How to advance from minimally invasive coronary artery bypass grafting to totally endoscopic coronary bypass grafting: challenges in Europe versus United States of America

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F24%3A00010005" target="_blank" >RIV/00023884:_____/24:00010005 - isvavai.cz</a>

Result on the web

<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC11491180/" target="_blank" >https://pmc.ncbi.nlm.nih.gov/articles/PMC11491180/</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.21037/acs-2023-rcabg-0210" target="_blank" >10.21037/acs-2023-rcabg-0210</a>

Result language

angličtina

Original language name

How to advance from minimally invasive coronary artery bypass grafting to totally endoscopic coronary bypass grafting: challenges in Europe versus United States of America

Original language description

Robotic coronary and intra-cardiac surgery has been available for more than 25 years. In this period, multiple studies have demonstrated the beneficial effects of robotic surgery over conventional open surgery. Throughout the years, technical developments have enabled us to perform totally endoscopic coronary artery bypass (TECAB) grafting. But these techniques remained in the hands of a small group of pioneers because of a lack of structured training programs and the absence of long-term results at that time. Currently, a renewed interest and a wide dispersion of robotic platforms, thanks to use of robotics in other disciplines, has led to an exponential increase in robotic cardiac centers both in Europe and USA. Nonetheless, this increase was slowed down in Europe as a result of the uncertainty introduced by the implementation of a revised regulatory framework for medical devices [Regulation 2017/745, 'Medical Device Regulation' ('MDR')]. The MDR was introduced with the goal of increasing patient safety and supporting innovation. Implementing the MDR has proven to be exceptionally challenging and risks to the supply of essential devices have been identified. Changes to both regulatory and market dynamics led to a circumstance where the only available robotic platform for cardiac surgery decided to cease marketing of essential accessories for conducting surgery. This resulted in the disappearance of dedicated tools such as the Endowrist stabilizer, essential for TECAB, and the atrial retractor which is essential for intra-cardiac surgery. In the mean-time, further clinical evidence was published demonstrating the superiority of robotic cardiac surgery over other minimally invasive approaches. This has demonstrated the need to better define the clinical evidence requirements for regulatory purposes to ensure that dedicated tools for evidence-based interventions in robotic coronary surgery remain available such that TECAB can continue in Europe.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30201 - Cardiac and Cardiovascular systems

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2024

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Annals of Cardiothoracic Surgery

ISSN

2225-319X

e-ISSN

—

Volume of the periodical

13

Issue of the periodical within the volume

5

Country of publishing house

AU - AUSTRALIA

Number of pages

12

Pages from-to

397-408

UT code for WoS article

001341287200002

EID of the result in the Scopus database

2-s2.0-85206132970