A new opportunity for patient selection and optimization: Systematic review of cognitive frailty in patients undergoing left ventricular assist device implantation.

The prognostic implication of cognitive frailty assessment in patients undergoing left ventricular assist device (LVAD) implantation remains unclear. We conducted a systematic review to evaluate assessment strategies and their significance for patients undergoing LVAD implantation. A comprehensive search of PubMed, Embase, and the Cumulative Index to Nursing and Allied Health Literature from inception until September 2022 and a review of meeting proceedings were performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies that investigated the prognostic value of cognitive frailty or any related cognition-based assessment in patients undergoing LVAD implantation were included. Study characteristics, patient demographics, and type of cognitive assessment were extracted. Primary outcomes included length of stay, readmissions, and all-cause mortality. Of 664 records retrieved, 12 (4 prospective, 8 retrospective) involving 16 737 subjects (mean age, 56.9 years; 78.3% men) met inclusion criteria; 67% of studies used the Montreal Cognitive Assessment to assess cognitive frailty. Outcomes reported were highly variable, with 42% reporting readmission, 33% reporting LOS, and 83% reporting mortality data; only two studies provided data on all three. Cognitive frailty was associated with prolonged length of stay in 75% of studies reporting this outcome. Only 40% and 60% of studies that reported readmissions and mortality outcomes, respectively, suggested a predictive association. Pre-LVAD cognitive frailty is likely associated with worse outcomes postimplant. However, the heterogenous reporting of outcomes data and lack of consistent definitions in the literature limit its prognostic value. Additional research on markers for cognitive frailty and improved standards of reporting may allow for future analyses and enhance preoperative risk assessment and patient care. Geriatr Gerontol Int 2024; 24: 204-210.

Left Ventricular Assist Device Use in Minorities: An Analysis of the National Inpatient Sample.

Minorities are less likely to receive a left ventricular assist device (LVAD). This, however, is based on total implant data. By examining rates of LVAD implant among patients admitted with heart failure complicated by cardiogenic shock, we sought to further elucidate LVAD utilization rates and racial disparities. Utilizing the National Inpatient Sample from 2013 to 2019, all patients admitted with a primary diagnosis of heart failure complicated by cardiogenic shock were included for analysis. Those who then received an LVAD during that hospitalization defined the LVAD utilization which was examined for any racial disparities. Left ventricular assist device utilization was low across all racial groups with no significant difference noted in univariate analysis. Non-Hispanic Blacks had the highest length of stay (LOS), the highest proportion of discharge to home (71.52%), and the lowest inpatient mortality (6.33%). Multivariable modeling confirmed the relationship between race and LOS; however, no differences were noted in mortality. Non-Hispanic Blacks were found to be less likely to receive an LVAD; however, when controlling for payer, median household income, and comorbidities, this relationship was no longer seen. Left ventricular assist devices remain an underutilized therapy in cardiogenic shock. When using a multivariable model, race does not appear to affect LVAD utilization.

Prognostic Value of Frailty for Heart Failure Patients Undergoing Left Ventricular Assist Device Implantation: A Systematic Review.

Frailty is associated with poor clinical outcomes in heart failure patients. The impact of frailty on outcomes following left ventricular assist device (LVAD) implantation, however, is less clearly defined. We therefore sought to conduct a systematic review to evaluate current frailty assessment strategies and their significance for patients undergoing LVAD implantation. We conducted a comprehensive electronic search of PubMed, Embase, and CINAHL databases from inception until April 2021 for studies examining frailty in patients undergoing LVAD implantation. Study characteristics, patient demographics, type of frailty measurement, and outcomes were extracted. Outcomes were organized into 5 basic categories: implant length of stay (iLOS), 1-year mortality, rehospitalization, adverse events, and quality of life (QOL). Of the 260 records retrieved, 23 studies involving 4935 patients satisfied the inclusion criteria. Approaches to measuring frailty varied, with the 2 most common being sarcopenia determined by computed tomography and Fried's frailty phenotype assessment. Outcomes of interest were also widely variable, with iLOS stay and mortality being the most frequently reported, albeit with differing definitions of both between studies. The heterogeneity among included studies precluded quantitative synthesis. Narrative synthesis showed that frailty by any measure is more likely to be associated with higher mortality, longer iLOS, more adverse events and worse QOL post-LVAD implant. Frailty can be a valuable prognostic indicator in patients undergoing LVAD implantation. Further studies are needed to determine the most sensitive frailty assessment, as well as the ways in which frailty may serve as a modifiable target to improve outcomes following LVAD implantation.

Timing and Outcomes of Concurrent and Sequential Biventricular Assist Device Implantation: A Society of Thoracic Surgeons Intermacs Analysis.

BACKGROUND: Biventricular heart failure remains a clinically challenging condition to manage. Available literature describing the use of durable biventricular assist device (BiVAD) support has numerous limitations hindering the development of useful treatment algorithms. Analysis of BiVAD use within a large multicenter data set is needed to clarify outcomes associated with this therapy. METHODS: The Society of Thoracic Surgeons Intermacs database was queried to identify adults aged ≥18 years who received durable circulatory support from January 1, 2010, to December 31, 2220. The data set was divided into the following cohorts: (1) left ventricular assist device (LVAD) only (n = 27,325), (2) LVAD and concurrent right ventricular assist device (RVAD) (n = 1090), and (3) LVAD and sequential RVAD (n = 556). Propensity score matching was used to compare 1-year mortality and adverse events between concurrent (n = 565) and sequential BiVADs (n = 565). RESULTS: Overall survival within 1 year was significantly worse for the BiVAD cohort compared with the LVAD-only cohort (12-month survival: 50.8% vs 82.6%; log-rank P < .001). In a propensity-matched cohort, patients implanted with a BiVAD concurrently had an improved survival compared with those implanted an LVAD and an RVAD sequentially (12-month survival: 55.8% vs 41.8%; log-rank P < .001). Early (<3 months) adverse event rates were higher among patients receiving sequential BiVADs for bleeding, infection, neurologic dysfunction, and renal dysfunction (P < .01). CONCLUSIONS: After matching for patient and disease characteristics, patients with sequential BiVAD implantation have worse outcomes than patients with concurrent BiVAD implantation.

Effect of Angiotensin II Antagonism on Gastrointestinal Bleeding in Patients With Left Ventricular Assist Devices: A Systematic Review and Meta-Analysis.

The importance of medical therapy to ameliorate the incidence and impact of left ventricular assistance device-related gastrointestinal bleeding has been highlighted recently with several single-center studies. Electronic databases were searched for studies that compared the incidence of gastrointestinal bleeding for those people on left ventricular assist support with and without angiotensin II inhibition. Angiotensin II inhibition was associated with a lower incidence of gastrointestinal bleeding (pooled RR 0.58, 95% confidence interval (CI): 0.34-0.98; p = 0.04], with a trend toward toward lower incidence with arteriovenous malformation-associated gastrointestinal bleeding (pooled RR 0.50, 95% CI: 0.25-1.03; p = 0.06).

Fixed-dose aspirin monotherapy compared with thromboelastography directed antiplatelet therapy in long-term management of left ventricular assist devices.

BACKGROUND AND AIM: The role of thromboelastography (TEG) in managing antiplatelet therapy (APT) in left ventricular assist devices (LVADs) is controversial. Our aim was to determine whether removal of TEG from an LVAD-specific APT protocol reduced late-onset bleeding without increasing thromboembolic complications. METHODS: We performed a single-center, retrospective cohort study including all recipients of a continuous-flow LVAD between April 2005 and November 2019 (n = 293). LVAD recipients before June 1, 2017 (n = 221) whose APT was monitored and adjusted using TEG were compared with LVAD recipients after June 1, 2017 (n = 72) where TEG was not utilized. Occurrence of late-onset bleeding events after postoperative Day 7 and thromboembolic events were collected. APT doses, warfarin use and International normalized ratio (INR) values were collected at discharge and at 1, 3, 6, and 12-months postimplantation. RESULTS: Over a median 12-month follow-up, INTERMACS major bleeding events occurred in 35% of patients where TEG was utilized compared with 29% where TEG was not utilized (p = 0.375), and procedural intervention was required in 29% compared with 18%, respectively (p = 0.058). Use of TEG was associated with higher doses of aspirin (>325 mg) (41% compared with none) and use of a second antiplatelet (dipyridamole) (43% compared to 1%). Despite this, there was no significant difference in thromboembolic events (15% in each). CONCLUSIONS: Our study suggests the use of TEG led to increased doses of aspirin as well as adding a second antiplatelet agent, without improving outcomes in LVAD recipients. Furthermore, the removal of TEG from an LVAD-specific APT protocol did not worsen thromboembolic outcomes.

Impact of Laparoscopic Sleeve Gastrectomy on Cardiovascular Pharmacotherapy in Left Ventricular Assist Device Patients.

ABSTRACT: Left ventricular assist device (LVAD) implantation is increasingly utilized in patients with advanced heart failure and morbid obesity. Laparoscopic sleeve gastrectomy (LSG) can facilitate weight loss in this population and can ultimately change the pharmacokinetics of heart failure therapeutics. In this study, we aimed to explore the changes in cardiovascular pharmacotherapy post LSG intervention. We conducted a retrospective observational cohort study of morbidly obese LVAD patients between 2013 and 2019 at the University of Florida with available pharmacotherapeutic data at 1 and 6 months. Thirteen post-LSG patients and 13 control subjects were included in the final analysis. In the post-LSG group, the mean body mass index decreased significantly (44 ± 5 vs. 34 ± 4.9, P < 0.001), and 7 patients were successfully bridged to cardiac transplantation. Only 3 patients required adjustment of their LVAD speed. Mean return to flow decreased by 8 mm Hg, despite a 45% reduction in the mean number of vasodilators per patient (1.2 vs. 0.7, P = 0.03). Mean weekly warfarin dose decreased by 35% after 6 months (32.9 ± 20.9 vs. 50.7 ± 26.6, P = 0.01). The use of diuretics, vasodilators, and beta-blockers was significantly reduced by 50%, 45%, and 35%, respectively. None of these changes were observed in the control group at 6-month follow-up post LVAD. In this single-center experience, weight loss post LSG is associated with decreased vasodilator, diuretic, and anticoagulant medication requirements in LVAD patients.

Contemporary Mechanical Circulatory Support With Continuous-Flow Biventricular Assist Devices: A Systematic Review.

As the incidence of heart failure increases, so too has that of biventricular failure. While transplantation remains the gold standard therapy for end-stage heart failure, the limited organ supply has increased the need for durable mechanical circulatory support. We therefore sought to conduct a systematic review of continuous-flow ventricular assist devices in a biventricular configuration (CF-BiVAD). An electronic search of PubMed and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases was performed using the keyword "BIVAD." Studies were reviewed to identify discrete variables, including implant indication, INTERMACs profile, timing of implant, mean age and BMI, and the anticoagulation/antiplatelet regimens employed post implant. Outcomes of interest included mortality and the incidence of thrombus, bleeding, infection, stroke, and renal failure. A total of 25 studies met inclusion criteria. No single variable was consistently reported, with only 4 studies reporting all 5 adverse effects. INTERMACs profile at implant and anticoagulation/antiplatelet regimen were reported in less than 50% of studies. Of those reporting mortality, there was a wide range of follow-up, from less than 6 months to >10 years, and the survival rate was similarly widely variable. Additionally, more than 50% of studies failed to isolate CF-BiVAD from alternative means of biventricular support, such as temporary support platforms, TAH, and pulsatile VADs. Therefore, high-quality quantitative analysis is not possible. In summary, the CF-BiVAD literature has a very heterogenous reporting of data. Standard reporting criteria may allow for future analyses to determine which patient characteristics portend a favorable outcome with CF-BiVAD implantation.

Intravenous administration of umbilical cord lining stem cells in left ventricular assist device recipient: Rationale and design of the uSTOP LVAD BLEED pilot study.

Background: Left ventricular assist device (LVAD) implantation provides a robust survival advantage, however despite improvements in mortality, the adverse event burden of durable mechanical circulatory support remains high. Bleeding complications are one such significant complication. The uSTOP LVAD BLEED (Utilization of umbilical cord lining Stem cells TO Prevent LVAD associated angiodysplastic BLEEDing) pilot study is designed to evaluate the safety and tolerability of escalating doses of umbilical cord lining stem cells (ULSCs) in LVAD recipients to ameliorate the dysregulation of angiogenic factors seen in this population. Design: This Phase Ia single-ascending dose pilot study will evaluate the IV administration of ULSCs in stable out-patients supported with an LVAD. In a 3 + 3 design, a maximum of 18 patients will receive an IV infusion of ULSCs. Main outcome measures: The primary endpoints are safety and tolerability, secondary exploratory endpoints will include biomarker evaluation of angiogenic dysregulation. Summary: This represents a novel cell type and route of administration in this population, while collecting initial data regarding the magnitude and duration of effects of cell therapy, and assessing the possibility of decreasing bleeding by a strategy of vascular stabilization. Clinical trial registration: ClinicalTrials.gov Identifier: NCT04811261. https://clinicaltrials.gov/ct2/show/NCT04811261.

A varied approach to left ventricular assist device follow-up improves cost-effectiveness.

BACKGROUND: Left ventricular assist device (LVAD) implantation improves outcomes in advanced heart failure, however, the optimal frequency of outpatient assessments to improve cost-effectiveness and potentially avert readmissions is unclear. METHODS: To test if varying the frequency of follow-up after LVAD implantation reduces readmissions and improves cost-effectiveness, a less intensive follow-up (LIFU) strategy with scheduled visits at 1 month and then every 6 months was compared to an intensive follow-up (IFU) group with scheduled visits at 1, 2, and 4 weeks, and then every 3 months post-implant. We developed a decision-tree model to evaluate the cost-effectiveness of different follow-up schedules at 3, 6, and 12-months. The readmission rates for LIFU and IFU, along with the associated costs, were estimated using data from the IBM MarketScan Commercial Claims Databases (2015-2018). A total of 349 patients were enrolled, with 193 and 156 in the IFU and LIFU groups. RESULTS: Patients with IFU were found to have a lower risk for readmission at 3 months (HR: 0.69, 95% confidence interval (CI): 0.60-0.79), but this difference diminished overtime at 6 months (HR: 0.84, 95% CI: 0.73-0.96) and 12 months (HR: 0.94, 95% CI: 0.83-1.06). The incremental net benefit of IFU, when compared with LIFU, is greatest in the first 3 months and also diminishes over time (3 months: $19616, 6 months $9257, 12 months $717). CONCLUSIONS: An initial IFU strategy, followed by a period of de-escalation at the 6-month post-implant mark in lower-risk patients, may be a more cost-effective strategy to provide follow-up care while not predisposing patients to a higher risk of readmission.

Predictors of perioperative bleeding in left ventricular assist device implantation.

Study objective: Early bleeding is a common source of morbidity associated with left ventricular assist device (LVAD) implantation. Our objective was to identify potential predictors of peri-implant bleeding. Methods: We conducted a retrospective cohort study of LVAD implants at our institution between January 2010 and November 2018. A total of 210 patients were included. Data were collected for the duration of implant hospitalization, including perioperative invasive hemodynamics, echocardiography and operative details, antiplatelet and anticoagulant use, bleeding events and blood product use, and thromboembolic events. Peri-operative bleeding was defined as a transfusion requirement of >4 units of packed red blood cells in the intraoperative and first 7 days postoperative period, or a major 7-day post-implant overt bleeding event requiring procedural intervention. Results: Perioperative bleeding occurred in 32% of patients and required surgical re-exploration in 9%. Multivariable logistic regression analysis identified history of previous sternotomy (OR 2.63, 95% CI 1.29 to 5.35, p-value 0.008), preoperative glomerular filtration rate <60 ml/min (OR 2.58, 95% CI 1.34 to 4.94, p-value 0.004), preoperative right atrial pressure >13 mm Hg (OR 2.36, 95% CI 1.19 to 4.67, p-value 0.014) and concomitant tricuspid valve repair (OR 2.48, 95% CI 1.23 to 5.01, p-value 0.011) as independent predictors of perioperative bleeding. In-hospital thromboembolic events occurred in 5% of patients, but there were no significant predictors for them. Conclusions: Elevated right atrial pressure appears to be a reversible risk factor for early bleeding that should be targeted during pre-implant optimization of LVAD candidates.

Patterns of emergency department utilization for LVAD patients compared with non-LVAD patients.

BACKGROUND: Left ventricular assist device (LVAD) patients are vulnerable to over-utilization of resources. METHODS AND RESULTS: We explored the pattern of emergency department (ED) presentations of LVAD patients and their costs compared with non-LVAD heart failure patients. ED visits between 7/2008 and 7/2017 were reviewed to identify 145 LVAD patients, and 435 patients with known heart failure were selected using propensity score matching for age and sex. ED evaluation metrics, hospitalization cost, and length of stay (LOS) were analyzed. Although the most common ED presentations and their frequency differed between groups, few were LVAD specific. LVAD patients were more likely to have taken personal vehicles or be flown to the ED. They had similar times to triage, rooming, and physician evaluation compared with non-LVAD patients. However, LVAD patients were noted to have a shorter time from physician assessment to disposition (109.8 min vs. 177.0 min, p < 0.001) and, overall, LVAD patients had shorter ED LOS (6.33 vs. 9.82 hrs, p = 0.0001). For patients admitted, no significant difference was found between groups in hospital LOS (6.67 vs 6.58 days, p = 0.928) or total cost ($28,766 vs $21,524, p = 0.087). CONCLUSION: Shorter disposition times without increases in LOS or costs may identify a created healthcare disparity among LVAD patients.

CE: Assessing and Managing Pain, Agitation, and Delirium in Hospitalized Older Adults.

: In the acute care setting, pain, agitation, and delirium (PAD) often occur as interrelated parts of a syndrome rather than as separate entities. Because the three facets of PAD may be similar in presentation, it is often difficult for clinicians to recognize the syndrome and to assess and treat it. The challenge is particularly great in older patients, who are more likely than their younger counterparts to have such comorbid conditions as dementia, which may impair the ability to report pain, or age-related physiologic changes that may affect the metabolism and clearance of certain medications. This article provides an overview of each aspect of PAD, discusses clinical considerations related to the assessment and treatment of the syndrome in older adults receiving acute care, and illustrates the application of published PAD guidelines through the use of a hypothetical patient scenario.