Related Experiment Video
Updated: Sep 20, 2025
Creation of Patient-Specific Silicone Cardiac Models with Applications in Pre-surgical Plans and Hands-on Training
Published on: February 10, 2022
[Proposal of a common model for informed consent for interventional procedures in congenital heart disease patients]
Massimo Chessa1, Gabriella Agnoletti2, Ilaria Amici3
1Unità di Cardiologia del Congenito Adulto, Centro di Cardiologia Pediatrica e del Congenito Adulto, IRCCS Policlinico San Donato, San Donato Milanese (MI) - Università Vita Salute San Raffaele, Milano.
Insights
A new informed consent form for interventional procedures in congenital cardiology was developed by physicians and jurists. This standardized document aims to improve patient care and meet new legal requirements for congenital heart disease centers.
Area of Science:
- Cardiology
- Medical Law
- Patient Advocacy
Background:
- A multidisciplinary group of physicians and jurists convened to address informed consent for common interventional procedures in congenital heart disease.
- Existing consent processes required review and standardization to meet current medical and legal expectations.
Purpose of the Study:
- To develop and approve a comprehensive informed consent document for frequent interventional procedures in pediatric cardiology.
- To ensure the informed consent process aligns with evolving legal standards and patient needs.
Main Methods:
- Collaboration between physicians from the Italian Society of Pediatric Cardiology and Congenital Heart Disease (SICP) and legal experts in health case-law.
- Consultation with major Italian centers performing congenital interventional procedures and the Italian Patients Association of Congenital Heart Diseases (AICCA).
Main Results:
- A finalized informed consent form was created, comprising a general statement and a procedure-specific section.
- The developed form is suitable for direct use or adaptation by individual centers.
Conclusions:
- The multidisciplinary effort, supervised by SICP, yielded a novel informed consent for congenital cardiology interventions, addressing legal requirements.
- Standardized or harmonized informed consent forms across Congenital Heart Disease Centers are proposed to enhance patient and family care.
Background:
A multidisciplinary study group involving physicians and jurists was established to review and approve an informed consent about the most frequent interventional procedures for congenital heart diseases.
Methods:
The authors worked together with representatives of the Italian Society of Pediatric Cardiology and Congenital Heart Disease (SICP) Council and Jurist's expert in the field of health case-law. The final draft was shared with the major Italian centers involved in congenital interventional procedures and with AICCA, the Italian Patients Association of Congenital Heart Diseases - Adults and Children.
Results:
At the end of this review process, a final informed consent form was developed for the most frequent procedures performed in our catheterization laboratories. All of them consist of two parts: a general statement and a procedure-related one.
Conclusions:
The work performed by this multidisciplinary study group, under the supervision of the SICP, resulted in a new dedicated informed consent about interventional procedures in the field of congenital cardiology, taking into account the new legal requests. This informed consent is intended to be both a document that can be used as such and a document from which to derive a specific document for each center. We believe that using similar informed consents in all Congenital Heart Disease Centers or at least have informed consents all inspired by the same setting, could be a further improvement in taking care of the patients and their families.
More Related Videos
Related Concept Videos
01:28Cardiac Catheterization I: Pre-Procedure Overview
01:29Cardiomyopathy V: Interprofessional Care