Accuracy and correlation of bed and standing scale weights in monitoring volume status in heart failure patients.

Introduction: Accurate volume status monitoring is crucial for effective diuretic therapy in patients with acute decompensated heart failure (ADHF). While guidelines recommend daily standing body weight measurement as an indicator of volume status, bed scales are commonly used in healthcare facilities. Methods: A method-comparison design was used to compare bed and standing scale weights among adults hospitalized with ADHF at Los Angeles County-University of Southern California Medical Center between March and April 2023. Results & Conclusion: Among 51 weight pairs from 43 participants, a clinically significant mean difference of 1.42 ± 1.18 kg was observed, exceeding the recommended threshold. Inaccuracies, with 71% showing differences >0.6 kg, highlight potential fluid management errors when relying on bed scales in ADHF hospitalizations.

Successful Pregnancy After Left Ventricular Assist Device Explantation for Myocardial Recovery.

A 36 year old woman with history of heart failure and left ventricular assist device (LVAD) implantation, with subsequent explantation after myocardial recovery, presented for management of preconception counseling and subsequent pregnancy. To our knowledge, this case represents the first documented successful pregnancy after LVAD explantation. Management details are provided, and relevant literature is reviewed.

New UNOS allocation system associated with no added benefit in waitlist outcomes and worse post-transplant survival in heart-kidney patients.

BACKGROUND: The 2018 United Network for Organ Sharing (UNOS) heart transplant policy change (PC) sought to improve waitlist risk stratification to decrease waitlist mortality and promote geographically broader sharing for high-acuity patients awaiting heart transplantation. Our analysis sought to determine the effect of the UNOS PC on outcomes in patients waiting for, or who have received, a heart-kidney transplantation. METHODS: We analyzed adult (≥18 years old), first-time, heart-only and heart-kidney transplant candidates and recipients from the UNOS Registry. Patients were divided into pre-PC (PRE: October 18, 2016-May 30, 2018) and post-PC (POST: October 18, 2018-May 30, 2020) groups for comparison. Competing risks analysis (subdistribution and cause-specific hazards analyses) was performed to assess for differences in waitlist death/deterioration or heart transplantation. One-year post-transplant survival was assessed with Kaplan-Meier and Cox analyses. We included an interaction term (policy era × heart ± kidney) in our analyses to evaluate the effect of PC on outcomes in heart-kidney patients. RESULTS: One-year post-transplant survival was similar (p = 0.83) for PRE heart-kidney and heart-only recipients, but worse (p < 0.001) for POST heart-kidney vs heart-only recipients. There was a policy-era interaction between heart-kidney and heart-only recipients (HR 1.92[1.04,3.55], p = 0.038) indicating a detrimental effect of policy on 1-year survival in POST vs PRE heart-kidney recipients. No added beneficial effect of PC on waitlist outcomes in heart-kidney vs heart-only candidates was observed. CONCLUSIONS: There was no added policy-era benefit on waitlist outcomes for heart-kidney candidates when compared to heart-only candidates. POST heart-kidney recipients experienced worse 1-year survival compared to PRE heart-kidney recipients with no policy effect on heart-only recipients.

Effect of the UNOS policy change on rates of rejection, infection, and hospital readmission following heart transplantation.

BACKGROUND: The 2018 adult heart allocation policy sought to improve waitlist risk stratification, reduce waitlist mortality, and increase organ access. This system prioritized patients at greatest risk for waitlist mortality, especially individuals requiring temporary mechanical circulatory support (tMCS). Posttransplant complications are significantly higher in patients on tMCS before transplantation, and early posttransplant complications impact long-term mortality. We sought to determine if policy change affected early posttransplant complication rates of rejection, infection, and hospitalization. METHODS: We included all adult, heart-only, single-organ heart transplant recipients from the UNOS registry with pre-policy (PRE) individuals transplanted between November 1, 2016, and October 31, 2017, and post-policy (POST) between November 1, 2018, and October 31, 2019. We used a multivariable logistic regression analysis to assess the effect of policy change on posttransplant rejection, infection, and hospitalization. Two COVID-19 eras (2019-2020, 2020-2021) were included in our analysis. RESULTS: The majority of baseline characteristics were comparable between PRE and POST era recipients. The odds of treated rejection (p = 0.8), hospitalization (p = 0.69), and hospitalization due to rejection (p = 0.76) and infection (p = 0.66) were similar between PRE and POST eras; there was a trend towards reduced odds of rejection (p = 0.08). In both COVID eras, there was a clear reduction in rejection and treated rejection with no effect on hospitalization for rejection or infection. Odds of all-cause hospitalization was increased in both COVID eras. CONCLUSIONS: The UNOS policy change improves access to heart transplantation for higher acuity patients without increasing early posttransplant rates of treated rejection or hospitalization for rejection or infection, factors which portend risk for long-term posttransplant mortality.

UNOS policy change benefits high-priority patients without harming those at low priority.

The heart transplantation policy change (PC) has improved outcomes in high-acuity (Old 1A, New 1-3) patients, but the effect on low-priority (Old 1B/2, New 4-6) patients is unknown. We sought to determine if low-priority patient outcomes were compromised by benefits to high-priority patients by evaluating for interaction between PC and priority status (PS). We included adult first-time heart transplant candidates and recipients from the UNOS registry during a 19-month period before and after the PC. We compared clinical characteristics and performed competing risks and survival analyses stratified by PC and PS. There was a dependence of PC and PS on waitlist death/deterioration with an interaction sub-distribution hazard ratio (adjusted sdHR) of 0.59 (0.45-0.78), p-value < .001. There was a trend toward a benefit of PC on waitlist death/deterioration (adjusted sdHR: 0.86 [0.73-1.01]; p = .07) and an increase in heart transplantation (adjusted sdHR: 1.08 [1.02-1.14], p = .007) for low-priority patients. There was no difference in 1-year post-transplant survival (log-rank p = .22) when stratifying by PC and PS. PC did not negatively affect waitlisted or transplanted low-priority patients. High-priority, post-PC patients had a targeted reduction in waitlist death/deterioration and did not come at the expense of worse post-transplant survival.

Effect of UNOS policy change and exception status request on outcomes in patients bridged to heart transplant with an intra-aortic balloon pump.

BACKGROUND: Intra-aortic balloon pumps (IABP) are used to bridge select end-stage heart disease patients to heart transplant (HT). IABP use and exception requests both increased dramatically after the UNOS policy change (PC). The purpose of this study was to evaluate the effect of PC and exception status requests on waitlist and post-transplant outcomes in patients bridged to HT with IABP support. METHODS: We analyzed adult, first-time, single-organ HT recipients from the UNOS Registry either on IABP at the time of registration for HT or at the time of HT. We compared waitlist and post-HT outcomes between patients from the PRE (October 18, 2016 to May 30, 2018) and POST (October 18, 2018 to May 30, 2020) eras using Kaplan-Meier curves and time-to-event analyses. RESULTS: A total of 1267 patients underwent HT from IABP (261 pre-policy/1006 post-policy). On multivariate analysis, PC was associated with an increase in HT (sub-distribution hazard ratio (sdHR): 2.15, p < .001) and decrease in death/deterioration (sdHR: 0.55, p = .011) on the waitlist with no effect on 1-year post-HT survival (p = .8). The exception status of patients undergoing HT was predominantly seen in the POST era (29%, 293/1006); only four patients in the PRE era. Exception requests in the POST era did not alter patient outcomes. CONCLUSIONS: In patients bridged to heart transplant with an IABP, policy change is associated with decreased rates of death/deterioration and increased rates of heart transplantation on the waitlist without affecting 1-year post-transplant survival. While exception status use has markedly increased post-PC, it is not associated with patient outcomes.

Patient selection for heart transplant: balancing risk.

PURPOSE OF REVIEW: Heart failure incidence continues to rise despite a relatively static number of available donor hearts. Selecting an appropriate heart transplant candidate requires evaluation of numerous factors to balance patient benefit while maximizing the utility of scarce donor hearts. Recent research has provided new insights into refining recipient risk assessment, providing additional tools to further define and balance risk when considering heart transplantation. RECENT FINDINGS: Recent publications have developed models to assist in risk stratifying potential heart transplant recipients based on cardiac and noncardiac factors. These studies provide additional tools to assist clinicians in balancing individual risk and benefit of heart transplantation in the context of a limited donor organ supply. SUMMARY: The primary goal of heart transplantation is to improve survival and maximize quality of life. To meet this goal, a careful assessment of patient-specific risks is essential. The optimal approach to patient selection relies on integrating recent prognostication models with a multifactorial assessment of established clinical characteristics, comorbidities and psychosocial factors.

Amyloid and the Heart.

PURPOSE OF REVIEW: While morbidity and mortality remain high for amyloid cardiomyopathy (AC), increased awareness, earlier diagnosis, and advances in treatment have improved patient outcomes. This review will discuss the pathophysiology, contemporary diagnostic strategies, and novel and investigational therapeutic strategies for light-chain (AL) and transthyretin (ATTR) AC. RECENT FINDINGS: Diagnostic strategies for AC now include cardiac magnetic resonance imaging and bone scintigraphy. Proteosome inhibitor therapy is now front-line therapy for AL AC followed by autologous stem cell transplantation. Emerging disease-modifying strategies for ATTR AC include the recently FDA-approved TTR-stabilizer, tafamadis. ATTR gene-silencing therapy and amyloid fibril degradation therapy are two other strategies under investigation. Heart transplantation and durable mechanical circulatory support remain a final potential option; however, contemporary outcomes are improving with better patient selection. Patient outcomes for AC are expected to improve as increased awareness leads to earlier diagnosis and prompt treatment with emerging pharmacotherapy or advanced heart therapies.

A Systems-Based Analysis of the CardioMEMS HF Sensor for Chronic Heart Failure Management.

BACKGROUND: Hemodynamic-guided therapy using the CardioMEMS™ system has been shown to reduce heart failure hospitalization (HFH) in both clinical trials and real-world settings. However, the CardioMEMS system requires input from multiple independent elements to achieve its effect, and no studies have been done to investigate those elements. Consistent patient participation and health care provider participation are two of those key elements, and this study sought to assess how they affect HFHs. METHODS: This was a single-center, retrospective cohort study of patients with the CardioMEMS sensor. The primary outcome was the number of HFH days patients experienced in the 1 year following CardioMEMS sensor implant. The primary independent variables were the average number of days between patient transmissions of data and the average number of days between health care provider reviews of those data. Covariates included patient demographics, medical comorbidities, history of HFHs, and initial pressure response to hemodynamic-guided therapy at 28 days after implant. Data were fit to a zero-inflated negative binomial regression. RESULTS: Seventy-eight patients were included in the study. The mean age was 64 ± 15 years, 52 (67%) were male, and 58 (76%) had heart failure with reduced ejection fraction. During the study period, there were 538 cumulative HFH patient-days. Based on the regression model, there was an exponential relationship between HFH days and the mean number of days between patient transmissions (IRR = 1.74, 95% CI: 1.09-2.75, p=0.019). There was also an exponential relationship between HFH days and the mean number of days between health care provider reviews (IRR = 1.03, 95% CI: 1.01-1.05, p=0.013). CONCLUSIONS: This single-center study suggests that more frequent patient transmissions and health care provider reviews of the CardioMEMS system are associated with a decreased number of HFH days, but larger multicentered studies are required. Further systems-based analyses of the CardioMEMS system may be a useful approach to guiding effective use of the CardioMEMS device.

Preoperative hemoglobin A1c levels and increased risk of adverse limb events in diabetic patients undergoing infrainguinal lower extremity bypass surgery in the Vascular Quality Initiative.

BACKGROUND: The impact of preoperative glycemic control on the risk of adverse perioperative outcomes in diabetic patients undergoing lower extremity bypass (LEB) surgery is not well-understood. We determined whether higher preoperative hemoglobin A1c (HbA1c) levels are associated with an increased risk of major adverse limb events, major adverse cardiovascular events, and mortality in diabetic patients undergoing infrainguinal LEB. METHODS: A retrospective review of all infrainguinal LEB surgeries in the Vascular Quality Initiative registry from January 2012 to February 2017 was performed. Only surgeries performed on diabetic patients with complete demographic and clinical data, including HbA1c value at the time of LEB, were included for analysis (n = 7727). Entries were stratified according to the following HbA1c levels: 6 or less (n = 1087), greater than 6 to 7 or less (n = 2137), greater than 7 to 8 or less (n = 1657), and greater than 8 (n = 2846). Multivariate logistic regression was used to determine the association of preoperative HbA1c levels on the risk of in-hospital major adverse limb events (above ankle amputation, loss of primary graft patency), major adverse cardiovascular events (myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia), and mortality. RESULTS: The number of surgeries complicated by adverse limb and cardiovascular events were 356 (4.6%) and 1314 (17.0%), respectively. There were 72 in-hospital deaths (0.9%). After adjustment for clinical and demographic variables, patients with high HbA1c values (≥8%) were at an increased risk of adverse limb events (odds ratio [OR], 1.37; 95% confidence interval [CI], 1.01-1.86) compared with those with a normal HbA1c (>6% to ≤7%). High HbA1c values were not associated with an increased risk of cardiovascular events (OR, 1.07; 95% CI, 0.81-1.43) or mortality (OR, 1.57; 95% CI, 0.83-3.03). Patients with low HbA1c values (≤6%) did not experience a significantly higher risk for any of the three outcomes. In a stratified analysis, the association of high HbA1c values with adverse limb events was only present in those presenting without critical limb ischemia (OR 1.82; 95% CI, 1.05-3.16). CONCLUSIONS: Poor preoperative glycemic control in diabetic individuals undergoing infrainguinal LEB, particularly in those without critical limb ischemia, is associated with an increased risk of in-hospital limb events. Further study should evaluate whether improved efforts to identify individuals with poorly controlled diabetes and subsequent interventions to better optimize glycemic control during the preoperative period improve limb outcomes after LEB.

Chronic heart failure management and remote haemodynamic monitoring.

Heart failure (HF) has a large societal and economic burden and is expected to increase in magnitude and complexity over the ensuing years. A number of telemonitoring strategies exploring remote monitoring and management of clinical signs and symptoms of congestion in HF have had equivocal results. Early studies of remote haemodynamic monitoring showed promise, but issues with device integrity and implantation-associated adverse events hindered progress. Nonetheless, these early studies established that haemodynamic congestion precedes clinical congestion by several weeks and that remote monitoring of intracardiac pressures may be a viable and practical management strategy. Recently, the safety and efficacy of remote pulmonary artery pressure-guided HF management was established in a prospective, single-blind trial where randomisation to active pressure-guided HF management reduced future HF hospitalisations. Subsequent commercial use studies reinforced the utility of this technology and post hoc analyses suggest that tight haemodynamic management of patients with HF may be an additional pillar of therapy alongside established guideline-directed medical and device therapy. Currently, there is active exploration into utilisation of this technology and management paradigm for the timing of implantation of durable left ventricular assist devices (LVAD) and even optimisation of LVAD therapy. Several ongoing clinical trials will help clarify the extent and utility of this strategy along the spectrum of patient with HF from individuals with chronic, stable HF to those with more advanced disease requiring heart replacement therapy.

Baseline diastolic pressure gradient and pressure reduction in chronic heart failure patients implanted with the CardioMEMS™ HF sensor.

AIMS: Remote haemodynamic monitoring (RHM) decreases hospitalization rates in patients with chronic heart failure (HF). Many patients with chronic HF develop pulmonary hypertension (PH) secondary to left heart disease with some acquiring combined pre-capillary and post-capillary PH (Cpc-PH). The efficacy of RHM in achieving pulmonary pressure reductions in patients with Cpc-PH vs. isolated post-capillary PH (Ipc-PH) is unknown. The purpose of this study is to evaluate whether a higher baseline diastolic pressure gradient (DPGbaseline ) measured at the time of CardioMEMS™ HF sensor implantation is associated with lower reductions in pulmonary artery diastolic pressures (PADP). METHODS AND RESULTS: This was a retrospective analysis of 32 patients meeting clinical indications for CardioMEMS™ implantation. DPGbaseline categorized patients as Cpc-PH (DPG ≥ 7 mmHg) or Ipc-PH (DPG < 7 mmHg). Minimum achievable PADP (PADPmin ) and ∆PADP (PADPbaseline  - PADPmin ) were determined. Pearson's correlation analysis and comparison of mean pressure changes were assessed. Median age was 69 years, and median left ventricular ejection fraction (LVEF) was 25%. Eight patients (25%) had a LVEF ≥40%. Twenty-five patients (78%) met criteria for Ipc-PH and seven (22%) for Cpc-PH. Neither PADPmin (ρ = 0.27; P = 0.13) nor ΔPADP (ρ = 0.07; P = 0.72) was correlated with DPGbaseline . A trend towards higher ΔPADP was seen in Cpc-PH vs. Ipc-PH patients (15.2 vs. 9.88 mmHg; P = 0.12). There was a moderate positive correlation between baseline PADP and ΔPADP [ρ = 0.55 (0.26-0.76); P < 0.001]. CONCLUSIONS: Decreased PADP reduction was not seen in Cpc-PH vs. Ipc-PH patients. Higher PADPbaseline was associated with greater ΔPADP. Larger studies are needed to elaborate our findings.

Effects of pressure variation and atrial fibrillation on CardioMEMS™ HF measured pulmonary artery diastolic pressure: comparison of device-averaged and visually inspected waveforms.

OBJECTIVE: Heart failure (HF) management guided by implantable hemodynamic monitoring reduces hospitalization rates. Hemodynamic data from the CardioMEMS™ HF system includes device-averaged pulmonary artery pressures (PAP) and heart rate. Agreement of device-averaged values compared to the standard method of visual inspection of pressure waveforms at end-expiration is unknown. We evaluated the agreement between device-averaged and visually inspected end-expiratory PAP. APPROACH: Twenty-one patients implanted with the CardioMEMS™ HF system were evaluated. Eight-hundred twenty-three PAP waveforms from the Merlin remote monitoring website were visually inspected and pulmonary artery systolic pressure (PASP) and pulmonary artery diastolic pressure (PADP) at end-expiration were recorded. Waveforms were evaluated for pressure variation (PV), defined as the difference between highest and lowest PASP measurement of ⩾20 mmHg. Bland-Altman analysis quantified differences between device-averaged and visually inspected waveforms. MAIN RESULTS: All patients were NYHA functional class III, mean age was 67 ± 15 years and 15 (71%) had AF. Bland-Altman analysis of all waveforms revealed a mean-difference in PADP of -1.4 mmHg, indicating that visually inspected values were higher than device-averaged values. For PV ⩾20 mmHg, this value increased to -2.8 mmHg. The mean-difference comparing waveforms from patients with or without AF was -1.3 and -1.6 mmHg, respectively. The 95% limits of agreement were >50% wider for waveforms from patients with versus without AF (10.3 versus 6.7 mmHg). SIGNIFICANCE: There is good agreement between device-averaged and visually inspected waveforms when pressure variation is <20 mmHg and for patients without atrial fibrillation.

New pharmacotherapies for pulmonary hypertension: where do they fit in?

Pulmonary arterial hypertension (PAH) is a rare, progressively worsening disease characterized by dysfunction among endothelial and smooth muscle cells within the pulmonary vasculature with a resultant increase in pulmonary vascular resistance, right ventricular maladaptation and failure, and ultimately early death. The three major therapeutic classes of medications available to treat PAH act as either prostacyclin analogs or endothelin receptor antagonists (ERAs) or by increasing local nitric oxide (NO) levels by means of phosphodiesterase type 5 inhibitors. Several recent trials have investigated the use of oral prostanoid therapy, next-generation ERAs, and soluble guanylate cyclase stimulators (to increase NO levels) as well as novel formulations of pre-existing therapies. The goal of this manuscript is to briefly review established therapies and then discuss recent developments and practical considerations in each of the major drug classes.

The effect of inaccurate FIM instrument ratings on prospective payment: a study of clinician expertise and FIM rating difficulty as contributing to inaccuracy.

OBJECTIVE: To test whether clinician expertise and FIM instrument rating difficulty explain clinician overconfidence in FIM rating accuracy. DESIGN: Participants answered 60 true/false FIM questions and, for each question, completed a 6-category scale to assess confidence in the accuracy of their responses. Experts and novices, as well as hard and easy items, were identified through a Rasch analysis. The relation between confidence and accuracy was examined for these different groups. SETTING: Three urban medical centers. PARTICIPANTS: Fifty medical rehabilitation professionals, including physical therapists, occupational therapists, rehabilitation psychologists, speech pathologists, and rehabilitation nurses. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Observed proportion of correct responses to 60 true/false questions and responses from the 6-category confidence scale. RESULTS: The amount of overconfidence was mediated by the difficulty of the FIM task and the level of expertise of the clinical judge. CONCLUSIONS: Decreasing the level of overconfidence in FIM scoring is a promising avenue for improving the accuracy of functional assessment. Accurate assessment of functional status for case-mix group classification will be of even greater importance under the recently initiated Medicare prospective payment system.