Robotic Percutaneous Coronary Intervention Research Articles

Abstract 15585: Robotic versus Manual Percutaneous Coronary Intervention: An Updated Systematic Review and Meta-Analysis

Introduction: Robotic percutaneous coronary intervention (PCI), a recent development in managing coronary artery disease, offers potential advantages such as enhanced precision, stability, and radiation protection over traditional manual PCI. Despite these promises, a comprehensive and current comparison of safety and effectiveness between these methods remains to be established. Hypothesis: This study aims to evaluate and compare the outcomes of robotic and manual PCI. Methods: A comprehensive search of electronic databases, including PubMed, EMBASE, and the Cochrane Library, was carried out up to May 2023, aiming to identify studies comparing robotic and manual PCI. The primary outcomes were major cardiovascular events and myocardial infarction rates, and secondary outcomes included contrast volume used (in mL), procedural time (in minutes), and fluoroscopy time (in minutes). Relative risk (RR) for categorical outcomes and mean difference for continuous outcomes were calculated using a random-effects model. All statistical analyses were performed using R software (version 4.0.3) with the metafor and meta packages. Results: Our search strategy identified eight studies, including 2339 patients (703 in the robotic group and 1636 in the manual group). The pooled RR of major cardiovascular events was 0.91 (95% CI: 0.48-1.70, P=0.76, I2=0%), and myocardial infarction rate was 0.88 (95% CI: 0.43-1.83, P=0.73, I2=0%), indicating no significant difference between robotic and manual PCI. Notably, robotic PCI was associated with a statistically significant mean reduction in the contrast volume of -14.28 mL (95% CI: -23.65 to -4.93, P<0.01, I2=0%). However, the differences in procedural time and fluoroscopy time did not reach statistical significance, with 2.73 minutes (95% CI: -4.71 to 10.17, P=0.47, I2=62%) and -2.15 minutes (95% CI: -4.35 to 0.05, P=0.06, I2=51%) respectively. Conclusions: Compared to its manual counterpart, this study highlights that robotic PCI significantly decreases contrast volume use while maintaining similar outcomes in other procedural parameters. This underscores robotic PCI's potential in interventional cardiology, also indicating the need for more high-quality trials for long-term outcome confirmation.

Enhancing percutaneous coronary intervention with heuristic path planning and deep-learning-based vascular segmentation

Percutaneous coronary intervention (PCI) is a minimally invasive technique for treating vascular diseases. PCI requires precise and real-time visualization and guidance to ensure surgical safety and efficiency. Existing mainstream guiding methods rely on hemodynamic parameters. However, these methods are less intuitive than images and pose some challenges to the decision-making of cardiologists. This paper proposes a novel PCI guiding assistance system by combining a novel vascular segmentation network and a heuristic intervention path planning algorithm, providing cardiologists with clear and visualized information. A dataset of 1077 DSA images from 288 patients is also collected in clinical practice. A Likert Scale is also designed to evaluate system performance in user experiments. Results of user experiments demonstrate that the system can generate satisfactory and reasonable paths for PCI. Our proposed method outperformed the state-of-the-art baselines based on three metrics (Jaccard: 0.4091, F1: 0.5626, Accuracy: 0.9583). The proposed system can effectively assist cardiologists in PCI by providing a clear segmentation of vascular structures and optimal real-time intervention paths, thus demonstrating great potential for robotic PCI autonomy.

Safety and feasibility of intravascular ultrasound-guided robotic percutaneous coronary intervention.

Previous studies have demonstrated the benefit of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) for preventing longitudinal geographic miss (LGM). However, it is yet unclear whether IVUS guidance is useful for robotic-PCI (robotic-assisted perctaneous coronary intervention [R-PCI]). A total of 58 consecutive patients with stable angina who underwent IVUS-guided R-PCI were enrolled. The stent landing position was angiographically marked using a balloon marker before stenting, followed by measurements of the expected stent length using balloon pullback. Subsequently, prestenting IVUS was performed to determine stent landing. All pre-PCI IVUS images were assessed for lesion length and percent plaque volume (%PV) using both IVUS and angiographic marking. LGM was defined as a residual %PV >50% at either the distal or proximal stent edge, any stent edge dissection, or additional stent deployment immediately after stenting. The included patients had an average age of 67.1 ± 10.1 years. IVUS guidance had significantly longer lesion lengths compared with angiographic marking. Based on IVUS-guided stent deployment, nine cases exhibited LGM immediately after stenting. IVUS-marked landing points had a significantly smaller %PV and significantly larger lumen area compared with those for angiography. IVUS-guided R-PCI was well-tolerated and may be better at preventing LGM compared with angiography-guided R-PCI.

Robotic Percutaneous Coronary Intervention in Coronary Heart Disease: Applications and Recent Advances

Traditional percutaneous coronary intervention (T-PCI) has long been an effective method for treating coronary heart disease (CHD), but the radiation hazards and orthopedic injuries among T-PCI operators are concerning. These problems have been mitigated with the emergence of robotic percutaneous coronary intervention (R-PCI), which is expected to increase intervention accuracy and safety. In this review, we first summarize the current status of PCI development, including robot systems, and PCI application and evaluation. Second, we compare T-PCI and R-PCI to identify the benefits for patients and physicians. In addition, we describe a new R-PCI system, R-PCI WSER-CD01, which incorporates multi-instrument collaborative delivery and provides full-process assistance in minimally invasive vascular intervention. This system introduces three key innovations that address safety concerns, and improve the accuracy, wire compatibility, and remote operation capabilities of existing of vascular intervention robot systems. Finally, we discuss prospects for the development of R-PCI. As an emerging technology, R-PCI aligns well with the trends of precision medicine and telemedicine, and therefore warrants continued innovation.

Learning Curve of Robotic Percutaneous Coronary Intervention: A Single-Center Experience

<h2>Abstract</h2><h3>Background</h3> Robotic percutaneous coronary intervention (R-PCI) has been shown to provide benefits to operators and patients when compared with traditional percutaneous coronary intervention. Despite being available for 16 years in the United States, utilization of R-PCI remains low. This may be because of an expected learning curve with this technology. We sought to describe the characteristics and magnitude of the learning curve with R-PCI. <h3>Methods</h3> Consecutive patients undergoing R-PCI (Corpath GRX-2) at a tertiary care center by a single operator were studied prospectively. Demographic, angiographic, and procedural variables were collected. The primary study endpoints included fluoroscopy time, procedure time, and contrast volume. The distributions of each of these variables were plotted against the case numbers in chronological sequence, and the best curve fits were identified. Using the best model, the slope of the relationships was analyzed. Flattening of the slope of these plots were considered suggestive of a learning effect. <h3>Results</h3> A total of 546 R-PCI and 1654 traditional percutaneous coronary intervention procedures were studied; 22 crossovers to traditional percutaneous coronary intervention occurred. Most of the crossovers occurred in the first quartile of procedures; no crossovers occurred in the latter half of the cohort. Procedure time decreased as the procedure number increased, with the slope flattening at procedure number 50. Contrast volume decreased as experience increased, with a slope flattening at procedure number 30. Both parameters continued to decrease as experience increased. Fluoroscopy time demonstrated a flattening slope after procedure number 15. This likely is driven by the lower complexity by Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score remained stable over the procedure sequence, with no significant complexity change over the study period. <h3>Conclusion</h3> The "learning effect" of R-PCI is observed with steep improvement in study metrics up to 50 procedures and a continuing improvement of lesser magnitude afterward.

Hybrid Coronary Revascularization: Early Outcomes and Midterm Follow-Up in Patients Undergoing Single or Multivessel Robotic TECAB and PCI.

Hybrid coronary revascularization (HCR) is the integration of sternal-sparing coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (CAD). It is traditionally performed with single-vessel bypass (left internal mammary artery [LIMA] to left anterior descending artery [LAD]) and PCI but can also be accomplished with multiple arterial grafts using bilateral IMA conduits. We sought to review our HCR experience over an 8-year period with robotic totally endoscopic coronary artery bypass (TECAB) and PCI. Of 694 patients undergoing beating-heart TECAB from August 2013 to June 2022, 306 patients were designated as intention-to-treat HCR candidates. Patients underwent PCI prior to, the same day as, or following TECAB, performed using single or bilateral IMA grafts. We retrospectively reviewed early and midterm outcomes up to 8 years in this cohort of patients. The mean Society of Thoracic Surgeons predicted risk of mortality was 1.5% ± 2.5%. There were 44 patients (14%) who had ≥70% left main disease and 218 patients (71%) who had triple-vessel disease. A total of 193 patients (63%) underwent multivessel grafting (advanced HCR), with 83% bilateral IMA use. Mean operative time was 263 ± 80 min, and mean length of stay was 2.6 days. The mean number of vessels bypassed per patient was 1.7 ± 0.6. The mean number of vessels stented was 1.2 ± 0.5. Of the patients, 84% underwent TECAB first, 14% PCI first, and 2% same-day TECAB/PCI. Mortality was 0.6% (observed to expected ratio: 0.42). Early graft patency was 97% (328 of 339 grafts); LIMA-LAD patency was 98%. At 8-year follow-up (mean 37 ± 26 months), all-cause and cardiac-related mortality were 13% and 2.6%, respectively. Freedom from major adverse cardiac and cerebrovascular events was 92%. In patients with multivessel CAD, integrating robotic single and multivessel TECAB with PCI resulted in excellent early and midterm outcomes. In experienced hands, the robotic endoscopic approach allows the routine use of multiple arterial grafting during HCR.

An observational study to assess the feasibility, risks and benefits of robotic PCI(percutaneous coronary intervention) and the clinical profile and outcomes of patients undergoing robotic-PCI in a tertiary care centre in North India’.

An observational study to assess the feasibility, risks and benefits of robotic PCI(percutaneous coronary intervention) and the clinical profile and outcomes of patients undergoing robotic-PCI in a tertiary care centre in North India’.

Dois anos de pandemia da COVID-19: implicações para as salas de hemodinâmica e suas práticas atuais

COVID-19 continues to overwhelm healthcare systems. During the peak of the pandemic, cardiac catheterization labs across the world observed a significant decrease in procedure volumes due to several reasons, including reallocation of medical resources, deployment of interventional cardiologists to the COVID-19 wards, and physician and patient concerns about viral transmission. In particular, structural heart disease interventions experienced a significant reduction in volume by more than 90%. To address these challenges, healthcare systems employed new safety measures and protocols, including COVID-19 rapid polymerase chain reaction pretesting, Personal Protective Equipment, and vaccination mandates to ensure safety of patients and healthcare workers. Although these measures partly addressed safety concerns, diagnosis and management of acute myocardial injury remained challenging throughout the pandemic. While the pathophysiological mechanisms leading to myocardial injury is not fully elucidated, most studies have suggested COVID-19 is a pro-inflammatory disease associated with a hypercoagulable state. Ongoing randomized studies are evaluating the efficacy of more aggressive antithrombic regimens in COVID-19. In addition, the presentation of acute coronary syndrome with concomitant COVID-19 infection is variable, more likely atypical, delayed, and is associated with higher rates of adverse cardiovascular events and death. It was necessary to implement protocols to expedite diagnosis, triage and management of patients with acute coronary syndrome, while minimizing the risk of viral transmission to hospital staff. Robotic percutaneous coronary intervention may offer in the future a potential solution to many of the safety concerns faced by interventional cardiologists during the COVID-19 era; however, it has its own set of limitations.

Safety and Efficacy of Robotic-Assisted PCI.

Robotics has been used in multiple areas of procedural medical intervention. Robotic percutaneous coronary intervention (PCI) has been available since 2004. Its adoption has been slow with initial application in simple cases. With increasing adoption, robotic PCI has been applied to a broader variety of coronary substrates with demonstration of safety and efficacy. Improvements in the robotic console with future generation devices should add to the utility of this platform. Robotic PCI advances the innovations in endovascular space into a different dimension, removing the dependence of the procedure on patient-operator ergonomics and likely operator skill.

D-27 | Feasibility and Efficacy of Robotically Performed Diagnostic Coronary Angiography

Robotic percutaneous coronary intervention is now being performed at multiple centers worldwide and is associated with marked reductions in physician radiation exposure. Whether diagnostic coronary angiography can also be performed robotically has not been adequately explored.

Safety and effectiveness of introducing a robotic-assisted percutaneous coronary intervention program in a tertiary center: a prospective study.

Robotic-assisted percutaneous coronary intervention (PCI) is a novel technology that permits remote operation of interventional devices. However, little is known about the safety and effectiveness of introducing a robotic PCI program in a hospital already experienced in traditional coronary angioplasty. Prospective single-arm survey to assess the safety and effectiveness of robotic-assisted PCI in comparison to pre-defined performance goals. The study cohort comprised all consecutive cases treated with robotic PCI since its introduction. The safety primary endpoint was a composite of (I) overall death or (II) non-fatal adverse events related to target vessel complications (stent thrombosis, myocardial infarction, vessel perforation or cardiac tamponade, or repeat invasive treatment) during the index hospitalization. The efficacy primary endpoint was robotic-assisted procedural success, a composite of (I) successful dilatation of the target lesion and (II) successful robotic assistance, defined as absent non-planned manual conversion. A total of 83 patients and 112 lesions were prospectively enrolled. The rate of angiographic success was 99.1%. From these, 97 lesions (86.6%) were treated with only robotic PCI or with hybrid according to the pre-interventional plan. The rates of efficacy and safety primary endpoints were 85.7% and 2.4% respectively (P<0.01 for non-inferior to the pre-defined performance threshold). Introduction of robotic-assisted PCI in a tertiary center was associated with safe and effective results, comparable to pre-defined goals of optimal performance.

Robotic Percutaneous Coronary Intervention: The Good, the Bad, and What is to Come

The introduction of robots into healthcare has brought a wealth of opportunity for technical advancements, ranging from cleaning robots to disinfect hospital rooms to the high-tech surgical robots used in the operating room. Robotic-assisted percutaneous coronary intervention (R-PCI) has been a more recent development in the field, and is particularly revolutionary in that it serves to benefit the interventional cardiologist as well as the patient. Published data on R-PCI have shown its feasibility, safety, and more recently, its potential benefits. This review examines the current role of the robot in the catheterization laboratory, the authors’ experience with the most current generation of the robot, and what is yet to come.

A Novel Robotic Control System Mimics Doctor’s Operation to Assist Percutaneous Coronary Intervention

Objectives: The use of current robotic systems to assist in percutaneous coronary intervention (PCI) fundamentally differs from performing conventional PCI. To overcome this problem, we developed a novel master-slave robotic control system to assist in PCI, and evaluated its safety and feasibility in the delivery and manipulation of coronary guidewires in vitro and in vivo. Methods: The novel robotic assist PCI system is composed of three parts: 1) a master actuator, which imitates the traditional torque used by surgeons in conventional PCI, 2) a slave actuator, including a guidewire delivery system and force monitoring equipment, and 3) a local area network based communication system. Results: The experiment was performed in six pigs. Both robotic and manual control completed the operation with no device- or procedure-associated complications. An experienced interventional cardiologist who was a first-time user of the novel robotic PCI system was able to advance the guidewire into a distal branch of a coronary artery within a similar time to that required with the manual procedure. Conclusion: This early in vivo experiment with the novel robotic assisted PCI control system demonstrated that its feasibility, safety, and procedural effectiveness are comparable to those of manual operation. The novel robotic-assisted PCI control system required significantly less time to learn than other currently available systems.

Robotic percutaneous coronary intervention: current evidence, practical aspects and future perspectives

Robotic percutaneous coronary intervention (R-PCI) is an emerging technology designed to improve operator safety and procedural precision. The interventional cardiologist is able to manipulate guidewires, catheters and devices from a specific cockpit. A number of studies evaluating R-PCI have shown high procedural success rates with low complications. R-PCI advantages include the possibility to perform an accurate stent positioning, to reduce the operator radiation exposure and orthopedic injuries. However, there is a limited experience regarding R-PCI in complex anatomies, that may still require manual assistance. Moreover, the technique is limited by current incompatibility with specific materials, the lack of tactile feedback and the possibility to robotically manage only one wire/device at the same time. Globally, R-PCI is a novel approach with future interesting implications, but further investigations are necessary to overcome current limitations.

Latest Developments in Robotic Percutaneous Coronary Intervention

Interventional cardiovascular medicine has seen constant progress over the last few decades. Since the first angiograms and percutaneous transluminal coronary angioplasty were carried out, this progress has been tremendous and has led to a substantial decline in cardiovascular morbidity and mortality. The purpose of this article is to report and review the latest developments and evidence in robotics-assisted percutaneous coronary intervention (rPCI) and its potential future applications, opportunities, and limitations. Contemporary evidence shows that rPCI can lead to a significant reduction in radiation exposure as well as medical hazards for cardiologists. Rates of device and procedural success remain high and there is no evidence of a disadvantage for the patient. The accuracy of implantation with a reduced geographic mismatch is a further advantage that can result in a higher quality of treatment. Even in complex coronary lesions and procedures, rPCI seems to be safe and efficient. The latest developments include telestenting over hundreds of kilometers from a remote platform. Currently, the main limitations are the absence of large-scale randomized trials for the valid assessment of the benefits and disadvantages of rPCI as well as the technical limitations of the currently available rPCI systems. rPCI is a forward-looking innovation in cardiology that is applicable to a wide range of coronary interventions. Despite the present lack of knowledge and the limited data concerning the outcome for the patient, the available literature reveals promising results that should lead to improvements for physicians and patients.

TCT CONNECT-188 Safety and Feasibility of Intravascular Ultrasound Guided Robotic Percutaneous Coronary Intervention in Stable Angina

TCT CONNECT-188 Safety and Feasibility of Intravascular Ultrasound Guided Robotic Percutaneous Coronary Intervention in Stable Angina

Robotic telestenting performance in transcontinental and regional pre-clinical models.

This study was conducted to evaluate the association of geographic distance with robotic telestenting performance by comparing performance measures in transcontinental and regional pre-clinical models of telestenting. Robotic telestenting, in which percutaneous coronary intervention (PCI) is performed on a remotely located patient, might improve PCI access, but has not been attempted over vast distances likely required to reach many underserved regions. Telestenting performance was compared in regional (Boston to New York [206 miles]) and transcontinental (Boston to San Francisco [3,085 miles]) ex vivo models of telestenting, wherein a physician in Boston attempted robotic PCI on endovascular simulators in New York and San Francisco, respectively. PCI was attempted over both wired and fifth generation (5G)-wireless networks. Outcome measures included procedural success, procedural time, and perceived latency. Procedural success was achieved in 20 consecutive target lesions in the regional model and in 16 consecutive target lesions in the transcontinental model. The transcontinental model had a greater latency than the regional model over both wired (121.5 ± 2.4 ms vs. 67.8 ± 0.9 ms; p < .001) and 5G-wireless networks (162.5 ± 1.1 ms vs. 86.6 ± 0.6 ms; p < .001), but perceived latencies were graded "imperceptible" in all cases in both models. Transcontinental and regional models did not have significantly different procedural times over wired (4.1 ± 1.9 min vs. 9.0 ± 7.1 min; p = .051) or 5G-wireless (3.0 ± 0.6 vs. 6.3 ± 1.2; p = .36) networks. Transcontinental robotic manipulation of coronary devices is now possible and was not associated with adverse performance compared to robotic telestenting conducted regionally.

Remote robotic percutaneous coronary intervention: An animal feasibility study.

The purpose of this study was to explore the feasibility and safety of robotic PCI performed using an off-siteremote-control system in an animal model. Access to primary percutaneous coronary intervention (PCI) remains a challenge in acute myocardial infarction management. The combination of telemedicine and robotic PCI allow the potential delivery of primary PCI to remote locations without the delay of transfer. This single-center prospective pilot preclinical feasibility study compared robotic PCI with remote PCI on swine across three stages (adjacent room, different floor of the same building, two different buildings). Latency up to 1,000 ms was introduced into the operating environment to simulate decreased network quality (blinded to operator). The primary outcome measures were technical success and acute safety. The secondary outcome measures included lesion wiring time, procedural time and qualitative scoring of the PCI experience by the operator. Across 52 experiments in 15 animals, technical success was 100%. No procedural complications occurred during the study. No significant difference in lesion treatment time was detected between stages (p = .11) and between time per target vessel when latency up to 1,000 ms was introduced (p = .58). Injected delay >250 ms had the greatest impact on procedure perceived lag. Longer procedure time was associated with lower procedure impact score, regardless of injected latency. Remote robotic PCI was feasible and safe in an animal model. Procedural duration was acceptable and unaffected by network latency. Future studies are needed to determine the safety and feasibility of remote PCI in humans.

Feasibility and safety of robotic PCI in China: first in man experience in Asia.

ObjectivesTo evaluate the feasibility and safety of a second generation robotic percutaneous coronary intervention (R-PCI) system in China.BackgroundRobotic PCI has been shown to be an effective method for conducting coronary interventions. It has further benefits of more accurate lesion measurement, improved stent deployment, reduced incidence of geographic miss and reduction of operator radiation exposure.MethodsThis single center evaluation enrolled 10 consecutive patients who had been selected for PCI. Clinical success was defined as residual stenosis < 30% and no in-hospital major adverse cardiovascular events. Learning curve effect was assessed by comparing efficiency metrics of early vs. later cases.ResultsEleven lesions were treated all successfully without manual interruption or MACE events. Most lesions (63%) were ACC/AHA class B2 and C. Mean procedure time was 57.7 ± 26.4 min, however two procedures were part of live demonstrations. Excluding the two live cases, the mean procedure time was 51.8 ± 23.7 min. Procedural efficiency tended to improve from early cases to later cases based on PCI time (48.3 ± 32.9 vs. 25.5 ± 13.0 min, P = 0.27), fluoroscopy time (20.3 ± 8.2 vs. 12.5 ± 4.6 min, P = 0.16), contrast volume (145.0 ± 28.9 vs. 102.5 ± 17.1 mL, P = 0.05) and Air Kerma dose (1932 ± 978 vs. 1007 ± 70 mGy, P = 0.31).ConclusionsSecond generation robotic PCI was safe, effective and there were trends toward improvements in procedural efficiency during this early experience in China.

Shields and garb for decreasing radiation exposure in the cath lab

ABSTRACTIntroduction: Decreasing radiation exposure of the cardiac catheterization laboratory staff is critical for minimizing radiation-related adverse outcomes and can be accomplished by decreasing patient dose and by shielding.Areas covered: protection from ionizing radiation can be achieved with architectural, equipment-mounted, and disposable shields, as well as with personal protective equipment.Expert commentary: Radiation protective aprons are the most commonly used personal protective equipment and provide robust radiation protection but can cause musculoskeletal strain. Use of a thyroid collar is recommended, as is use of ‘shin guards’, lead glasses and radioprotective caps, although the efficacy of the latter is being debated. Alternatives to lead aprons include shielding suspended from the ceiling and robotic percutaneous coronary intervention. Radiation protective gloves and cream can be used to protect the hands, but the best protection is to not directly expose them to the radiation beam. Devices that provide real time operator radiation dose monitoring can enable real time adjustments in positioning and shield placement, reducing radiation dose. Shielding can be achieved with architectural, equipment-mounted, and disposable shields. Equipment-mounted shielding includes ceiling-suspended shields, table-suspended drapes, and radioabsorbent drapes. Personal protective equipment and shielding should be consistently and judiciously utilized by all catheterization laboratory personnel.