Publications by authors named "Raj R Makkar"

Background: There is paucity of data regarding sex-related differences among patients with bicuspid aortic valve (BAV) undergoing transcatheter aortic valve replacement (TAVR).

Methods: The AD-HOC was an observational, retrospective, investigator-initiated registry enrolling consecutive patients with Sievers type 1 BAV stenosis who underwent TAVR at 24 international centers from 2016 to 2023. The primary endpoint was major adverse events (MAEs), including death, neurologic events and heart failure hospitalization.

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Background: Mitral annular calcification (MAC) presents challenges for transcatheter edge-to-edge repair (TEER). Limited data exist on how the anatomical features of MAC, assessed by computed tomography (CT), may be associated with TEER outcomes.

Aims: We sought to examine the association between CT features of MAC and clinical outcomes after TEER at 3 years.

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Background: Bicuspid aortic valve (BAV) stenosis poses several challenges when transcatheter aortic valve implantation (TAVI) is performed, including the risk of high residual gradients (HRG).

Objective: To identify incidence, predictors and outcomes of HRG after TAVI in Sievers type 1 BAV stenosis.

Methods: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVI at 24 international centers from 2016 to 2023 were enrolled.

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Background: Transcatheter tricuspid valve replacement (TTVR) has been introduced as a minimally invasive treatment for tricuspid regurgitation. Cardiac implantable electronic devices (CIEDs) commonly coexist with tricuspid regurgitation, and TTVR may cause bradyarrhythmias necessitating pacing.

Objective: The purpose of this study was to describe CIED outcomes after TTVR, including the incidence of bradyarrhythmias and pacemaker implantation, as well as outcomes in patients with preexisting CIEDs.

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Background: Iatrogenic atrial septal defects (iASD) are created during transseptal (TS) mitral valve-in-valve (MViV) implantation to facilitate access. Although most iASD remain untreated, the outcomes of closing iASD during TS MViV are unclear. This study evaluates outcomes of concomitant iASD closure during TS MViV.

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Background: The clinical impact of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) is not well known in young and low-risk patients.

Objectives: The aim of this single-center study was to evaluate the incidence, predictors, and long-term impact of PPM in young and low-risk patients with severe native aortic stenosis (AS) following TAVR.

Methods: From August 2015 to December 2022, a total of 3,549 patients underwent TAVR with newer generation balloon-expandable valves.

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Background: In patients with diabetes mellitus (DM) and high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI), the optimal duration of dual antiplatelet therapy (DAPT) remains uncertain.

Aims: We sought to compare early DAPT discontinuation in DM and non-DM patients enrolled in the prospective XIENCE Short DAPT programme.

Methods: The effects of 1- versus 3-month DAPT on ischaemic and bleeding outcomes were compared using propensity score stratification.

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Background: Sievers type 1 bicuspid aortic valve (BAV) stenosis presents unique challenges for trans-catheter aortic valve implantation (TAVI), particularly when calcified raphe is present. The impact of raphe localization on TAVI outcomes remains unclear.

Objectives: This study aimed to compare procedural and clinical outcomes in patients with right-left (R-L) and right-non coronary (R-NC) raphe-type BAV treated with TAVI.

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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: Subclinical leaflet thrombosis, as indicated by hypoattenuated leaflet thickening (HALT) on computed tomography (CT) imaging, remains a major concern owing to its potential impact on valve function and patient outcomes.

Aims: We aimed to evaluate the association between HALT and clinical outcomes in patients undergoing valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) with balloon-expandable valves and to identify predictors of leaflet thrombosis.

Methods: Consecutive patients who underwent ViV TAVI with balloon-expandable valves at the Cedars-Sinai Medical Center were retrospectively analysed.

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Background: Quantifying hypoattenuating leaflet thickening (HALT) on computed tomography angiography (CTA) may provide insights into its clinical implications and guide decisions on oral anticoagulation therapy following transcatheter aortic valve implantation (TAVI).

Aims: We sought to assess the association between quantitative CTA features of HALT and its evolution over time in a real-world cohort after TAVI.

Methods: Among 612 patients who underwent CTA 30 days post-TAVI with balloon-expandable bioprostheses, HALT was detected in 118 (19%).

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Background: One-year outcomes of TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System Pivotal) found that transcatheter edge-to-edge repair (TEER) for the treatment of severe, symptomatic tricuspid regurgitation improved quality of life compared with medical therapy alone with similar rates of mortality and heart failure hospitalization. However, additional follow-up is necessary to determine the prolonged benefits of tricuspid TEER.

Methods: A total of 572 patients with severe, symptomatic tricuspid regurgitation were randomized to either tricuspid TEER+medical therapy (device group) or medical therapy alone (control).

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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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Article Synopsis
  • This study focused on comparing long-term outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in lower-risk patients with severe aortic stenosis.
  • The analysis included data from six trials with over 5,300 participants and found that TAVR led to a 20% lower risk of all-cause death and a 19% lower risk of death or disabling stroke compared to SAVR after five years.
  • However, there was no significant difference in stroke rates between the two procedures.
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Background: Valve-in-valve transcatheter aortic valve replacement (TAVR) is a recognized alternative for treating the structural valve deterioration of bioprosthetic valves. Recent guidelines and trials have expanded the indications for TAVR to include younger patients with structural valve deterioration. In this study, we aimed to examine the outcomes of valve-in-valve TAVR across different age groups to understand the age-related clinical outcomes of treating structural valve deterioration following surgical aortic valve replacement and TAVR.

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Background: Lifetime treatment of aortic valve disease is a matter of increasing debate. Although the risks of a second aortic valve intervention are recognized, little attention has been given to the challenges of a third.

Objectives: This study delves into the clinical characteristics, indications, and outcomes of patients undergoing 3 aortic valve interventions.

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Article Synopsis
  • The study examines the outcomes of mitral transcatheter edge-to-edge repair (TEER) performed during off-hours (before 7:30 am, after 5:30 pm, or on weekends/holidays) to see how they compare to procedures done during regular hours.
  • The analysis included 1,177 procedures, with 117 (9.9%) occurring off-hours; off-hours procedures were often urgent and involved higher-risk patients, yet technical success was high in both groups.
  • Although baseline MR severity and functional class improved for both groups, off-hours patients experienced higher rates of deaths and heart failure hospitalizations, with no procedural timing linked to outcomes in matched comparisons, suggesting experienced interventionalists can conduct these procedures safely regardless
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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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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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Article Synopsis
  • 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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Article Synopsis
  • - 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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