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. 2022 Cardiovascular Diagnosis and Therapy. All rights reserved.
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. 2022 Cardiovascular Diagnosis and Therapy. All rights reserved.
Authors: Guy F A Prado; Expedito E Ribeiro; Pedro H M C Melo; Fabio A Pinton; Antonio Esteves-Filho; Celso K Takimura; Jose Mariani; Luiz J Kajita; Gilberto Marchiori; Breno de Alencar Araripe Falcao; Micheli Z Galon; Paulo R Soares; Silvio Zalc; Pedro A Lemos Journal: Cardiovasc Diagn Ther Date: 2015-12
Authors: Giora Weisz; Nathaniel R Smilowitz; D Christopher Metzger; Ronald Caputo; Juan Delgado; J Jeffrey Marshall; George Vetrovec; Mark Reisman; Ron Waksman; Augusto Pichard; Juan F Granada; Jeffrey W Moses; Joseph P Carrozza Journal: Acute Card Care Date: 2014-03-21
Authors: Ariel Durán; Sim Kui Hian; Donald L Miller; John Le Heron; Renato Padovani; Eliseo Vano Journal: Catheter Cardiovasc Interv Date: 2013-03-08 Impact factor: 2.692
Authors: Giovanna Sarno; Bo Lagerqvist; Göran Olivecrona; Christoph Varenhorst; Mikael Danielewicz; Kristina Hambraeus; Daniel Lindholm; Truls Råmunddal; Nils Witt; Stefan James Journal: Catheter Cardiovasc Interv Date: 2017-05-22 Impact factor: 2.692