Publications by authors named "Paul Grayburn"
Background And Aims: The TRISCEND II trial demonstrated superior clinical benefits for patients with ≥severe tricuspid regurgitation (TR) treated with the EVOQUE transcatheter tricuspid valve replacement (TTVR) system plus medical therapy versus medical therapy alone. This work reports 1-year and 18-month outcomes in patients stratified by baseline TR severity.
Methods: The multicentre, prospective TRISCEND II trial enrolled 400 patients with symptomatic, ≥severe TR and randomised 2:1 to TTVR (n=267) or control (n=133).
Background: Differences between balloon- and self-expandable transcatheter heart valves (BE-THVs and SE-THVs, respectively) may influence the outcomes of transcatheter aortic valve replacement for bicuspid aortic valve (BAV) stenosis.
Methods: Consecutive patients undergoing transcatheter aortic valve replacement with BE-THV or SE-THV for computed tomography-diagnosed bicuspid aortic valve stenosis at 29 centers were included. The primary outcome was death or stroke.
The transcatheter EVOQUE tricuspid valve replacement system is an approved device for the treatment of patients with symptomatic severe tricuspid regurgitation despite medical therapy both in the United States and in Europe. Specific imaging requirements are needed in the screening and in the intraprocedural phase as well as to assess this valve after implantation, in order to assess its positioning and performance. In this review, focus will be on the postoperative echocardiographic assessment of device positioning and stability; evaluation of residual central tricuspid regurgitation or paravalvular leak; valve thrombosis/degeneration; interaction of the device frame with the right ventricle and adjacent structures, including the aortic valve and interventricular septum; and placement of pacemaker leads.
View Article and Find Full Text PDFBackground: Retrospective studies of patients with ischemic mitral regurgitation (iMR) undergoing coronary artery bypass grafting (CABG) with concomitant mitral valve surgery frequently report improved survival with mitral valve repair/annuloplasty (MVr) over replacement (MVR). However, the only randomized controlled trial found no survival difference.
Methods: Medicare claims data were queried to identify beneficiaries with iMR undergoing CABG/MVr or CABG/MVR.
Article Synopsis
- Severe tricuspid regurgitation (TR) significantly impacts patients' health status, affecting their symptoms, physical and social functions, and overall quality of life, but may improve with a procedure called transcatheter tricuspid valve replacement (TTVR).
- The TRISCEND II trial studied 400 patients with severe TR, comparing outcomes of those receiving TTVR combined with optimal medical therapy (OMT) to those receiving OMT alone, using established health status questionnaires.
- Results showed that patients receiving TTVR+OMT experienced significantly greater improvements in health status at every follow-up, with notable differences in scores indicating enhanced quality of life compared to those who only received
Article Synopsis
- A clinical trial was conducted with 400 patients suffering from severe tricuspid regurgitation, comparing outcomes between those who received transcatheter tricuspid-valve replacement alongside medical therapy and those who received medical therapy alone.
- The primary outcome measured included death rates, hospitalizations due to heart failure, and improvements in quality of life and functional capacity, showing a significant advantage for the valve-replacement group.
- After one year, the valve-replacement group demonstrated better overall health outcomes, although there was a higher incidence of severe bleeding compared to the control group.
EVOQUE Tricuspid Valve Replacement System: State-of-the-Art Screening and Intraprocedural Guidance.
JACC Cardiovasc Interv
September 2024
Article Synopsis
- The transcatheter EVOQUE tricuspid valve replacement system has been recently approved for treating severe tricuspid regurgitation, highlighting the importance of identifying suitable patients and their anatomical features.
- The document outlines necessary procedural steps and imaging techniques that facilitate successful implementation of the device.
- It also addresses how to manage complex situations that may arise during the procedure.
A Volume-Based Framework Reconciling COAPT, MITRA-FR, and RESHAPE-HF2.
J Am Coll Cardiol
December 2024
Pulmonary Vein Systolic Flow Reversal and Outcomes in Patients From the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) Trial.
Struct Heart
September 2024
Background: The implications of pulmonary vein (PV) flow patterns in patients with heart failure (HF) and mitral regurgitation (MR) are uncertain. We examined PV flow patterns in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) trial (NCT01626079), in which patients with HF and moderate-to-severe or severe functional MR were randomized to transcatheter edge-to-edge repair (TEER) with the MitraClip device plus guideline-directed medical therapy (GDMT) vs. GDMT alone.
View Article and Find Full Text PDFChanges in Left Ventricular Function and Outcomes After Trancatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation.
J Soc Cardiovasc Angiogr Interv
May 2024
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.
Cross-Validation of Risk Scores for Patients Undergoing Transcatheter Edge-to-Edge Repair for Mitral Regurgitation.
J Soc Cardiovasc Angiogr Interv
February 2024
Article Synopsis
- Risk scores like MitraScore and COAPT help identify patients with mitral regurgitation (MR) who are at risk of adverse events but may still benefit from transcatheter edge-to-edge repair (TEER).
- The study validated MitraScore in the COAPT trial with 614 patients and the COAPT risk score in the MIVNUT registry with 1007 patients, both focusing on predicting all-cause mortality over approximately 2 years.
- Results indicated that both scores had fair to good predictive accuracy for mortality, with higher effectiveness seen in TEER patients, confirming the benefits of combining TEER with guideline-directed medical therapy (GDMT) across different risk levels.
The Need for Comprehensive Risk Phenotyping in Aortic Stenosis.
JACC Cardiovasc Imaging
September 2024
Article Synopsis
- Severe tricuspid regurgitation is often inadequately treated due to a lack of effective options, but transcatheter tricuspid valve interventions are gaining attention as a potential solution.
- The TRISCEND II pivotal trial is the first randomized controlled trial to assess the safety and effectiveness of the EVOQUE transcatheter tricuspid valve replacement system, which received FDA Breakthrough Device Designation.
- This trial has a unique two-phase design that allows for early analysis of patient outcomes, helping to set a standard for future research in transcatheter valve devices.
Left Atrial Improvement in Patients With Secondary Mitral Regurgitation and Heart Failure: The COAPT Trial.
JACC Cardiovasc Imaging
September 2024
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.
View Article and Find Full Text PDFAims: This study aims to assess the applicability of the mitral regurgitation (MR) proportionality concept in patients with atrial functional mitral regurgitation (aFMR) treated with transcatheter edge-to-edge repair (M-TEER). We hypothesized that patients with disproportionate MR (higher MR relative to left ventricular size) would exhibit different outcomes compared to those with proportionate MR, despite undergoing M-TEER.
Methods And Results: We retrospectively analysed 98 patients with aFMR from the EuroSMR registry who underwent M-TEER between 2008 and 2019.
Background: Cardiovascular disease (CVD) is the leading cause of death worldwide, but prevalence estimates in former professional athletes are limited.
Objectives: HUDDLE (Heart Health: Understanding and Diagnosing Disease by Leveraging Echocardiograms) aimed to raise awareness and estimate the prevalence of CVD and associated risk factors among members of the National Football League (NFL) Alumni Association and their families through education and screening events.
Methods: HUDDLE was a multicity, cross-sectional study of NFL alumni and family members aged 50 years and older.
The Evolving Concept of Secondary Mitral Regurgitation Phenotypes: Lessons From the M-TEER Trials.
JACC Cardiovasc Imaging
June 2024
Conflicting results from 2 randomized clinical trials of transcatheter mitral valve edge-to-edge repair in secondary mitral regurgitation (SMR) have led to the recognition that SMR is a heterogeneous disease entity presenting with different functional and morphological phenotypes. This review summarizes the current knowledge on SMR caused primarily by atrial secondary mitral regurgitation (aSMR) and ventricular SMR pathology. Although aSMR is generally characterized by severe left atrial enlargement in the setting of preserved left ventricular anatomy and function, different patterns of mitral annular distortion cause different phenotypes of aSMR.
View Article and Find Full Text PDFArticle Synopsis
- Transcatheter edge-to-edge mitral valve repair (TEER) is a beneficial treatment for patients with severe mitral regurgitation who cannot undergo traditional surgery, and outcomes vary based on the repair center's volume.
- A study analyzing data from over 41,000 patients found that while TEER success rates were similar across different volume centers, higher-volume surgical centers showed better long-term outcomes, including lower one-year mortality and heart failure readmissions.
- The findings suggest that although TEER can be performed safely in low-volume centers, higher surgical volumes correlate with improved patient recovery and reduced risks over time.
Background: Functional tricuspid regurgitation (TR) can develop either because of right ventricular (RV) remodeling (ventricular functional TR) and/or right atrial dilation (atrial functional TR).
Objectives: This meta-analysis aimed to investigate the association between right heart remodeling and long-term (>1 year) all-cause mortality in patients with significant TR (at least moderate, ≥2+).
Methods: MEDLINE, ISI Web of Science, and SCOPUS databases were searched.
Tricuspid regurgitation burden following transcatheter aortic valve replacement requiring early pacemaker implantation.
Proc (Bayl Univ Med Cent)
February 2024
Background: Conduction abnormality requiring the implantation of a permanent pacemaker (PPM) is a well-known and clinically important complication of transcatheter aortic valve replacement (TAVR). However, PPM implantation may result in lead-associated tricuspid valve regurgitation (TR). This study sought to determine the incidence and progression of TR following PPM implantation after TAVR.
View Article and Find Full Text PDFGuidelines for the Evaluation of Prosthetic Valve Function With Cardiovascular Imaging: A Report From the American Society of Echocardiography Developed in Collaboration With the Society for Cardiovascular Magnetic Resonance and the Society of Cardiovascular Computed Tomography.
J Am Soc Echocardiogr
January 2024
In patients with significant cardiac valvular disease, intervention with either valve repair or valve replacement may be inevitable. Although valve repair is frequently performed, especially for mitral and tricuspid regurgitation, valve replacement remains common, particularly in adults. Diagnostic methods are often needed to assess the function of the prosthesis.
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