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Aims: Pulmonary artery catheter haemodynamics are associated with improved survival in cardiogenic shock (CS). We investigated the utility of aortic pulsatility index (API) and cardiac power output (CPO) as surrogates for left ventricular (LV) coupling and myocardial reserve, respectively, in patients with CS undergoing dynamic assessment after a milrinone bolus., Methods and Results: Patients with SCAI Stage C CS underwent a milrinone drug study (50 mcg/kg bolus infused over 10 min) to assess inotropic response. Haemodynamic measurements were obtained at baseline and following the bolus. Aortic pulsatility index and CPO were used to risk-stratify patients with the incidence of LV assist device (LVAD), orthotopic heart transplantation (OHT), or death at 1 year as the primary composite endpoint. Two hundred and twenty-four patients in SCAI Stage C CS underwent haemodynamics prior to milrinone bolus, and 117 patients had low baseline API < 1.45. Of the 117 patients, 88 had a final API < 2.2 after milrinone load, consistent with LV decoupling, in which 73% met the composite endpoint. The remaining 29 patients had a final API ≥ 2.2 consistent with LV recoupling, and only 55% met the composite endpoint ( P = 0.046). Of the 117 patients, 40 patients had low myocardial reserve (final CPO < 0.77 W), in which 78% met the composite endpoint. Of the 77 patients who demonstrated myocardial reserve (final CPO ≥ 0.77 W), only 64% met the composite endpoint ( P = 0.039)., Conclusion: The use of API and CPO in a dynamic assessment after provocative testing led to improved risk stratification in patients with SCAI Stage C CS for clinical outcomes including LVAD, OHT, or death at 1 year., Competing Interests: Conflict of interest: J.G. is a speaker for Abbott, Medtronic, Abiomed, and CH Biomedical. C.S. is a consultant to Medtronic and Abbott; educator for Abbott. V.J. is an advisory board member for Abbott. None of the other authors have relevant disclosures., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: Although impaired left ventricular (LV) global longitudinal strain (GLS) with apical sparing is a feature of cardiac amyloidosis (CA), its diagnostic accuracy has varied across studies. We aimed to determine the ability of apical sparing ratio (ASR) and most common echocardiographic parameters to differentiate patients with confirmed CA from those with clinical and/or echocardiographic suspicion of CA but with this diagnosis ruled out., Methods and Results: We identified 544 patients with confirmed CA and 200 controls (CTRLs) as defined above (CTRL patients). Measurements from transthoracic echocardiograms were performed using artificial intelligence software (Us2.AI, Singapore) and audited by an experienced echocardiographer. Receiver operating characteristic curve analysis was used to evaluate the diagnostic performance and optimal cut-offs for the differentiation of CA patients from CTRL patients. Additionally, a group of 174 healthy subjects (healthy CTRL) was included to provide insight on how patients and healthy CTRLs differed echocardiographically. LV GLS was more impaired (-13.9 ± 4.6% vs. -15.9 ± 2.7%, P < 0.0005), and ASR was higher (2.4 ± 1.2 vs. 1.7 ± 0.9, P < 0.0005) in the CA group vs. CTRL patients. Relative wall thickness and ASR were the most accurate parameters for differentiating CA from CTRL patients [area under the curve (AUC): 0.77 and 0.74, respectively]. However, even with the optimal cut-off of 1.67, ASR was only 72% sensitive and 66% specific for CA, indicating the presence of apical sparing in 32% of CTRL patients and even in 6% healthy subjects., Conclusion: Apical sparing did not prove to be a CA-specific biomarker for accurate identification of CA, when compared with clinically similar CTRLs with no CA., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Tricuspid regurgitation(TR) following heart transplantation could adversely affect clinical outcomes. In an effort to reduce the incidence of TR, prophylactic donor heart tricuspid valve annuloplasty has been performed during heart transplantation in our institution. We assessed early and long-term outcomes., Methods: Between August 2011 and August 2021, 349 patients who underwent prophylactic tricuspid valve annuloplasty were included. Tricuspid valve annuloplasty was performed using the DeVega annuloplasty technique. The clinical outcomes of the interests included complete atrioventricular block requiring pacemaker implantation, the occurrence of significant TR(defined as moderate or greater), and survival. Long-term survival was compared in patients with and without significant TR using the Kaplan-Meier method. The Cox proportional hazards regression with time-dependent covariate analysis was used to see if significant TR affected the long-term survival., Results: There was one patient(0.3%) who required pacemaker implantation for complete atrioventricular block. No patients developed tricuspid valve stenosis that required intervention. Significant TR developed in 31 patients(8.9%) during the follow-up period. The survival rate of patients who developed significant TR was significantly lower than that of those who did not(log rank < 0.01). Significant TR was associated with the long-term mortality(HR2.92, 95%CI 1.47-5.82, p < 0.01)., Conclusions: Prophylactic donor heart tricuspid valve annuloplasty has the potential to reduce the occurrence of significant TR and can be performed safely. The significant TR that developed in patients with prophylactic annuloplasty negatively affected survival and was an independent predictor of long-term mortality., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Objectives: It remains unknown if the left atrial appendage closure (LAAC) at the time of left ventricular assist device (LVAD) surgery can reduce ischaemic cerebrovascular accidents., Methods: Consecutive 310 patients who underwent LVAD surgery with HeartMate II or 3 between January 2012 and November 2021 were included in this study. The cohort was divided into 2 groups: patients with LAAC (group A) and without LAAC (group B). We compared the clinical outcomes including the incidence of cerebrovascular accident between 2 groups., Results: Ninety-eight patients were included in group A, and 212 patients in group B. There were no significant differences between 2 groups in age, preoperative CHADS2 score and history of atrial fibrillation. In-hospital mortality did not differ significantly between the 2 groups (group A: 7.1%, group B: 12.3%, P = 0.16). Thirty-seven patients (11.9%) experienced ischaemic cerebrovascular accident (5 patients in group A and 32 patients in group B). The cumulative incidence from ischaemic cerebrovascular accidents in group A (5.3% at 12 months and 5.3% at 36 months) was significantly lower than that in group B (8.2% at 12 months and 16.8% at 36 months; P = 0.017). In a multivariable competing risk analysis, LAAC was associated with reducing ischaemic cerebrovascular accidents (hazard ratio 0.38, 95% confidence interval 0.15-0.97, P = 0.043)., Conclusions: Concomitant LAAC in LVAD surgery can reduce ischaemic cerebrovascular accidents without increasing perioperative mortality and complications., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Aims: While cardiac magnetic resonance (CMR) is often obtained early in the evaluation of suspected cardiac amyloidosis (CA), it currently cannot be utilized to differentiate immunoglobulin (AL) and transthyretin (ATTR) CA. We aimed to determine whether a novel CMR and light-chain biomarker-based algorithm could accurately diagnose ATTR-CA., Methods and Results: Patients with confirmed AL or ATTR-CA with typical late gadolinium enhancement (LGE) and Look-Locker pattern for CA on CMR were retrospectively identified at three academic medical centres. Comprehensive light-chain analysis including free light chains, serum, and urine electrophoresis/immunofixation was performed. The diagnostic accuracy of the typical CMR pattern for CA in combination with negative light chains for the diagnosis of ATTR-CA was determined both in the entire cohort and in the subset of patients with invasive tissue biopsy as the gold standard. A total of 147 patients (age 70 ± 11, 76% male, 51% black) were identified: 89 ATTR-CA and 58 AL-CA. Light-chain biomarkers were abnormal in 81 (55%) patients. Within the entire cohort, the sensitivity and specificity of a typical LGE and Look-Locker CMR pattern and negative light chains for ATTR-CA was 73 and 98%, respectively. Within the subset with biopsy-confirmed subtype, the CMR and light-chain algorithm were 69% sensitive and 98% specific., Conclusion: The combination of a typical LGE and Look-Locker pattern on CMR with negative light chains is highly specific for ATTR-CA. The successful non-invasive diagnosis of ATTR-CA using CMR has the potential to reduce diagnostic and therapeutic delays and healthcare costs for many patients., Competing Interests: Conflict of interest: The authors have no relevant conflicts of interest to disclose, (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Competing Interests: Conflict of interest: Dr. Slivnick receives funding from IONIS Pharmaceuticals through a young investigator grant. The other authors have no relevant conflicts of interest to disclose.

Background: Heart failure (HF) is a prevalent chronic disease and is associated with increases in mortality and morbidity. HF is a leading cause of hospitalizations and readmissions in the United States. A potentially promising area for preventing HF readmissions is continuous remote patient monitoring (CRPM)., Objective: The primary aim of this study is to determine the feasibility and preliminary efficacy of a CRPM solution in patients with HF at NorthShore University HealthSystem., Methods: This study is a feasibility study and uses a wearable biosensor to continuously remotely monitor patients with HF for 30 days after discharge. Eligible patients admitted with an HF exacerbation at NorthShore University HealthSystem are being recruited, and the wearable biosensor is placed before discharge. The biosensor collects physiological ambulatory data, which are analyzed for signs of patient deterioration. Participants are also completing a daily survey through a dedicated study smartphone. If prespecified criteria from the physiological data and survey results are met, a notification is triggered, and a predetermined electronic health record-based pathway of telephonic management is completed. In phase 1, which has already been completed, 5 patients were enrolled and monitored for 30 days after discharge. The results of phase 1 were analyzed, and modifications to the program were made to optimize it. After analysis of the phase 1 results, 15 patients are being enrolled for phase 2, which is a calibration and testing period to enable further adjustments to be made. After phase 2, we will enroll 45 patients for phase 3. The combined results of phases 1, 2, and 3 will be analyzed to determine the feasibility of a CRPM program in patients with HF. Semistructured interviews are being conducted with key stakeholders, including patients, and these results will be analyzed using the affective adaptation of the technology acceptance model., Results: During phase 1, of the 5 patients, 2 (40%) were readmitted during the study period. The study completion rate for phase 1 was 80% (4/5), and the study attrition rate was 20% (1/5). There were 57 protocol deviations out of 150 patient days in phase 1 of the study. The results of phase 1 were analyzed, and the study protocol was adjusted to optimize it for phases 2 and 3. Phase 2 and phase 3 results will be available by the end of 2022., Conclusions: A CRPM program may offer a low-risk solution to improve care of patients with HF after hospital discharge and may help to decrease readmission of patients with HF to the hospital. This protocol may also lay the groundwork for the use of CRPM solutions in other groups of patients considered to be at high risk., International Registered Report Identifier (irrid): DERR1-10.2196/36741., (©Courtney Reamer, Wei Ning Chi, Robert Gordon, Nitasha Sarswat, Charu Gupta, Safwan Gaznabi, Emily White VanGompel, Izabella Szum, Melissa Morton-Jost, Jorma Vaughn, Karen Larimer, David Victorson, John Erwin, Lakshmi Halasyamani, Anthony Solomonides, Rema Padman, Nirav S Shah. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 25.08.2022.)

Aims: Heart transplantation involves many factors such as donor selection, recipient management, multidisciplinary assessment, coordination with other organ teams, and transportation. Because of some unpredictable factors, heart transplantation can be conducted at any time of day. The purpose of this study is to investigate if outcomes differ between heart transplants taking place inside or outside of normal working hours., Methods and Results: We reviewed patients who underwent heart transplantation at our institution from January 2010 to July 2020 (n = 329). Based on the documented start time of the recipient surgeries, the cohort was divided into two groups: working hours (Group A: 7:30 to 17:00; n = 92) and after hours (Group B: 17:00 to 7:30; n = 237). We compared these groups using propensity score matching analysis. After propensity score matching, 78 pairs of patients were successfully matched. We reviewed early and late clinical outcomes including survival. Long-term survival was compared using the Kaplan-Meier method. In the propensity-score matched patients, there were no significant differences in the baseline characteristics between two groups. In-hospital mortality was not significantly different between the two groups (Group A: 6.4% vs. Group B: 2.6%, P = 0.44). Ischaemic time and cross-clamp time did not differ between the groups. In terms of postoperative complications, there were no significant differences between two groups in stroke (6.4% vs. 3.9%, P = 0.72), primary graft dysfunction requiring extracorporeal membrane oxygenation (5.1% vs. 7.7%, P = 0.75), re-exploration for bleeding (9.0% vs. 12.8%, P = 0.44), and newly required haemodialysis (7.7% vs. 6.4%, P = 0.75). The survival rate in Group A (88.1% at 1 year, 81.3% at 3 years) was not significantly different from Group B (90.5% at 1 year, 82.3% at 3 years, log rank = 0.96)., Conclusion: There was no significant difference in clinical outcomes between heart transplants taking place inside or outside of working hours. A high quality of care can be provided for heart transplant patients even during after hours., (© 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Competing Interests: Dr Sarswat has been a consultant and has served on advisory boards for Alnylam, Akcea, and Pfizer; and has received grant funding from Pfizer. Dr Derman has served on an advisory board for Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Hereditary transthyretin-mediated amyloidosis, also known as ATTRv amyloidosis (v for variant), is a rare, autosomal dominant, fatal disease, in which systemic amyloid progressively impairs multiple organs, leading to disability and death. The recent approval of disease-modifying therapies offers the hope of stabilization or eventual reversal of disease progression, and yet highlights a lack of disease-management guidance. A multidisciplinary panel of expert clinicians from France and the US came to consensus on monitoring the disease and identifying progression through a clinical opinion questionnaire, a roundtable meeting, and multiple rounds of feedback., Monitoring Disease and Progression: A multidisciplinary team should monitor ATTRv amyloidosis disease course by assessing potential target organs at baseline and during follow-up for signs and symptoms of somatic and autonomic neuropathy, cardiac dysfunction and restrictive cardiomyopathy, and other manifestations. Variability in penetrance, symptoms, and course of ATTRv amyloidosis requires that all patients, regardless of variant status, undergo regular and standardized assessment in all these categories. Progression in ATTRv amyloidosis may be indicated by: worsening of several existing quantifiable symptoms or signs; the appearance of a new symptom; or the worsening of a single symptom that results in a meaningful functional impairment., Conclusions: We suggest that a multisystem approach to monitoring the signs and symptoms of ATTRv amyloidosis best captures the course of the disease. We hope this work will help form the basis of further, consensus-based guidance for the treatment of ATTRv amyloidosis., (© 2021. The Author(s).)

Objective: We report on our experience of deploying a continuous remote patient monitoring (CRPM) study soft launch with structured cascading and escalation pathways on heart failure (HF) patients post-discharge. The lessons learned from the soft launch are used to modify and fine-tune the workflow process and study protocol., Methods: This soft launch was conducted at NorthShore University HealthSystem's Evanston Hospital from December 2020 to March 2021. Patients were provided with non-invasive wearable biosensors that continuously collect ambulatory physiological data, and a study phone that collects patient-reported outcomes. The physiological data are analyzed by machine learning algorithms, potentially identifying physiological perturbation in HF patients. Alerts from this algorithm may be cascaded with other patient status data to inform home health nurses' (HHNs') management via a structured protocol. HHNs review the monitoring platform daily. If the patient's status meets specific criteria, HHNs perform assessments and escalate patient cases to the HF team for further guidance on early intervention., Results: We enrolled five patients into the soft launch. Four participants adhered to study activities. Two out of five patients were readmitted, one due to HF, one due to infection. Observed miscommunication and protocol gaps were noted for protocol amendment. The study team adopted an organizational development method from change management theory to reconfigure the study protocol., Conclusion: We sought to automate the monitoring aspects of post-discharge care by aligning a new technology that generates streaming data from a wearable device with a complex, multi-provider workflow into a novel protocol using iterative design, implementation, and evaluation methods to monitor post-discharge HF patients. CRPM with structured escalation and telemonitoring protocol shows potential to maintain patients in their home environment and reduce HF-related readmissions. Our results suggest that further education to engage and empower frontline workers using advanced technology is essential to scale up the approach., Competing Interests: The study devices, monitoring platform, and tech support are non-financial support by physIQ. K.L. is an employee of physIQ. All other authors do not have any conflict of interest. K.L. reports employment and equity from physIQ, during the conduct of the study; other from physIQ, outside the submitted work. N.S.S. reports non-financial support from physIQ, during the conduct of the study. J.E. reports and I serve on the ACCMedAxiom Board of Trustees. This is the for-profit arm of the ACC. While I have no direct relationships with vendors, the Board approves partnerships with vendors. U.R. is funded by the Daniel F. and Ada L. Rice Foundation. The foundation is not involved in the research design, implementation, or production of the manuscript in any way. Therefore, there is no conflict of interest. W.N.C. is funded by the Daniel F. and Ada L. Rice Foundation. The foundation is not involved in the research study design, implementation, or production of the manuscript in any way. Therefore, there is no conflict of interest., (Thieme. All rights reserved.)

Background: Because transthyretin amyloid cardiomyopathy (ATTR-CM) poses unique diagnostic and therapeutic challenges, referral of patients with known or suspected disease to specialized amyloidosis centers is recommended. These centers have developed strategic practices to provide multidisciplinary comprehensive care, but their best practices have not yet been well studied as a group., Methods: A qualitative survey was conducted by telephone/email from October 2019 to February 2020 among eligible healthcare providers with experience in the management of ATTR-CM at US amyloidosis centers, patients with ATTR-CM treated at amyloidosis centers, and patient advocates from amyloidosis patient support groups., Results: Fifteen cardiologists and 9 nurse practitioners/nurses from 15 selected amyloidosis centers participated in the survey, with 16 patients and 4 patient advocates. Among participating healthcare providers, the most frequently cited center best practices were diagnostic capability, multidisciplinary care, and time spent on patient care; the greatest challenges involved coordination of patient care. Patients described the "ideal" amyloidosis program as one that provides physicians with expertise in ATTR-CM, sufficient time with patients, comprehensive patient care, and opportunities to participate in research/clinical trials. The majority of centers host patient support group meetings, and patient advocacy groups provide support for centers with physician/patient education and research., Conclusions: Amyloidosis centers offer comprehensive care based on staff expertise in ATTR-CM, a multidisciplinary approach, advanced diagnostics, and time dedicated to patient care and education. Raising awareness of amyloidosis centers' best practices among healthcare providers can reinforce the benefits of early referral and comprehensive care for patients with ATTR-CM., Competing Interests: Declaration of conflicting interests:The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JNN or his institution receives funding for research and serving on advisory boards from Alnylam, Akcea, Pfizer, and Eidos. NS has served as a consultant and participated in advisory boards for Pfizer, Alnylam, and Akcea; and has received funding for research grants from Pfizer. JF and MF have no conflicts of interest to report. YA, AC, and AH are full-time employees of Pfizer and own Pfizer stock/stock options. LK received funding from Pfizer to conduct this research and owns Pfizer stock., (© The Author(s) 2021.)

Background: Elevated lactic acid (LA) levels carry a poor prognosis in patients with shock. Data are lacking on the significance of LA levels in patients with acute decompensated heart failure (ADHF)., Hypothesis: This study assessed the relationship between LA levels, hemodynamics and clinical outcomes., Methods: This was a retrospective analysis of registry data of 100 advanced heart failure patients presenting for right heart catheterization (RHC) for concern of ADHF. LA levels (normal ≤2.1 mmol/L) were obtained prior to RHC; no significant changes in therapy were made between LA collection and RHC., Results: Median age was 58 (47.3, 64.8) years; 57% were receiving inotropes prior to RHC. Median pulmonary capillary wedge pressure (PCWP) and cardiac index (CI) were 28 (21, 35) mmHg and 2.0 (1.7, 2.5) L/min/m 2 , respectively. Eighty patients had normal LA prior to RHC. There was no correlation between LA levels and PCWP (R = 0.09, p = .38); 63% of the normal LA group had a PCWP >24 mmHg. There was a moderate inverse correlation between LA and CI (R = - 0.40; p < .001); 58% of the normal LA group had a CI <2.2 L/min/m 2 . Thirty-day survival free of death/hospice, inotrope dependence, progression to heart transplant/left-ventricular assist device implant was comparable between the normal and elevated LA groups (28% vs. 20%; p = .17)., Conclusion: In patients presenting with ADHF, normal LA levels do not exclude the presence of depressed CI (a hemodynamic criteria for cardiogenic shock) and may not offer accurate risk stratification. Invasive hemodynamics should not be delayed based on normal LA levels alone., (© 2021 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

Aims: Aortic pulsatility index (API), calculated as (systolic-diastolic blood pressure)/pulmonary capillary wedge pressure (PCWP), is a novel haemodynamic measurement representing both cardiac filling pressures and contractility. We hypothesized that API would better predict clinical outcomes than traditional haemodynamic metrics of cardiac function., Methods and Results: The Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) trial individual-level data were used. Routine haemodynamic measurements, including Fick cardiac index (CI), and the advanced haemodynamic metrics of API, cardiac power output (CPO), and pulmonary artery pulsatility index (PAPI) were calculated after final haemodynamic-monitored optimization. The primary outcome was a composite endpoint of death or need for orthotopic heart transplant (OHT) or left ventricular assist device (LVAD) at 6 months. A total of 433 participants were enrolled in the ESCAPE trial of which 145 had final haemodynamic data. Final API measurements predicted the primary outcome, OR 0.47 (95% CI 0.32-0.70, P < 0.001), while CI, CPO, and PAPI did not. Receiver operator characteristic analyses of final advanced haemodynamic measurements indicated API best predicted the primary outcome with a cutoff of 2.9 (sensitivity 76.2%, specificity 55.3%, correctly classified 61.4%, area-under-the-curve 0.71), compared with CPO, CI, and PAPI. Kaplan-Meier analyses indicated API ≥ 2.9 was associated with greater freedom from the primary outcome (83.5%), compared with API < 2.9 (58.4%), P = 0.001. While PAPI was also significantly associated, CI and CPO were not., Conclusions: The novel haemodynamic measurement API better predicted clinical outcomes in the ESCAPE trial when compared with traditional invasive haemodynamic metrics of cardiac function., (© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: The axillary intraaortic balloon pump (IABP) is frequently used in selected patients for circulatory support as a bridge to heart transplantation. The purpose of this study was to investigate the safety and efficacy of axillary intraaortic balloon pump (IABP) support for heart transplant candidates., Methods: The study investigators collected data on 133 patients who underwent axillary IABP support as a bridge to transplantation from July 2009 to April 2019. Of these patients, 94 (70.7%) underwent IABP insertion with surgical axillary grafts, and 39 (29.3%) underwent percutaneous IABP insertion. The outcomes of interest included ambulatory data, IABP-related complications, and successful heart transplantation with this type of support., Results: The overall preoperative ejection fraction was 20.3% ± 8.0%. The median duration of axillary IABP support was 21days, with 131patients (98.5%) mobilizing with the device. Hemodynamic variables significantly improved after the axillary IABP support was placed. Overall, 122 patients (91.7%) were successfully bridged to heart transplantation. Six patients (4.5%) required escalation to further mechanical support. Two patients (1.5%) died while awaiting transplantation. Four patients (3.0%) experienced a stroke during axillary IABP support (3 before transplantation and1 after transplantation). Two of the 3 patients with a stroke diagnosis before transplantation recovered and eventually underwent heart transplantation., Conclusions: With axillary IABP support, most patients were able to ambulate and undergo physical rehabilitation while waiting for heart transplantation. This study demonstrates that axillary IABP results in a high success rate of bridge to transplantation and a low number of complications. Thus, an ambulatory axillary IABP provided efficient and safe support for selected patients as a bridge to heart transplantation., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background Metabolic impairment is common in heart failure patients. Continuous-flow left ventricular assist devices (CF-LVADs) improve hemodynamics and outcomes in patients with advanced heart failure; however, the effect of CF-LVADs on metabolic status is unknown. This study aims to evaluate the changes in metabolic status following CF-LVAD implantation and measure the correlation of metabolic status with outcomes. Methods and Results Prospective data on CF-LVAD patients were obtained. Metabolic evaluation, including hemoglobin A1C, free and total testosterone, thyroid-stimulating hormone (TSH), and free T4, was obtained before and at multiple time points following implantation. Patients with nonelevated thyroid-stimulating hormone and normal hemoglobin A1C and testosterone levels were defined as having normal metabolic status. Baseline characteristics, hemodynamics, and outcomes were collected. One hundred six patients were studied, of which 56 had paired data at baseline and 1- to 3-month follow-up. Before implantation, 75% of patients had insulin resistance, 86% of men and 39% of women had low free testosterone, and 44% of patients had abnormal thyroid function. There was a significant improvement in hemoglobin A1C, free testosterone, and thyroid-stimulating hormone following implantation ( P <0.001 for all). Patients with normal hemoglobin A1C (<5.7%) following implantation had higher 1-year survival free of heart failure readmissions (78% versus 23%; P <0.001). Patients with normal metabolic status following implantation also had higher 1-year survival free of heart failure readmissions (92% versus 54%; P =0.04). Conclusions Metabolic dysfunction is highly prevalent in advanced heart failure patients and improves after CF-LVAD implantation. Normal metabolic status is associated with a significantly higher rate of 1-year survival free of heart failure readmissions.

Aims: Left ventricular assist device (LVAD) therapy improves the haemodynamics of advanced heart failure patients. However, it is unknown whether haemodynamic optimization improves haemocompatibility-related adverse events (HRAEs). This study aimed to assess HRAEs in patients with optimized haemodynamics., Methods and Results: Eighty-three outpatients [aged 61 (53-67) years, 50 male] underwent a haemodynamic ramp test at 253 (95-652) days after LVAD implantation, and 51 (61%) had optimized haemodynamics (defined as central venous pressure < 12 mmHg, pulmonary artery wedge pressure < 18 mmHg, cardiac index > 2.2 L/min/m 2 ) following LVAD speed adjustment. One-year survival free of any HRAEs (non-surgical bleeding, thromboembolic event, pump thrombosis, or neurological event) was achieved in 75% of the optimized group and in 44% of the non-optimized group (hazard ratio 0.36, 95% confidence interval 0.18-0.73, P = 0.003). The net haemocompatibility score, using four escalating tiers of hierarchal severity to derive a total score for events, was significantly lower in the optimized group than the non-optimized group (1.02 vs. 2.00 points/patient; incidence rate ratio 0.51, 95% confidence interval 0.29-0.90, P = 0.021)., Conclusion: Left ventricular assist device patients in whom haemodynamics can be optimized had greater freedom from HRAEs compared to those without optimized haemodynamics., (© 2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology.)

Background: Left ventricular assist device (LVAD) therapy improves the hemodynamics of advanced heart failure patients. However, it is unknown whether hemodynamic optimization improves clinical outcomes. The aim of this study was to investigate whether hemodynamic optimization reduces hospital readmission rate in LVAD patients., Methods and Results: LVAD patients undergoing an invasive hemodynamic ramp test were prospectively enrolled and followed for 1 year. LVAD speed was optimized using a ramp test, targeting the following goals: central venous pressure <12 mm Hg, pulmonary capillary wedge pressure <18 mm Hg, and cardiac index >2.2 L/(min·m 2 ). The frequency and cause of hospital readmissions were compared between patients who achieved (optimized group) or did not achieve (nonoptimized group) these goals. Eighty-eight outpatients (median 61 years old, 53 male) underwent ramp testing 236 days after LVAD implantation, and 54 (61%) had optimized hemodynamics after LVAD speed adjustment. One-year survival after the ramp study was comparable in both groups (89% versus 88%). The total hospital readmission rate was lower in the optimized group compared with the nonoptimized group (1.15 versus 2.86 events/y, P<0.001). This result was predominantly because of a reduction in the heart failure readmission rate in the optimized group (0.08 versus 0.71 events/y, P=0.016)., Conclusions: LVAD patients, in whom hemodynamics were optimized, had a significantly lower rate of hospital readmissions, primarily because of fewer heart failure admissions. These findings highlight the importance of achieving hemodynamic optimization in LVAD patients.

Background: This retrospective single-institutional study investigated the effect of significant valvular regurgitation after left ventricular assist device (LVAD) implantation and the role of concomitant valve surgery during LVAD surgery., Methods: All patients receiving an LVAD (HeartMate II; Abbott, Abbott Park, IL) during 2008 and 2015 were enrolled. The cohort was divided into two groups based on the valve status at the end of the operation: patients without significant valvular regurgitation (no-VR) and those with significant valvular regurgitation (residual-VR)., Results: An LVAD was implanted in 270 patients. Of these, 233 had significant preoperative valve disease(s), and 180 (66.6%) received concomitant valve interventions (35 aortic, 90 mitral, 138 tricuspid). At the completion of the LVAD operation, 204 had no-VR and 66 had residual-VR. Short-term outcomes were similar in two groups, except for longer cardiopulmonary bypass time in the no-VR group (149 minutes) than in the residual-VR group (132 minutes, p = 0.038). During follow-up, mean pulmonary artery pressure (24 mm Hg in no-VR vs 27 mm Hg in residual-VR; p = 0.018) and pulmonary vascular resistance (1.8 Wood units in no-VR vs 2.7 Wood units in residual-VR, p = 0.008) significantly improved in no-VR group compared with the residual-VR group. Survival and heart failure admission-free rates at 1 year were significantly superior in the no-VR group compared with the residual-VR group (1-year survival: 72% ± 3% No-VR vs 55% ± 6% residual-VR; log-rank p = 0.026; admission-free survival: 91% ± 2% no-VR vs 74% ± 7% residual-VR; log-rank p = 0.026). Concomitant valve intervention was not an independent predictor of in-hospital death and morbidity., Conclusions: Absence of valvular lesion after LVAD implantation was associated with improved midterm hemodynamics and survival in the current study. Aggressive surgical intervention for significant valve disease(s) at the time of LVAD implant may be beneficial to selected patients., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background Right heart catheterization is the gold standard in clinical practice for the assessment of cardiovascular hemodynamics, but it is an invasive procedure requiring expertise in both insertion and reading. Remote dielectric sensing (Re DS ) is a noninvasive electromagnetic-based technology intended to quantify lung fluid content. Methods and Results In this prospective single-center study, Re DS readings were obtained in supine position just before right heart catheterization procedure in patients with heart failure. Agreement between Re DS and pulmonary artery wedge pressure ( PAWP ) was analyzed. Of all, 139 patients with heart failure received hemodynamic assessment and Re DS measurement. A good correlation was found between Re DS and PAWP measurement ( r=0.492, P<0.001). Receiver operating characteristic analysis of the ability to identify a PAWP ≥18 mm Hg resulted in a Re DS cutoff value of 34%, with an area under the curve of 0.848, a sensitivity of 90.7%, and a specificity of 77.1%. Overall, Re DS <34% carries a high negative predictive value of 94.9%. Conclusions Lung fluid content, as measured by Re DS , correlates well with PAWP . The high sensitivity and specificity and especially the high negative predictive value make Re DS a reliable noninvasive tool at the point of care, to rule out elevated PAWP in patients with heart failure and to help with medical management of patients with heart failure. Further studies are warranted to compare this tool with existing tests and to relate the findings to the clinical outcomes.

Background Gastrointestinal bleeding (GIB) is a common complication seen in patients supported with left ventricular assist devices (LVADs) and is related to increased inflammation and angiogenesis. Omega-3 is an unsaturated fatty acid that possesses anti-inflammatory and antiangiogenic properties. This study aims to assess the prophylactic efficacy of treatment with omega-3 on the incidence of GIB in LVAD patients. Methods and Results Among consecutive 166 LVAD patients enrolled in this analysis, 30 patients (49 years old and 26 male) received 4 mg/d of omega-3 therapy for 310±87 days and 136 patients in the control group (58 years old and 98 male) were observed for 302±102 days. One-year GIB-free rate was significantly higher in the omega-3 group as compared with the control group (97% versus 73%; P=0.02). Omega-3 therapy was associated with the occurrence of GIB in both the univariate (hazard ratio, 0.12; 95% CI, 0.02-0.91; P=0.040) and multivariate Cox proportional hazard ratio analyses (hazard ratio, 0.13; 95% CI, 0.02-0.98; P=0.047). The frequency of GIB was significantly lower in the omega-3 group (0.08±0.42 versus 0.37±0.93 events/y; P=0.01), accompanied by significantly lower blood product transfusion and shorter days in the hospital. The frequency of GIB remained lower among the omega-3 group after matching for patient background characteristics (96% versus 73%, P=0.028). Conclusions LVAD patients treated with omega-3 had a significant increase in freedom from GIB. A randomized controlled study is warranted to evaluate the use of omega-3 in LVAD patients.

Objectives: The intraaortic balloon pump (IABP) is currently an essential tool to improve hemodynamics in patients with advanced heart failure (HF). This study investigated predictors for hemodynamic improvement or stabilization with IABP therapy in patients with advanced HF., Methods: Patients with advanced HF and hemodynamic deterioration treated with IABP were enrolled in this retrospective study. Invasive hemodynamics were measured before IABP implantation and 2 weeks after IABP initiation. Significant degree of hemodynamic improvement was defined as 30% improvement in all three of the following variables: central venous pressure (CVP); pulmonary capillary wedge pressure (PCWP); and cardiac index (CI). Hemodynamic stabilization was counted in patients reaching CVP <12 mm Hg, PCWP <18 mm Hg, and CI >2.0 L/min/m² or CI >2.2 L/min/m² on inotropes., Results: Ninety-one patients (55 ± 12 years; 78% males) were evaluated. Seventeen patients (18.7%) achieved significant hemodynamic improvement, and baseline CVP >16 mm Hg was associated with this endpoint (P<.05). Thirty-two patients (35.2%) achieved hemodynamic stabilization; lower baseline heart rate (HR) and PCWP were associated with this stabilization (P<.05). Patients with HR <92 beats/min and PCWP <25 mm Hg achieved hemodynamic stabilization more frequently than those without HR <92 beats/min and PCWP <25 mm Hg (66.7% vs 19.7%; P<.05)., Conclusion: Elevated CVP and lower HR and PCWP before IABP initiation help predict high response to IABP.

Objectives: The purpose of this study was to investigate the differential impact of the 2 most commonly available left ventricular assist device (LVAD) types on the right ventricle (RV) and left ventricle (LV) using 3-dimensional (3D) echocardiography-based analysis of ventricular morphology., Background: LVADs have emerged as common therapy for advanced heart failure. Recent data suggest that the heart responds differently to speed settings in the 2 main devices available (HeartMate II [HMII], St Jude Medical, Pleasanton, California, and HVAD, HeartWare International, Framingham, Massachusetts). The authors hypothesized that 3D echocardiographic assessment of LV and RV volumes and shape would help describe the differential impact of the 2 LVAD types on the heart., Methods: Simultaneous 3D echocardiography, ramp test, and right heart catheterization were performed in 31 patients with LVADs (19 with HMII and 12 with HVAD). Device speed was increased stepwise (8,000 to 12,000 for HMII and 2,300 to 3,200 revolutions per minute for HVAD). 3D echocardiographic full-volume LV and RV datasets were acquired, and endocardial surfaces were analyzed using custom software to calculate LV sphericity, conicity (perfect sphere/cone = 1) and RV septal and free-wall curvature (0 = flat; <0 = concave; >0 = convex)., Results: For both devices, cardiac output increased and wedge pressure decreased with increasing speed. In HMII, LV volumes progressively decreased (meanΔ = 127 ml) as the LV became less spherical and more conical, whereas the RV volume initially remained stable, but subsequently increased at higher speeds (meanΔ = 60 ml). Findings for the HVAD were similar, but less pronounced (LV:meanΔ = 51 ml, RV:meanΔ = 22 ml), and the LV remained significantly more spherical even at high speeds. On average, in HMII patients, the RV septum became more convex (bulging into the LV) at the highest speeds whereas in HVAD patients, there was no discernable change in the RV septum., Conclusions: The heart responds differently to pump speed changes with the 2 types of LVAD, as reflected by the volume and shape changes of both the LV and RV. Our study suggests that adding RV assessment to the clinical echo-ramp study may better optimize LVAD speed. Further study is needed to determine whether this would have an impact on patient outcomes., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: A cohort of heart failure (HF) patients receiving left ventricular assist devices (LVADs) has decoupling of their diastolic pulmonary artery pressure and pulmonary capillary wedge pressure. However, the clinical implications of this decoupling remain unclear., Methods and Results: In this prospective study, patients with LVADs underwent routine invasive hemodynamic ramp testing with right heart catheterization, during which LVAD speeds were adjusted. Inappropriate decoupling was defined as a >5 mm Hg difference between diastolic pulmonary artery pressure and pulmonary capillary wedge pressure. The primary outcomes of survival and heart failure readmission rates after ramp testing were assessed. Among 63 LVAD patients (60±12 years old and 25 female [40%]), 27 patients (43%) had inappropriate decoupling at their baseline speed. After adjustment of their rotation speed during ramp testing, 30 patients (48%) had inappropriate decoupling. Uni/multivariable Cox analyses demonstrated that decoupling was the only significant predictor for the composite end point of death and heart failure readmission during the 1 year following the ramp study (total of 18 events; hazards ratio, 1.09; 95% confidence interval, 1.04-1.24; P <0.05). Furthermore, normalization of decoupling (n=8) during ramp testing was significantly associated with higher 1-year heart failure readmission-free survival rate compared with the non-normalized group (n=19, 100% versus 53%; P =0.035)., Conclusions: The presence of inappropriate decoupling was associated with worse outcomes in patients with LVADs. Prospective, large-scale multicenter studies to validate the result are warranted., (© 2017 American Heart Association, Inc.)

Background: Indications for concomitant intervention for mitral regurgitation (MR) during left ventricular assist device (LVAD) implantation remain controversial. The objective of this study was to determine the impact of the surgical correction of MR during LVAD implantation., Methods: From July 2008 to December 2014, 164 patients with significant preoperative MR underwent LVAD (HeartMate II; Thoratec, Pleasanton, CA) implantation. The MR resolved after LVAD implantation in 110 of 164 patients (67.1%) with either surgical or spontaneous correction. The cohort (n = 110) without significant postoperative MR was divided into two groups: a spontaneous correction group (n = 54, MR spontaneously resolved after LVAD implantation); and a surgical correction group (n = 56, MR surgically corrected). Patients who received aortic valve procedures (n = 17) were excluded from this study., Results: Patient demographics, perioperative outcomes including bleeding, prolonged intubation, and stroke, and inhospital mortality did not differ in the two groups except for significantly longer cardiopulmonary bypass time in the surgical correction group (spontaneous correction 123 minutes [interquartile range (IQR): 107 to 150] versus surgical correction 177 minutes [IQR: 132 to 198], p < 0.001). During follow-up, pulmonary wedge pressure (spontaneous correction 17 mm Hg [IQR: 12 to 23 mm Hg] versus surgical correction 12 mm Hg [IQR: 4 to 17 mm Hg], p = 0.015) and pulmonary vascular resistance (spontaneous correction 2.0 Wood units [IQR: 1.5 to 2.4] versus surgical correction 1.7 Wood units [IQR: 0.8 to 2.1], p = 0.047) were significantly improved in the surgical correction group compared with the spontaneous correction group. Overall survival rate and freedom from recurrent MR were significantly better in the surgical correction group compared with the spontaneous correction group (1-year survival, spontaneous correction 59.4% ± 6.9% versus surgical correction 69.6% ± 6.4%, log rank p = 0.030; 1-year freedom from recurrent MR, spontaneous correction 76.2% ± 7.5% versus surgical correction 95.0% ± 3.5%, log rank p = 0.028)., Conclusions: The LVAD patients with surgically corrected MR had improved midterm hemodynamics and survival compared with spontaneously resolved MR, along with low recurrence of MR. Aggressive surgical mitral valve intervention during LVAD implantation may be recommended., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: This study tested whether combined invasive hemodynamic and echocardiographic ramp tests can help optimize patient management., Background: Guidelines for optimizing speed and medications in continuous flow ventricular assist device (cfLVAD) patients are mainly based on expert opinion., Methods: Thirty-five cfLVAD patients (21 HeartMate II [Thoratec, Pleasanton, California] and 14 HVAD [HeartWare International, Framingham, Massachusetts]) underwent ramp tests with right heart catheterization (including central venous pressure [CVP], pulmonary artery pressure, pulmonary capillary wedge pressure [PCWP], and blood pressure) and echocardiography. Data were recorded at up to 9 speed settings. Speed changes were in steps of 400 revolutions per minute (RPM) for HeartMate II (8,000 to 12,000 RPM) and 100 RPM for HVAD (2,300 to 3,200 RPM) patients., Results: Only 42.9% of patients had normal CVPs and PCWPs at their original RPM settings. Going from lowest to highest speeds, cardiac output improved by 0.16 ± 0.19 l/min/step (total change 1.28 ± 1.41 l/min) and PCWP decreased by 1.23 ± 0.85 mm Hg/step (total change 9.9 ± 6.5 mm Hg). CVP and systolic blood pressure did not change significantly with RPM. RPM were adjusted based on test results to achieve CVPs and PCWPs as close to normal limits as possible, which was feasible in 56% of patients. For the remainder, results indicated which type of medical management should be pursued., Conclusions: Use of combined hemodynamic and echocardiographic ramp tests in patients provides objective means of optimizing RPM, and has the potential to guide medical management. It remains to be tested whether this strategy has a beneficial impact on quality of life or clinical outcomes., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)