bluuebunny/crossref_metadata_2025_split huggingface dataset:
Home- versus clinic-based exercise intervention in patients with heart failure (EXIT-HF trial): a pragmatic randomized controlled trial
Authors: Santos M , Schimdt C , Magalhaes S , Teixeira M , Oliveira M I , Ferreira J P , Ribeiro F 
Published: November 2023

Abstract

Background
The limited accessibility partially explains the low uptake of cardiac rehabilitation (ExCR) for heart failure (HF). Home-based programs might address those obstacles but few data from randomized trials are available.

Purpose
To compare the effectiveness of a home-based versus clinic-based ExCR intervention in HF patients.

Methods
Single-center, single-blind, parallel groups, non-inferiority pragmatic randomized control trial (1:1 and after COVID-19 2:1 home- vs clinic-based). Adult HF patients referred to our cardiac rehabilitation (CR) unit were randomized to either a clinic-based (24 supervised sessions at a CR unit of a tertiary hospital over 12 weeks) or home-based (4 supervised ExT sessions to familiarize with the training protocol and the remaining sessions continued at home) over 12 weeks. Exercise training protocol consisted of a combination of endurance (at 60%-80% of peak oxygen uptake [VO2peak] and resistance training (elastic bands). The primary endpoint was the change in VO2peak at the end of the 12-week program. Secondary outcomes included adherence (&gt;80% of sessions attendance) and change of Minnesota Living with HF Questionnaire (MLHFQ) scores.

Results
120 patients (mean age 64±11 years; 64% men) were randomized: 44 to clinic- and to 76 home-based intervention. 41% had an ischemic cardiomyopathy, 27% had an ICD/CRT, the mean LVEF was 36±11% (62% had LVEF &lt;40%), 73% were on NYHA class II, and the median NT-proBNP was 361 [IQR 170-1008] ng/mL. Intervention groups were well balanced, including basal VO2peak that was similar between groups (17.8±4.8 vs 18.1±5.2 mL/min/Kg; p=0.75). Adherence was similar between groups (87.5% vs 82.5%; p=0.50). At week 12, on average, patients increased VO2 peak by 0.9±2.5 mL/min/Kg compared to baseline (p&lt;0.001). No significant differences were found between clinic- and home-based interventions (p=0.25). Consistently, the MLHFQ total score decreased significantly overall (-10.3±1.7 points; p&lt;0.001), with no significant differences between groups (p=0.91). The drop-out rate was 14% and 17% in clinic- and home-based groups, respectively.

Conclusions
The clinical impact of home-based CR program on peakVO2 and health-related quality of life of HF patients was similar to a standard supervised clinic-based one. Our data support the home-based program as an effective alternative way of delivering CR in HF.
A systematic review of Australian hospitals' policies on the deactivation of implantable cardioverter defibrillators
Authors: Grose D , Smallwood N , Corbett C , Walker A , Lim W K , Zentner D 
Published: November 2023

Abstract

Introduction
Increasing numbers of older adults are living with implantable cardioverter defibrillators (ICD), reflecting expanded indications and increased insertion rates (1). Deactivation rates for those approaching end of life are low, risking undue distress and an undignified death (2). International guidelines recommend discussions regarding deactivation be part of pre-implantation consent (3). Local health service policies, procedures and guidelines regarding deactivation are crucial for best-practice end-of-life care.

Objective
This systematic review aimed to determine the availability and content of hospital policies, procedures and guidelines regarding ICD deactivation towards end of life.

Methods
Victorian (PROMPT) and South Australian hospital guidelines databases were systematically searched (September 2022 - February 2023) to identify all documents regarding ICD deactivation at end-of-life. Eligible documents were analysed using a data extraction tool.

Results
Of 4001 documents identified from 93 health services (population 8.45 million Australians), 11 were included, with 10 (91%) from public, and 8 (73%) from metropolitan, health services. Two (18%) documents provided recommendations for subacute healthcare settings and 1 (9%) for community-based patients.
Guidance for prompting ICD deactivation discussions was limited. Only 2 (18%) documents advised at time of insertion, 1 (9%) at generator change and 6 (55%) during advance care planning discussions (Figure 1).
Recommended indications for ICD deactivation varied and included: patients with a palliative condition (2, 18%) or receiving end-of-life care (11, 100%), patient’s request (7, 64%) and with an active do not resuscitate order (5, 45%). Nine (82%) documents provided key points for informed consent discussions including that deactivation does not cause/hasten death (8, 73%), does not deactivate pacing (8, 73%), aims to promote a peaceful death (8, 73%) and that reactivation is possible (8, 73%).
Instructions for temporary deactivation using a magnet were provided in 10 (91%) documents (8 (73%) included manufacturer-specific instructions, 2 (18%) including correct magnet placement diagram). Most (10, 91%) gave non-urgent deactivation instructions. Advice for managing ICDs after death was detailed in 4 (36%) documents.

Conclusion
There is a paucity of local health service guidance to support Australian clinicians navigate the challenges of ICD deactivation at end of life. Consistent, detailed, high-quality local health service guidance is required to facilitate active recognition of people with whom timely discussion and action regarding ICD deactivation is appropriate. This may contribute to improved end of life care. Additionally, given the geographical size and population spread of Australia and implications for cardiologist access, logistical caveats that allow adaptation for local health service should be highlighted.Figure 1
Warranty period for low risk positron emission tomography for detection of cardiac allograft vasculopathy
Authors: Abadie B , Albert C , Bhat P , Harb S , Jacob M , Starling R , Cremer P , Tang W H , Jaber W 
Published: November 2023

Abstract

Background
Positron emission tomography/computed tomography (PET/CT) is increasingly being used as an alternative to invasive coronary angiography for the detection of cardiac allograft vasculopathy (CAV) in heart transplant patients. The appropriate screening interval for patients with low-risk testing is unknown.

Purpose
The purpose of the study was to determine the number of patients with an initial-low risk PET/CT who progressed to a high-risk result with annual screening and what patient characteristics were associated with this progression.

Methods
Patients with heart transplant with no history of CAV 2/3 by angiography, whose initial PET/CT scan was low-risk, and who had a repeat PET/CT as part of an annual screening program were included in the study. A low-risk PET/CT was PET CAV score 0/1, and a high-risk PET/CT was PET CAV score 2/3, as defined by a previously published and validated diagnostic algorithm. The primary outcome was the percentage of patients who progressed to a high-risk result.

Results
The median time between PET/CT scans was 382 days (IQ 365 – 443). Only 2/163 (1.2%) patients with initial PET/CAV 0 progressed to PET CAV 2/3 on their repeat study compared to 7/37 (19%) for those with PET CAV 1 (RR 9.16, 95CI 2.97 – 28.29). During the study period, there were 0 episodes of urgent revascularization and 1 elective revascularization.

Conclusions
The risk of developing PET CAV 2/3 in patients with an initial result of PET CAV 0 is low at one year and annual screening may be unnecessary. Conversely, in patients initially classified as PET CAV 1, the risk of progression to PET CAV 2/3 is high and more frequent screening may be indicated.
Impact of new allocation system on length of stay following heart transplantation in the US
Authors: Briasoulis A , Doulamis I , Tzani A , Rempakos A , Kampaktsis P , Alvarez P 
Published: November 2023

Abstract

Background
United Network for Organ Sharing (UNOS) allocation criteria changed in 2018 in order to accommodate the increased prevalence of patients on ventricular assist device as a bridge to heart transplant and prioritize sicker people in anticipation of a heart graft.

Purpose
To assess the impact of the new allocation policy on length of stay following heart transplantation. Secondary outcomes include other risk factors for prolonged hospitalization and its effect on mortality and postoperative complications.

Methods
The UNOS Registry was queried to identify patients who solely underwent heart transplant in the US between 2000 and 2021. Patients were divided into groups according to their respective length of stay quartile.

Results
Patient demographics are summarized in Figure 1. Patients in the 4 th quartile of length of stay were more likely to be Status 1A (44% vs 37%, p&lt;0.001), be on a left ventricular assist device (12% vs 9%, p&lt;0.001), extracorporeal membrane oxygenator (5% vs 1%, p&lt;0.001) and have an intra-aortic balloon pump (13% vs 8%, p&lt;0.001) compared to the 1 st quartile. Length of stay was longer in the new allocation era (24±25 vs 20±29 days, p&lt;0.001). Prolonged length of stay was also associated with increased 10-year mortality (HR: 1.64; 95% CI: 1.58, 1.70, p&lt;0.001, Figure 2).

Conclusions
The longer hospital stay and the associated increased risk for mortality that is being observed in the era after the allocation criteria change reflect the rationale of this shift which was to prioritize heart transplant for sicker patients. Further studies are needed to track the progress of surgical and perioperative management of these studies over time.
Donor-derived cell-free DNA kinetics in the first year post-transplant in patients without acute cellular rejection
Authors: Jimenez-Blanco Bravo M , Crespo Leiro M , Gonzalez Sardinero E , Gomez Bueno M , Lopez Villela R , Ortiz Bautista C , Farrero M , Maestro Benedicto A , Diaz Molina B , Diez Lopez C , Rangel Sousa D , Salterain N , Garrido Bravo I , Segovia Cubero J 
Published: November 2023

Abstract

Background
Donor-derived cell-free DNA (dd-cfDNA) appears to be an excellent biomarker for acute cellular rejection (ACR) in heart transplant (HT) recipients. However, a significant rise in the immediate post-transplant phase probably related to direct myocardial damage during harvesting-implantation process has been described, and could potentially affect the biomarker’s performance in the first post-HT month. We sought to describe the biomarker’s kinetics in the first year post-HT in patients without ACR.

Methods
Prospective, multicentre study performed between 2019 and 2022. All patients underwent surveillance endomyocardial biopsy (EMB) at 7 pre-specified time points in the first post-HT year (0.5, 1, 2, 3, 4, 6 and 12 months). Dd-cfDNA levels were determined prior to each EMB, using Next Generation Sequencing technology.

Results
A total of 1006 pairs of EMB-dd-cfDNA from 206 patients were available for analysis (mean age 54 ±12 years, 74% male). Of these, 44 (4.3%) had clinically relevant rejection, defined as ACR grade ≥2, and 962 (95.7%) did not (562 0R and 400 1R). 15 samples that had pAMR≥1 were excluded from this analysis.
We divided the 947 samples with ACR 0-1 into three subgroups, according to the time of blood sampling: at 15 days (time point 1), at 30 days (time point 2) and 2 to 12 months post-HT (time point 3). Samples with 0R that were drawn at 15 and 30 days showed significantly higher levels of dd-cfDNA than those drawn between the second month and first year post-transplant (p &lt;0.001) (Figure 1A). When we included patients with 1R, a similar trend was observed (p &lt;0.001) (Figure 1B). Median dd-cfDNA levels for 0R and for 0-1R at the three time points are shown in Figure 2.

Conclusions
Dd-cfDNA levels in patients without clinically relevant rejection are significantly higher in the first month post-transplant. Further studies are needed in order to determine if a different cut-off point for ACR during the first post-HT month is useful for ACR diagnosis.Donor-derived cell-free DNA kineticsDd-cfDNA values at three time points
Reduction of cardiac allograft vasculopathy by PCI: Quantification and correlation with outcome after heart transplantation
Authors: Orban M , Kuehl A , Pechmajou L , Mueller C , Hausleiter J , Sfeir M , Bories M C , Martin A C , Ulrich S M , Dalla Pozza R , Mehilli J , Jouven X , Hagl C , Karam N , Massberg S 
Published: November 2023

Abstract

Background
Percutaneous coronary intervention (PCI) might improve outcome of heart transplanted (HTx) patients at severe stages of cardiac allograft vasculopathy (CAV). Yet, risk stratification of HTx patients after PCI remains challenging. The International Society for Heart and Lung Transplantation (ISHLT) provides a nomenclature for CAV classification that does not include patients after PCI (1). It is unclear how to define an individual optimal CAV reduction and how to stratify patients with CAV after PCI. Besides, whether risk-stratification tools of non-transplanted patients apply to HTx patients with CAV is uncertain.

Purpose
To assess whether the ISHLT CAV classification remains prognostic after PCI, and whether risk stratification models of non-transplanted patients can be applied to HTx patients with CAV.

Methods
At two European academic centers, 203 patients were stratified according to CAV severity and PCI history, and patients were assigned to only one cohort: cohort 1 (ISHLT CAV grade 1, without PCI, n=126) or cohort 2 (ISHLT CAV grades 2&3, with PCI). At first diagnosis of CAV or first PCI, respectively, ISHLT CAV grades, SYNTAX scores I and II (SXS-I and SXS-II) were used to quantify baseline and residual CAV (rISHLT, rSXS-I, rSXS-II). A rSXS-I&gt;0 defined incomplete revascularization (IR). Five-year mortality was assessed. For cohort 2, first reintervention was a secondary outcome. Baseline parameters were also included into analysis.

Results
SXS-II predicted mortality in cohort 1 (Hazard ratio [HR] 2.5 [1.4–4.8], p=0.004), whereas SXS-I (HR 4.2 [1.4–12.2], p=0.009) and SXS-II (HR 7.1 [2.0–24.5], p=0.002) predicted mortality in cohort 2. Post-PCI, IR (HR 5.4 [1.7–17.0], p=0.004), high rISHLT (HR 3.6 [1.3–10.2], p=0.02) and highest tertile of rSXS-II (HR 5.1 [1.6–15.9], p=0.006) were associated with higher mortality. In cohort 2, post-transplant interval and KDIGO category of renal function at timepoint 0 were also predictors of 5-year mortality after first PCI (HR 1.1 [1.0 – 1.2], p=0.004 and HR 4.5 [1.8–11.3], p=0.01, respectively). In bivariable Cox analysis, baseline SXS-II, IR, rSXS-II, post-transplant interval and KDIGO category of renal function remained predictors of 5-year mortality. The interval to first reintervention was inversely related to baseline SXS-I (r=-0.55, p&lt;0.001) and rSXS-I (r=-0.50, p=0.003).

Conclusion
A higher reduction of stenotic CAV was associated with improved 5-year survival rate after first PCI. ISHLT CAV classification could apply for risk stratification after PCI and SYNTAX-scores could be complemental for risk stratification and individualization of invasive follow-up of HTx patients with CAV.Figure 1.Study flow chart.Figure 2.Kaplan-Meier curves (cohort 2)
Prognostic impact of improvement in quality of life after discharge in patients with ADHF with preserved ejection fraction regardless of the course of HF -PURSUIT-HFpEF registry
Authors: Kondo T , Watanabe T , Yamada T , Seo M , Yano M , Hayashi T , Nakagawa A , Nakagawa Y , Tamaki S , Yasumura Y , Sotomi Y , Hikoso S , Nakatani D , Fukunami M , Sakata Y 
Published: November 2023

Abstract

Background
Lower quality of life (QOL) is associated with poor clinical outcome in patients with heart failure (HF). However, there is not fully clarified whether the changes in QOL could have prognostic value in patients with HF with preserved ejection fraction (HFpEF).

Purpose
The purpose of this study is to investigate the prognostic impact of changes in QOL in patients with HFpEF in relation to the changes in condition of heart failure.

Methods
We prospectively studied 435 patients with acute decompensated heart failure with preserved ejection fraction (ADHF-HFpEF) without the poor outcome within 1 year after the discharge. The patients’ QOL was evaluated at discharge and 1 year after the discharge using EuroQol 5 dimensions 5-level (EQ-5D-5L) and the difference in the EQ-5D-5L index at these two time points was used to assess the change in QOL. The primary outcome was all-cause death.

Results
The median EQ-5D-5L index were 0.753 (0.562-0.875) at discharge and 0.784 (0.646-0.895) at 1 year after the discharge. During a mean follow-up period of 1.6±1.2 years, primary outcome occurred in 92 patients. Patients with improved QOL (defined as equal to or greater than the EQ-5D-5L index at discharge) were significantly younger, had lower volume load on echocardiography and higher level of hemoglobin and serum sodium than those without improved QOL. Both the improved QOL and the improvement of HF (defined as more than -0.035 in the difference in Log NTproBNP value within 1 year after discharge by ROC analysis: AUC 0.570 [0.506-0.635]) were associated with primary outcome at univariate Cox proportional hazard analysis and the improved QOL was significantly independently associated with primary outcome after multivariable adjustment. Kaplan-Meier analysis revealed that patients with improved QOL had significantly lower risk for primary outcome than those without improved QOL not only in the whole study patients (14% vs 27%, p=0.0007) but also both in the group with improving HF (11% vs 22% p=0.0129) and in those with worsening HF (17% vs 31% p=0.0468).

Conclusion(s)
The improvement in QOL had the prognostic impact in patients with ADHF-HFpEF regardless of the course of heart failure.
Evidence-based heart failure therapies at discharge of patients with acute coronary syndromes and reduced ejection fraction: Data from the ACSIS survey
Authors: Zafrir B , Ovdat T , Abu Akel M , Bahouth F , Orvin K , Beigel R , Amir O , Elbaz-Greener G 
Published: November 2023

Abstract

Background
Guideline-directed medical therapies for heart failure (HF) may benefit patients with reduced left ventricular ejection fraction (LVEF) following acute coronary syndromes (ACS), even in the absence of overt HF. Few real-world data are available regarding early implementation of HF therapies in patients with ACS and reduced LVEF.

Methods
Data collected from the 2021 nationwide, prospective ACS Israeli Survey (ACSIS). Drug classes included: (a) angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI); (b) beta-blockers; (c) mineralocorticoid receptor antagonist (MRA) and (d) sodium-glucose cotransporter-2 inhibitors (SGLT2I). Utilization of HF therapies at discharge or 90-days following ACS was analyzed in relation to LVEF [reduced ≤40% (n=406) or mildly-reduced 41-49% (n=255)] and short-term adverse outcomes.

Results
History of HF, anterior wall myocardial infarction and Killip class II-IV (32% vs. 14% p&lt;0.001) were more prevalent in those with reduced compared to mildly-reduced LVEF. ACEI/ARB/ARNI and BBC were used by &gt;85% of patients in both LVEF groups, though ARNI was prescribed to only 3.9% (LVEF≤40%). MRA was used by 42.9% and 12.2% of patients with LVEF ≤40% and 41-49%, respectively, and SGLT2I in a quarter of both LVEF groups. Overall, ≥3 HF drug classes were documented in 44% of the patients. A trend towards higher rates of 90-day HF rehospitalizations, recurrent ACS or all-cause death was noted in those with reduced (7.6%) vs. mildly-reduced (3.7%) LVEF, p=0.084. No association was observed between the number of HF drug classes, or the use of ARNI and/or SGLT2I with adverse clinical outcomes.

Conclusions
In current clinical practice, the majority of patients with reduced and mildly-reduced LVEF are treated by ACEI/ARB and beta-blockers early following ACS, whereas MRA is underutilized and the adoption of SGLT2I and ARNI is low. A greater number of therapeutic classes was not associated with reduced short-term rehospitalizations or mortality.Drug therapies for heart failure
Impact of in-hospital initiation of sodium-glucose cotransporter-2 inhibitors in patients with heart failure and reduced ejection fraction
Authors: Burgos L , Ballari F , Spaccavento A , Ricciardi B , Suarez L , Baro Vila R , Campos Cevera L , Chicote F , Fasan M , Fescina J , Arias R , Santos Gallego C , Diez M 
Published: November 2023

Abstract

Introduction
Safety and early clinical benefit make sodium-glucose cotransporter-2 inhibitor (SGLT-2i) therapy suitable for in-hospital initiation in patients with heart failure and reduced ejection fraction (HFrEF). Despite randomized controlled trials and guideline recommendations, they are underused and clinical inertia may play a role.

Objectives
Primary: To assess the impact of initiating SGLT-2i at discharge on 90-day prescription rates in patients with HFrEF during hospitalization for acute heart failure (AHF). Secondary: To evaluate the presence of contraindications at discharge and the independent factors associated with in-hospital prescription, and to assess clinical outcomes at 90 days.

Methods
Retrospective analysis of a consecutive prospective single-center cohort. Adult patients hospitalized between January 2021 and October 2022 with a primary diagnosis of AHF and left ventricular ejection fraction (LVEF) &lt;40% were included. Patients who underwent heart transplantation during hospitalization, used SGLT2i before admission, died or were referred during the index hospitalization were excluded. Those who started SGLT-2i before or at discharge were compared with those who did not. The primary outcome was SGLT-2i prescription rate at 90 days, and the exploratory secondary endpoints was the composite of hospitalization or urgent visit for AHF or all-cause mortality at 90 days. Independent factors associated with inpatient SGLT-2i prescription were analyzed using a logistic regression model.

Results
Among 378 patients with documented HFrEF, 240 (64%) met the inclusion criteria. Mean age was 76±11 years, 75.4% were male and the mean LVEF was 25±13%. SGLT-2i was indicated during hospitalization in 31.6% of patients. A total of 86% of the cohort had a 90-day follow-up, and the SGLT2i prescription rate was 94.2% in those with in-hospital initiation and 14.4% in those without (p&lt;0.001). Among those without contraindications at discharge (n=141), the independent factor associated with inpatient prescription was lower age, OR 0.96 (0.93-0.99) for each year. There were no statistically significant differences between the two groups for the combined endpoint of all-cause death, HF rehospitalisation or unplanned HF visit at 90 days (p=0.3).

Conclusions
In-hospital initiation of SGLT-2-i was associated with significantly higher prescription rates 90 days after discharge, without differences in death from all causes and hospitalization or urgent visit for AHF at 90 days. This study reflects the presence of medical inertia, particularly in older patients. It also highlights the hospitalization period as an optimal time to start SGLT-2i and achieve the proven clinical benefits that accumulate rapidly over weeks, with solid safety and tolerability.