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.

Cardiothoracic Surgery Department Na Homolce Hospital Prague Czech Republic

Cardiovascular Center Aalst OLV Clinic Aalst Aalst Belgium

Department of Cardiac Surgery Humanitas Gavazzeni Bergamo Italy

Department of Cardiac Surgery University Medical Centre Utrecht Utrecht The Netherlands

Department of Cardio Thoracic Surgery University Hospital Henri Mondor Assistance Publique Hopitaux de Paris Créteil Paris France

Department of Cardiovascular Sciences Research Unit of Cardiac Surgery KU Leuven Leuven Belgium

Department of Cardiovascular Surgery Robert Bosch Hospital Stuttgart Germany

Division of Cardiac Surgery Department of Cardiothoracic Surgery University of Pittsburgh Medical Center Pittsburgh PA USA

ISALA Hospital Zwolle The Netherlands

School of Medicine Trinity College Dublin Dublin Ireland

The Liverpool Heart and Chest Hospital NHS Foundation Trust Liverpool UK

See more in PubMed

van Domburg RT, Kappetein AP, Bogers AJ. The clinical outcome after coronary bypass surgery: a 30-year follow-up study. Eur Heart J 2009;30:453-8. 10.1093/eurheartj/ehn530 PubMed DOI

Benetti FJ, Ballester C. Use of thoracoscopy and a minimal thoracotomy, in mammary-coronary bypass to left anterior descending artery, without extracorporeal circulation. Experience in 2 cases. J Cardiovasc Surg (Torino) 1995;36:159-61. PubMed

Gaudino M, Audisio K, Rahouma M, et al. Comparison of Long-term Clinical Outcomes of Skeletonized vs Pedicled Internal Thoracic Artery Harvesting Techniques in the Arterial Revascularization Trial. JAMA Cardiol 2021;6:1380-6. 10.1001/jamacardio.2021.3866 PubMed DOI PMC

Duhaylongsod FG, Mayfield WR, Wolf RK. Thoracoscopic harvest of the internal thoracic artery: a multicenter experience in 218 cases. Ann Thorac Surg 1998;66:1012-7. 10.1016/s0003-4975(98)00731-0 PubMed DOI

Cerny S, Oosterlinck W, Onan B, et al. Robotic Cardiac Surgery in Europe: Status 2020. Front Cardiovasc Med 2022;8:827515. Erratum in: Front Cardiovasc Med 2022;9:870390.10.3389/fcvm.2021.827515 PubMed DOI PMC

MDCG 2022-14, Medical Device Coordination Group, MDCG Position Paper - Transition to the MDR and IVDR, Notified Body Capacity and Availability of Medical Devices and IVDs, August 2022, Available online: Https://Health.Ec.Europa.Eu/Document/Download/2db053bc-283c-4d2e-93f4-C3e8032e66da_en?Filename=mdcg_2022-14_en.Pdf

Algoet M, Verbelen T, Jacobs S, et al. Robot-Assisted MIDCAB Using Bilateral Internal Thoracic Artery: A Propensity Score-Matched Study With OPCAB Patients. Innovations (Phila) 2024;19:184-91. 10.1177/15569845241245422 PubMed DOI

Mohr FW, Falk V, Diegeler A, et al. Computer-enhanced coronary artery bypass surgery. J Thorac Cardiovasc Surg 1999;117:1212-4. 10.1016/s0022-5223(99)70261-8 PubMed DOI

Oosterlinck W, Algoet M, Balkhy HH. Minimally Invasive Coronary Surgery: How Should It Be Defined? Innovations (Phila) 2023;18:22-7. 10.1177/15569845231153366 PubMed DOI

Bonatti J, Crailsheim I, Grabenwöger M, et al. Minimally Invasive and Robotic Mitral Valve Surgery: Methods and Outcomes in a 20-Year Review. Innovations (Phila) 2021;16:317-26. 10.1177/15569845211012389 PubMed DOI

Palmen M, Navarra E, Bonatti J, et al. Current state of the art and recommendations in robotic mitral valve surgery. Interact Cardiovasc Thorac Surg 2022;35:ivac160. 10.1093/icvts/ivac160 PubMed DOI PMC

Gao C, Yang M, Wang G, et al. Excision of atrial myxoma using robotic technology. J Thorac Cardiovasc Surg 2010;139:1282-5. 10.1016/j.jtcvs.2009.09.013 PubMed DOI

Kadirogullari E, Onan B, Timur B, et al. Transcatheter closure vs totally endoscopic robotic surgery for atrial septal defect closure: A single-center experience. J Card Surg 2020;35:764-71. 10.1111/jocs.14456 PubMed DOI

Wei LM, Cook CC, Hayanga JWA, et al. Robotic Aortic Valve Replacement: First 50 Cases. Ann Thorac Surg 2022;114:720-6. 10.1016/j.athoracsur.2021.08.036 PubMed DOI

Cavallaro P, Rhee AJ, Chiang Y, et al. In-hospital mortality and morbidity after robotic coronary artery surgery. J Cardiothorac Vasc Anesth 2015;29:27-31. 10.1053/j.jvca.2014.03.009 PubMed DOI

Bonatti J, Wallner S, Crailsheim I, et al. Minimally invasive and robotic coronary artery bypass grafting-a 25-year review. J Thorac Dis 2021;13:1922-44. 10.21037/jtd-20-1535 PubMed DOI PMC

Göbölös L, Ramahi J, Obeso A, et al. Robotic Totally Endoscopic Coronary Artery Bypass Grafting: Systematic Review of Clinical Outcomes from the Past two Decades. Innovations (Phila) 2019;14:5-16. 10.1177/1556984519827703 PubMed DOI

Lo CY, Yu CL, Chang Y, et al. Long-term results of robotic-assisted coronary artery bypass grafting with composite arterial grafts for multiple coronary anastomoses: 10-year experience. J Robot Surg 2023;17:63-71. 10.1007/s11701-022-01391-z PubMed DOI

Nifong LW, Rodriguez E, Chitwood WR, Jr. 540 consecutive robotic mitral valve repairs including concomitant atrial fibrillation cryoablation. Ann Thorac Surg 2012;94:38-42; discussion 43. 10.1016/j.athoracsur.2011.11.036 PubMed DOI

Murphy DA, Moss E, Binongo J, et al. The Expanding Role of Endoscopic Robotics in Mitral Valve Surgery: 1,257 Consecutive Procedures. Ann Thorac Surg 2015;100:1675-81; discussion 1681-2. 10.1016/j.athoracsur.2015.05.068 PubMed DOI

Gillinov AM, Mihaljevic T, Javadikasgari H, et al. Early results of robotically assisted mitral valve surgery: Analysis of the first 1000 cases. J Thorac Cardiovasc Surg 2018;155:82-91.e2. 10.1016/j.jtcvs.2017.07.037 PubMed DOI

Gammie JS, Zhao Y, Peterson ED, et al. J. Maxwell Chamberlain Memorial Paper for adult cardiac surgery. Less-invasive mitral valve operations: trends and outcomes from the Society of Thoracic Surgeons Adult Cardiac Surgery Database. Ann Thorac Surg 2010;90:1401-8, 1410.e1; discussion 1408-10. PubMed

Williams ML, Hwang B, Huang L, et al. Robotic versus conventional sternotomy mitral valve surgery: a systematic review and meta-analysis. Ann Cardiothorac Surg 2022;11:490-503. 10.21037/acs-2022-rmvs-21 PubMed DOI PMC

Fatehi Hassanabad A, Nagase FNI, Basha AM, et al. A Systematic Review and Meta-Analysis of Robot-Assisted Mitral Valve Repair. Innovations (Phila) 2022;17:471-81. 10.1177/15569845221141488 PubMed DOI PMC

Mori M, Parsons N, Krane M, et al. Robotic Mitral Valve Repair for Degenerative Mitral Regurgitation. Ann Thorac Surg 2024;117:96-104. 10.1016/j.athoracsur.2023.07.047 PubMed DOI

Kuo CC, Chang HH, Hsing CH, et al. Robotic mitral valve replacements with bioprosthetic valves in 52 patients: experience from a tertiary referral hospital. Eur J Cardiothorac Surg 2018;54:853-9. Erratum in: Eur J Cardiothorac Surg 2018;54:967.10.1093/ejcts/ezy134 PubMed DOI PMC

Arslanhan G, Senay S, Kocyigit M, et al. Robotic mitral valve replacement; results from the world's largest series. Ann Cardiothorac Surg 2022;11:533-7. 10.21037/acs-2022-rmvs-11 PubMed DOI PMC

Bonaros N, Schachner T, Oehlinger A, et al. Robotically assisted totally endoscopic atrial septal defect repair: insights from operative times, learning curves, and clinical outcome. Ann Thorac Surg 2006;82:687-93. 10.1016/j.athoracsur.2006.03.024 PubMed DOI

Bhatt AG, Steinberg JS. Robotic-Assisted Left Ventricular Lead Placement. Heart Fail Clin 2017;13:93-103. 10.1016/j.hfc.2016.07.008 PubMed DOI

The Original MDD 93/42/EEC, Annex X, Section 1.1. Available online: https://www.legislation.gov.uk/eudr/1993/42/annex/X

Higson GR. Medical Device Safety. The Regulation of Medical Devices for Public Health and Safety. 1st Edition. CRC Press; 2001:158.

MDR. Annex I - General Safety and Performance Requirements. Available online: https://www.medical-device-regulation.eu/2019/07/23/annex-i-general-safety-and-performance-requirements/

Kearney B, McDermott O. The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study. Ther Innov Regul Sci 2023;57:783-96. 10.1007/s43441-023-00527-z PubMed DOI PMC

FDA. Drug Efficacy Study Implementation (DESI). U.S. Food and Drug Administration. (2024). Available online: https://www.fda.gov/drugs/enforcement-activities-fda/drug-efficacy-study-implementation-desi