Pub Date : 2024-09-29Epub Date: 2024-04-03DOI: 10.21037/acs-2023-rcabg-0198
Joeri Van Puyvelde, Massimo Baudo, Gianluca Torregrossa, Wouter Oosterlinck
{"title":"The role of robotic coronary artery bypass grafting in the current practice of surgical myocardial revascularization.","authors":"Joeri Van Puyvelde, Massimo Baudo, Gianluca Torregrossa, Wouter Oosterlinck","doi":"10.21037/acs-2023-rcabg-0198","DOIUrl":"10.21037/acs-2023-rcabg-0198","url":null,"abstract":"","PeriodicalId":8067,"journal":{"name":"Annals of cardiothoracic surgery","volume":"13 5","pages":"439-441"},"PeriodicalIF":3.3,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11491182/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-29Epub Date: 2024-09-23DOI: 10.21037/acs-2024-rcabg-14
Senne De Groote, Nora Marain, Gianluca Torregrossa, Wouter Oosterlinck
The introduction of robotic surgical devices nearly two decades ago led to a significant reduction in the invasiveness of cardiac procedures. The further worldwide implementation of robotic surgical devices in cardiac surgery, especially coronary artery bypass grafting and mitral valve repair or replacement, has, however, been stalled by numerous challenges. First, there is the high complexity of the procedures that involve a significant learning curve; second, there is the significant cost of robotic surgical devices. Furthermore, significant changes in the medical device regulation have occurred in recent years, hindering further technological development and the emergence of new players on the market. Finally, clinical evidence regarding the benefits of robotic-cardiac procedures remains scarce at this time. We invited all players active in or planning to throw themselves into robotic-assisted cardiac surgery to discuss these challenges in a semi-structured interview. Two promising and ambitious companies showed interest in participating in this project: Medicaroid and SS Innovations. The main conclusions from the interview are that both companies aim (I) to launch an affordable alternative compared to the current robotic surgical devices, (II) to further develop their robotic devices based on the opinion of physicians, and (III) to engage in overcoming the steep learning curve correlated with robotic-assisted cardiac procedures.
近二十年前,机器人手术设备的引入大大降低了心脏手术的创伤性。然而,机器人手术设备在心脏外科,特别是冠状动脉旁路移植术和二尖瓣修复或置换术中的进一步全球应用却因众多挑战而停滞不前。首先,手术的复杂程度高,学习曲线长;其次,机器人手术设备的成本高昂。此外,近年来医疗器械法规发生了重大变化,阻碍了技术的进一步发展和市场新参与者的出现。最后,目前有关机器人心脏手术益处的临床证据仍然很少。我们邀请了所有活跃于或计划投身机器人辅助心脏手术领域的公司,通过半结构式访谈讨论这些挑战。两家前途无量、雄心勃勃的公司表示有兴趣参与该项目:Medicaroid 和 SS Innovations。访谈的主要结论是,这两家公司的目标是:(I) 推出比现有机器人手术设备更经济实惠的替代产品;(II) 根据医生的意见进一步开发机器人设备;(III) 致力于克服与机器人辅助心脏手术相关的陡峭学习曲线。
{"title":"Embracing industry in the development of robotic coronary bypass grafting-the sun rises in the East.","authors":"Senne De Groote, Nora Marain, Gianluca Torregrossa, Wouter Oosterlinck","doi":"10.21037/acs-2024-rcabg-14","DOIUrl":"10.21037/acs-2024-rcabg-14","url":null,"abstract":"<p><p>The introduction of robotic surgical devices nearly two decades ago led to a significant reduction in the invasiveness of cardiac procedures. The further worldwide implementation of robotic surgical devices in cardiac surgery, especially coronary artery bypass grafting and mitral valve repair or replacement, has, however, been stalled by numerous challenges. First, there is the high complexity of the procedures that involve a significant learning curve; second, there is the significant cost of robotic surgical devices. Furthermore, significant changes in the medical device regulation have occurred in recent years, hindering further technological development and the emergence of new players on the market. Finally, clinical evidence regarding the benefits of robotic-cardiac procedures remains scarce at this time. We invited all players active in or planning to throw themselves into robotic-assisted cardiac surgery to discuss these challenges in a semi-structured interview. Two promising and ambitious companies showed interest in participating in this project: Medicaroid and SS Innovations. The main conclusions from the interview are that both companies aim (I) to launch an affordable alternative compared to the current robotic surgical devices, (II) to further develop their robotic devices based on the opinion of physicians, and (III) to engage in overcoming the steep learning curve correlated with robotic-assisted cardiac procedures.</p>","PeriodicalId":8067,"journal":{"name":"Annals of cardiothoracic surgery","volume":"13 5","pages":"417-424"},"PeriodicalIF":3.3,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11491179/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-29Epub Date: 2024-09-24DOI: 10.21037/acs-2024-rcabg-15
Ashley R Wilson-Smith, Christian J Wilson-Smith, Jemilla Strode Smith, Rowen Osborn, Winky Lo, Dominic Ng, Bridget Hwang, Justin Shaw, Benjamin T Muston, Michael L Williams, Aditya Eranki, Aashray Gupta, Lucy Manuel, Malgorzata Szpytma, Luca Borruso, Advait Pandya, David Downes
Background: Coronary artery bypass grafting (CABG) has significantly reduced the morbidity and mortality of patients suffering from ischemic heart disease over its six decades of practice. In recent years, minimally invasive techniques have been increasingly described and utilized, with the promise of providing patients with the same standard of care without the need for the traditional full sternotomy, and in select cases without cardiopulmonary bypass, and thus providing improved recovery metrics. The present systematic review and meta-analysis sought to determine the outcomes of all patients receiving robotic-assisted CABG in an Atlantic patient demographic.
Methods: The methods for this systematic review and meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Four databases were searched, using appropriate search terminology. Meta-analysis using proportions or means, as appropriate, were applied, and were presented as per routine practice. Kaplan-Meier curves were digitized and aggregated using previously reported, validated techniques. Quality assessment and risk of bias of each study were assessed systematically. Patient populations were subcategorized as per established technical definitions.
Results: Thirty-five studies were identified through the literature search, with three studies having subgroupings appropriate for separate analysis (yielding 42 data points maximally). A total of 9,078 patients (69% male), with a mean age of 62.3 years, were identified across the study period. On actuarial assessment, survival at yearly assessment from 1-, 2-, 3-, 4- and 5-yearly intervals was determined to be 95%, 94%, 92%, 90%, and 88%, respectively.
Conclusions: The present systematic review and meta-analysis demonstrated that short-term mortality, operative time, and admission [intensive care unit (ICU) and overall length of stay] outcomes were encouraging in the Atlantic demographic. Freedom from long-term mortality assessment of a smaller cohort showed encouraging results. A major caveat to the present analysis is the high degree of heterogeneity in the reporting of data. Analysis of future randomized controlled trials will be vital in establishing these procedures as commonplace.
{"title":"The outcomes of robotic-assisted coronary artery bypass grafting surgery in the Atlantic demographic-a systematic review and meta-analysis of the literature.","authors":"Ashley R Wilson-Smith, Christian J Wilson-Smith, Jemilla Strode Smith, Rowen Osborn, Winky Lo, Dominic Ng, Bridget Hwang, Justin Shaw, Benjamin T Muston, Michael L Williams, Aditya Eranki, Aashray Gupta, Lucy Manuel, Malgorzata Szpytma, Luca Borruso, Advait Pandya, David Downes","doi":"10.21037/acs-2024-rcabg-15","DOIUrl":"10.21037/acs-2024-rcabg-15","url":null,"abstract":"<p><strong>Background: </strong>Coronary artery bypass grafting (CABG) has significantly reduced the morbidity and mortality of patients suffering from ischemic heart disease over its six decades of practice. In recent years, minimally invasive techniques have been increasingly described and utilized, with the promise of providing patients with the same standard of care without the need for the traditional full sternotomy, and in select cases without cardiopulmonary bypass, and thus providing improved recovery metrics. The present systematic review and meta-analysis sought to determine the outcomes of all patients receiving robotic-assisted CABG in an Atlantic patient demographic.</p><p><strong>Methods: </strong>The methods for this systematic review and meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Four databases were searched, using appropriate search terminology. Meta-analysis using proportions or means, as appropriate, were applied, and were presented as per routine practice. Kaplan-Meier curves were digitized and aggregated using previously reported, validated techniques. Quality assessment and risk of bias of each study were assessed systematically. Patient populations were subcategorized as per established technical definitions.</p><p><strong>Results: </strong>Thirty-five studies were identified through the literature search, with three studies having subgroupings appropriate for separate analysis (yielding 42 data points maximally). A total of 9,078 patients (69% male), with a mean age of 62.3 years, were identified across the study period. On actuarial assessment, survival at yearly assessment from 1-, 2-, 3-, 4- and 5-yearly intervals was determined to be 95%, 94%, 92%, 90%, and 88%, respectively.</p><p><strong>Conclusions: </strong>The present systematic review and meta-analysis demonstrated that short-term mortality, operative time, and admission [intensive care unit (ICU) and overall length of stay] outcomes were encouraging in the Atlantic demographic. Freedom from long-term mortality assessment of a smaller cohort showed encouraging results. A major caveat to the present analysis is the high degree of heterogeneity in the reporting of data. Analysis of future randomized controlled trials will be vital in establishing these procedures as commonplace.</p>","PeriodicalId":8067,"journal":{"name":"Annals of cardiothoracic surgery","volume":"13 5","pages":"388-396"},"PeriodicalIF":3.3,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11491175/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-29Epub Date: 2024-09-09DOI: 10.21037/acs-2024-rcabg-0112
Gianluca Torregrossa, Amanda Yakobitis, Courtney Murray, Massimo Baudo
{"title":"Total endoscopic coronary artery bypass on a DaVinci Xi platform without an EndoWrist stabilizer combining the technology of GelPOINT Mini, AirSeal, and Octopus Nuvo.","authors":"Gianluca Torregrossa, Amanda Yakobitis, Courtney Murray, Massimo Baudo","doi":"10.21037/acs-2024-rcabg-0112","DOIUrl":"10.21037/acs-2024-rcabg-0112","url":null,"abstract":"","PeriodicalId":8067,"journal":{"name":"Annals of cardiothoracic surgery","volume":"13 5","pages":"461-463"},"PeriodicalIF":3.3,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11491176/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-29Epub Date: 2024-08-16DOI: 10.21037/acs-2023-rcabg-0188
Joshua S Newman, Omar A Jarral, Michael C Kim, Derek R Brinster, Varinder P Singh, S Jacob Scheinerman, Nirav C Patel
Background: Hybrid coronary revascularization (HCR) is a well-established technique for treating multi-vessel coronary disease. There remains a paucity of discussion assessing the efficacy of HCR with respect to the timing of the surgical component relative to that of the percutaneous coronary intervention (PCI).
Methods: A retrospective review was undertaken of our prospectively collected database from January 2009 to December 2019. Of 395 HCR patients analyzed, we examined the outcomes of 109 pairs of propensity-matched patients who either underwent robotic-assisted minimally-invasive direct coronary artery bypass (MIDCAB) first, or who had PCI prior to surgery.
Results: Thirty-day mortality was 0.25% (1 death) for the entire cohort. Mid-term survival for the total 'MIDCAB-first' group was 94.1% (17 deaths), not significantly different to that for the 'PCI-first' cohort (8 deaths, 92.7%), and this was also statistically comparable after propensity matching. Perioperative morbidity was not different between patient groups. Freedom from major adverse cardiac and cerebrovascular events (MACCE) and the incidence of repeat revascularization was similar between the two groups at up to 11-year follow-up. Elevated serum creatinine independently predicted increased MACCE for all patients, irrespective of the sequence of HCR revascularization employed.
Conclusions: In appropriately selected patients with multi-vessel coronary disease, HCR is associated with excellent short and longer-term results, irrespective of whether the MIDCAB or PCI procedure is performed first.
{"title":"Ten-year outcomes of hybrid coronary revascularization at a single center.","authors":"Joshua S Newman, Omar A Jarral, Michael C Kim, Derek R Brinster, Varinder P Singh, S Jacob Scheinerman, Nirav C Patel","doi":"10.21037/acs-2023-rcabg-0188","DOIUrl":"10.21037/acs-2023-rcabg-0188","url":null,"abstract":"<p><strong>Background: </strong>Hybrid coronary revascularization (HCR) is a well-established technique for treating multi-vessel coronary disease. There remains a paucity of discussion assessing the efficacy of HCR with respect to the timing of the surgical component relative to that of the percutaneous coronary intervention (PCI).</p><p><strong>Methods: </strong>A retrospective review was undertaken of our prospectively collected database from January 2009 to December 2019. Of 395 HCR patients analyzed, we examined the outcomes of 109 pairs of propensity-matched patients who either underwent robotic-assisted minimally-invasive direct coronary artery bypass (MIDCAB) first, or who had PCI prior to surgery.</p><p><strong>Results: </strong>Thirty-day mortality was 0.25% (1 death) for the entire cohort. Mid-term survival for the total 'MIDCAB-first' group was 94.1% (17 deaths), not significantly different to that for the 'PCI-first' cohort (8 deaths, 92.7%), and this was also statistically comparable after propensity matching. Perioperative morbidity was not different between patient groups. Freedom from major adverse cardiac and cerebrovascular events (MACCE) and the incidence of repeat revascularization was similar between the two groups at up to 11-year follow-up. Elevated serum creatinine independently predicted increased MACCE for all patients, irrespective of the sequence of HCR revascularization employed.</p><p><strong>Conclusions: </strong>In appropriately selected patients with multi-vessel coronary disease, HCR is associated with excellent short and longer-term results, irrespective of whether the MIDCAB or PCI procedure is performed first.</p>","PeriodicalId":8067,"journal":{"name":"Annals of cardiothoracic surgery","volume":"13 5","pages":"425-435"},"PeriodicalIF":3.3,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11491178/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-29Epub Date: 2024-06-26DOI: 10.21037/acs-2024-rcabg-0048
Danny Feike Hoogma, Wouter Oosterlinck, Steffen Rex
Robotic coronary artery bypass grafting (CABG) has emerged as a promising minimally invasive surgical technique for the treatment of coronary artery disease. This paper provides an in-depth analysis of the anesthetic management for robotic CABG. Challenges associated with robotic CABG are discussed and various anesthetic techniques, perioperative elements and pain management modalities that can contribute to enhanced patient recovery are explored.
{"title":"Small incisions still require great anesthesia: anesthesiology techniques to enhance recovery in robotic coronary bypass grafting.","authors":"Danny Feike Hoogma, Wouter Oosterlinck, Steffen Rex","doi":"10.21037/acs-2024-rcabg-0048","DOIUrl":"10.21037/acs-2024-rcabg-0048","url":null,"abstract":"<p><p>Robotic coronary artery bypass grafting (CABG) has emerged as a promising minimally invasive surgical technique for the treatment of coronary artery disease. This paper provides an in-depth analysis of the anesthetic management for robotic CABG. Challenges associated with robotic CABG are discussed and various anesthetic techniques, perioperative elements and pain management modalities that can contribute to enhanced patient recovery are explored.</p>","PeriodicalId":8067,"journal":{"name":"Annals of cardiothoracic surgery","volume":"13 5","pages":"409-416"},"PeriodicalIF":3.3,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11491184/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-29Epub Date: 2024-09-24DOI: 10.21037/acs-2024-rcabg-0034
MaryAnn C Wertan, Serge Sicouri, Yoshiyuki Yamashita, Massimo Baudo, Trisha A Senss, Danielle Spragan, Gianluca Torregrossa, Francis P Sutter
Coronary artery bypass grafting (CABG) is the treatment of choice for coronary artery disease. The traditional method of performing CABG via a full sternotomy has its drawbacks, including increased postoperative morbidity, a higher incidence of complications, and extended hospitalizations. Although minimally invasive and robotic-assisted technology offer promising alternatives, they have not gained wide acceptance, largely because of the limited amount of literature supporting hybrid and robotic-assisted CABG. Since 2005, Lankenau Heart Institute's cardiothoracic surgical team has been developing and refining for selected patients a method for coronary revascularization that involves robotic harvesting of the left internal mammary artery (LIMA) and beating heart surgery through a limited minithoracotomy. This technique precisely places the robotic endoscopic port over the target site of the left anterior descending (LAD) artery. The LIMA is harvested using the enhanced visualization and precision of the robotic platform. The robotic instruments are then removed, and the endoscopic port site is slightly enlarged to become the minithoracotomy, allowing for LIMA-to-LAD anastomosis. The other two robotic ports are used for drains, eliminating the need for additional incisions. The method has been used in over 2,850 patients. The method has been used in over 2,850 patients. This article describes in detail our standardized technique for robotic-assisted minimally invasive direct coronary artery bypass (R-MIDCAB).
{"title":"Step-by-step technique of robotic-assisted minimally invasive direct coronary artery bypass.","authors":"MaryAnn C Wertan, Serge Sicouri, Yoshiyuki Yamashita, Massimo Baudo, Trisha A Senss, Danielle Spragan, Gianluca Torregrossa, Francis P Sutter","doi":"10.21037/acs-2024-rcabg-0034","DOIUrl":"10.21037/acs-2024-rcabg-0034","url":null,"abstract":"<p><p>Coronary artery bypass grafting (CABG) is the treatment of choice for coronary artery disease. The traditional method of performing CABG via a full sternotomy has its drawbacks, including increased postoperative morbidity, a higher incidence of complications, and extended hospitalizations. Although minimally invasive and robotic-assisted technology offer promising alternatives, they have not gained wide acceptance, largely because of the limited amount of literature supporting hybrid and robotic-assisted CABG. Since 2005, Lankenau Heart Institute's cardiothoracic surgical team has been developing and refining for selected patients a method for coronary revascularization that involves robotic harvesting of the left internal mammary artery (LIMA) and beating heart surgery through a limited minithoracotomy. This technique precisely places the robotic endoscopic port over the target site of the left anterior descending (LAD) artery. The LIMA is harvested using the enhanced visualization and precision of the robotic platform. The robotic instruments are then removed, and the endoscopic port site is slightly enlarged to become the minithoracotomy, allowing for LIMA-to-LAD anastomosis. The other two robotic ports are used for drains, eliminating the need for additional incisions. The method has been used in over 2,850 patients. The method has been used in over 2,850 patients. This article describes in detail our standardized technique for robotic-assisted minimally invasive direct coronary artery bypass (R-MIDCAB).</p>","PeriodicalId":8067,"journal":{"name":"Annals of cardiothoracic surgery","volume":"13 5","pages":"442-451"},"PeriodicalIF":3.3,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11491183/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456638","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-29Epub Date: 2024-09-23DOI: 10.21037/acs-2023-rcabg-0210
Michiel Algoet, Tom Melvin, Stepan Cerny, Johannes Bonatti, Sandeep Singh, Thierry Folliguet, Paul Modi, Ulrich Franke, Monica Gianoli, Alfonso Agnino, Filip Casselman, Wouter Oosterlinck
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.
{"title":"How to advance from minimally invasive coronary artery bypass grafting to totally endoscopic coronary bypass grafting: challenges in Europe versus United States of America.","authors":"Michiel Algoet, Tom Melvin, Stepan Cerny, Johannes Bonatti, Sandeep Singh, Thierry Folliguet, Paul Modi, Ulrich Franke, Monica Gianoli, Alfonso Agnino, Filip Casselman, Wouter Oosterlinck","doi":"10.21037/acs-2023-rcabg-0210","DOIUrl":"10.21037/acs-2023-rcabg-0210","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":8067,"journal":{"name":"Annals of cardiothoracic surgery","volume":"13 5","pages":"397-408"},"PeriodicalIF":3.3,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11491180/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456634","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-29Epub Date: 2024-06-28DOI: 10.21037/acs-2023-rcabg-0189
Joshua S Newman, Daniel Lambert, Stevan S Pupovac, Nirav C Patel
{"title":"How to robotically take down a mammary artery.","authors":"Joshua S Newman, Daniel Lambert, Stevan S Pupovac, Nirav C Patel","doi":"10.21037/acs-2023-rcabg-0189","DOIUrl":"10.21037/acs-2023-rcabg-0189","url":null,"abstract":"","PeriodicalId":8067,"journal":{"name":"Annals of cardiothoracic surgery","volume":"13 5","pages":"455-457"},"PeriodicalIF":3.3,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11491173/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}