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

Background

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.

Methods

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.

Results

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).

Conclusions

Introduction of robotic-assisted PCI in a tertiary center was associated with safe and effective results, comparable to pre-defined goals of optimal performance.

Informations de copyright

2022 Cardiovascular Diagnosis and Therapy. All rights reserved.

Déclaration de conflit d'intérêts

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://cdt.amegroups.com/article/view/10.21037/cdt-21-442/coif). PAL is supported in part by a grant from The National Council for Scientific and Technological Development (CNPq)—Brazil (grant number 306677/2019-9). He serves as an unpaid editorial board member of Cardiovascular Diagnosis and Therapy from September 2021 to September 2022. The other authors have no conflicts of interest to declare.