Publications by authors named "Makkar R"

Background: - Little is known about mitral transcatheter edge-to-edge repair (TEER) performed outside of usual working hours. We aimed to explore the prevalence, correlates, and outcomes of mitral TEER initiated off-hours, i.e.

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Background: Surgery remains an important treatment for low-risk patients with severe symptomatic aortic stenosis (AS). We evaluated 5-year outcomes in low-risk patients undergoing isolated surgical aortic valve replacement (SAVR) or SAVR with concomitant procedures within the randomized PARTNER 3 trial.

Methods: In the PARTNER 3 trial, 454 patients underwent surgery for severe, symptomatic, tri-leaflet AS and were followed for 5 years.

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Worldwide, valvular heart disease (VHD) is a common cause of hospitalization for acute heart failure. In acute heart failure caused by VHD, symptoms result from rapid haemodynamic changes and subsequent decline in cardiac function, and if left untreated, leads to acute decompensation and cardiogenic shock. Current evidence remains scarce and recommendations regarding the management of acute heart failure caused by VHD are lacking in most recent international guidelines.

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Article Synopsis
  • Untreated severe tricuspid regurgitation (TR) is linked to poor health outcomes, making effective treatment essential.
  • The study evaluated the 1-year results of transcatheter edge-to-edge repair (TEER) using the TriClip system in patients with complex tricuspid valve issues, finding significant improvements in patient survival and quality of life.
  • Results showed that 81% of patients experienced a reduction in TR to moderate or less after one year, with no major adverse effects noted in the first 30 days post-procedure.
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Transcatheter tricuspid valve replacement (TTVR) has emerged as a promising intervention for the treatment of severe tricuspid regurgitation with complex valve morphology. This consensus document provides a comprehensive overview of the current state of orthotopic TTVR, focusing on patient selection, procedural details, and follow-up care. Clinical outcomes from initial studies and compassionate use cases are discussed, highlighting the effectiveness of TTVR in reducing tricuspid regurgitation, inducing reverse right ventricular remodeling, and enhancing patients' quality of life.

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Background: Prognostically meaningful tricuspid regurgitation (TR) is not well-defined in the mitral transcatheter edge-to-edge repair arena. We aimed to explore the prevalence, correlates, and consequences of TR grades and postprocedural trends in this setting.

Methods And Results: A single-center registry of isolated, first-time interventions was retrospectively assessed for pre-, intra-, and postprocedural aspects up to 1 year, of them the primary composite outcome of all-cause deaths or heart failure (HF) hospitalizations, all according to TR severity at baseline and at 1 month following mitral transcatheter edge-to-edge repair.

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  • Balloon-expandable valves (BEVs) and self-expanding valves (SEVs) are compared for their effects on patients with Sievers type 1 bicuspid aortic valve (BAV) stenosis undergoing transcatheter aortic valve replacement.
  • The analysis, based on a registry of 955 patients, found no significant difference in midterm major adverse events or technical success between BEVs and SEVs after adjusting for baseline differences.
  • However, BEVs had lower risks of new permanent pacemaker implantation and moderate or greater paravalvular regurgitation, but a higher risk of severe patient-prosthesis mismatch compared to SEVs.
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Background: An enhanced classification of primary mitral regurgitation (PMR) based on extramitral cardiac involvement may refine patient selection and optimize the timing of transcatheter edge-to-edge repair (TEER).

Aims: This study aimed to assess the prognostic significance of a recently established classification system that characterizes the extent of extramitral cardiac damage in patients undergoing TEER for PMR.

Methods: Consecutive PMR patients who received MitraClip implantation were categorized according to the presence of extramitral cardiac damage, determined through preprocedural echocardiography.

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  • 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
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  • 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.
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  • - The TRILUMINATE Pivotal trial assessed the effects of tricuspid transcatheter edge-to-edge repair (T-TEER) on reducing tricuspid regurgitation (TR), a significant heart condition linked to increased health risks.
  • - Involving 572 patients, mostly elderly women with prior heart conditions, the trial found that T-TEER effectively improved quality of life, with nearly half of those treated experiencing significant improvements in heart health assessments.
  • - Results showed that while the treatment and control groups had similar rates of survival and heart-related surgeries, those who underwent T-TEER had notably better outcomes in TR severity and overall quality of life.
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Importance: Transcatheter aortic valve replacement (TAVR) is an established treatment option for many patients with severe symptomatic aortic stenosis; however, debris dislodged during the procedure can cause embolic stroke. The Sentinel cerebral embolic protection (CEP) device is approved for capture and removal of embolic material during TAVR but its efficacy has been debated.

Objective: To explore regional differences in the association of CEP utilization with stroke outcomes in patients undergoing TAVR.

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Background: For patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction, current guidelines recommend routine clinical surveillance every 6 to 12 months. Data from randomized trials examining whether early intervention with transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients are lacking.

Methods: At 75 centers in the United States and Canada, we randomly assigned, in a 1:1 ratio, patients with asymptomatic severe aortic stenosis to undergo early TAVR with transfemoral placement of a balloon-expandable valve or clinical surveillance.

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  • 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.
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  • The study examines the characteristics and outcomes of patients with tapered raphe-type bicuspid aortic valve (BAV) when undergoing trans-catheter aortic valve replacement (TAVR), focusing on the safety and effectiveness of modern heart valves.
  • Researchers analyzed data from 897 patients, finding that those with tapered configurations showed similar success rates and safety between two sizing strategies: annular and supra-annular.
  • The results indicate that TAVR is a safe and effective procedure for these patients, regardless of the sizing method used, maintaining a high rate of clinical efficacy at mid-term follow-up.
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Background: Research on the role of transcatheter heart valve (THV) deformation and calcium distribution in patients with bicuspid aortic valves (BAVs) undergoing transcatheter aortic valve replacement (TAVR) remains limited.

Objectives: The aim of this study was to evaluate the impact of THV deformation on clinical outcomes in individuals with BAVs undergoing TAVR and the influence of calcium on these outcomes.

Methods: In total, 229 consecutive patients with BAVs who underwent TAVR with balloon-expandable valves and had computed tomography (CT) performed 30 days post-TAVR were analyzed.

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Article Synopsis
  • The TRILUMINATE Pivotal trial investigated the impact of tricuspid regurgitation (TR) on end-organ function and the effectiveness of transcatheter edge-to-edge repair (TEER) compared to medical therapy alone in patients with severe TR.
  • The study included 572 patients who were split into TEER and control groups, examining how changes in end-organ function correlate with hospitalizations for heart failure (HF) and mortality over 12 months.
  • Results showed that while TEER did not significantly differ from medical therapy alone in overall end-organ function improvements, successful TEER did lead to enhanced function in specific patient subgroups, indicating potential benefits in targeted treatment.
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  • A study assessed the procedural and early outcomes of transjugular transcatheter tricuspid valve replacement (TTVR) for patients with symptomatic tricuspid regurgitation using the LuX-Valve Plus system across 15 centers from January 2022 to February 2024.
  • Among 76 patients with a median age of 78, the procedure significantly reduced tricuspid regurgitation, with 95% of patients showing improvement at one month.
  • While there were some adverse events including 4 in-hospital deaths and some bleeding, overall survival at one month was high at 94.4%, and patients reported better functional status.
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  • Tricuspid regurgitation (TR) is common in patients undergoing transcatheter aortic valve replacement (TAVR), but specific management guidelines are not clearly defined.
  • A study analyzed data from over 312,000 TAVR patients, finding that severe TR correlated with higher mortality rates both in-hospital and at one and three years post-procedure.
  • The research also indicated that a significant number of patients (76.4%) with severe TR improved after TAVR, and several factors predicted this improvement, although ongoing severe TR was linked to increased mortality.
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Transcatheter aortic valve (TAV) thrombosis may manifest as subclinical leaflet thrombosis (SLT) and clinical valve thrombosis. SLT is relatively common (10%-20%) after transcatheter aortic valve replacement, but clinical implications are uncertain. Clinical valve thrombosis is rare (1.

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Background Quantifying the fibrotic and calcific composition of the aortic valve at CT angiography (CTA) can be useful for assessing disease severity and outcomes of patients with aortic stenosis (AS); however, it has not yet been validated against quantitative histologic findings. Purpose To compare quantification of aortic valve fibrotic and calcific tissue composition at CTA versus histologic examination. Materials and Methods This prospective study included patients who underwent CTA before either surgical aortic valve replacement for AS or orthotopic heart transplant (controls) at two centers between January 2022 and April 2023.

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Tricuspid regurgitation (TR) is common, and its prevalence increases with age. It was previously estimated that there are 1.6 million patients in the United States with moderate or worse TR, and more contemporary data suggest the age-adjusted prevalence of TR is 0.

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Background: Transcatheter aortic valve replacement (TAVR) is an important treatment option for patients with severe symptomatic aortic stenosis. It is important to identify predictors of excellent outcomes (good clinical outcomes, more time spent at home) after TAVR that are potentially amenable to improvement.

Objectives: The purpose of the study was to use machine learning to identify potentially modifiable predictors of clinically relevant patient-centered outcomes after TAVR.

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