Evidence map›Paper›PMID 35334060›Full record

ReviewJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2023

Evaluation of cardiovascular implantable electronic device leads post implant: ElectroPhysiology Predictable And SuStainable Implementation Of National Registries (EP PASSION).

Sanket S Dhruva, Emily P Zeitler, Daniel Caños, Hetal Odobasic, Jacqueline M Major, Li Wang, Steven Mullane, Yelena Nabutovsky, Valerie Smith, Lei Zhang and 1 more

Abstract readReview
PubMed Publisher
In one paragraph

Review in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
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  4. Using real-world data from health systems to evaluate the safety and effectiveness of a catheter to treat ischemic ventricular tachycardia.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2023
    Article
  5. Article
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  7. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Sanket S DhruvaUniversity of California San Francisco School of Medicine, San Francisco, CA, USA. sanket.dhruva@ucsf.edu.ORCID http://orcid.org/0000-0003-0674-2032
Emily P ZeitlerGeisel School of Medicine at Dartmouth, Hanover, NH, USA.ORCID http://orcid.org/0000-0002-4848-4775
Daniel CañosCenter for Devices and Radiological Health, Food and Drug Administration, White Oak, MD, USA.
Hetal OdobasicCenter for Devices and Radiological Health, Food and Drug Administration, White Oak, MD, USA.
Jacqueline M MajorCenter for Devices and Radiological Health, Food and Drug Administration, White Oak, MD, USA.
Li WangCenter for Devices and Radiological Health, Food and Drug Administration, White Oak, MD, USA.
Steven MullaneBIOTRONIK, Inc, Lake Oswego, OR, USA.ORCID http://orcid.org/0000-0002-3877-4322
Yelena NabutovskyAbbott, Santa Clara, CA, USA.
Valerie SmithBoston Scientific, St. Paul, MN, USA.
Lei ZhangMedtronic, Fridley, MN, USA.ORCID http://orcid.org/0000-0002-3067-305X
Kimberly A SelzmanVeterans Affairs Salt Lake City Health Care System, Salt Lake City, UT, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Post-market evaluation is important to ensure the ongoing safety and effectiveness of cardiovascular implantable electronic device (CIED) leads. The Twenty-First Century Cures Act and subsequent Food and Drug Administrative (FDA) Guidance provide an opportunity to leverage real-world data sources for this purpose. The past 4 years have seen the development of EP PASSION: a multi-stakeholder, collaborative effort between the FDA, CIED manufacturers, Heart Rhythm Society, and academics. Using real-world data, EP PASSION enables longitudinal evaluation of the long-term safety of CIED leads, addressing limitations of current approaches to generate evidence that informs regulatory, clinical, and manufacturer decision-making. This state of the art article describes the impetus for and launch of EP PASSION, the lessons learned, its current state, the current analytic approach, and the strengths and limitations of leveraging extant data sources for post-market lead evaluation. We also compare EP PASSION to traditional post-approval studies and describe possible future directions.

Indexed as

Cardiac ElectrophysiologyDefibrillators, ImplantableHumansLungRegistriesAdverse eventsCardiovascular implantable electronic devicesLeadsPost-marketReal-world evidenceSurveillance

Identifiers

PMID35334060

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.