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Background: Aortic root thrombosis(ART) is a complication of continuous-flow left ventricular assist device therapy. However, the incidence and related complications of ART in HeartMate 3 (HM3) patients remain unknown., Methods: Patients who underwent HM3 implantation from November 2014 to August 2020 at a quaternary academic medical center were included. Demographics and outcomes were abstracted from the medical record. Echocardiograms and contrast-enhanced computed tomography studies were reviewed to identify patients who developed ART and/or moderate or greater aortic insufficiency (AI) on HM3 support., Results: The study cohort included 197 HM3 patients with a median postimplant follow-up of 17.5 months. Nineteen patients (9.6%) developed ART during HM3 support, and 15 patients (7.6%) developed moderate or greater AI. Baseline age, gender, race, implantation strategy, and INTERMACS classification were similar between the ART and no-ART groups. ART was associated with an increased risk of death, stroke, or aortic valve (AV) intervention (subhazard ratio [SHR] 3.60 [95% confidence interval (CI) 1.71-7.56]; p = 0.001) and moderate or greater AI (SHR 11.1 [CI 3.60-34.1]; p < 0.001) but was not associated with a statistically significantly increased risk of death or stroke on HM3 support (2.12 [0.86-5.22]; p = 0.10). Of the 19 patients with ART, 6 (31.6%) developed moderate or greater AI, necessitating more frequent AV interventions (ART: 5 AV interventions [3 surgical repairs, 1 surgical replacement, 1 transcatheter replacement; 26.3%]; no-ART: 0)., Conclusions: Nearly 10% of HM3 patients developed ART during device support. ART was associated with increased risk of a composite end-point of death, stroke, or AV intervention as well as moderate or greater AI., (Copyright © 2023. Published by Elsevier Inc.)

Background: Aortic regurgitation (AR) is a common complication following left ventricular assist device (LVAD) implantation. We evaluated the hemodynamic implications of AR in patients with HeartMate 3 (HM3) LVAD at baseline and in response to speed changes., Methods and Results: Clinically stable outpatients supported by HM3 who underwent a routine hemodynamic ramp test were retrospectively enrolled in this analysis. Patients were stratified based on the presence of at least mild AR at baseline speed. Hemodynamic and echocardiographic parameters were compared between the AR and non-AR groups. Sixty-two patients were identified. At the baseline LVAD speed, 29 patients (47%) had AR, while 33 patients (53%) did not. Patients with AR were older and supported on HM3 for a longer duration. At baseline speed, all hemodynamic parameters were similar between the groups including central venous pressure, pulmonary capillary wedge pressure, pulmonary arterial pressures, cardiac output and index, and pulmonary artery pulsatility index (p > 0.05 for all). During the subacute assessment, AR worsened in some, but not all, patients, with increases in LVAD speed. There were no significant differences in 1-year mortality or hospitalization rates between the groups, however, at 1-year, ≥ moderate AR and right ventricular failure (RVF) were detected in higher rates among the AR group compared to the non-AR group (45% vs. 0%; p < 0.01, and 75% vs. 36.8%; p = 0.02, respectively)., Conclusions: In a cohort of stable outpatients supported with HM3 who underwent a routine hemodynamic ramp test, the presence of mild or greater AR did not impact the ability of HM3 LVADs to effectively unload the left ventricle during early subacute assessment. Although the presence of AR did not affect mortality and hospitalization rates, it resulted in higher rates of late hemodynamic-related events in the form of progressive AR and RVF., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: This study analyses the position of the HeartMate 3 left ventricular assist device on serial radiographs to assess positional change and possible correlation with adverse events., Methods: We retrospectively analysed 59 left ventricular assist device recipients who had serial chest radiographs at 1 month, 6 months and 12 months post-implantation between November 2014 and June 2018. We measured pump angle, pump-spine distance and pump-diaphragm depth and investigated their relationship to a composite outcome of heart failure readmission, low flow alarms, stroke or inflow/outflow occlusion requiring surgical repositioning through recurrent event survival modelling., Results: Between 1 and 6 months, the absolute pump-spine distance changed by 10.00 mm (P < 0.01) and the absolute pump-diaphragm depth changed by 18.80 mm (P < 0.01). These parameters did not change significantly between 6 and 12 months post-implantation. Pump angle did not change significantly over any period. Twenty-six patients experienced the composite outcome; in these patients, the median 1-month pump angle was 66.2° (interquartile range 54.5-78.0) as compared to 59.0° (interquartile range 47.0-65.0) in the 33 patients who did not have adverse events (P = 0.04). Pump depth and pump-spine distance at 1 month were not associated with the composite outcome. Change in pump depth between 1 and 6 months [hazard ratio (HR) 1.019; 95% confidence interval (CI) 1.000-1.039] and between 6 and 12 months (HR 1.020; 95% CI 1.000-1.040) were weakly associated with the composite outcome., Conclusions: Larger pump angles are associated with the composite outcome of position-related adverse events. Pump depth movement is weakly associated with the composite outcome., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

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%)., (© 2020 Wiley Periodicals LLC.)

Inflow or outflow obstruction is a rare, but critical complication after HeartMate 3 left ventricular assist device implantation. We retrospectively reviewed 166 patients who underwent primary HeartMate 3 implantation at our centre between November 2014 and July 2019. Three cases of inflow obstruction and 3 cases of outflow obstruction were identified. Presence of low flow alarm was the most common presenting sign and they were free from heart failure symptoms except in 1 case. They all underwent surgical correction and the median time from primary implantation to reintervention was 406.5 days. Computed tomography angiogram identified a problem in 5 out of 6 cases. Clinical symptoms and/or alarms resolved after surgery, but 1 case developed recurrent low flow alarm due to partial occlusion of inflow by fibrous tissue who eventually underwent heart transplant. All patients remain alive with median follow-up of 433.5 days. Prompt surgical intervention in late inflow and outflow obstruction after HeartMate 3 implantation resulted in favourable outcomes., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

The number of patients on destination therapy is increasing as long-term survival on continuous-flow left ventricular assist device (CF-LVAD) therapy has improved. Gastrointestinal bleeding (GIB) is a common complication after CF-LVAD implantation, and its risk correlates with longer support time, emphasizing the importance of GIB management. The lower pulsatility of CF-LVADs may promote arteriovenous malformations, which amplify the bleeding risk. Here, we retrospectively analyzed the location, incidence, and survival effect of GIB events in HeartMate II (HM-II) and HeartWare Ventricular Assist Device (HVAD) recipients to provide specific details regarding these complications. From November 2003 to March 2016, 526 patients with chronic heart failure underwent primary implantation of an HM-II (n = 403) or HVAD (n = 123) CF-LVAD at our center. Of the 526 patients, 140 (26.6%) had a GIB event (HM-II: n = 100; HVAD: n = 40), 92 (17.5%) had a single GIB event, and 48 (9.1%) had multiple GIB events (range: 2-9 events). HVAD recipients had a higher incidence of both upper and lower GIB events (p < 0.001 and P = 0.002, respectively) than HM-II recipients. Arteriovenous malformation was the most common etiology for GIB (50 patients/72 events); for this group, the average time-to-event was 300.4 days, the recurrence rate was 34%, and the 90-day and 1-year survival rates were 88.3% and 66.7%, respectively. Age at implantation was the only predictor of GIB. In conclusion, our study provides detailed information about GIB events associated with current CF-LVADs. Additional studies are required to evaluate strategies to reduce the incidence of GIB morbidity.

Objectives: Some patients who undergo continuous-flow left ventricular assist device (CF-LVAD) implantation require concomitant procedures that can be performed with or without cardiac arrest under aortic cross-clamping (AXC). Procedures normally performed with cardiac arrest are sometimes avoided or performed without cardiac arrest because it may be detrimental to right heart function. However, the effects of cardiac arrest on patients with advanced heart failure necessitating CF-LVAD support have not been thoroughly studied. We examined our single-centre experience to determine whether cardiac arrest during CF-LVAD implantation was associated with worse patient outcomes., Methods: From November 2003 to March 2016, a total of 526 patients with chronic end-stage heart failure underwent primary CF-LVAD implantation. Preoperative demographics, postoperative complications and mortality rates were compared between patients who required cardiac arrest with AXC (n = 50) and those who did not (n = 476)., Results: The most frequently performed procedure requiring AXC was aortic valve closure (n = 23, 26.1%). Although the AXC group had longer cardiopulmonary bypass times (P < 0.01), long-term (5-year) survival was similar in AXC and non-AXC patients (P = 0.13). Also, postoperative right heart failure (P = 0.15) and neurological dysfunction (P = 0.89) rates were not significantly different between the 2 groups. Cox proportional hazards analysis showed that cardiac arrest with AXC was not an independent predictor of mortality (hazard ratio, 0.89; P = 0.73)., Conclusions: Cardiac arrest with AXC during CF-LVAD implantation did not negatively affect long-term survival or the incidence of right ventricular failure or stroke. These findings should be considered in deciding surgical strategies. Additional investigation may be warranted to further understand the effects of cardiac arrest during LVAD implantation., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

There is a paucity of evidence on cannulation and flow strategy for extracorporeal life support (ECLS). Our center employs a partial flow ECLS strategy for cardiogenic shock (CS) in which patients on peripheral ECLS are managed with partial flow using a 15F-17F arterial cannula regardless of patient body size to minimize cannula-related complications. Here we describe our clinical experience of partial flow ECLS strategy for CS. We retrospectively reviewed 145 cases who developed CS requiring ECLS insertion between January 2019 and June 2021. We excluded 6 cases who were cannulated at outside hospital and 29 cases of central ECLS. Etiology for cardiogenic shock was as follows (including 6 cases of extracorporeal cardiopulmonary resuscitation): Post-cardiotomy shock 15, acute on chronic heart failure 25, acute ischemic cardiogenic shock 20, primary graft dysfunction 6, distributive shock 10, acute myocarditis 7, acute right ventricular failure 4, arrhythmia 5, and other 14. Mean age was 57.3 years and length of ECLS support was 7.2 days. Left ventricular venting strategy was used in 63% (67/106) of cases (IABP 50, Impella 17). Arterial cannula size: 15Fr 92%, 17Fr 7% and distal perfusion catheter was placed in 30% of cases. Average ECLS flow was 1.57L/min/m2 (3.0L/min). 53% (57/106) recovered and were decannulated, 28% (30/106) were bridged to advanced therapy (extracorporeal VAD 11, Impella 7, durable LVAD 6, transplant 6). ECLS related complications were as follows: Vascular injury 1, toe necrosis 1, leg ischemia required fasciotomy 0, bleeding from cannulation site 2, pseudoaneurysm 1, permanent neurodeficit 1, transient neurodeficit 2, Groin complication (dehiscence/infection/lymphocele) 11. The rate of survival to discharge was 61% (65/106). Partial flow strategy is a feasible approach with a low rate of fatal complications and can effectively bridge patients to recovery or other advance therapy. Cannula-related complications complications remain a problem with this strategy. [ABSTRACT FROM AUTHOR]

We aimed to compare 5-year survival and readmissions of patients who received HeartMate 3 (HM3) left ventricular assist device (LVAD) or orthotopic heart transplantation (OHT) as primary treatment for advanced heart failure. We retrospectively analyzed 501 adult patients who received HM3 or OHT between January 2014 and March 2021. To minimize crossover bias, OHT patients with prior LVAD were excluded and HM3 patients were censored at time of transplant. Cohorts were propensity score-matched (PSM) to reduce selection bias using a nearest-neighbor algorithm with the following baseline characteristics: age, sex, body mass index (BMI, calculated as weight in kilograms divided by height in meters squared), serum creatinine, serum albumin, pulmonary artery (PA) systolic pressure, etiology, cardiac device history, and surgery after the 2018 UNOS allocation change. Primary outcome was 5-year survival, evaluated by Kaplan-Meier survival curves with log-rank testing for significance. Secondary outcome was mean cumulative, all-cause, unplanned readmission up to five years of follow-up. Our cohort consisted of 219 (65%) HM3 patients and 118 (35%) OHT. PSM matched 72 patients in each cohort, with a SMD < 0.1 for all parameters, except for device history (SMD = 0.102) and surgery after UNOS change (SMD = 0.168). After PSM, there was no statistical difference in 2-year (HM3 89.6% vs. OHT 89.7%, P = 0.88) and 5-year survival (HM3 67.2% vs. OHT 84.0%, P = 0.76) (Figure 1A). HM3 patients ages 18-58 had superior survival compared to those ages 59 and older (84.7% vs 58.9 %, P = 0.0039), resembling that of OHT overall (Figure 1B). Mean cumulative readmission at 5-years was significantly higher in the HM3 cohort (5.89 vs 2.99, P < 0.05) (Figure 1C). Our data suggests that HM3 provided comparable long-term survival to OHT as a primary treatment for heart failure, especially in younger patients but had significantly increased readmissions. [ABSTRACT FROM AUTHOR]

The HeartMate3 (HM3) is the dominant durable left ventricular assist device (LVAD) therapy for patients (pts) with advanced heart failure refractory to medical therapy. However, information on HM3 outcomes beyond 2 years (y) are limited to the recently published results of the MOMENTUM 3 trial, which showed a 5-year survival of 56%. We report 5-year actuarial survival and cumulative incidence of major adverse events of HM3 pts implanted at a single large-volume center. We retrospectively reviewed all pts who underwent HM3 implant from 11/2014 to 7/2022 at our institution. Survival and major adverse events (de novo long-term renal replacement therapy (RRT), stroke, gastrointestinal bleeding (GIB) and driveline infection (DLI)) up to 5 y after implant were analyzed. Survival was estimated using Kaplan-Meier method. Nelson-Aelen nonparametric method was used to estimate cumulative incidence function for each adverse event. 280 HM3 pts (age 60±13 years, 44 (16%) female, 144(41%) ischemic etiology 176 (63%) INTERMACS profile 1-2, 238 (85%) destination therapy)) were studied. Over a follow up of 590 [295-1101] days, 45 (16%) died, 68 (24%) had heart transplant, 2(1%) were explanted, 6 (2%) transferred care and 159 (57%) remained on LVAD support. Two (1%) pts required de novo RRT at discharge, 19 (7%) experienced a stroke and 49 (17%) a DLI. Ninety-two GIBs occurred in 64 (23%) pts. Five-year actuarial survival was 68% (95%CI 57-79%) (Fig 1A). Cumulative probability of stroke was 0.08 (95%CI 0.05-0.12) (Fig 1B), GIB 0.35 (95%CI 0.27-0.42) (Fig 1C) and DLI 0.33 (95%CI 0.24-0.42) (Fig 1D). The probability of stroke was 0.04 at 30 days, 0.06 at 180 days, and 0.08 at 5 years. This observational single center report of HM3 pts shows excellent survival and acceptable rates of adverse events up to 5 years. These results suggest that an established multidisciplinary and protocolized approach to LVAD care may yield improved long-term outcomes for HM3 pts. [ABSTRACT FROM AUTHOR]

There are limited data depicting access to advanced heart failure (AHF) therapies by race/ethnicity. We aimed to determine the actual-to-expected utilization of AHF therapies in the United States (US) across racial/ethnic groups. The actual allocation of AHF therapies was obtained from the United Network for Organ Sharing database and the Interagency Registry for Mechanically Assisted Circulatory Support database from 2015 - 2019. The expected allocation of AHF therapies was estimated using 1) current US census data, 2) prevalence of heart failure (HF) among racial/ethnic groups, 3) prevalence of AHF within the HF population, and 4) the assumption that the allocation of AHF therapies within racial/ethnic groups will be proportional to the overall allocation (accounting for equal access to care) of therapies in the US. Next, we calculated the actual-to-expected ratios (reported as percentages) of AHF therapies (AHFT). Assuming the prevalence of AHF among HF patients is 10% and ∼50% have reduced ejection fraction, then 310,000 people in the US have AHF that could necessitate AHFT. The average annual volumes of left ventricular assist devices (LVADs) and heart transplants (HT) were 2,921.4 LVADs and 3,239.8 HT (1.9% of the total AHF population). LVAD allocation was 63.1% White, 26.8% Black, 7% Hispanic and 3% Asian (1842, 782, 207, and 89 LVADs per year, respectively). HT allocation was 62.4% White, 22.5% Black, 11.2% Hispanic, 3.8% Asian (1994, 720, 357.6, and 121.4 HTs per year, respectively). Based on established rates of HF among each race/ethnicity (3.8% White, 6.9% Black, 4.1% Hispanic), 8, 046.5 LVADs and 6, 583.5 HTs in Whites, 2, 926 LVADs and 2, 394 HTs in Blacks, and 2, 612.5 LVADs and 2, 137.5 HTs in Hispanics were expected during the study period. The actual-to-expected ratios of AHF therapies are in Figure 1. Although AHF therapies are underused in all races/ethnicities, there is greater disparity in access to AHF therapies among Hispanics than among Whites or Blacks. [ABSTRACT FROM AUTHOR]

Treatment of cardiogenic shock associated with late allograft failure after heart transplant (HT) is poorly characterized and infrequently reported. In this study, we examined the role of mechanical circulatory support (MCS) as a method to treat patients with severe late graft failure. From 2000 - 2018, there were 1275 adult HT at our institution. Of those, 26 patients (2.0%) were identified who required MCS for cardiogenic shock due to late allograft failure. Patient demographics and outcomes were retrospectively reviewed. Median age of the cohort was 37.3 years (IQR: 17.3) and 69% were male. Median time from initial transplant to MCS was 2.9 years. At the time of shock, median hemodynamic values were as follows: CVP 18 mmHg, mean PA pressure 29 mmHg, PCWP 25 mmHg, and CI 1.87 L/min/m2. On echocardiogram, median LVEF was 25% and 77% of patients had moderate or severe right ventricular dysfunction. Seven patients (27%) had severe allograft coronary disease, while all remaining patients had chronic or acute worsening rejection. Initial MCS used included veno-arterial extracorporeal membrane oxygenation in 15 patients (58%), biventricular assist device in 10 patients (38%), and total artificial heart in 1 patient (4%). 8 patients underwent revision of MCS during the same hospitalization, on average 18 days after initial placement. While on MCS, the most common treatments for rejection were pulse dose steroids (69%), thymoglobulin (54%), and plasmapheresis (31%), with nearly all patients receiving combination therapy. Six patients (23%) weaned from MCS following medical therapy. Median duration of MCS was 33 days (IQR 55). Major morbidities included bleeding events in 39%, new renal replacement therapy in 23%, major infection in 27%, and stroke in 23%. Eight patients (31%) underwent re-heart transplant, all within one year of MCS, and survival for this cohort was 100% at 1 year. However, for those patients who were not offered re-transplant or who died while awaiting re-transplant, 1 year survival was only 22%, with 61% of deaths occurring in the hospital. Late graft failure resulting in cardiogenic shock carries significant morbidity and mortality, despite use of contemporary MCS. [ABSTRACT FROM AUTHOR]