Publications by authors named "Maria Alu"

Article Synopsis
  • - This study examined the effects of transcatheter aortic valve replacement (TAVR) on patients with heart failure and moderate aortic stenosis, comparing TAVR with clinical surveillance followed by valve replacement if the condition worsened.
  • - A total of 178 patients were randomly assigned to either TAVR or surveillance, and results indicated that TAVR was associated with better clinical outcomes, though the statistical significance was borderline.
  • - TAVR led to a more substantial improvement in heart failure symptoms, as measured by the Kansas City Cardiomyopathy Questionnaire, compared to the surveillance group after one year of follow-up.
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Background: Transcatheter edge-to-edge repair (TEER) improved outcomes in patients with heart failure (HF) and severe secondary mitral regurgitation (SMR) compared with guideline-directed medical therapy (GDMT) alone regardless of the severity of baseline left ventricular ejection fraction (LVEF). The study aimed to evaluate the effect of early changes in LVEF after TEER and GDMT alone in patients with HF and severe SMR.

Methods: Within the COAPT trial, we evaluated outcomes according to changes in LVEF from baseline to 30 days.

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Background: Functional mitral regurgitation induces adverse effects on the left ventricle and the left atrium. Left atrial (LA) dilatation and reduced LA strain are associated with poor outcomes in heart failure (HF). Transcatheter edge-to-edge repair (TEER) of the mitral valve reduces heart failure hospitalization (HFH) and all-cause death in selected HF patients.

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Aims: Evaluation of left and right ventricular (RV) longitudinal systolic function may enhance risk stratification following aortic valve replacement (AVR). The study objective was to evaluate the changes in left and RV longitudinal systolic function and RV-pulmonary artery (RV-PA) coupling from baseline to 30 days and 1 year after AVR.

Methods And Results: Left ventricular (LV) longitudinal strain (LS), tricuspid annulus plane systolic excursion (TAPSE), and RV-PA coupling were evaluated in patients from the PARTNER 2A surgical AVR (SAVR) arm (n = 985) and from the PARTNER 2 SAPIEN 3 registry (n = 719).

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Article Synopsis
  • The study aimed to assess the effects of patient-prosthesis mismatch (PPM) on patients who underwent surgical aortic valve replacement over a two-year period as part of the PARTNER trials.
  • It classified PPM into moderate and severe categories, finding that patients without PPM had better outcomes compared to those with moderate or severe PPM.
  • The results indicated that while severe PPM was less common than predicted, it was linked to worse health outcomes, highlighting the importance of surgical techniques to reduce the occurrence of PPM.
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Background: Baseline left ventricular diastolic dysfunction (LVDD) is associated with poor health status in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), but health status improvement after TAVR appears similar across all grades of LVDD. Here, we aim to examine the relationship between changes in LVDD severity and health status outcomes following TAVR.

Methods: Patients who underwent TAVR and had evaluable LVDD at both baseline and 1 year in the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registries and PARTNER 3 trial were analyzed.

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Article Synopsis
  • Interest in the management of tricuspid regurgitation (TR) has increased due to studies showing worse outcomes with greater TR severity, even when considering other health issues.
  • Historically, surgery for TR has had high mortality rates, prompting the creation of transcatheter treatment options.
  • The Tricuspid Valve Academic Research Consortium aims to standardize disease definitions and trial endpoints to improve research and patient outcomes related to TR.
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Article Synopsis
  • Interest in tricuspid regurgitation (TR) has increased due to studies linking higher TR severity to worse patient outcomes, even considering other health conditions.
  • Due to high in-hospital mortality with traditional surgery for TR, new less invasive transcatheter treatment options have been developed.
  • The first document from the Tricuspid Valve Academic Research Consortium aims to standardize definitions and endpoints for research trials to improve understanding and management of TR, with a follow-up document planned to focus on trial design and further endpoint definitions.
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Article Synopsis
  • Interest in tricuspid regurgitation (TR) has increased due to studies showing worse patient outcomes correlating with higher severity of TR.
  • Surgery for the tricuspid valve has historically had high in-hospital mortality rates, prompting the development of new, less invasive transcatheter treatment options.
  • The first document from the Tricuspid Valve Academic Research Consortium aims to standardize definitions of TR and trial endpoints, which will enhance comparison and understanding in future clinical trials.
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Background Left ventricular (LV) global longitudinal strain (GLS) provides incremental prognostic information over LV ejection fraction in patients with heart failure (HF) and secondary mitral regurgitation. We examined the prognostic impact of LV GLS improvement in this population. Methods and Results The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial randomized symptomatic patients with HF with severe (3+/4+) mitral regurgitation to transcatheter edge-to-edge repair with the MitraClip device plus maximally tolerated guideline-directed medical therapy (GDMT) versus GDMT alone.

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Article Synopsis
  • Previous studies showed that older balloon-expandable valves for transcatheter aortic valve replacement (TAVR) were as effective as surgical aortic valve replacement (SAVR) in preventing death and disabling strokes for intermediate-risk patients.
  • This study compared 5-year outcomes of TAVR using the newer SAPIEN 3 valve against SAVR in intermediate-risk patients with severe aortic stenosis.
  • The findings indicated that the rates of death and disabling stroke were similar for both TAVR and SAVR, but S3 TAVR patients experienced more mild paravalvular regurgitation, highlighting the need for further long-term studies on valve durability and complications.
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Article Synopsis
  • Mitral regurgitation is a common heart valve issue affecting over 5 million Americans, with a focus on real-world data collection for regulatory and clinical purposes.
  • The study aimed to create a standard set of essential data elements for mitral interventions, going through 703 options and reaching consensus on 127 core elements for effective data use.
  • This core data set will enhance the national registry for transcatheter mitral devices, supporting safety monitoring, regulatory submissions, and improving hospital care quality.
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Background: The relationship between left ventricular (LV) remodeling and clinical outcomes after treatment of severe mitral regurgitation (MR) in heart failure (HF) has not been examined.

Objectives: The aim of this study was to evaluate the association between LV reverse remodeling and subsequent outcomes and assess whether transcatheter edge-to-edge repair (TEER) and residual MR are associated with LV remodeling in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial.

Methods: Patients with HF and severe MR who remained symptomatic on guideline-directed medical therapy (GDMT) were randomized to TEER plus GDMT or GDMT alone.

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Background: The extent of extravalvular cardiac damage is associated with increased risk of adverse events among patients with severe aortic stenosis undergoing aortic valve replacement (AVR).

Objectives: The goal was to describe the association of cardiac damage on health status before and after AVR.

Methods: Patients from the PARTNER (Placement of Aortic Transcatheter Valves) 2 and 3 trials were pooled and classified by echocardiographic cardiac damage stage at baseline and 1 year as previously described (stage 0-4).

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Article Synopsis
  • * In lower-risk patients, TAVI showed lower mortality rates and a reduced incidence of death or disabling stroke within the first year compared to SAVR, but no significant differences were observed in the long term.
  • * For higher-risk patients, no significant differences in outcomes were noted for either procedure; however, TAVI was associated with fewer complications like new-onset atrial fibrillation and major bleeding, yet had more instances of certain adverse effects like vascular complications.
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Background: Anemia is associated with increased mortality in patients undergoing transcatheter aortic valve replacement (TAVR); however, data on the effect of the severity of and recovery from anemia on clinical outcomes are limited. This study examined the impact of the severity of and recovery from anemia after TAVR.

Methods: Patients with symptomatic, severe aortic stenosis across all surgical risk groups from the Placement of Aortic Transcatheter Valves (PARTNER) I, II, and III trials and registries who underwent TAVR were analyzed.

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Background: Physiologic right ventricle-pulmonary artery (RV-PA) coupling may be impaired in patients with aortic stenosis (AS).

Objectives: This study aimed to assess the incidence and prognostic significance of impaired RV-PA coupling in low-risk patients with symptomatic severe AS undergoing transcatheter aortic valve replacement or surgical aortic valve replacement.

Methods: RV-PA coupling was measured by transthoracic echocardiography as the ratio of tricuspid annular plane systolic excursion (TAPSE) to pulmonary artery systolic pressure (PASP) in patients in the PARTNER (Placement of Aortic Transcatheter Valve) 3 trial.

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Importance: In patients with severe aortic stenosis and left ventricular ejection fraction (LVEF) less than 50%, early LVEF improvement after transcatheter aortic valve replacement (TAVR) is associated with improved 1-year mortality; however, its association with long-term clinical outcomes is not known.

Objective: To examine the association between early LVEF improvement after TAVR and 5-year outcomes.

Design, Setting, And Participants: This cohort study analyzed patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 1, 2, and S3 trials and registries between July 2007 and April 2015.

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Background: The impact of aortic valve replacement (AVR) on progression/regression of extravalvular cardiac damage and its association with subsequent prognosis is unknown.

Objectives: The purpose of this study was to describe the evolution of cardiac damage post-AVR and its association with outcomes.

Methods: Patients undergoing transcatheter or surgical AVR from the PARTNER (Placement of Aortic Transcatheter Valves) 2 and 3 trials were pooled and classified by cardiac damage stage at baseline and 1 year (stage 0, no damage; stage 1, left ventricular damage; stage 2, left atrial or mitral valve damage; stage 3, pulmonary vasculature or tricuspid valve damage; and stage 4, right ventricular damage).

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Article Synopsis
  • TAVR is recognized as the standard treatment for severe aortic stenosis, making real-world data collection critical for assessing its benefits and risks across various health organizations, like the FDA and Medicare.
  • A systematic review of existing TAVR research was conducted to identify essential data elements necessary for efficient data collection, resulting in the consensus on 132 core elements from an original pool of 276.
  • The established core dataset aims to streamline evidence gathering for TAVR, enhancing regulatory submissions, safety monitoring, and evaluations of best practices in healthcare institutions.
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Article Synopsis
  • Transcatheter aortic valve replacement (TAVR) is the main treatment option for patients with severe aortic stenosis, and real-world data collection is crucial for evaluating its benefits and risks.
  • A systematic review was conducted to identify essential data elements needed for effective data collection related to TAVR, involving key organizations and experts.
  • The final consensus identified 132 core data elements, focusing on efficient, reusable data for regulatory, safety, and quality assessments while considering the practical challenges of data collection.
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Objectives: The purpose of this study is to investigate the viability of transcatheter aortic valve replacement (TAVR) for severe symptomatic aortic stenosis (AS) in patients with prior chest radiation therapy (cXRT).

Background: Since patients with prior cXRT perform poorly with surgical aortic valve replacement, TAVR can be a viable alternative. However, clinical outcomes after TAVR in this patient population have not been well studied.

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Background: Circadian rhythms may influence myocardial tolerance to ischemia-reperfusion phenomena occurring during cardiac procedures. While conflicting results exist on the effect of time-of-day on surgical aortic valve replacement (SAVR), afternoon procedures could be associated with a reduced risk of death, rehospitalization or periprocedural myocardial infarction, compared with morning procedures. We examined the impact of procedure time-of-day on outcomes after transcatheter aortic valve replacement (TAVR) or SAVR.

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Background: Randomized trials have shown short- and mid-term benefits with transcatheter versus surgical aortic valve replacement (TAVR versus SAVR) for patients at intermediate or low-risk for surgery. Frailty and prefrailty could explain some of this benefit due to an impaired ability to recover fully from a major surgical procedure.

Methods: We examined 2-year outcomes (survival and Kansas City Cardiomyopathy Questionnaire [KCCQ] scores) among patients at intermediate or low surgical risk treated with transfemoral-TAVR or SAVR within the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial, SAPIEN 3 intermediate-risk registry, and PARTNER 3 trial.

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Background: Surgical aortic valve replacement can be performed through a minimally invasive (MI) or full sternotomy (FS) approach. The present study compared outcomes of MI vs FS for isolated surgery among patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 3 low-risk trial.

Methods: Patients with severe, symptomatic aortic stenosis at low surgical risk with anatomy suitable for transfemoral access were eligible for PARTNER 3 enrollment.

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