Robotic Percutaneous Coronary Intervention: Time to Focus on the Patient

Robotic-Assisted PCI: The Future of Coronary Intervention?

R-One is a robotic percutaneous coronary intervention (PCI) system (CE mark 2019) designed to reduce operator radiation exposure, improve ergonomics, and accurately navigate, position, and deliver guidewires/devices during PCI. We aimed to evaluate the safety and efficacy of the R-One system for PCI. The European multicentre prospective R-EVOLUTION study included patients with a de novo coronary artery stenosis (length <38 mm, reference diameter 2.5-4.0 mm) undergoing stent implantation. Patients with recent ST-segment elevation myocardial infarction, ostial or left main lesion, bifurcation, severe tortuosity, or calcification were excluded. Clinical success was defined as the absence of major intraprocedural complications. Technical success was defined as the successful advancement and retraction of all PCI devices (guidewires/balloon/stents) without total manual conversion. Radiation exposure to patients, to a simulated manual operator, and to robotic PCI operators was measured. Sixty-two consecutive patients (B2/C lesions: 25.0% [16/64]) underwent robotic PCI. Radial access was used in 96.8% (60/62) of procedures. The mean robotic procedure duration was 19.9±9.6 min and the mean fluoroscopy time was 10.3±5.4 min. Clinical success was 100% with no complications at 30 days. Technical success was 95.2% (59/62). Total manual conversion was required in 4.8% (3/62) cases, with 1 case directly related to the robotic system. Operator radiation exposure was reduced by 84.5% under and 77.1% on top of the lead apron, compared to doses received on the patient table. This study suggests that robotic PCI using R-One is safe and effective with markedly lower radiation exposure to the operator. Further studies are needed to evaluate R-One in larger patient populations with more complex lesions. (ClinicalTrials.gov: NCT04163393).

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.

Innovation has been the cornerstone of progress in the field of percutaneous coronary intervention (PCI) since its inception. Refinements in procedural technique and interventional tools have improved patient outcomes and overall safety. Despite this progress, however, the health risks posed to operators and staff remain undeniably high. Robotic PCI (R-PCI) offers a new era in coronary revascularization poised to address this dilemma. To date, R-PCI procedures have been widely performed in clinical practice for over a decade and multiple novel endovascular robotic systems are currently under development. This review serves as an up-to-date understanding of R-PCI, focusing on the origins, clinical evidence, current state, and future targets of robotic therapy.

A 34-year-old woman with history of surgical correction (Takeuchi procedure) of anomalous left coronary artery from the pulmonary artery (ALCAPA) presented with reduced left ventricular ejection fraction of 48% and severe ischemia quantified as 21% by stress Positron Emission Tomography (PET) scan. A coronary angiogram revealed ostial 90% stenosis of the left main coronary artery (LMCA). A guidewire (Sion Blue, Asahi Intecc USA, Inc., Santa Ana, CA) was navigated robotically and after pre-dilation with 3.5 × 15 mm cutting balloon, the lesion length was measured by marking the distal end of the lesion with the balloon marker and withdrawing back robotically to the ostium of the LMCA. A 3.5 × 16 mm drug-eluting stent was deployed robotically after intravascular ultrasound (IVUS) with good results. The main advantage of robotic percutaneous coronary intervention includes the precise measurement and positioning of the stent. Since the guide catheter and balloon can be adjusted without guide catheter and device interaction, precise placement of stent is possible by advancing the device distal to the lesion, positioning the guide catheter just proximal to the proximal edge of the stent and pulling the guidecatheter and device back as a unit. Final IVUS after post-dilation with 4.0 noncompliant and 5.0 compliant balloon revealed precise placement at the ostium and full stent expansion.

Vascular interventional robot is becoming increasingly popular in assisting doctors for the treatment of cardiovascular diseases (CVDs). However, natural manipulations and motion patterns of surgeons in percutaneous coronary intervention (PCI), including finger motion and hand motion, are potentially altered more or less through this solution. Since clinical success is highly dependent on the skills and dexterous manipulation strategies of the surgeons, but these skills and experience remains an underused resource in robot-assisted intervention. In this paper, surface electromyography (sEMG) of surgeons' hand and arm muscles, a feature of manipulation skills in intervention, is acquired to recognize six interventional manipulations with Back-Propagation (BP) neural network. A modified principal component analysis (PCA) is presented to select a sensitive and principal muscle subset for improving the fiexibility of subjects' manipulations. Experimental results show that the sensitive muscle subset with the recognition rate over 90% performs better than the insensitive one, and the sEMG-based BP neural network has the ability to recognize interventional manipulations with a high accuracy.