Publications by authors named "Michael J Reardon"

Secondary mitral regurgitation (SMR) remains a prevalent and challenging complication in patients with heart failure (HF), associated with poor prognosis despite optimal guideline-directed medical therapy (GDMT) and cardiac resynchronization therapy. Current American and European guidelines recommend GDMT as first-line therapy, with transcatheter edge-to-edge repair (TEER) reserved for severe symptomatic SMR patients who remain refractory. However, both guidelines preceded the reporting of pivotal randomized controlled trials (RESHAPE-HF2, MATTERHORN, and EFFORT) and emerging evidence in new clinical scenarios.

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•Pressure-regulated deployment (PRD) results in consistent and excellent transcatheter aortic valve (TAV) performance.•PRD produces superior valve hemodynamics in patients with small aortic annuli.•PRD mitigates the risk of annular injury even among patients at high anatomic risk.

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Background: Severe tricuspid regurgitation (TR) is associated with poor prognosis, and guideline-directed medical therapy (GDMT) alone has limited efficacy. Transcatheter edge-to-edge repair (T-TEER) has emerged as a promising therapeutic option, but its impact on clinical outcomes remains debated.

Aims: Evaluation of the efficacy and safety of T-TEER compared to GDMT.

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Background: A recently proposed staging system for cardiac structural and functional abnormalities demonstrated incremental prognostic value in aortic stenosis.

Objectives: The authors investigate a staging system incorporating cardiac magnetic resonance (CMR) in moderate or severe aortic regurgitation (AR).

Methods: Patients prospectively enrolled in DEBAKEY-CMR (DeBakey Cardiovascular Magnetic Resonance Study; NCT04281823) between 2009 and 2020 who had moderate or severe AR by CMR were studied.

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Background: ACURATE neo2 is an open-cell, supra-annular, self-expanding transcatheter heart valve that is commercially available in over 50 countries but has not previously been evaluated in a randomised trial. ACURATE-IDE aimed to prospectively evaluate the safety and efficacy of transcatheter aortic valve replacement (TAVR) with the ACURATE neo2 valve compared with commercially available valves for the treatment of severe symptomatic aortic stenosis.

Methods: In this multicentre, randomised, controlled, non-inferiority trial, patients with symptomatic severe aortic stenosis and any level of surgical risk were recruited from 71 medical centres in the USA and Canada.

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Background: In the ACURATE IDE (Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement) randomized controlled trial, ACURATE neo2 failed to show noninferiority to commercially available balloon-expandable (SAPIEN 3/3 Ultra) and self-expanding (Evolut R/PRO/PRO+/FX) valves for the primary endpoint of all-cause mortality, stroke, or rehospitalization at 1 year. A retrospective investigation was undertaken to evaluate potential factors contributing to these outcomes.

Objectives: The goal of this study was to assess the impact of ACURATE neo2 valve expansion on clinical outcomes in the ACURATE IDE trial.

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Background: The clinical significance of elevated baseline natriuretic peptide level and prior heart failure hospitalization (HFH) within the prior year in mitral transcatheter edge-to-edge repair outcomes is unclear. This analysis examined the impact of BNP (B-type natriuretic peptide) or NT-proBNP (N-terminal pro-B-type natriuretic peptide) and prior HFH on outcomes in patients with severe secondary mitral regurgitation.

Methods: The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) was a randomized controlled trial of subjects assigned to mitral valve transcatheter edge-to-edge repair with the MitraClip device versus guideline-directed medical therapy alone.

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Introduction: Bicuspid aortic valve affects 0.5-2% of the population in developed countries. Given uncertainties about the best aortic valve replacement (AVR) option in this often younger, low-risk, population, it is important to understand how newer bioprostheses perform in these patients.

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Background: The impact of mitral valve (MV) surgery type after failed mitral transcatheter edge-to-edge repair (M-TEER) has not been well studied.

Objectives: The aim of this study was to compare the outcomes of MV repair vs replacement after failed M-TEER.

Methods: From 2009 to 2020, a total of 332 patients across 34 centers from the CUTTING-EDGE registry underwent MV surgery after M-TEER.

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Background: There are limited data comparing coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) in patients presenting with non-ST-segment elevation acute coronary syndrome (NSTE-ACS).

Objectives: The aim of this study was to evaluate differences in outcomes in patients presenting with or without NSTE-ACS after CABG compared with fractional flow reserve (FFR)-guided PCI using current generation drug-eluting stents.

Methods: The FAME 3 trial (Fractional flow reserve versus Angiography for Multivessel Evaluation; NCT02100722) was an investigator-initiated, randomized controlled trial to attest noninferiority of FFR-guided PCI using the current-generation drug-eluting stents to CABG with respect to the primary endpoint, defined as a composite of death, myocardial infarction (MI), stroke, or repeat revascularization at 1 year, in 1,500 patients with 3-vessel coronary artery disease.

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Background: The incidence and clinical importance of bioprosthetic valve dysfunction (BVD) in patients undergoing supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) or surgery is not well understood.

Objectives: The purpose of this study was to evaluate the 5-year incidence and clinical outcomes of BVD in patients undergoing CoreValve/Evolut TAVR or surgery.

Methods: This post hoc analysis pooled data from the U.

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Article Synopsis
  • The FAME 3 trial analyzed the long-term effectiveness of FFR-guided PCI versus CABG in patients with three-vessel coronary artery disease over a 5-year period, involving multiple hospitals across Europe, the USA, Canada, Australia, and Asia.
  • Results showed no significant differences in major adverse outcomes (death, stroke, or myocardial infarction) between the PCI and CABG groups, with 16% of PCI patients and 14% of CABG patients experiencing these events by the end of the study.
  • The trial's findings indicate that both treatment options have similar long-term outcomes, as the rates of death and other complications were comparable for both techniques, suggesting that advancements in care did not
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Background: The Evolut Low Risk trial demonstrated that transcatheter aortic valve replacement (TAVR) was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. Outcomes at 5 years have not been reported.

Objectives: This study sought to evaluate 5-year clinical and hemodynamic outcomes with TAVR vs surgery in patients from the Evolut Low Risk trial.

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Background: Current treatment paradigms assume aortic regurgitation (AR) patients to be a homogenous population, but varied courses of disease progression and outcomes are observed clinically.

Objectives: The aim of this study was to first use unsupervised machine learning to identify unique patient phenoclusters in AR, and subsequently evaluate their prognostic relevance.

Methods: Clinical and cardiac magnetic resonance (CMR) characterization of moderate or severe AR patients was performed across 4 U.

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•Study design: Utilized the National Readmission Database from 2018-2020. The study included patients over 18 years of age who underwent transcatheter edge-to-edge repair and analyzed readmission for mitral valve (MV) surgery within 180 days.•Readmission rate: Only 1.

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This updated Heart Valve Collaboratory framework addresses the growing concern for transcatheter valve failure (TVF) following transcatheter aortic valve replacement (TAVR). With the increasing volume of redo-TAV and surgical TAV explantation, there is a critical need for standardized pathways and protocols for evaluating TVF using echocardiography and cardiac computed tomography (CT) angiography. This document clarifies prior definitions of bioprosthetic valve deterioration and bioprosthetic valve failure in a practical, imaging directed context for TAVR.

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Background: The native aortic annulus for self-expanding transcatheter aortic valve replacement (TAVR) has variable ellipticity. A noncircular and underexpanded transcatheter aortic valve (TAV) may impact hemodynamic performance. This study aimed to quantify Evolut TAV (Medtronic) frame ellipticity and expansion 30 days post-TAVR and evaluate their impact on 1-year hypoattenuating leaflet thickening and 4-year hemodynamics.

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Background: Longer-term outcomes are especially important for lower-risk patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Additional randomized data comparing TAVR and SAVR have recently become available.

Objectives: The purpose of this study was to perform an updated systematic review with conventional pairwise meta-analyses and pooled survival analyses using reconstructed time-to-event individual participant data (IPD) including the totality of randomized evidence comparing longer-term clinical outcomes after TAVR and SAVR in lower-risk patients.

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Around 2% of resected cardiac masses are ascribed to primary cardiac hemangiomas. With a variety of symptoms and variable natural history, these masses can be challenging to diagnose. This paper describes a case of a left ventricular mass in a young patient which was ultimately excised and diagnosed as a cavernous hemangioma.

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Background: Hypoattenuated leaflet thickening (HALT) is believed to reflect leaflet thrombosis; however, no systematic histological examination of HALT has ever been performed. The aim of this study was to evaluate histological findings of explanted self-expanding transcatheter aortic bioprosthetic valves from clinical trials and to compare microCT findings of suspected HALT with histology findings of valve thrombosis and its characterization over time.

Methods: A total of 123 self-expanding transcatheter aortic valves were collected through autopsy (n=89) or surgical explant (n=34) from 11 CoreValve/Evolut clinical trials.

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Tricuspid regurgitation (TR) is a common valvular heart disease that is associated with increased morbidity and mortality. Traditional surgical interventions, though definitive, carry considerable complexities and risks, especially for high-risk patients, with in-hospital mortality rates of ˜9%. This resulted in the undertreatment of many patients with TR, creating a substantial unmet need.

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