PREDICT HF: Risk stratification in advanced heart failure using novel hemodynamic parameters.

BACKGROUND: Invasive hemodynamics are fundamental in assessing patients with advanced heart failure (HF). Several novel hemodynamic parameters have been studied; however, the relative prognostic potential remains ill-defined. HYPOTHESIS: Advanced hemodynamic parameters provide additional prognostication beyond the standard hemodynamic assessment. METHODS: Patients from the PRognostic Evaluation During Invasive CaTheterization for Heart Failure (PREDICT-HF) registry who underwent right heart catheterization (RHC) were included in the analysis. The primary endpoint was survival to orthotopic heart transplant (OHT) or durable left ventricular assist device (LVAD), or death within 6 months of RHC. RESULTS: Of 846 patients included, 176 (21%) met the primary endpoint. In a multivariate model that included traditional hemodynamic variables, pulmonary capillary wedge pressure (PCWP) (OR: 1.10, 1.04-1.15, p < .001), and cardiac index (CI) (OR: 0.86, 0.81-0.92, p < .001) were shown to be predictive of adverse outcomes. In a separate multivariate model that incorporated advanced hemodynamic parameters, cardiac power output (CPO) (OR: 0.76, 0.71-0.83, p < .001), aortic pulsatility index (API) (OR: 0.94, 0.91-0.96, p < .001), and pulmonary artery pulsatility index (OR: 1.02, 1.00-1.03, p .027) were all significantly associated with the primary outcome. Positively concordant API and CPO afforded the best freedom from the endpoint (94.7%), whilst negatively concordant API and CPO had the worst freedom from the endpoint (61.5%, p < .001). Those with discordant API and CPO had similar freedom from the endpoint. CONCLUSION: The advanced hemodynamic parameters API and CPO are independently associated with death or the need for OHT or LVAD within 6 months. Further prospective studies are needed to validate these parameters and elucidate their role in patients with advanced HF.

New-Onset Neurosarcoidosis Following Heart Transplant for Cardiac Sarcoidosis.

A 63-year-old woman who underwent heart transplantation for cardiac sarcoidosis developed new headache and vision changes. Extensive workup resulted in a diagnosis of neurosarcoidosis treated with pulse dose steroids and infliximab. Recurrence of sarcoidosis after transplantation for isolated cardiac sarcoidosis occurs, but optimal surveillance methods remain unknown.

Development and Validation of a Risk Score Predicting Death Without Transplant in Adult Heart Transplant Candidates.

Importance: The US heart allocation system prioritizes medically urgent candidates with a high risk of dying without transplant. The current therapy-based 6-status system is susceptible to manipulation and has limited rank ordering ability. Objective: To develop and validate a candidate risk score that incorporates current clinical, laboratory, and hemodynamic data. Design, Setting, and Participants: A registry-based observational study of adult heart transplant candidates (aged ≥18 years) from the US heart allocation system listed between January 1, 2019, and December 31, 2022, split by center into training (70%) and test (30%) datasets. Adult candidates were listed between January 1, 2019, and December 31, 2022. Main Outcomes and Measures: A US candidate risk score (US-CRS) model was developed by adding a predefined set of predictors to the current French Candidate Risk Score (French-CRS) model. Sensitivity analyses were performed, which included intra-aortic balloon pumps (IABP) and percutaneous ventricular assist devices (VAD) in the definition of short-term mechanical circulatory support (MCS) for the US-CRS. Performance of the US-CRS model, French-CRS model, and 6-status model in the test dataset was evaluated by time-dependent area under the receiver operating characteristic curve (AUC) for death without transplant within 6 weeks and overall survival concordance (c-index) with integrated AUC. Results: A total of 16 905 adult heart transplant candidates were listed (mean [SD] age, 53 [13] years; 73% male; 58% White); 796 patients (4.7%) died without a transplant. The final US-CRS contained time-varying short-term MCS (ventricular assist-extracorporeal membrane oxygenation or temporary surgical VAD), the log of bilirubin, estimated glomerular filtration rate, the log of B-type natriuretic peptide, albumin, sodium, and durable left ventricular assist device. In the test dataset, the AUC for death within 6 weeks of listing for the US-CRS model was 0.79 (95% CI, 0.75-0.83), for the French-CRS model was 0.72 (95% CI, 0.67-0.76), and 6-status model was 0.68 (95% CI, 0.62-0.73). Overall c-index for the US-CRS model was 0.76 (95% CI, 0.73-0.80), for the French-CRS model was 0.69 (95% CI, 0.65-0.73), and 6-status model was 0.67 (95% CI, 0.63-0.71). Classifying IABP and percutaneous VAD as short-term MCS reduced the effect size by 54%. Conclusions and Relevance: In this registry-based study of US heart transplant candidates, a continuous multivariable allocation score outperformed the 6-status system in rank ordering heart transplant candidates by medical urgency and may be useful for the medical urgency component of heart allocation.

Standardization of the Right Heart Catheterization and the Emerging Role of Advanced Hemodynamics in Heart Failure.

The accurate assessment of hemodynamics is paramount to providing timely and efficacious care for patients presenting in cardiogenic shock. Recently, the regular use of the pulmonary artery catheter in cardiogenic shock has had a resurgence with emerging data indicating improved survival in the modern era. Optimal multidisciplinary management of advanced heart failure and cardiogenic shock relies on our ability to effectively communicate and understand the complete hemodynamic assessment. Standardization of data acquisition and a renewed focus on the physiological processes, and thresholds driving disease progression, including the coupling ratio and myocardial reserve, are needed to fully understand and interpret the hemodynamic assessment. This State-of-the-Art review discusses best practices in the cardiac catheterization laboratory as well as emerging data on the prognostic role of emerging advanced hemodynamic parameters.

Adverse Hemodynamic Consequences of Continuous Left Ventricular Mechanical Support: JACC Review Topic of the Week.

Left ventricular assist devices (LVADs) provide lifesaving therapy for patients with advanced heart failure. The recognition of pump thrombosis, stroke, and nonsurgical bleeding as hemocompatibility-related adverse events (HRAEs) led to pump design improvements and reduced adverse event rates. However, continuous flow can predispose patients to right-sided heart failure (RHF) and aortic insufficiency (AI), especially as patients live longer with their device. Given the hemodynamic contributions to AI and RHF, these comorbidities can be classified as hemodynamic-related events (HDREs). Hemodynamic-driven events are time dependent and often manifest later than HRAEs. This review examines the emerging strategies to mitigate HDREs, with a focus on defining best practices for AI and RHF. As we head into the next generation of LVAD technology, it is important to differentiate HDREs from HRAEs so that we can continue to advance the field and improve the true durability of the pump-patient continuum.

Selection of percutaneous mechanical circulatory support in cardiogenic shock: patient-specific considerations and insights from contemporary clinical data.

PURPOSE OF REVIEW: Cardiogenic shock remains a complex and variable disease process requiring early recognition and prompt, multidisciplinary treatment. Available data link usage of high-dose and/or multiple vasopressors in cardiogenic shock to increased mortality. This review proposes a structured approach to escalation of percutaneous mechanical circulatory support (pMCS) in cardiogenic shock, based on the hemodynamic and metabolic parameters highlighted in the revised SCAI Shock Classification, and supported by the available clinical data. RECENT FINDINGS: Intra-aortic balloon pumps (IABP) may improve hemodynamics in early cardiogenic shock (stage B) but offer little benefit in stage C-E shock where percutaneous ventricular assist devices (pVAD) improve cardiac power/index and may improve survival in certain subsets. In stage D-E shock, escalation from standalone pVADs to devices in combination is often appropriate. Left ventricular venting, with IABP or Impella, in conjunction with VA ECMO, appears to be beneficial. SUMMARY: Graded escalation of pMCS support should be considered in SCAI stage B shock patients onwards, with the choice of support allowable by local expertise, matched to the degree and anticipated trajectory of hemodynamic and metabolic compromise. Additional clinical data are required before timing, and escalation of pMCS initiation may be integrated into a single treatment algorithm.

The prognostic role of advanced hemodynamic variables in patients with left ventricular assist devices.

BACKGROUND: Invasive hemodynamic variables obtained from right heart catheterization have been used for risk-stratifying patients with advanced heart failure (HF). However, there is a paucity of data on the prognostic value of invasive hemodynamic variables in patients with left ventricular assist devices (LVAD). We hypothesized that cardiac power output (CPO), cardiac power efficiency (CPE), and left ventricular stroke work index (LVSWI) can serve as prognostic markers in patients with LVADs. METHODS: Baseline hemodynamic data from patients who had LVAD ramp studies at our institution from 4/2014 to 7/2018 were prospectively collected, from which advanced hemodynamic variables (CPO, CPE, and LVSWI) were retrospectively analyzed. Univariate and multivariable analyses were performed for hemocompatibility-related adverse events (HRAE), HF admissions, and mortality. RESULTS: Ninety-one participants (age 61 ± 11 years, 34% women, 40% Black or African American, and 38% ischemic cardiomyopathy) were analyzed. Low CPE was significantly associated with mortality (HR 2.42, 95% CI 1.02-5.74, p = 0.045) in univariate analysis and Kaplan-Meier analysis (p = 0.04). Low LVSWI was significantly associated with mortality (HR 2.13, 95% CI 1.09-4.17, p = 0.03) in univariate analysis and Kaplan-Meier analysis (p = 0.02). CPO was not associated with mortality. CPO, CPE, and LVSWI were not associated with HRAE or HF admissions. CONCLUSIONS: Advanced hemodynamic variables can serve as prognostic indicators for patients with LVADs. Low CPE and LVSWI are prognostic for higher mortality, but no variables were associated with HF admissions or HRAEs.

Postoperative tolvaptan use in left ventricular assist device patients: The TOLVAD randomized pilot study.

PURPOSE: Tolvaptan, a selective vasopressin type-2 antagonist, has been shown to increase serum sodium (Na) and urine output in hyponatremic left ventricular assist device (LVAD) patients in retrospective studies. In this prospective randomized pilot study, we aimed to assess the efficacy of tolvaptan in this population. METHODS: We conducted a prospective, randomized, non-blinded pilot study of LVAD recipients with post-operative hyponatremia (Na < 135 mEq/L) (NCT05408104). Eligible participants were randomized to receive tolvaptan 15 mg daily in addition to usual care versus usual care alone. The primary outcome was a change in Na level and estimated glomerular filtration rate (eGFR), from the first post-operative day of hyponatremia (the day of randomization) to discharge. RESULTS: A total of 33 participants were enrolled, and 28 underwent randomization (median age 55 [IQR 50-62]), 21% women, 54% Black, 32% ischemic cardiomyopathy, median baseline Na 135 (IQR 134-138). Fifteen participants were randomized to tolvaptan (TLV) and 13 were randomized to usual care alone (No-TLV). Mean change in Na from randomization to discharge in the TLV group was 2.7 mEq/L (95%CI 0.7-4.7, p = 0.013) and 1.8 (95%CI 0.5-4.0, p = 0.11) in the No-TLV group, though baseline and final Na levels were similar between groups. The mean change in eGFR was 2.6 ml/min/1.73 m2 (95%CI 10.1-15.3, p = 0.59) in TLV versus 7.5 ml/min/1.73 m2 (95%CI 5.2-20.2, p = 0.15) in No-TLV. TLV participants had significantly more urine output than No-TLV patients during their first 24 h after randomization (3294 vs 2155 ml, p = 0.043). CONCLUSION: TLV significantly increases urine output, with nominal improvement in Na level, in hyponatremic post-operative LVAD patients without adversely impacting renal function.

Management of Heart Failure.

This JAMA Clinical Guidelines Synopsis summarizes the 2022 ACC/AHA/HFSA guidelines for management of heart failure in adults with a diagnosis of or at risk for heart failure.

Physiology and Clinical Utility of HeartMate Pump Parameters.

The HeartMate 3 left ventricular assist device (LVAD) is now the only centrifugal pump intended for durable support being actively manufactured and implanted for adults in the United States. The changes in preload and afterload that accompany common clinical scenarios experienced by patients with an LVAD will cause specific changes to the LVAD pump parameters, namely, the pump power, pulsatility index, and flow. Appropriate care of this unique, and growing, population requires a full understanding of these variables as well as the underlying physiologic principles governing their derivation. The aim of this review is to focus on the updated functionality of the HeartMate 3, specifically in comparison to the HeartMate II, as well as the application of pump parameter interpretation to common clinical scenarios.

Improved Prognostic Performance of Cardiac Power Output With Right Atrial Pressure: A Subanalysis of the ESCAPE Trial.

BACKGROUND: The initial derivation of cardiac power output (CPO) included the difference between mean arterial pressure (MAP) and right atrial pressure (RAP) in the numerator, before multiplying by cardiac output (CO). We hypothesized that the inclusion of RAP (CPO-RAP) would enhance the prognostic performance of this parameter in those with an elevated RAP. METHODS AND RESULTS: We obtained patient-level data from the ESCAPE trial via the Biolincc database. Participants with full final hemodynamics were included in the analysis. The CPO-RAP was calculated as [(MAP - RAP) × CO)]/451 Watts (W), and the CPO was calculated as (MAP × CO)/451. The primary outcome was freedom from left ventricular assist device, heart transplant, or death at 6 months. Included participants (n = 157) were a median of 58 years of age (interquartile range [IQR] 49-67 years), 27% were women, and 59% had ischemic cardiomyopathy. The median CPO was 0.70 W (IQR 0.50-0.90 W), and the median CPO-RAP was 0.62 W (IQR 0.47-0.79 W). In univariable logistic regressions, the CPO was not associated with the primary outcome (odds ratio 0.32, 95% confidence interval 0.08-1.29, P = .11), but the CPO-RAP was (odds ratio 0.10, 95% confidence interval 0.02-0.54, P < .01). In Kaplan-Meier analyses, there were no significant difference in outcomes with CPO (76% vs 64%, P = .08), but for CPO-RAP, there were significant differences in outcomes (81% vs 63%, P = .01). When further delineating CPO-RAP by RAP above or below the median, there was no significant difference in the outcome for participants with a RAP 8 or less (94% vs 79%, P = .07), but a significant difference in participants with a RAP of more than 8 mm Hg (66% vs 45%, P < .05). CONCLUSIONS: The inclusion of RAP resulted in a significant association with the primary outcome; CPO alone was not.