One-year outcome of robotical vs. manual percutaneous coronary intervention.

Coronary artery disease Outcome Percutaneous coronary intervention R-PCI Robotic

Journal

Clinical research in cardiology : official journal of the German Cardiac Society
ISSN: 1861-0692
Titre abrégé: Clin Res Cardiol
Pays: Germany
ID NLM: 101264123

Informations de publication

Date de publication:
21 Aug 2024
Historique:
received: 06 06 2024
accepted: 14 08 2024
medline: 21 8 2024
pubmed: 21 8 2024
entrez: 21 8 2024
Statut: aheadofprint

Résumé

Robotic-assisted percutaneous coronary intervention (R-PCI) is a promising technology for optimizing the treatment of patients with coronary heart disease. For a better understanding of the potential of R-PCI in clinical routine compared to conventional manual PCI (M-PCI) both initial treatment success of the index procedure and long-term outcome have to be analysed. Prospective evaluation from the FRiK (DRKS00023868) registry of all R-PCI cases with the CorPath GRX Cardiology by Siemens Healthineers and Corindus in the Freiburg University Heart Center between 04/2022 and 03/2023. Index procedure success and safety, radiation dose of patients and personnel, and 1-year outcome will be reported. Findings will be compared to a prospective control group of M-PCI patients treated by the same team of interventionalists during the same observation period. Seventy patients received R-PCI and were included in the registry. PCI success rate was 100%, with 19% requiring manual assistance. No complications (MACE-major adverse cardiovascular events) occurred. Compared with 70 matched-pair M-PCI patients, there was a higher median procedural time (103 min vs. 67 min, p < 0.001) and fluoroscopy time (18 min vs. 15 min, p = 0.002), and more contrast volume was used (180 ml vs. 160 ml, p = 0.041) in R-PCI vs. M-PCI patients. However, there was no significant difference of the dose-area product (4062 vs. 3242 cGycm R-PCI is feasible and safe. Compared to M-PCI, index procedure success rate is high, safety profile is favourable, and manual assistance was required in only few cases. At 1-year follow-up results for R-PCI vs. M-PCI considering mortality, rehospitalisation, morbidity and target vessel failure were equal.

Sections du résumé

BACKGROUND BACKGROUND
Robotic-assisted percutaneous coronary intervention (R-PCI) is a promising technology for optimizing the treatment of patients with coronary heart disease. For a better understanding of the potential of R-PCI in clinical routine compared to conventional manual PCI (M-PCI) both initial treatment success of the index procedure and long-term outcome have to be analysed.
METHODS METHODS
Prospective evaluation from the FRiK (DRKS00023868) registry of all R-PCI cases with the CorPath GRX Cardiology by Siemens Healthineers and Corindus in the Freiburg University Heart Center between 04/2022 and 03/2023. Index procedure success and safety, radiation dose of patients and personnel, and 1-year outcome will be reported. Findings will be compared to a prospective control group of M-PCI patients treated by the same team of interventionalists during the same observation period.
RESULTS RESULTS
Seventy patients received R-PCI and were included in the registry. PCI success rate was 100%, with 19% requiring manual assistance. No complications (MACE-major adverse cardiovascular events) occurred. Compared with 70 matched-pair M-PCI patients, there was a higher median procedural time (103 min vs. 67 min, p < 0.001) and fluoroscopy time (18 min vs. 15 min, p = 0.002), and more contrast volume was used (180 ml vs. 160 ml, p = 0.041) in R-PCI vs. M-PCI patients. However, there was no significant difference of the dose-area product (4062 vs. 3242 cGycm
CONCLUSION CONCLUSIONS
R-PCI is feasible and safe. Compared to M-PCI, index procedure success rate is high, safety profile is favourable, and manual assistance was required in only few cases. At 1-year follow-up results for R-PCI vs. M-PCI considering mortality, rehospitalisation, morbidity and target vessel failure were equal.

Identifiants

DOI: 10.1007/s00392-024-02524-0 PMID: 39167194
pubmed: 39167194
doi: 10.1007/s00392-024-02524-0
pii: 10.1007/s00392-024-02524-0
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s).

Références

Beyar R, Gruberg L, Deleanu D et al (2006) Remote-control percutaneous coronary interventions: concept, validation, and first-in-humans pilot clinical trial. J Am Coll Cardiol 47:296–300
pubmed: 16412850
Granada JF, Delgado JA, Uribe MP et al (2011) First-in-human evaluation of a novel robotic-assisted coronary angioplasty system. JACC Cardiovasc Interv 4:460–465
pubmed: 21511227
Madder RD, VanOosterhout SM, Jacoby ME et al (2017) Percutaneous coronary intervention using a combination of robotics and telecommunications by an operator in a separate physical location from the patient: an early exploration into the feasibility of telestenting (the REMOTE-PCI study). EuroIntervention 12:1569–1576
pubmed: 28105993
Mahmud E, Naghi J, Ang L et al (2017) Demonstration of the safety and feasibility of robotically assisted percutaneous coronary intervention in complex coronary lesions: results of the CORA-PCI study (complex robotically assisted percutaneous coronary intervention). JACC Cardiovasc Interv 10:1320–1327
pubmed: 28683937
Walters D, Reeves RR, Patel M, Naghi J, Ang L, Mahmud E (2019) Complex robotic compared to manual coronary interventions: 6- and 12-month outcomes. Catheter Cardiovasc Interv 93:613–617
pubmed: 30456889
Kagiyama K, Mitsutake Y, Ueno T et al (2021) Successful introduction of robotic-assisted percutaneous coronary intervention system into Japanese clinical practice: a first-year survey at single center. Heart Vessels 36:955–964
pubmed: 33502572
Patel TM, Shah SC, Soni YY et al (2020) Comparison of robotic percutaneous coronary intervention with traditional percutaneous coronary intervention: a propensity score-matched analysis of a large cohort. Circ Cardiovasc Interv 13:e008888
pubmed: 32406263
Orme NM, Rihal CS, Gulati R et al (2015) Occupational health hazards of working in the interventional laboratory: a multisite case control study of physicians and allied staff. J Am Coll Cardiol 65:820–826
pubmed: 25720626
Klein LW, Tra Y, Garratt KN et al (2015) Occupational health hazards of interventional cardiologists in the current decade: Results of the 2014 SCAI membership survey. Catheter Cardiovasc Interv 86:913–924
pubmed: 25810341
Weisz G, Metzger DC, Caputo RP et al (2013) Safety and feasibility of robotic percutaneous coronary intervention: PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) Study. J Am Coll Cardiol 61:1596–1600
pubmed: 23500318
Benchimol EI, Smeeth L, Guttmann A et al (2015) The REporting of studies conducted using observational routinely-collected health Data (RECORD) statement. PLoS Med 12:e1001885
pubmed: 26440803 pmcid: 4595218
Thygesen K, Alpert JS, Jaffe AS et al (2018) Fourth universal definition of myocardial infarction (2018). J Am Coll Cardiol 72:2231–2264
pubmed: 30153967
Kossman CE (1964) Nomenclature and criteria for the diagnosis of cardiovascular diseases. Circulation 30:321–325
pubmed: 14210612
Campeau L (2002) The Canadian Cardiovascular Society grading of angina pectoris revisited 30 years later. Can J Cardiol 18:371–379
pubmed: 11992130
Herdman M, Gudex C, Lloyd A et al (2011) Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 20:1727–1736
pubmed: 21479777 pmcid: 3220807
Chan PS, Jones PG, Arnold SA, Spertus JA (2014) Development and validation of a short version of the Seattle angina questionnaire. Circ Cardiovasc Qual Outcomes 7:640–647
pubmed: 25185249 pmcid: 4282595
Konigstein M, Redfors B, Zhang Z et al (2022) Utility of the ACC/AHA lesion classification to predict outcomes after contemporary DES treatment: individual patient data pooled analysis from 7 randomized trials. J Am Heart Assoc 11:e025275
pubmed: 36515253 pmcid: 9798816
Safarian H, Alidoosti M, Shafiee A, Salarifar M, Poorhosseini H, Nematipour E (2014) The SYNTAX score can predict major adverse cardiac events following percutaneous coronary intervention. Heart Views 15:99–105
pubmed: 25774251 pmcid: 4348991
Bay B, Kiwus LM, Goßling A et al (2024) Procedural and one-year outcomes of robotic-assisted versus manual percutaneous coronary intervention. EuroIntervention 20:56–65
pubmed: 38165113
Nef HMAS, Birkemeyer R, Bufe A, Dörr O, Elsässer A, Gaede L, Gori T (2021) Manual der Arbeitsgruppe Interventionelle Kardiologie (AGIK) der Deutschen Gesellschaft für Kardiologie: Herz- und Kreislaufforschung e. V. (DGK) Teil 1: „Durchführung der diagnostischen Herzkatheteruntersuchung. Kardiologe 15:370–403

Auteurs

Constantin von Zur Mühlen (C)

Department of Cardiology and Angiology, Faculty of Medicine, Heart Center Freiburg University, University of Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.

Marvin Jeuck (M)

Department of Cardiology and Angiology, Faculty of Medicine, Heart Center Freiburg University, University of Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.

Timo Heidt (T)

Department of Cardiology and Angiology, Faculty of Medicine, Heart Center Freiburg University, University of Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.
Max Grundig Klinik, Bühl, Germany.

Thomas Maulhardt (T)

Department of Cardiology and Angiology, Faculty of Medicine, Heart Center Freiburg University, University of Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.

Tau Hartikainen (T)

Department of Cardiology and Angiology, Faculty of Medicine, Heart Center Freiburg University, University of Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.

Alexander Supady (A)

Interdisciplinary Medical Intensive Care, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.
Heidelberg Institute of Global Health, University of Heidelberg, Heidelberg, Germany.

Ingo Hilgendorf (I)

Department of Cardiology and Angiology, Faculty of Medicine, Heart Center Freiburg University, University of Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.

Dennis Wolf (D)

Department of Cardiology and Angiology, Faculty of Medicine, Heart Center Freiburg University, University of Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.

Klaus Kaier (K)

Institute of Medical Biometry and Statistics, Faculty of Medicine, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany.

Dirk Westermann (D)

Department of Cardiology and Angiology, Faculty of Medicine, Heart Center Freiburg University, University of Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.

Jonathan Rilinger (J)

Department of Cardiology and Angiology, Faculty of Medicine, Heart Center Freiburg University, University of Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany. jonathan.rilinger@uniklinik-freiburg.de.
ORCID: 0000-0001-9333-3629

Classifications MeSH