO is associated with reduced TEs, and this effect may be independent of atrial fibrillation. A prospective randomized study to examine the efficacy LAAO in prevention of TE is needed to confirm these findings.

Left ventricular (LV) unloading with a LV assist device (LVAD) reverse remodels the heart and may lead to favorable changes in cellular architecture and LV geometry promoting myocardial recovery. Currently, there are no standardized methods for evaluating myocardial recovery. This study assesses the systolic slope of the LVAD outflow cannula as a marker for myocardial contractility. Doppler echocardiography (transthoracic echocardiogram [TTE]) of the LVAD outflow cannula and TTE of the LV cavity were prospectively collected in 57 patients with LVADs. Systolic acceleration of the LVAD outflow cannula was measured in each patient as the peak change of velocity over time (dv/dt) during systole from continuous-wave Doppler signal acquired from the LVAD outflow cannula. Ventricular volumes were concurrently measured by TTE. In a subset of 10 patients, the systolic slope was measured during each stage of a ramp study to study the properties of this parameter across a variety of loading conditions. The systolic slope of the LVAD outflow cannula was successfully measured in 53 of 57 patients (93%). Systolic slope strongly correlated with ejection fraction (EF) (R = 0.92). Analysis of systolic slope stratified by EF (EF >30%, EF 20–30%, EF 10–20%, and EF

Background: The MOMENTUM 3 study (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) has demonstrated that the HeartMate 3 (HM3) pump is associated with reduced strokes compared with the HeartMate II (HMII) device. We now perform a comprehensive analysis of stroke events to evaluate their longitudinal occurrence, clinical correlates, patterns, and impact on outcome across the 2-year duration of support. Methods: MOMENTUM 3 is a randomized controlled trial of the HM3 centrifugal-flow pump versus the HMII axial-flow pump in patients with advanced heart failure, regardless of the intended goal of support (bridge to transplantation or destination therapy). Baseline and postimplantation clinical correlates of stroke events were assessed with multivariable analyses. Longitudinal patterns, including device association, type of stroke (hemorrhagic versus ischemic), changing severity of impairment assessed with the modified Rankin Scale (disabling [modified Rankin Scale score >3] versus nondisabling [modified Rankin Scale score ≤3]) over time, and association with outcome, were determined. Results: In 361 patients with the intended implant (189 HM3 and 172 HMII), 65 strokes (40 ischemic strokes and 25 hemorrhagic strokes) occurred in 52 patients at a median of 131 (range, 1–733) days. No difference in stroke rate was noted between 0 and 180 days of follow-up between devices. However, stroke incidence in the long-term period (181–730 days after left ventricular assist device) was 3.3 times lower for the HM3 group (HM3: 0.04 versus HMII: 0.13 events per patient-year; odds ratio, 0.23; 95% CI, 0.08–0.63; P =0.01). Treatment with the HM3 pump was the only independent predictor of lower stroke events. We found no direct association of blood pressure or antithrombotic regimens with observed stroke rates. A stroke event significantly lowered 2-year postimplantation survival regardless of subtype or initial severity of neurological impairment compared with patients without a stroke (43±12% for hemorrhagic stroke, 57±9% for ischemic stroke, 51±11% for disabling, and 51±11% for nondisabling compared with 85±2% 2-year survival for patients without stroke). Conclusions: The HM3 pump is associated with a marked reduction in stroke rates compared with the HMII device, with benefits observed in the long-term period (>6 months). The occurrence of stroke of any type (hemorrhagic and ischemic) or of any functional severity (disabling and nondisabling) is predictive of a poor 2-year clinical outcome. Clinical Trial Registration: URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT02224755.

Background The NupulseCV intravascular ventricular assist system (iVAS), which consists of a durable pump placed through the subclavian artery, provides extended-duration ambulatory counterpulsation. This study investigated the effect of iVAS on biventricular cardiac function. Methods and Results We reviewed all heart failure patients who received iVAS implantation as a bridge to transplantation or a bridge to candidacy since April 2016 as part of the iVAS first-in-humans and subsequent feasibility study. We compared data of transthoracic echocardiography performed just before implantation (without iVAS support) and again at 30 days or just before explantation (on iVAS support). Eighteen patients (58.8 ± 7.4 years old and 15 male) received iVAS support for 53 ± 43 days. Fourteen patients were bridged to cardiac replacement therapy after 35 ± 19 days and the remaining 4 patients had been supported for 118 ± 41 days. There were no deaths during iVAS support. At 30 days, there was a significant improvement in left ventricular ejection fraction (16.5% ± 11.9% vs 24.4% ± 12.8%; P = .007) and marked reduction in left atrial size (62.7 ± 35.7 mL/m2 vs 33.8 ± 17.2 mL/m2; P Conclusions Improvement in biventricular cardiac function was observed after 30 days of iVAS support. Further studies should examine the use of this technology as a bridge to recovery.

Background: 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 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.

Heart transplantation is the gold standard therapeutic option for select patients with end-stage heart failure. Unfortunately, successful long-term outcomes of heart transplantation can be hindered by immune-mediated rejection of the cardiac allograft, specifically acute cellular rejection, antibody-mediated rejection, and cardiac allograft vasculopathy. Extracorporeal photopheresis is a cellular immunotherapy that involves the collection and treatment of white blood cells contained in the buffy coat with a photoactive psoralen compound, 8-methoxy psoralen, and subsequent irradiation with ultraviolet A light. This process is thought to cause DNA and RNA crosslinking, ultimately leading to cell destruction. The true mechanism of therapeutic action remains unknown. In the last three decades, extracorporeal photopheresis has shown promising results and is indicated for a variety of conditions. The American Society for Apheresis currently recommends the use of extracorporeal photopheresis for the treatment of cutaneous T-cell lymphoma, scleroderma, psoriasis, pemphigus vulgaris, atopic dermatitis, graft-versus-host disease, Crohn's disease, nephrogenic systemic fibrosis, and solid organ rejection in heart, lung, and liver transplantation. In this review, we aim to explore the proposed effects of extracorporeal photopheresis and to summarize published data on its use as a prophylactic and therapy in heart transplant rejection.

A 77-year-old man who underwent a heart transplant 7 years ago presented with multiple bloody bowel movements. Endoscopic and histologic evaluation revealed chronic active ileitis, granulomatous inflammation, multinucleated giant cells, and a rare, equivocal acid-fast bacterium in the terminal ileum. Positive sputum cultures for Mycobacterium tuberculosis and acid-fast bacilli established a diagnosis of intestinal tuberculosis, and RIPE (rifabutin, isoniazid, pyrazinamide, ethambutol) therapy was initiated. Elevated IgG levels on quantitative immunoglobulin testing and a bone marrow biopsy specimen of ≥60% plasma cells confirmed the diagnosis of multiple myeloma that later transformed into its aggressive form, plasma cell leukemia. Induction chemotherapy was initiated; however, the patient experienced retroperitoneal bleeding and pancytopenias, limiting the continuation of chemotherapy, and as a result, the patient was transitioned to palliative care.

OBJECTIVES Obesity may complicate the peripheral cannulation and delivery of veno-arterial extracorporeal life support (ECLS). With rising global body mass indices (BMI), obesity is becoming increasingly prevalent in severe cardiogenic shock yet its impact on outcomes is not well described. This study sought to examine the relationship between BMI and veno-arterial ECLS outcomes to better inform clinical decision-making. METHODS All cardiogenic shock patients undergoing peripheral veno-arterial ECLS at our institution from March 2008 to January 2019 were retrospectively analysed (n = 431). Patients were divided into 4 groups, BMI 17.5–24.9, 25–29.9, 30–34.9 and ≥35 kg/m2, and compared on clinical outcomes. Multivariable logistic regression was performed to identify variables associated with survival to discharge, the primary outcome of interest. RESULTS The median BMI was 28.3 kg/m2 (interquartile range 24.8–32.6) with a range of 17.0–69.1 kg/m2. Obese patients achieved significantly lower percentages of predicted flow rates compared with BMI CONCLUSIONS In conclusion, with the rising global prevalence of obesity, the results of our study suggest that clinicians need not treat obesity as a negative prognostic factor in cardiogenic shock requiring ECLS.

Left ventricular assist devices (LVADs) are associated with the development of antihuman leukocyte antigen (HLA) antibodies, which can create a challenge for future transplantation in these patients. The differential effects of Heartmate 3 (HM3) versus Heartmate II (HMII) on de novo HLA allosensitization remain unknown. Patients who underwent HMII or HM3 implantation and had no prior HLA antibodies by solid-phase assay (Luminex) testing were included in this study. Complement-dependent cytotoxicity (CDC) panel reactive antibody (PRA) levels and Luminex antibody profiles were followed until cardiac transplantation, device explantation, or death. Electronic medical records were reviewed to examine posttransplant outcomes. Thirty-eight HM3 and 34 HMII patients with complete data were followed for 1.5 ± 1.1 years on device support. HM3 and HMII groups had similar age at implant, female gender, ischemic heart failure etiology, bridge strategy at implant, as well as intraoperative and postoperative transfusion requirements. 39.5% of HM3 and 47.1% of HMII patients developed detectable HLA antibodies by Luminex testing (p = 0.516). Development of high-level (mean fluorescence intensity >10,000) antibodies was significantly lower in HM3 than HMII patients (5.3 vs. 20.6%, p = 0.049). CDC PRA testing showed fewer HM3 patients with a positive result (PRA > 0%) than HMII patients (39.4 vs. 70.0%, p = 0.015). Among transplanted patients, those who had developed de novo sensitization on LVAD support showed a trend toward incidence of moderate to severe grade rejection compared with unsensitized patients (23.8 vs. 4.8%, p = 0.078). HM3 is associated with lower risk of de novo HLA sensitization compared with HMII.

Background Adult congenital heart disease (ACHD) patients who require orthotopic heart transplantation are surgically complex due to anatomical abnormalities and multiple prior surgeries. In this study, we investigated these patients outcomes using our institutional database. Methods ACHD patients who had prior intracardiac repair and subsequent heart transplant were included (2008-2018). Adult patients without ACHD were extracted as a control. A comparison of patients with functional single ventricular (SV) and biventricular (BV) hearts was performed. Results There were 9 SV and 24 BV patients. The SV group had higher central venous pressure/pulmonary capillary wedge pressure (p=0.028), hemoglobin concentration (p=0.010), alkaline phosphatase (p=0.022), and were more likely to have liver congestion (p= 0.006). Major complications included infection in 16 (48.5%), temporary dialysis in 12 (36.4%), and graft dysfunction requiring perioperative mechanical support in 7 (21.2%). Overall in-hospital mortality was 15.2%. Kaplan-Meier analysis showed a higher, but not statistically significant, survival after 10 years between the ACHD and control groups (ACHD 84.9% vs. control 67.5%, p=0.429). There was no significant difference in 10-year survival between SV and BV groups (78% vs. 88%, p=0.467). Conclusions Complex ACHD cardiac transplant recipients have a high incidence of early morbidities after transplantation. However, long-term outcomes were acceptable.