Manual 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.

First-in-human evaluation of an independently developed Chinese robot-assisted system for percutaneous coronary intervention.

Several studies have proved the safety and feasibility of robot-assisted percutaneous coronary intervention (PCI) in reducing the occupational hazards of interventionists while achieving precision medicine. However, an independently developed robot-assisted system for PCI in China has not yet emerged. This study aimed to evaluate the safety and feasibility of a robot-assisted system for elective PCI in China. This preclinical trial included 22 experimental pigs and preliminarily supported the safety and feasibility of the ETcath200 robot-assisted system for PCI. Then, eleven patients with coronary heart disease who met the inclusion criteria and had clinical indications for elective PCI were enrolled. PCI was performed using a robot-assisted system. The primary outcomes were clinical success (defined as visual estimated residual stenosis < 30% after PCI and no major adverse cardiovascular events during hospitalization and within 30 days after PCI) and technical success (defined as the ability to use the robot-assisted system to complete PCI successfully without conversion to the traditional manual PCI). Eleven patients were included in this clinical trial. A drug-eluting stent with a diameter of 3 mm (interquartile range: 2.75-3.5 mm) and a length of 26 mm (interquartile range: 22-28 mm) was deployed in all patients. The clinical success rate was 100%, with no PCI-related complications and no in-hospital or 30-day major adverse cardiovascular events, and the technical success rate was 100%. The results strongly suggest that the use of the independently developed robot-assisted system in China for elective PCI is feasible, safe, and effective.

Cath Lab Robotics: Paradigm Change in Interventional Cardiology?

To review the contemporary evidence for robotic-assisted percutaneous coronary and vascular interventions, discussing its current capabilities, limitations, and potential future applications. Robotic-assisted cardiovascular interventions significantly reduce radiation exposure and orthopedic strains for interventionalists, while maintaining high rates of device and clinical success. The PRECISE and CORA-PCI studies demonstrated the safety and efficacy of robotic-assisted percutaneous coronary intervention (PCI) in increasingly complex coronary lesions. The RAPID study demonstrated similar findings in peripheral vascular interventions (PVI). Subsequent studies have demonstrated the safety and efficacy of second-generation devices, with automations mimicking manual PCI techniques. While innovations such as telestenting continue to bring excitement to the field, major limitations remain-particularly the lack of randomized trials comparing robotic-assisted PCI with manual PCI. Robotic technology has successfully been applied to multiple cardiovascular procedures. There are limited data to evaluate outcomes with robotic-assisted PCI and other robotic-assisted cardiovascular procedures, but existing data show some promise of improving the precision of PCI while decreasing occupational hazards associated with radiation exposure.

Demonstration of the Safety and Feasibility of Robotically Assisted Percutaneous Coronary Intervention in Complex Coronary Lesions: Results of the CORA-PCI Study (Complex Robotically Assisted Percutaneous Coronary Intervention)

ObjectivesThe aims of this study were to evaluate the feasibility and technical success of robotically assisted percutaneous coronary intervention (R-PCI) for the treatment of coronary artery disease (CAD) in clinical practice, especially in complex lesions, and to determine the safety and clinical success of R-PCI compared with manual percutaneous coronary intervention (M-PCI). BackgroundR-PCI is safe and feasible for simple coronary lesions. The utility of R-PCI for complex coronary lesions is unknown. MethodsAll consecutive PCI procedures performed robotically (study group) or manually (control group) over 18 months were included. R-PCI technical success, defined as the completion of the procedure robotically or with partial manual assistance and without a major adverse cardiovascular event, was determined. Procedures ineligible for R-PCI (i.e., atherectomy, planned 2-stent strategy for bifurcation lesion, chronic total occlusion requiring hybrid approach) were excluded for analysis from the M-PCI group. Clinical success, defined as completion of the PCI procedure without a major adverse cardiovascular event, procedure time, stent use, and fluoroscopy time were compared between groups. ResultsA total of 315 patients (mean age 67.7 ± 11.8 years; 78% men) underwent 334 PCI procedures (108 R-PCIs, 157 lesions, 78.3% type B2/C; 226 M-PCIs, 336 lesions, 68.8% type B2/C). Technical success with R-PCI was 91.7% (rate of manual assistance 11.1%, rate of manual conversion 7.4%, rate of major adverse cardiovascular events 0.93%). Clinical success (99.1% with R-PCI vs. 99.1% with M-PCI; p = 1.00), stent use (stents per procedure 1.59 ± 0.79 with R-PCI vs. 1.54 ± 0.75 with M-PCI; p = 0.73), and fluoroscopy time (18.2 ± 10.4 min with R-PCI vs. 19.2 ± 11.4 min with M-PCI; p = 0.39) were similar between the groups, although procedure time was longer in the R-PCI group (44:30 ± 26:04 min:s vs. 36:34 ± 23:03 min:s; p = 0.002). Propensity-matched analysis confirmed that procedure time was longer in the robotic group (42:59 ± 26:14 min:s with R-PCI vs. 34:01 ± 17:14 min:s with M-PCI; p = 0.007), although clinical success remained similar (98.8% with R-PCI vs. 100% with M-PCI; p = 1.00). ConclusionsThis study demonstrates the feasibility, safety, and high technical success of R-PCI for the treatment of complex coronary disease. Furthermore, comparable clinical outcomes, without an adverse effect on stent use or fluoroscopy time, were observed with R-PCI and M-PCI.

Effect of Gradual Computerized Angioplasty on Outcomes of Patients Undergoing Coronary Stenting

Mechanical trauma caused by percutaneous coronary intervention is a major factor contributing to subsequent cardiac events, restenosis, and the need for target lesion revascularization (TLR). To minimize this trauma, we developed a Computerized Angioplasty Pressure Sensor and Inflator Device (CAPSID) for gradual inflation. The objective of the present prospective randomized study was to examine whether the use of this novel device reduced TLR, as well as cardiac events, in patients undergoing stenting. Patients undergoing coronary stenting were eligible and randomized to receive CAPSID or standard manual percutaneous coronary intervention. In the CAPSID group, slow, gradual balloon inflation was performed using a personal computer. Patients with acute ST-elevation myocardial infarction or the need for percutaneous coronary intervention for total occlusions, left main disease, and vein grafts were excluded. Clinical follow-up for major adverse cardiac events, including death, acute myocardial infarction, and TLR, was performed at 12 months. A total of 310 patients were enrolled in the study. No significant differences were found in the clinical characteristics between the CAPSID and control groups. At 1 year of follow-up, the CAPSID group had had a significantly lower rate of major adverse cardiac events (8% vs 18%, p <0.01) driven by significantly lower rates of acute myocardial infarction (1% vs 7%, p <0.01) and TLR (5% vs 12%, p <0.05). In conclusion, gradual computerized balloon inflation using CAPSID as a platform for angioplasty and stenting significantly reduced TLR and major adverse cardiac events at 1 year in patients undergoing coronary stenting. The use of this novel device may improve outcomes in patients undergoing coronary stenting.