Evaluation of cardiovascular implantable electronic device leads post implant: ElectroPhysiology Predictable And SuStainable Implementation Of National Registries (EP PASSION).
J Interv Card Electrophysiol
; 66(4): 997-1004, 2023 Jun.
Article
em En
| MEDLINE
| ID: mdl-35334060
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.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Desfibriladores Implantáveis
/
Eletrofisiologia Cardíaca
Tipo de estudo:
Guideline
/
Prognostic_studies
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Risk_factors_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article