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Background There is a paucity of data on depression, anxiety and post-traumatic stress disorder after left ventricular assist device (LVAD) implantation. We designed an observational study to integrate these with functional capacity and health-related quality of life (HR-QOL) in surviving LVAD patients. Methods and Results Consenting patients between 1 month and 9 years after LVAD implantation (n = 121) were screened for functional capacity (World Health Organization Disability Assessment Schedule 2.0 [WHODAS 2.0)]); HR-QOL (European Quality of Life [EQ-5D] and Visual Assessment Scales [EQ-VAS]), depression (Patient Health Questionnaire [PHQ-9], anxiety (Generalized Anxiety Disorder Scale [GAD-7]) and post-traumatic stress disorder (Impact of Event Scale Revised [IES-R]). Of the 94% of patients who consented, 34.7% reported impaired functional capacity (WHODAS 2.0 score of ≥25%), 23.1%–34.7% HR-QOL problems (domain EQ-5D of ≥3), 10.7% “poor health” (EQ-VAS of ≤40), 14.9% depression (PHQ-9 of >14), 11.7% suicidal ideation and 17.5% anxiety (GAD-7 of >10). Among these patients, 23.5% had a positive screen for post-traumatic stress disorder (IES-R of ≥24). An EQ-VAS of 80 or greater predicted good functional capacity (P Conclusions One-third of discharged LVAD patients reported impaired function, HR-QOL, and psychological issues. A standardized evaluation before and after LVAD implantation could facilitate psychologic prehabilitation, inform decision-making, and identify indications for mental health intervention.

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.

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 Few data exist on the use of del Nido cardioplegia in adults, specifically during operations requiring prolonged aortic cross-clamp. In this pilot study, we evaluate outcomes of patients undergoing surgery with cross-clamp time >3 h based on re-dosing strategy, using either full dose (FD; 1:4 blood to crystalloid ratio) or dilute (4:1 blood to crystalloid ratio) solution. METHODS Consecutive adult patients (>18 years) undergoing cardiac surgery from 2012 to 2018 with cross-clamp time >3 h were reviewed. Patients were excluded if del Nido cardioplegia was not used. Patients were categorized into FD or dilute groups based on re-dosing solution. Propensity score matching was used to control for baseline differences between groups. The primary endpoint was in-hospital mortality. Other outcomes examined included: postoperative mechanical support, arrhythmia, stroke, dialysis and cardiac function. RESULTS Included for analysis were 173 patients (115 male) with median age of 63.8 (interquartile range 53.9–73.1). Major comorbidities included diabetes (45), cerebrovascular disease (34), hypertension (131), atrial fibrillation (52) and previous cardiac surgery (83). There were 108 patients (62%) who received FD re-dosing, while 65 (38%) received dilute. A greater proportion of patients in the dilute group received retrograde delivery, for both induction (32/108 vs 39/65, P CONCLUSIONS Del Nido cardioplegia has been used in complex cardiac surgery requiring prolonged cross-clamp. Re-dosing can be performed with either FD or dilute del Nido solution with no statistical difference in outcomes.

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.

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.

While rates of stroke have declined with the HeartMate3 (HM3) continuous- flow (CF) left ventricular assist device (LVAD), the impact of non-pulsatile flow and artificial pulse physiology on cerebrovascular function is not known. We hypothesized that improved hemodynamics and artificial pulse physiology of HM3 patients would augment cerebrovascular metabolic reactivity (CVR) compared with HeartMate II (HMII) CF-LVAD and heart failure (HF) patients.Mean, peak systolic and diastolic flow velocities (MFV, PSV, MinFV, respectively) and cerebral pulsatility index were determined in the middle cerebral artery (MCA) before and after a 30 sec breath-hold challenge in 90 participants: 24 healthy controls; 30 HF, 15 HMII, and 21 HM3 patients.In HM3 patients, breath-holding increased MFV (Δ8 ± 10 cm/sec, p.0001 vs baseline) to levels similar to HF patients (Δ9 ± 8 cm/sec, p.05), higher than HMII patients (Δ2 ± 8 cm/sec, p.01) but lower than healthy controls (Δ13 ± 7 cm/sec, p.05). CF-LVAD altered the proportion of systolic and diastolic flow responses as reflected by a differential cerebral pulsatility index (p = .03). Baseline MFV was not related to CVR (rCompared with HMII, HM3 patients have a significantly improved CVR. However, CVR remains lower in HM3 and HF patients than in healthy controls, therefore suggesting that changes in cerebral hemodynamics are not reversed by CF-LVAD therapy. Further research on the mechanisms and the long-term impact of altered cerebral hemodynamics in this unique patient population are warranted.

In the general population, increased aortic stiffness is associated with an increased risk of cardiovascular events. Previous studies have demonstrated an increase in aortic stiffness in patients with a continuous flow left ventricular assist device (CF-LVAD). However, the association between aortic stiffness and common adverse events is unknown.Forty patients with a HeartMate II (HMII) (51 $ 11 years; 20% female; 25% ischemic) implanted between January 2011 and September 2017 were included. Two-dimensional transthoracic echocardiograms of the ascending aorta, obtained before HMII placement and early after heart transplant, were analyzed to calculate the aortic stiffness index (AO-SI). The study cohort was divided into patients who had an increased vs decreased AO-SI after LVAD support. A composite outcome of gastrointestinal bleeding, stroke, and pump thrombosis was defined as the primary end point and compared between the groups. While median AO-SI increased significantly after HMII support (AO-SI 4.4-6.5, P = .012), 16 patients had a lower AO-SI. Patients with increased (n = 24) AO-SI had a significantly higher rate of the composite end point (58% vs 12%, odds ratio 9.8, P.01). Similarly, those with increased AO-SI tended to be on LVAD support for a longer duration, had higher LVAD speed and reduced use of angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers.Increased aortic stiffness in patients with a HMII is associated with a significantly higher rates of adverse events. Further studies are warranted to determine the causality between aortic stiffness and adverse events, as well as the effect of neurohormonal modulation on the conduit vasculature in patients with a CF-LVAD.

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 Vasoplegia is a frequent complication of left ventricular assist device (LVAD) implantation. We investigated the effectiveness of methylene blue (MB) for vasoplegia in LVAD recipients. Methods Twenty-seven patients received MB for vasoplegia after LVAD implantation and met study criteria between March 2015 and May 2018. Propensity score inverse probability weighting identified 41 controls who did not receive MB for post-LVAD vasoplegia. Clinical outcomes were compared between control and MB groups and between patients who received doses during (n = 15) and after surgery (n = 12). Hemodynamics and vasopressor requirements were analyzed using analysis of covariance. Results Median total MB dose was 1.9 mg/kg (interquartile range, 1.2-2.2 mg/kg). Methylene blue recipients experienced a transient initial decline in norepinephrine requirement from 141 ng/kg per min (95% confidence interval [CI], 81-201 ng/kg per min) to 117 ng/kg per min (95% CI, 58-176 ng/kg per min; P = .022) and a delayed decline in vasopressin from 4.8 U/h (95% CI, 3.8-5.8 U/h) to 4.0 U/h (95% CI, 2.8-5.1 U/h) (P = .004). In-hospital mortality, postoperative complications, and end-organ dysfunction did not differ from those of controls. There were no observed differences in mean arterial pressure, vasopressor requirements, or outcomes between patients who received doses during or after surgery. Weighted overall mortality in the entire study cohort was 8.8%. Conclusions Although MB may affect vasopressor requirements, clinical outcomes in vasoplegia after LVAD implantation did not improve and were not affected by the timing of administration.

Whether to repair nonsevere tricuspid regurgitation (TR) during surgery for ischemic mitral valve regurgitation (IMR) remains uncertain.The goal of this study was to investigate the incidence, predictors, and clinical significance of TR progression and presence of ≥moderate TR after IMR surgery.Patients (n = 492) with untreated nonsevere TR within 2 prospectively randomized IMR trials were included. Key outcomes were TR progression (either progression by ≥2 grades, surgery for TR, or severe TR at 2 years) and presence of ≥moderate TR at 2 years.Patients' mean age was 66 ± 10 years (67% male), and TR distribution was 60% ≤trace, 31% mild, and 9% moderate. Among 2-year survivors, TR progression occurred in 20 (6%) of 325 patients. Baseline tricuspid annular diameter (TAD) was not predictive of TR progression. At 2 years, 37 (11%) of 323 patients had ≥moderate TR. Baseline TR grade, indexed TAD, and surgical ablation for atrial fibrillation were independent predictors of ≥moderate TR. However, TAD alone had poor discrimination (area under the curve, ≤0.65). Presence of ≥moderate TR at 2 years was higher in patients with MR recurrence (20% vs. 9%; p = 0.02) and a permanent pacemaker/defibrillator (19% vs. 9%; p = 0.01). Clinical event rates (composite of ≥1 New York Heart Association functional class increase, heart failure hospitalization, mitral valve surgery, and stroke) were higher in patients with TR progression (55% vs. 23%; p = 0.003) and ≥moderate TR at 2 years (38% vs. 22%; p = 0.04).After IMR surgery, progression of unrepaired nonsevere TR is uncommon. Baseline TAD is not predictive of TR progression and is poorly discriminative of ≥moderate TR at 2 years. TR progression and presence of ≥moderate TR are associated with clinical events. (Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting [CABG] Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation, NCT00806988; Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation, NCT00807040).

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.

Background Hematoma expansion (HE) is associated with poor outcome in patients with intracerebral hemorrhage (ICH), but the impact on patients with an left ventricular assist device (LVAD) is unknown. We aimed to define the occurrence of HE in the LVAD population and to determine the association between HE and mortality. Methods We performed a retrospective cohort study of LVAD patients and intentionally matched anticoagulated controls without LVAD admitted to Columbia University Irving Medical Center with ICH between 2008 and 2019. We compared HE occurrence between patients with an LVAD and those without an LVAD using regression modeling, adjusting for factors known to influence HE. We evaluated pump thrombosis following anticoagulation reversal. We examined the association between HE and hospital mortality using Poisson regression modeling adjusting for factors associated with poor outcome. Results Among 605 patients with an LVAD, we identified 28 patients with ICH meeting the study’s inclusion criteria. Our LVAD ICH cohort was predominantly male (71%), with a mean age of 56 ± 10 years. The median baseline hematoma size was 20.1 mL3 (interquartile range [IQR], 8.6–46.9 mL3), and the median ICH score was 1 (IQR, 1–2). There was no significant difference in occurrence of HE in LVAD patients and matched non-LVAD patients (adjusted odds ratio [OR], 1.3; 95% confidence interval [CI], 0.4–4.2). There was an association between HE and in-hospital mortality in LVAD patients (adjusted OR, 4.8; 95% CI, 1.4–6.2). Conclusions HE occurrence appears to be similar in LVAD and non-LVAD patients. HE has a significant impact on LVAD ICH mortality, underscoring the importance of adequate coagulopathy reversal and blood pressure management in these patients.

Left-sided staphylococcal, streptococcal, and enterococcal infective endocarditis (IE) is associated with poor clinical outcomes. Our primary aim is to compare clinical outcomes of staphylococcal, streptococcal, and enterococcal IE patients who undergo valve replacement surgery and outcomes of patients who are treated solely with antibiotics.All patients were treated medically or surgically for left-sided staphylococcal, streptococcal, or enterococcal IE at our institution from 1998 to 2014 and were retrospectively studied. The primary outcome of interest was 30-day and 1-year mortality, and secondary outcomes included posttreatment septic shock, embolic events, stroke, and end-stage renal disease at 30 days. Inverse probability treatment weights, derived from propensity scores, were used to balance the medical and surgical cohorts across clinical risk factors, The Society of Thoracic Surgeon scores, and pathogens. Outcomes were compared comprehensively and in a staphylococcal-only subanalysis.Study population consisted of 245 surgical patients and 164 medical patients. Mortality at 30 days was higher in the medical cohort, both in aggregate and for staphylococcal only (all, 7% vs 16%, P.001; staphylococcal only, 7% vs 22%, P.001). Surgical patients had a higher incidence of septic shock and renal dysfunction; however, stroke and embolic events at 30 days were not different between cohorts. Cox survival analysis demonstrated that surgical treatment provided a 1-year survival benefit, with a hazard ratio of 0.48 (95% confidence interval, 0.36 to 0.64) that was robust regardless of pathogen.Compared with medical management, valve replacement surgery in patients with left-sided staphylococcal, streptococcal, or enterococcal IE appears to confer a survival advantage at 30 days and 1 year.

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%).

Enhanced recovery after surgery (ERAS) protocols recognize early postoperative mobilization as a driver of faster postoperative recovery, return to normal activities, and improved long-term patient outcomes. For patients undergoing open cardiac surgery, an opportunity for facilitating earlier mobilization and a return to normal activity lies in the use of improved techniques to stabilize the sternal osteotomy. By following the key orthopedic principles of approximation, compression, and rigid fixation, a more nuanced approach to sternal precaution protocols is possible, which may enable earlier patient mobilization, physical rehabilitation, and recovery.

Post-cardiotomy shock (PCS) is associated with substantial morbidity and mortality. We reviewed our 12-year experience of venoarterial extracorporeal membrane oxygenation (VA-ECMO) therapy for PCS. Between July 2007 and June 2018, 156 consecutive patients underwent VA-ECMO for PCS. We retrospectively investigated patient characteristics, indications, and management to determine factors affecting outcomes. Secondary analysis was performed by dividing the cohort into Era 1 (2007–2012, n = 52) and Era 2 (2013–2018, n = 104) for comparison. After a median of 4.70 days (interquartile range [IQR] 2.76–8.53) of ECMO support, 72 patients (46.1%) survived to discharge. In-hospital mortality decreased in Era 2 from 75 to 43.3% (P

Gut microbial imbalance may contribute to endotoxemia, inflammation, and oxidative stress in heart failure (HF). Changes occurring in the intestinal microbiota and inflammatory/oxidative milieu during HF progression and following left ventricular assist device (LVAD) or heart transplantation (HT) are unknown. We aimed to investigate variation in gut microbiota and circulating biomarkers of endotoxemia, inflammation, and oxidative stress in patients with HF (New York Heart Association, Class I-IV), LVAD, and HT.We enrolled 452 patients. Biomarkers of endotoxemia (lipopolysaccharide and soluble [sCD14]), inflammation (C-reactive protein, interleukin-6, tumor necrosis factor-α, and endothelin-1 adiponectin), and oxidative stress (isoprostane) were measured in 644 blood samples. A total of 304 stool samples were analyzed using 16S rRNA sequencing.Gut microbial community measures of alpha diversity were progressively lower across worsening HF class and were similarly reduced in patients with LVAD and HT (p0.05). Inflammation and oxidative stress were elevated in patients with Class IV HF vs all other groups (all p0.05). Lipopolysaccharide was elevated in patients with Class IV HF (vs Class I-III) as well as in patients with LVAD and HT (p0.05). sCD14 was elevated in patients with Class IV HF and LVAD (vs Class I-III, p0.05) but not in patients with HT.Reduced gut microbial diversity and increased endotoxemia, inflammation, and oxidative stress are present in patients with Class IV HF. Inflammation and oxidative stress are lower among patients with LVAD and HT relative to patients with Class IV HF, whereas reduced gut diversity and endotoxemia persist in LVAD and HT.

Antibody-mediated rejection (AMR) driven by the development of donor-specific antibodies (DSA) directed against mismatched donor human leukocyte antigen (HLA) is a major risk factor for graft loss in cardiac transplantation. Recently, the relevance of non-HLA antibodies has become more prominent as AMR can be diagnosed in the absence of circulating DSA. Here, we assessed a single-center cohort of 64 orthotopic heart transplant recipients transplanted between 1994 and 2014. Serum collected from patients with ≥ pAMR1 (n = 43) and non-AMR (n = 21) were tested for reactivity against a panel of 44 non-HLA autoantigens. The AMR group had a significantly greater percentage of patients with elevated reactivity to autoantigens compared to non-AMR (P = .002) and healthy controls (n = 94, P .0001). DSA-positive AMR patients exhibited greater reactivity to autoantigens compared to DSA-negative (P .0001) and AMR patients with DSA and PRA 10% were identified as the subgroup with significantly elevated responses. Reactivity to 4 antigens, vimentin, beta-tubulin, lamin A/C, and apolipoprotein L2, was significantly different between AMR and non-AMR patients. Moreover, increased reactivity to these antigens was associated with graft failure. These results suggest that antibodies to non-HLA are associated with DSA-positive AMR although their specific role in mediating allograft injury is not yet understood.

OBJECTIVES The onset of the coronavirus disease 2019 (COVID-19) pandemic has forced our cardiac surgery programme and hospital to enact drastic measures that has forced us to change how we care for cardiac surgery patients, assist with COVID-19 care and enable support for the hospital in terms of physical resources, providers and resident training. METHODS In this review, we review the cardiovascular manifestations of COVID-19 and describe our system-wide adaptations to the pandemic, including the use of telemedicine, how a severe reduction in operative volume affected our programme, the process of redeployment of staff, repurposing of residents into specific task teams, the creation of operation room intensive care units, and the challenges that we faced in this process. RESULTS We offer a revised set of definitions of surgical priority during this pandemic and how this was applied to our system, followed by specific considerations in coronary/valve, aortic, heart failure and transplant surgery. Finally, we outline a path forward for cardiac surgery for the near future. CONCLUSIONS We recognize that individual programmes around the world will eventually face COVID-19 with varying levels of infection burden and different resources, and we hope this document can assist programmes to plan for the future.

BACKGROUND: Gastrointestinal bleeding (GIB) is a common complication of left ventricular assist device (LVAD) therapy accounting for frequent hospitalizations and high resource utilization. METHODS: We previously developed an endoscopic algorithm emphasizing upfront evaluation of the small bowel and minimizing low-yield procedures in LVAD recipients with GIB. We compared the diagnostic and therapeutic yield of endoscopy, health-care costs, and re-bleeding rates between conventional GIB management and our algorithm using chi-square, Fisher’s exact test, Wilcoxon-Mann-Whitney, and Kaplan-Meier analysis. RESULTS: We identified 33 LVAD patients with GIB. Presentation was consistent with upper GIB in 20 (61%), lower GIB in 5 (15%), and occult GIB in 8 (24%) patients. Forty-one endoscopies localized a source in 23 (56%), resulting in 14 (34%) interventions. Algorithm implementation compared with our conventional cohort was associated with a 68% increase in endoscopic diagnostic yield (P< .01), a 113% increase in therapeutic yield (P= .01), a 27% reduction in the number of procedures per patient (P < .01), a 33% decrease in length of stay (P < .01), and an 18% reduction in estimated costs (P < .01). The same median number of red blood cell transfusions were used in the 2 cohorts, with no increase in re-bleeding events in the algorithm cohort (33.3%) compared with our conventional cohort (43.7%). CONCLUSIONS: Our endoscopic management algorithm for GIB in LVAD patients proved effective in reducing low-yield procedures, improving the diagnostic and therapeutic yield of endoscopy, and decreasing health-care resource utilization and costs, while not increasing the risk of a re-bleeding event.

Continuous-flow left ventricular assist devices (CF-LVADs) are increasingly used in advanced heart failure patients. Recent studies suggest that low socioeconomic status (SES) predicts worst survival after heart transplantation. Both individual-level and neighborhood-level SES (nSES) have been linked to cardiovascular health; however, the impact of SES in CF-LVAD patients remains unknown. We hypothesized that SES is a major determinant of CF-LVAD candidacy and postimplantation outcomes. A retrospective chart review was conducted on 362 patients between February 2009 and May 2016. Neighborhood-level SES was measured using the American Community Survey data and the Agency for Healthcare Research and Quality SES index score. Individual-level SES was self reported. Kaplan-Meier survival analysis and multivariable Cox proportional hazards regression determined survival statistics. Patients in the highest SES tertile were older (58 ± 13 vs. 53 ± 14; p < 0.001), less likely to be black or Hispanic (26% vs. 70%; p < 0.001), more likely to be married (87% vs. 65%; p < 0.001), more likely to have private insurance (50% vs. 39%; p < 0.001), and more likely to have employment (29% vs. 15%; p < 0.001) compared with patients in the lowest tertile. Low nSES was associated with a decreased risk of death (hazard ratio [HR], 0.580; 95% confidence interval [CI], 0.347-0.970; p = 0.038) in comparison to the high nSES. However, after adjusting for baseline clinical morbidities, the relationship was no longer present. When selecting patients for a LVAD, SES should not be thought of as an immutable risk factor. Carefully selected low-SES patients could be safely implanted with CF-LVAD with outcomes comparable to high-SES patients.

OBJECTIVES Right heart failure after left ventricular assist device (LVAD) implantation is associated with significant morbidity and mortality. A new generation of percutaneous right ventricular assist devices (RVADs) may mitigate the need for invasive surgical RVAD implantation. The purpose of this study was to evaluate the safety and efficacy of the Protek Duo (TandemLife, Pittsburgh, PA, USA) RVAD in patients who developed severe acute right heart failure in the intensive care unit after LVAD implantation. METHODS This was a retrospective cohort study of 27 patients who received a Protek Duo after LVAD implantation from January 2016 to March 2019 at our centre. The primary outcome of interest was survival to hospital discharge. Secondary outcomes included procedural success, device-related complications and conversion to a surgical RVAD. RESULTS The median age of patients was 63 years (interquartile range 58–71), 78% were men and 78% were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 or 2. Patients were on a median of 2 inotropes and 2 pressors prior to Protek Duo insertion. The device successfully implanted on the first attempt in all patients a median of 1 day (interquartile range 1–2) after LVAD implantation and the median duration of support was 11 days (interquartile range 7–16). Device weaning occurred in 86% of patients, with 15% in-hospital mortality. Major complications related to the device included new moderate-to-severe tricuspid regurgitation (36%), haemolysis (14%) and cannula migration (7%). Three patients (11%) required conversion to surgical RVAD. Overall survival to 1 year was 81%. CONCLUSIONS The use of the Protek Duo as a percutaneous RVAD is a safe and feasible treatment for patients who develop acute right heart failure after LVAD implantation.

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.

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

Our study assesses differences between male and female patients placed on venoarterial extracorporeal membrane oxygenation for cardiogenic shock.We retrospectively analyzed 574 adult patients placed on venoarterial extracorporeal membrane oxygenation for cardiogenic shock at our institution between January 2007 and December 2018. Baseline characteristics and outcomes were assessed. Propensity score matching was used to compare outcomes. The primary end point was in-hospital mortality. Secondary outcomes include limb ischemia, limb ischemia interventions, distal perfusion cannula placement, stroke, bleeding, and continuous venovenous hemofiltration initiation.There were 394 male patients (69%) and 180 female patients (31%). After adjusting for baseline differences, propensity score matching compared 171 male patients with 171 female patients. No difference was seen between men and women in in-hospital mortality (60.2% vs 56.7%; P = .59), limb ischemia (47.4% vs 45.6%; P = .83), limb ischemia surgery (15.2% vs 12.9%; P = .64), bleeding (49.7% vs 49.1%; P = 1), continuous venovenous hemofiltration initiation (39.2% vs 32.7%; P = .26), and stroke (8.2% vs 9.4%; P = .85). Multivariable logistic regression showed that female patients who died were more likely to have had chronic kidney disease (odds ratio [OR], 2.67; 95% confidence interval [CI], 1.09-6.53; P = .032) than surviving women. Male patients who died were more likely to have had coronary artery disease (OR, 2.25; 95% CI, 1.34-3.78; P = .002) and higher lactate levels (OR, 1.14; 95% CI, 1.08-1.21; P .001) than surviving men. Women with cardiac transplant primary graft dysfunction were more likely to survive (OR, 0.04; 95% CI, 0.01-0.27; P = .001), whereas men with cardiac transplant primary graft dysfunction were less likely to survive (OR, 0.28; 95% CI, 0.11-0.71; P = .007), than patients with other shock etiologies.After adjusting for baseline difference, there was no difference in outcomes between male and female patients despite differing risk profiles for in-hospital mortality.

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.

The aim of this study was to evaluate the fluid dynamics in the aortic valve and proximal aorta during continuous-flow left ventricular assist device (LVAD) support using epiaortic echocardiography and vector flow mapping technology. A total of 12 patients who underwent HeartMate 3 implantation between December 2018 and February 2020 were prospectively examined. The wall shear stress (WSS) on the ascending aorta, aortic root, and aortic valve was evaluated before and after LVAD implantation. The median age of the cohort was 62 years and 17% were women. The peak WSS on the ascending aorta (Pre 1.48 [0.86-1.69] [Pascal {Pa}] vs. Post 0.33 [0.21-0.58] [Pa]; p = 0.002), aortic root (Pre 0.46 [0.31-0.58] (Pa) vs. Post 0.18 [0.12-0.25] (Pa); p = 0.001), and ventricularis of the aortic valve (Pre 1.76 [1.59-2.30] (Pa) vs. Post 0.30 [0.10-0.61] (Pa); p = 0.001) was significantly lower after LVAD implantation. No difference in WSS was observed on the fibrosa of the aortic valve (Pre 0.36 [0.22-0.53] (Pa) vs. Post 0.38 [0.38-0.52] (Pa); p = 0.850) before and after implantation. The WSS on the ascending aorta, aortic root, and ventricularis of the aortic valve leaflets was significantly altered by LVAD implantation, providing preliminary data on the potential contribution of fluid dynamics to LVAD-induced aortic insufficiency and root thrombus.

Background Antibody mediated rejection (AMR) is an increasingly studied cause of graft failure after heart transplantation . AMR diagnosis previously required the detection of circulating donor specific antibodies (DSA); however, the most recent criteria only require pathological findings. This classification defined a subset of patients with AMR, yet without known antibodies. Here, we sought to evaluate differences in the transcriptome profile associated with different types of AMR. Methods RNA sequencing was used on endomyocardial biopsies to analyze and compare transcriptomic profiles associated with different subtypes of AMR defined by immunopathological and histopathological findings, as well as the presence or absence of DSA. Gene expression profiles were characterized for each diagnostic group. Results The most divergent gene expression profiles were observed between patients with or without DSA. AMR subtypes associated with DSA showed expression of signature genes involved in monocyte activation and response to interferon . There was also substantial difference between the transcriptomic profiles of AMR defined by histopathological and immunopathological findings, the latter being associated with expression of mucin genes. In contrast, there was no differential RNA expression between patients with pAMR1i without DSA and those without AMR. Likewise, no differential expression was observed between patients with pAMR1h with DSA and pAMR2. Conclusions Overall, our studies reveal different expression profiles in endomyocardial biopsies in relation to some key criteria used to diagnose AMR. These findings support the view that the diagnosis of AMR encompasses several phenotypes that may rely on distinct mechanisms of injury.

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.

This study examined left-ventricular assist device (LVAD) patients with pre-LVAD ventricular arrhythmias (VAs) to determine the rate of recurrent post-LVAD VAs and the impact of pre-LVAD atrial fibrillation (AF) on recurrent post-LVAD VAs. Medical records of 195 consecutive LVAD patients were reviewed. Descriptive statistics were generated and Cox proportional hazard models were used to assess the association of clinical variables with the time to recurrent VA. Forty-seven percent of 195 CHF patients who received LVAD-manifested significant VAs prior to LVAD implant (82% Heartmate II, 14% HVAD, 4% other; median follow-up = 17 months), 41% of whom manifested recurrent post-LVAD VAs. Pre-LVAD AF was associated with recurrent VAs (hazard ratio = 3.73; 95% CI 1.33, 10.48; p = 0.012). Recurrent VAs were associated with increased mortality (hazard ratio = 3.06; 95% CI 1.17, 7.98; p = 0.023). A history of AF is prevalent in over half of LVAD patients with recurrent VAs and is associated with time to recurrence of VA.

Prophylactic DeVega tricuspid annuloplasty (DVA) of the donor heart has been reported to improve tricuspid regurgitation (TR), renal dysfunction, and mortality in cardiac transplant recipients. This is the first study to investigate the electrical, as well as, hemodynamic effects of DVA during orthotopic heart transplantation (OHT). Electrocardiographic, echocardiographic, and hemodynamic data of 76 patients with DVA and 104 patients without DVA who underwent OHT between 2013 and 2017 at Columbia University Medical Center (New York, NY) were studied. Patients with DVA were older (56.5 ± 1.2 vs. 52.4 ± 1.0 years of age; p = 0.017) and predominantly men (78% vs. 68%; p = 0.02). There were no significant differences in right ventricular function and TR. Patients with DVA had increased incidence of right bundle branch block compared with without DVA (37% ± 5.9% vs. 9% ± 2.9%; p < 0.001). Three patients with DVA developed complete heart block (CHB), whereas no patients without DVA developed CHB (p = 0.04). Four patients with DVA received a pacemaker (PPM), whereas only one patient in the without DVA group received a PPM. Complete heart block was significantly increased in patients who received prophylactic DVA. Possible risk of conduction abnormalities should be considered with performance of DVA annuloplasty in cardiac transplant recipients.

Background: Bridge to transplantation (BTT) with left ventricular assist devices (LVADs) is a mainstay of therapy for heart failure in patients awaiting heart transplantation (HT). Criteria for HT listing do not differ between patients medically managed and those mechanically bridged to HT. The objectives of the present study were to evaluate the impact of BTT with LVAD on posttransplantation survival, to describe differences in causes of 1-year mortality in medically and mechanically bridged patients, and to evaluate differences in risk factors for 1-year mortality between those with and those without LVAD at the time of HT. Methods: Using the United Network of Organ Sharing database, we identified 5486 adult, single-organ HT recipients transplanted between 2008 and 2015. Patients were propensity matched for likelihood of LVAD at the time of HT. Kaplan–Meier survival estimates were used to assess the impact of BTT on 1- and 5-year mortality. Logistic regression analysis was used to evaluate the odds ratio of 1-year mortality for patients BTT with LVAD compared with those with medical management across clinically significant variables at various thresholds. Results: Early mortality was higher in mechanically bridged patients: 9.5% versus 7.2% mortality at 1 year ( P −1 ·1.73 m −2 (odds ratio, 1.69; P =0.003) and −1 ·1.73 m −2 (odds ratio, 2.16; P =0.005). A similar trend was seen in patients with a body mass index of 25 to 30 kg/m 2 (odds ratio, 1.88; P =0.024) and >30 kg/m 2 (odds ratio, 2.11; P 60 years, estimated glomerular filtration rate −1 ·1.73 m −2 , and body mass index >30 kg/m 2 , there were significant differences in 1-year mortality between medium- and high-risk medically and mechanically bridged patients, with 1-year mortality in high-risk BTT patients at 17.6% compared with 10.4% in high-risk medically managed patients. Conclusions: Bridge to HT with LVAD, although necessary because of organ scarcity and capable of improving wait list survival, confers a significantly higher risk of early posttransplantation mortality. Patients bridged with mechanical support may require more careful consideration for transplant eligibility after LVAD placement.

The use of short-term mechanical circulatory support (ST-MCS) has increased for refractory cardiogenic shock. However, there are scant data about bridge-to-recovery patients.We retrospectively reviewed 502 patients with cardiogenic shock who received venoarterial extracorporeal membrane oxygenation or a temporary surgical ventricular assist device as ST-MCS between 2010 and 2016. There were 178 patients (35.5%) who survived through device explantation. Of these, 149 patients (29.7%) survived to discharge and were included for analysis. The primary outcome was midterm survival without undergoing heart replacement therapy.In our bridge-to-recovery cohort, 101 patients (67.8%) were men, and the median age was 59 years (interquartile range, 51 to 67 years). Etiology of cardiogenic shock included postcardiotomy shock in 35.6% of patients (n = 53), allograft failure in 26.8% (n = 40), acute myocardial infarction (AMI) in 24.2% (n = 36), and other acute decompensated heart failure in 14.4% (n = 20). There were 24 major events (16.1%) recorded, including 21 patients who died and 3 patients who received heart replacement therapy during median follow-up of 306 days (interquartile range, 58.25 to 916.75 days). Overall freedom from event at 3 years was 74.2%. In subgroup analysis, AMI patients had a significantly worse freedom-from-event rate at 40.4% (p0.001). By univariate Cox analysis, AMI etiology (p = 0.003), length of ST-MCS (p = 0.06), blood urea nitrogen (p = 0.012), and left ventricular ejection fraction (p = 0.005) at discharge were predictors for adverse events.The overall midterm outcome of patients explanted from ST-MCS is favorable except for AMI patients.

Background Venoarterial extracorporeal membrane oxygenation (VA-ECMO) can be life-saving in refractory cardiogenic shock but carries a risk of neurologic complications such as stroke and hemorrhage. As little is known about the effects of different peripheral VA-ECMO cannulation sites on cerebral blood flow (CBF), transcranial Doppler (TCD) was used to determine whether the cannulation site affects CBF. Methods Thirty-seven patients receiving VA-ECMO for cardiogenic shock via axillary or femoral artery cannulation were prospectively enrolled. Measured bilateral middle cerebral artery (MCA), mean flow velocities (MFV), and pulsatility indices (PI) were the primary outcomes and adverse neurologic events were secondary outcomes. Results The median age was 58 years (IQR 51-66) with 26 (70%) males. Median VA-ECMO flow was 3.8 L/min (IQR 3.2-4.9) with mean arterial pressures of 80 mm Hg (IQR 75-86). Nineteen patients received right axillary artery cannulation while 18 underwent femoral cannulation. Compared with the femoral group, MFV was higher in the axillary group in the right MCA (46 cm/s [IQR 26-57] vs 27 [17-36], P = 0.03) and left (43 [IQR 35-60] vs 29 cm/s [16-48], P = 0.05). Axillary PI was significantly lower compared with the femoral group (right: 0.48 cm/s [0.25-0.65] vs 0.83 [0.66-0.93], P = 0.02; left: 0.41 cm/s [0.29-0.63] vs 1.02 [0.7-1.3], P = 0.004). One axillary patient experienced a stroke with deficits. Conclusions TCD appears to be an effective tool for indirect monitoring of CBF in patients with ECMO with limited pulsatility. Axillary artery cannulation seems to provide higher cerebral flow rates without any difference in neurologic outcomes. Future studies may incorporate TCD into regulating ECMO flows to achieve physiologic CBF.

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.).

Venoarterial extracorporeal membrane oxygenation (VA ECMO) is an established method of short-term mechanical support for patients in cardiogenic shock, but can create left ventricular (LV) distension. This paper analyzes the physiologic basis of this phenomenon and treatment methods. This is a retrospective review of the existing literature on VA ECMO and LV distension. We undertook a PubMed review of all peer-reviewed papers focusing on VA ECMO, LV distension, and LV venting. We reviewed these papers and synthesized our findings. We also will discuss the various methods of LV venting and venting strategies we use at Columbia. LV distension is becoming an increasingly appreciated aspect of caring for patients on VA ECMO support. The literature demonstrates that the consequences of failing to anticipate, recognize, and treat LV distension are grave, and will worsen an already distended and hypocontractile LV. Myocardial recovery will be hindered, and LV thrombus formation more likely. Early recognition and aggressive management of LV distension is paramount in helping care for this critically ill patient population.

Objectives This study examined sex-related differences in use and outcomes of continuous-flow left ventricular assist devices (CF-LVADs) among individuals awaiting heart transplantation using the United Network for Organ Sharing registry. Background Advanced therapies for heart failure including CF-LVADs remain underused in women. There have been contradictory results regarding sex-specific outcomes. Many studies have been limited by small sample sizes or included pulsatile-flow devices. Methods De-identified patient-level data were obtained from the United Network for Organ Sharing database. The database was queried to identify adult patients (≥18 years of age) who required mechanical circulatory support with HeartWare HVAD (Medtronic, Minneapolis, Minnesota), HeartMate II (Abbott, Lake Bluff, Illinois), or HeartMate 3 (Abbott) as bridge to heart transplantation between 2008 and 2018. Each patient was assigned a propensity score. The primary outcomes of interest were rates of transplantation and death. Results A total of 13,305 patients (2,771 women, 20.8%) received support with CF-LVAD in the study period. There were significant sex disparities in CF-LVAD use in listed patients (29.9% men vs. 18.9% women in 2017). Female patients receiving CF-LVAD support had lower chances of heart transplantation (55.1% vs. 67.5%), increased risk of waitlist mortality (7.0% vs. 4.2%), and delisting for worsening clinical status (8.5% vs. 4.7%) at 2 years post-implantation (all p Conclusions Durable mechanical circulatory support with CF-LVADs remains underused in women. When matched with similar male control subjects, women experienced higher mortality and lower rates of heart transplantation.

Red cell distribution width (RDW) measures the variance in size of circulating red blood cells and is a strong independent predictor of morbidity and mortality in cardiovascular disease and heart failure. Predictive power of RDW on mortality after continuous-flow left ventricular assist device (CF-LVAD) implantation remains largely unknown. Four hundred nine patients who underwent CF-LVAD implantation between April 2004 and December 2015 were retrospectively analyzed. The primary outcome of interest was 90 day mortality after CF-LVAD implantation. Median RDW before CF-LVAD implantation was 15.8%. Patients with elevated RDW (>15.8%) at baseline had significantly lower hemoglobin (10.6 ± 1.8 vs. 11.9 ± 2.1 mg/dl; p < 0.001), lower mean corpuscular volume (84.9 ± 7.7. vs. 88.7 ± 5.9; p < 0.001), higher blood urea nitrogen (BUN; 36.3 ± 21.8 vs. 30.1 ± 17.1; p < 0.001), lower albumin (3.4 ± 0.6 vs. 3.7 ± 0.5; p < 0.001), and higher total bilirubin levels (1.67 ± 2.21 vs. 1.29 ± 0.96). Red cell distribution width was independently predictive of 90 day mortality (odds ratio [OR], 1.16 for 1% increase; CI, 1.04-1.31; p = 0.010). Discriminatory power of RDW alone was comparable to model of end-stage liver disease excluding international normalized ratio (MELD-Xi) and HeartMate II risk scores. Mechanical unloading with CF-LVAD was associated with a reduction in RDW levels. These findings suggest that RDW, a simple and inexpensive test available through routine complete blood count, can be successfully used for mortality risk assessment in CF-LVAD candidates.

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.

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.