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

Autor: Pedro A. Lemos, Felipe Ramalho, José Mariani, Gabriel Albuquerque, Marcelo Franken, Adriano Caixeta, Felipe Nasser, Stefano Garzon, Leonardo Galastri, Ivanise Gomes, Fabio G. Pitta, Breno Boueri Affonso, Irisvaldo S. de Oliveira, Leonardo Guedes Moreira Valle, Guy F. A. Prado, Rodrigo Gobbo Garcia, Breno Oliveira Almeida
Rok vydání: 2022
Předmět:
Zdroj: Cardiovasc Diagn Ther
ISSN: 2223-3660
2223-3652
Popis: 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
Databáze: OpenAIRE