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BACKGROUND: Clinical trials inform on average efficacy, but individualized risk assessments for outcome prediction are important in guiding treatment implementation. OBJECTIVES: The authors developed and validated a patient-specific risk score to predict survival at 1 and 2 years after HeartMate 3 (HM3) left ventricular assist device (LVAD) implantation. METHODS: The MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) trial includes 2,200 HM3 LVAD patients in the pivotal trial and Continued Access Protocol study (2014-2018). The authors randomly assigned all patients to a derivation cohort (n = 1,540) or validation cohort (n = 660). Univariate mortality predictors were screened for potential model inclusion, stepwise selection was used to build the multivariable Cox proportional hazards regression model, and performance (discrimination and calibration) was evaluated. RESULTS: Age, prior cardiac surgery (coronary artery bypass grafting [CABG] or valve procedure), lower serum sodium, higher blood urea nitrogen (BUN), small left ventricular size, and right atrial pressure-to-pulmonary capillary wedge pressure (RAP/PCWP) ratio >0.6 were significant risk factors for mortality. Receiver-operating characteristic (ROC) analysis in the validation cohort demonstrated an area under the curve (AUC) of 0.76 (95% CI: 0.70-0.81) at 1 year and 0.71 (95% CI: 0.66-0.77) at 2 years. Calibration between predicted and observed survival of the risk quintiles was high, with Pearson correlation coefficients of 0.986 and 0.994 at 1 and 2 years, respectively. Patients were successfully stratified into tertiles with higher-than-average, average, and lower-than-average survival, and observed mortality risk increased by 2-fold from one tertile to the next. CONCLUSIONS: A practical, easy-to-use HM3 Survival Risk Score with 6 components was developed to accurately predict 1- and 2-year survival after HM3 LVAD implantation. The survival risk score can be used to provide individual survival estimates to facilitate shared decision making when considering HM3 LVAD therapy. (MOMENTUM 3 Trial Portfolio; NCT02224755, NCT02892955).

Background Placement of an interatrial shunt device reduces pulmonary capillary wedge pressure during exercise in patients with heart failure and preserved or mildly reduced ejection fraction. We aimed to investigate whether an interatrial shunt can reduce heart failure events or improve health status in these patients.Methods In this randomised, international, blinded, sham-controlled trial performed at 89 health-care centres, we included patients (aged >= 40 years) with symptomatic heart failure, an ejection fraction of at least 40%, and pulmonary capillary wedge pressure during exercise of at least 25 mm Hg while exceeding right atrial pressure by at least 5 mm Hg. Patients were randomly assigned (1:1) to receive either a shunt device or sham procedure. Patients and outcome assessors were masked to randomisation. The primary endpoint was a hierarchical composite of cardiovascular death or non-fatal ischemic stroke at 12 months, rate of total heart failure events up to 24 months, and change in Kansas City Cardiomyopathy Questionnaire overall summary score at 12 months. Pre-specified subgroup analyses were conducted for the heart failure event endpoint. Analysis of the primary endpoint, all other efficacy endpoints, and safety endpoints was conducted in the modified intention-to-treat population, defined as all patients randomly allocated to receive treatment, excluding those found to be ineligible after randomisation and therefore not treated. This study is registered with ClinicalTrials.gov, NCT03088033.Findings Between May 25, 2017, and July 24, 2020, 1072 participants were enrolled, of whom 626 were randomly assigned to either the atrial shunt device (n=314) or sham procedure (n=312). There were no differences between groups in the primary composite endpoint (win ratio 1.0 [95% CI 0.8-1.2]; p=0.85) or in the individual components of the primary endpoint. The prespecified subgroups demonstrating a differential effect of atrial shunt device treatment on heart failure events were pulmonary artery systolic pressure at 20W of exercise (p(interaction)=0.002 [>70 mm Hg associated with worse outcomes]), right atrial volume index (p(interaction)=0.012 [>= 29.7 mL/m(2), worse outcomes]), and sex (p(interaction=)0.02 [men, worse outcomes]). There were no differences in the composite safety endpoint between the two groups (n=116 [38%] for shunt device vs n=97 [31%] for sham procedure; p=0.11).Interpretation Placement of an atrial shunt device did not reduce the total rate of heart failure events or improve health status in the overall population of patients with heart failure and ejection fraction of greater than or equal to 40%. Copyright (C) 2022 Elsevier Ltd. All rights reserved.

Patients experiencing vasoplegia, a type of distributive shock, have limited options when conventional vasopressors are not appropriate or sufficient. This is especially true for patients with cardiac dysfunction, whether after heart transplant or ventricular assist device (VAD) implantation. Angiotensin II has been used in various clinical settings for distributive shock; however, its role in patients after orthotopic heart transplant or VAD implantation is not well studied. We present two cases where angiotensin II played a vital role in correcting vasoplegia for critical cardiac patients.

Cardiac diseases are one of the most common causes of morbidity and mortality following liver transplantation (LT). Prior studies have shown that cardiac diseases affect close to one-third of liver transplant recipients (LTRs) long term and that their incidence has been on the rise. This rise is expected to continue as more patients with advanced age and/or non-alcoholic steatohepatitis undergo LT. In view of the increasing disease burden, a multidisciplinary initiative was developed to critically review the existing literature (between January 1, 1990 and March 17, 2021) surrounding epidemiology, risk assessment, and risk mitigation of coronary heart disease, arrhythmia, heart failure, and valvular heart disease and formulate practice-based recommendations accordingly. In this review, the expert panel emphasizes the importance of optimizing management of metabolic syndrome and its components in LTRs and highlights the cardioprotective potential for the newer diabetes medications (e.g., sodium glucose transporter-2 inhibitors) in this high-risk population. Tailoring the multidisciplinary management of cardiac diseases in LTRs to the cardiometabolic risk profile of the individual patient is critical. The review also outlines numerous knowledge gaps to pave the road for future research in this sphere with the ultimate goal of improving clinical outcomes.

An outflow graft twist of a left ventricular assist device (LVAD) remains a challenging clinical diagnosis and may even be misdiagnosed for other outflow obstructions. We present a case of a patient with two LVAD exchanges due to suspected outflow graft twisting in both clinical scenarios. As new LVADs continue to be designed and upgraded, clinicians must have a high index of suspicion for this rare complication.

An unprecedented global pandemic caused by a novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS‐CoV‐2) has quickly overwhelmed the health care systems worldwide. While there is an absence of consensus among the community in how to manage solid organ transplant recipients and donors, a platform provided by the American Society of Transplantation online community “Outstanding Questions in Transplantation”, hosted a collaborative multicenter, multinational discussions to share knowledge in a rapidly evolving global situation. Here, we present a summary of the discussion in addition to the latest published literature.

Coronavirus disease 2019 (COVID-19) is a pandemic that has affected more than 1.8 million people worldwide, overwhelmed health care systems owing to the high proportion of critical presentations, and resulted in more than 100,000 deaths. Since the first data analyses in China, elevated cardiac troponin has been noted in a substantial proportion of patients, implicating myocardial injury as a possible pathogenic mechanism contributing to severe illness and mortality. Accordingly, high troponin levels are associated with increased mortality in patients with COVID-19. This brief review explores the available evidence regarding the association between COVID-19 and myocardial injury.

Described herein is a 42-year-old woman who suddenly developed a spontaneous isolated coronary arterial dissection which led to massive acute myocardial infarction with shock, unsuccessful coronary artery bypass grafting, transiently successful extracorporeal life support, and finally successful heart transplant. Such a sequence of events is exceedingly rare for patients with coronary dissection and prompted this report.

Purpose We describe a method for implanting the Abbot HeartMate 3™ (HM3) Left Ventricular Assist Device (LVAD) that may reduce perioperative bleeding and the use of blood products. Methods First a median sternotomy is performed and the HM3 prepared. The driveline is tunneled through the subcutaneous tissue and the patient is placed on cardiopulmonary bypass (CPB). The HM3 is implanted via the “cut then sew” method. A ring is made from Teflon™ felt and placed over the cuff of the HM3 sewing ring (Figure 1A-C). After coring the LV apex, a second donut shaped felt ring (1D) is placed (1E). Sutures are placed through the felt and LV wall and passed through the sewing cuff. The cuff is lowered, sutures tightened (1F-G), and more sutures are placed through the cuff and passed through the myocardium and felt strip (1H). The inflow and outflow cannula are attached, and patient removed from CPB. To determine the effect of this method on perioperative bleeding, we reviewed the charts of 114 patients that underwent HM3 placement in our institution between October 2015 and June 2019 by 4 surgeons, 1 of whom used this method. Results Table 1 shows our results and suggests that the novel method results in less perioperative bleeding, as indicated by both comparison of pre and postoperative hemoglobin and hematocrit and the amount of blood products given intraoperatively. The novel method also resulted in a shorter procedure time, possibly due to improved hemostasis. Conclusion Our addition of Teflon™ felt strips around the sewing cuff of the HM3 may reduce perioperative bleeding and the use of perioperative blood products.

Introduction Left ventricular assist devices (LVADs) are used in cases of heart failure refractory to medical therapy. In certain cases, myocardial function recovers and LVADs can be explanted. Weaning protocols and post explantation management are lacking. We describe the case of successful Heartmate III (HM III) LVAD insertion, followed by myocardial recovery and successful explanation. Case Report 35-year-old male with a history of chronic systolic heart failure due to poly-substance abuse with a left ventricular ejection fraction (EF) of 15% presented in acute cardiogenic shock, INTEMACS 2. A HM III was implanted and he remained stable. Over a period of 14 months, he was able to tolerate up titration of his goal directed medical therapy that included valsartan 160 mg twice daily, spironolactone 50 mg daily, digoxin 125 mcg daily, isosorbide mononitrate 60 mg daily, hydralazine 100 mg three times a day, and carvedilol 25 mg twice a day. On repeat imaging, he demonstrated a decrease in left ventricular (LV) size and an increase in intrinsic function (EF50%), represented by an aortic valve that opens with every beat and low flow alarms necessitating lower speeds. The decision was made to wean him from the LVAD. He was given 5000 units of IV heparin and under echo guidance his LVAD speed was decreased from 5000 to 4500 rpm. He walked 537 m on a 6-minute walk test. He was admitted for further reduction in HM III dependence. He received additional heparin and his LVAD speed was dropped to 4,000rpm for a cardiopulmonary exercise test, which was notable for peak VO2 of 13 with an RER of 1.4 and a VE/VCO2 slope of 39. His RHC demonstrated acceptable intra-cardiac pressures with a normal cardiac index. HM III was explanted and he was discharged. Summary To date no weaning protocols for HM III have been accepted or standardized. We describe the case of a patient who required LVAD insertion, followed by myocardial recovery and explanation. We suggest the above protocol for the evaluation of patients deemed appropriate for LVAD explant.

Introduction Many known risks are associated with cardiac transplantation. Although dangers surround the transplant itself, immunosuppression increases the vulnerability to infection and malignancy. Without expertise in transplant medicine, diagnosing and managing patients with complications of immunosuppression can become challenging. Case Description : A 67-year-old male 4 months post orthotopic heart transplant (OHT), without induction therapy, tolerating appropriate immunosuppression and antimicrobial prophylaxis presented to an outside hospital (OSH) for new-onset seizures and fevers of up to 104° F. At the OSH he was started on Keppra and underwent a brain MRI showing enhancing masses with edema, suspicious for metastatic disease with primary lung carcinoma, as the patient had a known lung nodule pre-OHT. The OSH called us for transfer, however, the patient refused due to wanting to stay near his home to take care of his cats. However, he continued to deteriorate despite being on steroids and anti-epileptics and on day 3, he agreed to be transferred to our facility. Transthoracic echocardiogram showed normal ejection fraction, no vegetations or abscess or evidence of graft dysfunction. Repeat MRI at our institution revealed 3 ring-enhancing lesions within the supratentorial parenchyma consistent with cerebral abscesses. CT scan showed a 2.5 cm pulmonary nodule in the left lingula. Lumbar puncture indicated white blood cells and predominant neutrophils. He was originally scheduled for a lung biopsy, but pre-procedure CT revealed the lung nodule decreased in size, suggesting an infectious etiology. He began IV Meropenem and Bactrim since all evidence was suggestive of infection and not malignancy. Brain biopsy revealed the lesions were abscesses and culture demonstrated gram-positive filamentous rods, consistent with Nocardia. Linezolid was added to his current antibiotic regiment for better broader coverage. Bacterial speciation detected Nocardia cyriacigeorgica. The patient continued to improve after antibiotic initiation and was discharged to rehab. Conclusion : Immunosuppressed patients are susceptible to opportunistic infections, such as that of N. cyriacigeorgica, especially in the first year following OHT. These infections can lead to clinical manifestations that may be mistaken for malignancy at centers lacking expertise in transplant medicine. Transplant patients should be aware of the risks of chronic immunosuppression therapy and counseled to return to the implanting center for serious conditions.

The FDA recently issued a warning regarding the heartmate 3 left ventricular assist device (LVAD) due to concerns of an outflow graft assembly that may cause it to twist. However, this complication has not been reported in the heartmate 2 (HM2). A 54 year old Caucasian male presents three years

See Article by Saku et al Myocardial infarction (MI) and ischemic heart disease are leading causes of morbidity and mortality. Globally, 110 million people live with ischemic heart disease,1 and >8 million per year die secondary to ischemic heart disease.2 As for MI, the 2018 Heart and Disease Stroke Statistics update of the American Heart Association reported a prevalence of 7.9 million adults in the United States alone. In 2015, >110 000 patients died because of MI, with 30-day in-hospital mortality of 15%.3 Both of these conditions combine as the most common cause of heart failure (HF), either from chronic ischemia or from resultant injury after MI. Up to 40% of individuals with MI develop left ventricular (LV) dysfunction.4 The infarct size with resultant adverse ventricular remodeling is directly associated with the development of HF after MI.4 Cardiogenic shock, the worst expression of HF, in the setting of acute myocardial dysfunction is preceded by myocardial contractile dysfunction, which leads to inadequate tissue perfusion and, in turn, can result in multiorgan failure. Although the prevalence of cardiogenic shock among patients with MI is relatively low (5%–10%),5 cardiogenic shock has historically had an early mortality rate as high as 80%, whereas recent studies have suggested a decline in mortality to ≈40%,6 which is nevertheless still too high. Traditionally, coronary artery reperfusion using percutaneous intervention has been the cornerstone therapy to reduce myocardial damage and subsequent HF. Moreover, early percutaneous coronary intervention, using the latest generation of drug-eluted stents and novel antithrombotics and pharmacological therapies, has significantly reduced mortality in MI-related cardiogenic …

Background The development of right ventricular failure (RVF) is common following continuous-flow left ventricular assist device (CF-LVAD) implantation, occurring in 13%-40% of patients. With the LVAD and right heart operating in series, LVAD function relies heavily on RV function for adequate preload. Severe RVF can lead to systemic hypoperfusion, multi-organ failure, prolonged hospitalization, poor quality of life, and death. Hypothesis Identifying patients at risk of developing severe RVF post-implantation may assist the care team in taking the necessary precautions to potentially avoid RVF or to be aggressive in its management. Methods This was a single-center review of CF-LVAD implantations from 2014 to 2016. Excluded were INTERMACS1 patients, redo LVADs, preoperative advanced RVF, refractory pulmonary vascular resistance >6 WU, and prosthetic mitral or tricuspid valve. RVF was defined as requiring RVAD or inhaled nitric oxide or other pulmonary vasodilator post-op for ≥48h or inotropic therapy for ≥7d any time post-op. Assessment of pre-implant RV function was based on an extensive set of echocardiographic parameters ( Tables 1 & 2 ). Results Of 55 patients (95% were HeartMate II), a total of 46 (84%) developed significant RVF. Those with and without RVF did not differ in gender or age. RV stroke volume (P=0.04), RV stroke volume index (P=0.04), and mitral valve regurgitation jet area (P=0.05) were significantly lower in patients with RVF ( Table 1 ). Conclusion RV cardiac output is calculated as RV stroke volume x heart rate. Thus, early RVF post-LVAD may be explained by low RV stroke volume. In standard practice, however, RV stroke volume and RV stroke volume index are not routinely calculated from the pre-implant echocardiogram. This study, despite its small sample size, suggests potential prognostic value for these echo parameters for the evaluation of RVF. Larger studies are needed to validate these results.

Purpose Medication non-compliance after cardiac transplantation may be improved by simplifying dosing frequency to once-a-day extended-release tacrolimus, potentially reducing rejection rate and improving patient outcomes. Of the 2 distinct proprietary formulations for extended-release tacrolimus that are FDA approved for renal transplant patients, Meltdose tacrolimus tablets (LCP-Tacro or LCPT) has enhanced bioavailability, including in rapid metabolizers. There is limited data supporting the use of extended release tacrolimus in heart transplant recipients. Here we report initial safety and efficacy findings with extended-release tacrolimus in this population. Methods In an ongoing, phase II, single-center, open-label study (NCT03373227), 20 de novo adult heart transplant recipients have been enrolled to receive LCPT. Primary endpoints included incidence of rejection and graft failure. Secondary endpoints included compliance, incidence of adverse effects, infections, re-admissions, and survival. Therapeutic tacrolimus levels were monitored for overall drug compliance. A CYP3A5 genotype sub-study has been added to examine the associations between genotype and efficacy and safety. Results Demographics and findings are shown in Table 1. During a median post-transplant follow-up of 22 weeks (range 2-45), no serious drug related adverse events were observed and no safety issues identified. Percent of time in therapeutic range was consistent with low incidence of rejection; 2 patients had an episode of treated rejection, which resolved with steroid therapy. Conclusion Our findings demonstrate favorable early safety and efficacy profile of LCPT in heart transplant recipients.

Purpose Over the past decade, novel temporary percutaneous ventricular assist devices (PVAD) have emerged with active continuous flow support for the management of cardiogenic shock. The hemodynamic benefit of PVADs over the intra-aortic balloon pump (IABP) is established. However, data comparing the clinical use and outcomes of these devices have been sparse and controversial. Methods A single center, retrospective chart review was performed on adult patients who required temporary mechanical support with an IABP or PVAD (Abiomed Impella 5.0, Danvers, MA) for at least 72 hours in duration for the management of refractory, acute cardiogenic shock. These patients were adjudicated to have cardiogenic shock defined by cardiac index (CI) Results 43 patients met inclusion requirements for this study, with 28 patients receiving a PVAD and 15 patients receiving an IABP. Age, sex, ethnicity, and baseline hemodynamics were similar. Baseline serum creatinine (Cr) was higher in PVAD vs IABP (2.3 vs 1.6 mg/dL; p=0.033). Following intervention, PVAD had a higher likelihood for successful bridge to Tx/VAD compared to IABP (p=0.003). Both modalities showed similar 30-day mortality (Figure 1, p=0.26). Cardiac index improved for both PVAD and IABP. Renal function improved only after PVAD (Cr, 2.4 vs 1.8 mg/dL; p=0.02). Non-fatal bleeding was higher with PVAD. Conclusion In this single center study, PVAD was associated with more successful bridge to Tx/VAD, improved PCWP, CI and end-organ function. There was a trend towards higher survival compared to IABP albeit with a higher incidence of minor bleeding complications. Further studies are needed to distinguish the benefits of PVAD therapy.

Current guidelines regarding patients suffering from post infarct ventricular septal defect (VSD) do not account for the full spectrum of modern mechanical circulatory support (MCS). A 69-year-old man was transferred to our hospital with 2 weeks of progressive respiratory symptoms. His exam was

Introduction Treatment guidelines for asymptomatic acute cellar rejection of ISHLT grade 2 (2R ACR) are dictated by clinical judgement and patient risk. In higher risk cases, a course of intravenous (IV) corticosteroids may be recommended, while in others a short course of oral steroids is given. There is also variability in pathologic rejection grading on endomyocardial biopsy. We aimed to determine if treatment choice predicts outcomes in 2R ACR patients. Methods We reviewed all patients with biopsy-proven 2R ACR following heart transplantation at our institution from 2012-2016. Treatment strategies were classified as IV corticosteroids or “other” (ie, pulse oral corticosteroids or adjustment of baseline immunosupprants.) These two strategies were compared for time to re-hospitalization, time to recurrence of ≥2R ACR, development of cardiac allograft vasculopathy or renal insufficiency, and 1-year survival. Results Among 305 heart transplant recipients, 73 patients developed 117 separate episodes of 2R ACR. 37 patients (51%) received IV corticosteroids and were more likely to be hospitalized (24% versus 3%) for treatment. However, the two strategy groups did not differ in time to re-hospitalization (46% versus 33%, p=0.78) (Fig 1), time to recurrence (98 days versus 51 days, p=0.48), development of cardiac allograft vasculopathy (67% versus 57%, p=0.47) or renal insufficiency (58% versus 65%, p=0.634). Admission for infection was the reason for re-hospitalization in 19% vs 3% of cases. Additionally there was no difference in 1-year survival (95% versus 94%, p=0.45) (Fig 2). Conclusions While this study is limited by a small cohort, results suggests there is no significant difference in outcomes among patients treated with either aggressive IV steroids versus adjustment of oral immunosuppressants, including oral corticosteroids. Aggressive treatment may not be needed for biopsy proven 2R ACR in patients without hemodynamic compromise.