Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting.
Clinical trial
Heart failure
Stem cell
Therapeutics
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
received:
10
04
2020
revised:
26
06
2020
accepted:
26
06
2020
pubmed:
12
7
2020
medline:
19
8
2021
entrez:
12
7
2020
Statut:
ppublish
Résumé
The aim of this study was to characterize the clinical safety profile of transendocardial injection catheters (TIC) reported in the published literature. Transendocardial delivery is a minimally invasive approach to deliver potential therapeutic agents directly into the myocardium. The rate of adverse events across TIC is uncertain. A systematic search was performed for trial publications using TIC. Procedure-associated adverse event data were abstracted, pooled and compared across catheters for active treatment and placebo injected patients. The transendocardial injection associated serious adverse events (TEI-SAE) was defined as the composite of death, myocardial infarction, stroke or transient ischemic attack within 30 days and cardiac perforation causing death or requiring evacuation, serious intraprocedural arrhythmias and serious coronary artery or peripheral vascular complications. The search identified 4 TIC systems: a helical needle (HN), an electro-anatomically tracked straight needle (EAM-SN), a straight needle without tracking elements (SN), and a curved needle (CN). Of 1799 patients who underwent transendocardial injections, the combined TEI-SAE was 3.4% across all catheters, and 1.1%, 3.3%, 7.1%, and 8.3% for HN, EAM-SN, SN and CN, respectively. However, TIC procedure duration and post procedural cardiac biomarker levels were reported in only 24% and 36% of published trials, respectively. Transendocardial injection is associated with varied TEI-SAE but the data are very limited. The HN catheter appeared to be associated with lower TEI-SAE, versus other catheters. Procedure duration and post procedure cardiac biomarker levels were under-reported. Clearly, standardized, procedure-related event reporting for trials involving transcatheter delivery would improve our understanding of complications across different systems.
Sections du résumé
OBJECTIVES
The aim of this study was to characterize the clinical safety profile of transendocardial injection catheters (TIC) reported in the published literature.
BACKGROUND
Transendocardial delivery is a minimally invasive approach to deliver potential therapeutic agents directly into the myocardium. The rate of adverse events across TIC is uncertain.
METHODS
A systematic search was performed for trial publications using TIC. Procedure-associated adverse event data were abstracted, pooled and compared across catheters for active treatment and placebo injected patients. The transendocardial injection associated serious adverse events (TEI-SAE) was defined as the composite of death, myocardial infarction, stroke or transient ischemic attack within 30 days and cardiac perforation causing death or requiring evacuation, serious intraprocedural arrhythmias and serious coronary artery or peripheral vascular complications.
RESULTS
The search identified 4 TIC systems: a helical needle (HN), an electro-anatomically tracked straight needle (EAM-SN), a straight needle without tracking elements (SN), and a curved needle (CN). Of 1799 patients who underwent transendocardial injections, the combined TEI-SAE was 3.4% across all catheters, and 1.1%, 3.3%, 7.1%, and 8.3% for HN, EAM-SN, SN and CN, respectively. However, TIC procedure duration and post procedural cardiac biomarker levels were reported in only 24% and 36% of published trials, respectively.
CONCLUSIONS
Transendocardial injection is associated with varied TEI-SAE but the data are very limited. The HN catheter appeared to be associated with lower TEI-SAE, versus other catheters. Procedure duration and post procedure cardiac biomarker levels were under-reported. Clearly, standardized, procedure-related event reporting for trials involving transcatheter delivery would improve our understanding of complications across different systems.
Identifiants
pubmed: 32651159
pii: S1553-8389(20)30416-4
doi: 10.1016/j.carrev.2020.06.031
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
100-108Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Disclosures ANR: Research or educational grants from Fujifilm Cellular Dynamics, Siemens Healthcare, BioCardia, Biologics Delivery Systems, Johnson & Johnson and Cellular Logistics Inc., NIH/NHLBI 1U01HL148690-01, NIH 5T32HL007936-15. Consultant - Cellular Logistics Inc., Blue Rock Therapeutics Inc. CJP: Research or educational grants to the University of Florida-Amarin; AMGEN; Alnylam; AstraZeneca; BioCardia, Inc.; Biologic Delivery Systems, Johnson & Johnson, Brigham and Women's Hospital via NHLBI; CSL Behring; LLC &Duke University for DCRI; DoD CDMRP PR161603; Capricor Inc.; Cytori Therapeutics; GE Health Care; McJunkin Family Foundation; PCORnet; Mesoblast, Inc.; NIH/NHLBI 1 R01 HL146158-01, R01 HL132448 and UM1 HL087366; Pfizer; and Sanofi US Services, Inc. Consultant-BioCardia Inc.; Cladriuis Biosciences, Inc.; Imbria Pharmaceuticals, Inc.; Ironwood Pharmaceuticals, Inc.; Mesoblast, Inc.; Milestone Pharmaceuticals; Novartis Pharmaceuticals; Takeda Pharmaceutical USA, Inc.; Verily Life Sciences LLC; and XyloCor Therapeutics, Inc.