First-in-human transcatheter endocardial alginate-hydrogel implantation for the treatment of heart failure.
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ABSTRACT:
SUBMITTER: Wang B
PROVIDER: S-EPMC9860372 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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First-in-human transcatheter endocardial alginate-hydrogel implantation for the treatment of heart failure.
Wang Bo B Lee Randall J RJ Tao Ling L
European heart journal 20230101 4
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Project description:AIMS:Patients with aortic stenosis (AS) may have concomitant heart failure (HF) that determines prognosis despite successful transcatheter aortic valve implantation (TAVI). We compared outcomes of TAVI patients with low stroke volume index (SVI) ≤35 ml/m2 body surface area in different HF classes. METHODS AND RESULTS:Patients treated by transfemoral TAVI at our center (n = 1822) were classified as 1) 'HF with preserved ejection fraction (EF)' (HFpEF, EF ≥50%), 2) 'HF with mid-range EF' (HFmrEF, EF 40-49%), or 3) 'HF with reduced EF' (HFrEF, EF <40%). Patients with SVI >35 ml/m2 served as controls. The prevalence of cardiovascular disease and symptoms increased stepwise from controls (n = 968) to patients with HFpEF (n = 591), HFmrEF (n = 97), and HFrEF (n = 166). Mortality tended to be highest in HFrEF patients 30 days post-procedure, and it became significant after one year: 10.2% (controls), 13.5% (HFpEF), 13.4% (HFmrEF), and 23.5% (HFrEF). However, symptomatic improvement in survivors of all groups was achieved in the majority of patients without differences among groups. CONCLUSIONS:Patients with AS and HF benefit from TAVI with respect to symptom alleviation. TAVI in patients with HFpEF and HFmrEF led to an identical, favorable post-procedural prognosis that was significantly better than that of patients with HFrEF, which remains a high-risk population.
| S-EPMC6879149 | biostudies-literature
Project description:The prevalence of heart failure (HF) continues to rise over time, with aging of the population and increased survival of incident cases. Major improvements occurred in drug therapy but morbidity and mortality of HF patients remain high. Some non-pharmacologic approaches to HF are already part of standard treatment for HF, including implantable cardioverter-defibrillators, cardiac resynchronization therapy (CRT) and left ventricular assist devices (LVADs). A number of transcatheter treatments and devices have been developed to improve management of valvular heart diseases (VHD), and some of them are being used or tested in specific HF conditions. For example, transcatheter aortic valve implantation (TAVI) to unload the left ventricle in patients with moderate aortic stenosis (AS) and HF or TAVI for severe aortic regurgitation (AR) in patients with LVADs. Similarly, percutaneous mitral valve repair can be used to improve prognosis and quality of life in patients with functional mitral valve regurgitation, and has been proposed as a bridge-to-LVAD or to heart transplant in selected patients. Other devices have been specifically developed for the treatment of chronic HF. In this review we describe the main devices used in the treatment of HF associated with aortic and mitral valve disease, as well as novel transcatheter interventions for chronic HF with different pathophysiologic targets.
| S-EPMC7944200 | biostudies-literature
Project description:Patients with heart failure with preserved ejection fraction (HFpEF) constitutes a considerable sized population like that of subjects with heart failure with reduced ejection fraction. The symptoms include exercise induced dyspnoea and fatigue besides an increased mortality rate when compared to the general population. There is limited evidence of benefit from pharmacological therapy. A main pathophysiological mechanism is a left ventricular filling pressure that might be near to normal during resting conditions but increases during exercise leading to pulmonary congestion. Based on observations like the apparent lesser symptomatology in patients with combined mitral valve stenosis and atrial septal defect (Lutembacher syndrome) when compared to patients with isolated mitral valve stenosis, several Inter-Atrial Shunt Devices (IASD) have been developed with the intent to unload the pressure in the left atrium by creating a shunt into the right atrium. Smaller studies have found that the IASDs reduce the left ventricular filling pressure during exercise and increase the functional status of patients both subjectively and objectively with reported low rates of complications. These devices are undergoing further investigations and might prove to be a new paradigm in the treatment of patients with HFpEF.
| S-EPMC9383341 | biostudies-literature
Project description: Not available
| S-EPMC10801808 | biostudies-literature
Project description:AimsIn low-risk patients with severe aortic stenosis (AS), sutureless surgical aortic valve replacement (SU-SAVR) may be an alternative to transcatheter aortic valve implantation (TAVI). The risk of heart failure hospitalization (HFH) after aortic valve replacement (AVR) in this population is incompletely characterized. This study aims to investigate the incidence, predictors, and outcomes of HFH in patients undergoing SU-SAVR versus TAVI.Methods and resultsPatients referred for AVR between 2013 and 2020 at two centres were consecutively included. The decision for SU-SAVR or TAVI was determined by a multidisciplinary Heart Team. Cox regression and competing risk analysis were conducted to assess adverse events. Of 594 patients (mean age 77.5 ± 6.4, 59.8% male), 424 underwent SU-SAVR, while 170 underwent TAVI. Following a mean follow-up of 34.1 ± 23.1 months, HFH occurred in 112 (27.8%) SU-SAVR patients and in 8 (4.8%) TAVI patients (P < 0.001). The SU-SAVR cohort exhibited higher all-cause mortality (138 [32.5%] patients compared with 30 [17.6%] in the TAVI cohort [P < 0.001]). These differences remained significant after sensitivity analyses with 1:1 propensity score matching for baseline variables. SU-SAVR with HFH was associated with increased all-cause mortality (61.6% vs. 23.1%, P < 0.001). Independent associates of HFH in SU-SAVR patients included diabetes, atrial fibrillation, chronic obstructive pulmonary disease, lower glomerular filtration rate and lower left ventricular ejection fraction. SU-SAVR patients with HFH had a 12-month LVEF of 59.4 ± 12.7.ConclusionsIn low-risk AS, SU-SAVR is associated with a higher risk of HFH and all-cause mortality compared to TAVI. In patients with severe AS candidate to SU-SAVR or TAVI, TAVI may be the preferred intervention.
| S-EPMC11424333 | biostudies-literature
Project description:Therapeutic options for patients with isolated severe to torrential tricuspid regurgitation have been limited. Because a surgical option is often not attractive, new catheter-based therapies are emerging. We report the first-in-human percutaneous transcatheter tricuspid valve replacement with the MonarQ system in a 75-year-old female patient with severely symptomatic torrential tricuspid regurgitation. (Level of Difficulty: Advanced.).
| S-EPMC10157149 | biostudies-literature
Project description:BackgroundEchocardiography-guided percutaneous intramyocardial alginate-hydrogel implantation (PIMAHI) is a novel treatment approach for heart failure (HF). We validated PIMAHI safety and efficacy in canine HF models.MethodsFourteen canines with HF [produced by coronary artery ligation, left ventricular ejection fraction (LVEF) < 35%] were randomised to PIMAHI treatment (n = 8) or controls (n = 6). Echocardiography, two-dimensional speckle tracking echocardiography, and pathological examinations after a 6-month follow-up were performed. Repeated-measures analysis of variance was used for within-group comparisons.ResultsAt 6-month follow-up, PIMAHI treatment reversed LV dilation and remodelling, increasing LV free wall thickness (LVFW, p = 0.002) and interventricular septum thickness (IVS, p < 0.001) and reducing LV end-diastolic volume (EDV, p = 0.008) and end-systolic volume (ESV, p = 0.004). PIMAHI significantly improved LV systolic function, increasing LVEF (EF, p = 0.004); enhanced LV myocardial contractility, including increased LV global longitudinal strain (GLS, p < 0.001), global circumferential strain (GCS, p = 0.006), and mitral annulus displacement (MAD, p = 0.001). Compared with controls at 6-month, PIMAHI group significantly increased LVFW thickness (8.5 ± 0.3 vs. 6.8 ± 0.2 mm, p = 0.002) and IVS (7.9 ± 0.1 vs. 6.1 ± 0.2 mm, p < 0.001); decreased LVEDV (30.1 ± 1.6 vs. 38.9 ± 4.5 ml, p = 0.049) and ESV (17.3 ± 1.2 vs. 28.7 ± 3.6 ml, p = 0.004); increased LV systolic function (42.7 ± 1.5 vs. 26.7 ± 1.1% in EF, p = 0.001); and enhanced LV myocardial contractility including GLS (13.5 ± 0.8 vs. 8.4 ± 0.6%, p = 0.002), GCS (16.5 ± 1.4 vs. 9.2 ± 0.6%, p = 0.001), and MAD (11.4 ± 3.5vs 4.6 ± 2.5 mm, p = 0.003). During PIMAHI treatment, no sustained arrhythmia, pericardial, or pleural effusion occurred.ConclusionsPIMAHI in canine HF models was safe and effective. It reversed LV dilation and improved LV function.
| S-EPMC10822984 | biostudies-literature
Project description:The transcatheter bicaval valve system is an emerging therapeutic option for tricuspid regurgitation, consisting of 2 biological valves to prevent caval reflux. The experience with this device is still scarce, and to the best of our knowledge, this is the first case of thrombosis ever reported. (Level of Difficulty: Advanced.).
| S-EPMC9871072 | biostudies-literature
Project description:Despite significant advances in the medical management of patients living with heart failure, there continues to be significant morbidity and mortality associated with the condition. There is a growing need for research and development of additional modalities to fill the management and treatment gaps, reduce hospitalisations and improve the quality of life for patients living with heart failure. In the last decade, there has been a rapid rise in the use of non-valvular catheter-based therapies for the management of chronic heart failure to complement existing guideline-directed management. They target well-defined mechanistic and pathophysiological processes critical to the progression of heart failure including left ventricular remodelling, neurohumoral activation, and congestion. In this review, we will explore the physiology, rationale, and current stages of the clinical development of the existing procedures.
| S-EPMC9936253 | biostudies-literature
Project description:BackgroundRegional left ventricular (LV) mechanics in mitral regurgitation (MR) patients, and local changes in function after transcatheter mitral valve implantation (TMVI) have yet to be evaluated. Herein, we introduce a method for creating high resolution maps of endocardial function from 4DCT images, leading to detailed characterization of changes in local LV function. These changes are particularly interesting when evaluating the effect of the Tendyne™ TMVI device in the region of the epicardial pad.MethodsRegional endocardial shortening from CT (RSCT) was evaluated in Tendyne (Abbott Medical) TMVI patients with 4DCT exams pre- and post-implantation. Regional function was evaluated in 90 LV segments (5 longitudinal × 18 circumferential). LV volumes and ejection fraction (EF) were also computed. A reproducibility study was performed in a subset of patients to determine the precision of RSCT measurements in this population.ResultsBaseline and local changes in RSCT post TMVI were highly variable and extremely spatially heterogeneous. Both inter- and intra-observer variability were low and demonstrated the high precision of RSCT for evaluating regional LV function.ConclusionRSCT is a reproducible metric which can be evaluated in patients with highly abnormal regional LV function and geometry. After TMVI, significant spatially heterogeneous changes in RSCT were observed in all subjects; therefore, it is unlikely that the functional state of TMVI patients can be fully described by changes in LV volume or EF. Measurement of RSCT provides precise characterization of the spatially heterogeneous effects of MR and TMVI on LV function and remodeling.
| S-EPMC8445197 | biostudies-literature