Robotic Percutaneous Coronary Intervention During COVID-19 Pandemic: Outcomes and Cost-Effectiveness With Procedural Distancing

Background. The COVID-19 pandemic raised many questions, including the need to maintain distancing and the importance of full personal protection equipment (PPE) for healthcare workers. Robotic-assisted percutaneous coronary intervention (R-PCI) can be advantageous during a pandemic to facilitate procedural distancing for cath lab personnel and to decrease the cumulative amount of PPE employed. Methods. All patients who underwent R-PCI during the early phase of the pandemic were evaluated at a single institution. Procedural characteristics, complexity of disease, and use of adjunctive imaging or physiology were queried. Mean R-PCI time, procedure and fluoroscopy times, radiation dose, and contrast volume were collected. Cost of PPE incurred with R-PCI was evaluated in comparison with traditional cases. Furthermore, procedural distancing from patients for operators was objectively quantified to compare with traditional cath lab cases. Results. Thirteen patients were treated using R-PCI. Radial access site was utilized in 54% and the left circumflex artery was treated most frequently (in 50% of cases). The complexity of cases performed was illustrated by revascularization of chronic total occlusions in 2 patients (14%) as well as adjunctive intravascular ultrasound or instantaneous wave-free ratio in 4 patients (29%). Mean R-PCI time was 45.38 minutes, manual time was 25.66 minutes, and total procedure time was 71.08 minutes. Average fluoroscopy time was 18.27 minutes, contrast volume was 143.85 mL, and radiation dose was 747.15 mGy. R-PCI was more cost effective, with total average PPE cost of $330.71 in comparison with $496.08 for traditional PCI (absolute difference, $165.36). Furthermore, R-PCI demonstrated substantial procedural distancing of operators from patients (8.14 feet for R-PCI vs 2.75 feet for traditional PCI; absolute difference, 5.39 feet). Conclusion. R-PCI could be a promising strategy during a pandemic by facilitating procedural distancing, minimizing staffing exposure risk, and decreasing PPE cost.

J INVASIVE CARDIOL 2022;34(2):E87-E91. Epub 2021 December 19.

Key words: COVID-19, percutaneous coronary intervention, robotic-assisted PCI

The SARS-CoV-2 (2019 novel coronavirus) achieved pandemic status in March 2020, and since then has been responsible for over 70 million cases and 1.5 million confirmed deaths worldwide.¹ The pandemic not only incited significant morbidity and mortality worldwide, but also exhausted the resources of healthcare systems globally and limited their ability to provide effective care. In the early phase of the pandemic, when rapid infection rates overwhelmed the supply of personal protective equipment (PPE), many hospitals temporarily closed or limited access to elective procedures such as surgeries, endoscopic procedures, and angiographic procedures like cardiac catheterization and percutaneous coronary intervention (PCI).² Only procedures that were considered a medical emergency, such as coronary angiography during acute coronary syndromes, were being performed in the cath lab with meticulous care to prevent unwarranted exposure and unnecessary disposal of PPE.

Robotic PCI (R-PCI) has witnessed increasing acceptance and adoption as part of coronary and peripheral interventions in the cath lab. While certain benefits of R-PCI, such as reduction of healthcare worker (HCW) and staff exposure to radiation, have been explored,³ there has been limited application to understand the scope of impact during a pandemic. Our early experience with the use of R-PCI revealed a plausible reduction in HCW exposure utilizing procedural distancing and reduction in PPE cost, which then prompted a systematic analysis of our case series to shed further light on these valuable insights for future pandemics.

CorPath GRX Robotic System. The CorPath GRX Robotic System (Corindus, A Siemens Healthineers Company) is a 2-part system that includes a robotic control console and an interventional cockpit in which the operator sits to perform R-PCI (Figure 1). After engagement of the coronary artery manually, the guide catheter is attached to the console and a bedside disposable cassette allows the operator to advance, retract, and rotate the guidewire from the interventional cockpit with precision.

Study design. This retrospective case series highlights PCIs performed between March and June 2020 utilizing R-PCI techniques as a means to mitigate exposure of HCW to patients that were positive for COVID-19 by rapid polymerase chain reaction testing, as well as to potentially reduce PPE use. The primary outcome measured was the mean cost of PPE utilized during the R-PCI procedures and the mean distance of the primary and secondary operators from the patient as compared with their respective values should R-PCI techniques not have been utilized. Several other parameters, including total length of procedure, type of intervention, and total fluoroscopic time, were also detailed.

Thirteen R-PCI cases were identified and well varied in terms of type of intervention performed (including type and number of lesions treated) and access used (radial vs femoral), and included complex PCI cases, including chronic total occlusion (CTO) revascularization and adjunctive devices such as physiologic testing and intravascular imaging (Table 1). Other characteristics, such as mean procedure time, R-PCI time, manual time, fluoroscopy time, and contrast use are outlined in Table 1.

Mean age of the patient population was 60.7 years and 7 patients (54%) were women. The majority of patients had traditional cardiovascular risk factors: 8 with diabetes (62%), 11 with hypertension and hyperlipidemia (85%), and 6 with history of smoking (46%). The mean ejection fraction of the studied population (50.4%) was slightly lower than the normal range (Table 1).

Of the 13 patients, the left circumflex coronary artery was treated most commonly (50%) and radial access was the most common access (54%). Adjunctive intravascular ultrasound (IVUS) was used in 1 case and instantaneous wave-free ratio (iFR) was performed in 3 patients. R-PCI hybrid CTO revascularization was performed in 2 patients (14%). R-PCI assisted time was 45.6 minutes, with a mean manual PCI time of 25.1 minutes and a total average procedure time of 71.1 minutes. Average radiation dose, fluoroscopy time, and contrast volume were 747.15 mGy, 18.28 minutes, and 143.85 mL, respectively (Table 1).

PPE cost. Total PPE cost for all scrubbed personnel without R-PCI in 13 cases, which would include 2 scrubbed operators (as procedures were performed at a teaching hospital) and 1 nurse was calculated at $496.08 USD. Alternatively, total PPE cost with utilization of R-PCI, which would include only 1 scrubbed secondary operator (fellow-in-training) and 1 nurse along with the primary operator behind the cockpit (not requiring PPE) was $330.72 USD (Table 2).

The use of R-PCI for 13 cases during the COVID-19 pandemic resulted in an absolute cost reduction of $165.36 USD ($496.08 USD vs $330.72 USD), and a relative cost reduction of 33.3% (Figure 2), which correlated directly to the ability to have 1 less scrubbed operator involved in the case. This reduction in staff involvement, and thus PPE cost, was universal regardless of the type of intervention performed (angioplasty, laser atherectomy, drug-eluting stent placement, etc), access site (radial vs femoral), or the need for adjunctive devices (iFR or IVUS) in more complex PCI cases.

Procedural distancing. The mean distance of the operator from the patient, based on the positioning of personnel in standard PCI cases (with primary and secondary operator at the bedside) measured 2.75 feet. Meanwhile, the average distance of the operator from the patient during R-PCI (with the primary operator in the interventional cockpit and the secondary operator at bedside) measured 8.14 feet (Table 3). The use of R-PCI resulted in an absolute increase in mean distance of 5.39 feet (2.75 feet vs 8.14 feet) (Figure 3) and a relative increase of 196%, which correlated with procedural distancing facilitated by R-PCI.

While the current COVID-19 pandemic has impacted our healthcare system in many ways, the scarcity of PPE during peak infectious periods and close contact with infected patients by HCWs are of particular concern, as these factors have caused inadvertent exposure to the virus, as well as negative financial strain on hospitals struggling to find and purchase adequate PPE for their employees. This is at least partially due to an unprecedented rise in demand and cost of PPE during the pandemic. Models that attempted to forecast this economic impact predicted the requirement of roughly $9.6 billion USD in government expenditure in order to prevent approximately 4.8 million HCW cases and 67,000 related deaths.⁴ While notable occupational health hazards, such as radiation exposure, have been well outlined by the Society of Cardiovascular Angiography and Intervention as recently as 2020, little has been mentioned about the potential economic impact of COVID-19 or future global pandemics on the healthcare workforce.⁵ R-PCI has been successfully utilized since 2011 for coronary interventions. The latest-generation CorPath GRX Robotic System has successfully been utilized for complex coronary, peripheral, neurovascular, and renal interventions.^6-9 In addition to reducing radiation dose to the interventional operator, the CorPath GRX system allows procedural distancing in these infectious environments and further reduces the cost of PPE by minimizing the personnel required to be present in close proximity to the patient in the catheterization laboratory.

Evidence for R-PCI. The multicenter, prospective, observational PRECISE study of 164 patients who underwent R-PCI with CorPath 200 Robotic System showed that R-PCI was successful without conversion to manual PCI in 98.8% of patients and resulted in 95.2% lower radiation exposure for the primary operator in the cockpit compared with standing at bedside in the traditional primary operator position (0.98 µGY vs 20.5 µGY, respectively; P<.001).¹⁰ The study also showed that there is a small learning curve, as only 3 cases were needed to gain competency in R-PCI, allowing it to be rapidly assimilated. Safety and feasibility of complex coronary artery disease treated with R-PCI was compared with manual PCI in the CORA-PCI study; 78.3% of the lesions treated were type B2/C, with an average Syntax score of 19.65. Technical success with R-PCI was 91.7%, with major adverse cardiovascular event rate of only 0.93% and similar clinical success of 99.1%, as well as similar mean stent use and fluoroscopy time, but longer procedure time with R-PCI (44:30 ± 26:04 minutes vs 36:34 ± 23:03 minutes with manual PCI; P<.01).¹¹ Furthermore, remote R-PCI was also successfully demonstrated by Patel et al, where 5 patients with type A coronary lesions were revascularized from a robotic interventional cockpit 20 miles away from the patient with 100% procedural success rate and no major adverse cardiac events.¹²

The technical limitations of R-PCI (using the previous generation CorPath 200 system) have been explored. A case series of 108 R-PCI procedures found an 18.5% rate of requiring either partial manual assistance or manual conversion. The reasons for manual assistance or conversion included guide catheter/wire support problems in 9 patients (45%), robotic platform technical limitations in 8 patients (40%), and clinical adverse events in 3 patients (15%).¹³

Benefits of R-PCIs during the COVID-19 pandemic.

Cost effectiveness. This study is the first case series to report feasibility, benefit, and cost effectiveness of R-PCI during the COVID-19 era. All 13 cases were completed successfully with R-PCI. The average fluoroscopy time was similar to the manual PCI arm of the CORA-PCI study (18.5 minutes vs 19.2 minutes, respectively) and less mean contrast volume was used (143.85 mL vs 202.5 mL, respectively).¹² More importantly, the use of R-PCI allowed the decrease of 1 scrubbed staff member in the room, resulting in a significant reduction of total PPE cost, not to mention conservation during high demand. The aforementioned breakthroughs in remote R-PCI allow these benefits to spread even further across large health systems by instituting a hub and spoke model, where many of these procedures could be performed at a single site remotely in order to mitigate their PPE costs and keep their HCWs from unnecessary exposure to COVID-19.

Procedural distancing. Limited case reports have been published on the benefits of R-PCI when used for a suspected COVID-19 patient. The first reported case report was a woman who presented with cardiac arrest and ST-segment elevation myocardial infarction with a chest computed tomography showing bilateral pulmonary infiltrates.⁶ The authors discussed the implications of increased distance between the scrubbed staff and cockpit operator, minimizing exposure with reduction of personnel required to be in the room and thus reduction in PPE requirement. Lemos et al took a further step by forming a minimum-contact strategy with R-PCI while treating a COVID-19 patient with myocardial infarction. In their case report, they discuss a zone of respirator particle spread of 4 meters (13.1 feet) marked around the center of the patient and the interventional team trained to minimize time spent in this zone.¹⁴ It is important to note that the formation of this zone is arbitrary, as 6 feet of social distancing has been popularized among the public. A recent study from South Korea shows that coronavirus can spread indoors within 5 minutes from 20 feet away.¹⁵ Advances in R-PCI technique and technology also allow for the operator to be located remotely.¹² This further distances the operator from the patient, allowing them to be outside of the angiography suite. Our study demonstrated significant increase in distancing of the operator from the patient using R-PCI (2.75 feet vs 8.14 feet). These findings further reinforce the benefits of procedural distancing during procedures involving a COVID-19 patient.

The implementation of remote R-PCI allows further extrapolation of this concept to then allow complete procedural distancing of the primary operator from the patient by maintaining the interventional cockpit at a remote location geographically distant from the infected patients.

The current COVID-19 pandemic has seen PPE quickly transition from an underappreciated accessory to a scarce resource, putting the safety of essential HCWs and the financial stability of many healthcare centers in the United States at risk. The adoption and implementation of R-PCI into angiographic suites has changed the landscape of interventional cardiology from a feasibility standpoint with various demonstrable benefits. Particularly through its ability to reduce PPE cost and increase procedural distancing in the angiographic suite, R-PCI also has the potential to impact HCW safety and mitigate financial impacts during this pandemic. The integration of R-PCI for peripheral and neurovascular interventions and further larger studies on remote R-PCI are warranted to establish benefits during the COVID-19 era.

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• Safety and Feasibility of a Novel, Second-Generation Robotic-Assisted System for Percutaneous Coronary Intervention: First-in-Human Report 
• Invasive Management of Acute Myocardial Infarctions During the Initial Wave of the COVID-19 Pandemic