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Related Concept Videos

Cardiac Catheterization II: Right Heart Catheterization01:21

Cardiac Catheterization II: Right Heart Catheterization

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Right Heart Catheterization: An OverviewRight heart catheterization is an invasive diagnostic procedure that measures right-sided cardiac and pulmonary artery pressures, calculates cardiac output, and identifies intracardiac shunts. It provides detailed hemodynamic data essential for diagnosing and managing various cardiovascular conditions, such as pulmonary hypertension.Access SitesCommon access sites for right heart catheterization include the internal jugular vein in the neck region, the...
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Cardiac Catheterization III: Left Heart Catheterization01:24

Cardiac Catheterization III: Left Heart Catheterization

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Left heart catheterization is an invasive diagnostic procedure used to evaluate the function and structure of the left side of the heart. It is generally performed to diagnose and treat cardiovascular conditions such as valve abnormalities, coronary artery disease, and congenital heart defects.Diagnostic and therapeutic purposesLeft heart catheterization serves various diagnostic and therapeutic purposes, including:Assessing coronary artery bypass grafts.Evaluating coronary artery disease in...
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Related Experiment Video

Updated: Jan 14, 2026

Real-Time Cardiac Mapping with a Noninvasive Imageless Electrocardiographic Imaging System
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Leadless Versus Transvenous Single-Chamber Ventricular Pacemakers: Real-World Evidence From Aveir VR Coverage With

James E Ip1, Peter A Brady2, Anne M Kroman3

  • 1Weill Cornell Medicine New York Presbyterian Hospital Division of Cardiology New York NY.

Journal of the American Heart Association
|October 23, 2025
PubMed
Summary
This summary is machine-generated.

The novel Aveir VR leadless pacemaker (LP) shows improved safety and fewer complications compared to traditional transvenous pacemakers (TV-VVI) in real-world Medicare data.

Keywords:
Aveirleadless pacemakersoutcomesreinterventionssafetytransvenous pacemakers

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Area of Science:

  • Cardiology and Medical Device Technology
  • Real-world evidence studies
  • Health outcomes research

Background:

  • The Aveir VR helix-fixation leadless pacemaker (LP) received FDA approval in 2022.
  • Real-world performance data comparing Aveir VR to transvenous single chamber ventricular pacemakers (TV-VVI) is limited.
  • This study evaluates the safety and outcomes of Aveir VR versus TV-VVI in Medicare beneficiaries.

Purpose of the Study:

  • To compare the safety and efficacy of the Aveir VR leadless pacemaker against traditional transvenous pacemakers.
  • To evaluate 30-day and 12-month complication rates, reinterventions, and mortality.
  • To assess real-world outcomes immediately following Aveir VR's commercialization.

Main Methods:

  • Observational study using Medicare fee-for-service and Abbott device registration data.
  • Identified de novo Aveir VR LP (6/2022-6/2024) and TV-VVI (1/2021-6/2024) implants.
  • Outcomes adjusted for demographics, comorbidities, and hospital characteristics.

Main Results:

  • Aveir VR showed significantly fewer acute device-related complications (1.4% vs 2.8%, P=0.002).
  • Overall 12-month complication rates were lower for Aveir VR (4.1% vs 5.7%, P=0.02), with 61% fewer reinterventions (1.2% vs 3.2%, P<0.0001).
  • Aveir VR demonstrated a lower 12-month mortality rate (17.0% vs 18.2%, P=0.02) with comparable 30-day mortality.

Conclusions:

  • Real-world evidence indicates superior safety for helix-fixation leadless pacemakers (Aveir VR) compared to traditional transvenous pacemakers (TV-VVI).
  • Aveir VR offers significant reductions in complications and reinterventions.
  • The findings support the safety and potential benefits of leadless pacemaker technology.