Earlier this month, the Society for Cardiovascular Angiography and Interventions (SCAI) held their annual Scientific Sessions in Orlando, FL. The meeting featured the presentations and discussions on the latest clinical data in interventional cardiology and emphasized the mission to "Save and Enhance Lives." Beginning with this meeting, one of the key initiatives SCAI will focus on this year is workplace safety. There is a growing body of data that sheds light on the serious occupational risks that cath lab teams face over the course of their careers. In the last 18 months, there has been a significant increase in the data that has been published and new findings such as increased risk of premature vascular aging and cognitive impairment have shed light on the scope of the problem.
The topic of workplace safety was highlighted at SCAI 2016 during the general sessions and other activities sponsored by the organization. Of note, attendees were offered complimentary cataract screenings in the exhibit hall for the duration of the show. The initiative was sponsored by the Dallas VA Research Corporation and spearheaded by Dr. Emmanouil Brilakis. In an article written by TCTMD, Dr. Brilakis notes that, “We expected people would be interested but not that interested. The first day [of exams] was supposed to be only 2 hours and ended up going for 5 hours. I think it’s something people are worried about, and it’s a good opportunity while they are here to get their eyes checked.”
There are several options to reduce radiation exposure and occupational hazards in the cath lab and presenters at SCAI emphasized that adoption of these technologies is critical to creating a safer working environment. Robotic therapy is among the solutions available to both reduce radiation exposure and potentially reduce orthopedic strain for interventionalists. In clinical trials, robotic-assisted PCI has been shown to reduce radiation exposure by over 95% for the primary operator.* In addition, when seated behind the interventional cockpit, operators are not required to wear lead as the cockpit is lead lined.
In one abstract presented at SCAI, Dr. Paul Campbell sought to understand the impact robotic therapy played in the reducing radiation exposure for the bedside staff, a topic we’ve discussed on this blog.
Staff Exposure to X-ray during PCI: Randomized Comparison of Robotic vs. Manual Procedures Campbell P. et al.
Background: R-PCI has been shown in the PRECISE trial to reduce the primary operator's radiation exposure by 95%. This study sought to determine whether R-PCI can reduce the radiation exposure for the entire cardiac catheterization staff.
- 30 patients were randomized to manual (N=15) and R-PCI (N=15).
- There was no significant difference in lesion complexity, fluoro time or PCI time.
- Tech radiation exposure in R-PCI was 15% lower than manual (1.1mSv to 1.3 mSv) in this study
- Tech radiation reduction enabled by utilizing extension tubing to move further from x-ray source and repositioning shielding to provide greater protection.
- R-PCI resulted in a highly significant reduction P=0.015 in physician radiation exposure
Conclusion: This trial demonstrated a significant reduction in the physician's radiation exposure with R-PCI and showed that with the use of R-PCI there is no increase, and this study showed a decrease in radiation exposure for the cath lab technicians.
Dr. Campbell presenting his data during the abstract poster sessions at SCAI
In addition to this abstract, there were 3 other abstracts presented on robotic-assisted PCI during the conference, as well as a Late Breaking Clinical Trial presentation. The study, presented by Dr. Ehtisham Mahmud, highlighted the feasibility of robotics for complex PCI. SCAI highlighted the results of the study in a press release issued during the meeting.
Demonstration of the Safety and Feasibility of Robotically Assisted Percutaneous Coronary Intervention in Complex Coronary Lesions: Results of the Complex Robotically Assisted Percutaneous Coronary Intervention (CORA-PCI) Trial Mahmud E, et al.
Background: CORA-PCI trial was designed to determine the feasibility of performing R-PCI on complex lesions. Three abstracts were generated from the trial and presented at ACC and SCAI 2016.
- 334 procedures – 108 R-PCI and 226 M-PCI
- Patients in R-PCI group were more likely to have type B2 or C lesions (78% vs. 69%, p=0.02)
- Patients classified by a PCI lesion complexity score with the sum of their lesions placing them into a low, medium or high PCI complexity group
- R-PCI is safe and feasible in patients with complex coronary disease, 108 procedures; 91.7% technical success, 99.1% clinical success
- Of the cases where robotics was used, 4 out 5 cases were done completely robotically, despite the complexity of the lesions in the high complexity group, procedure time was shorter for R-PCI compared to M-PCI
Conclusion: CORA-PCI demonstrated the use of CorPath PCI as an effective alternative to manual intervention in complex PCI procedures
Dr. Jesse Naghi presenting one of 3 abstracts on the CORA-PCI Trial
As adoption of robotics continues to grow, the depth of clinical research supporting robotic PCI as an alternative to manual PCI will increase, and more physicians and patients will have access to the benefits of robotic therapy. We look forward to reviewing additional data as it comes out throughout the year and at upcoming conferences.
*Weisz, G. et al. Safety and Feasibility of Robotic Percutaneous Coronary Intervention: PRECISE Study. J Am Coll Cardiol. 2013;61(15):1596-1600.