Sean C Beinart1, Andrea Natale2, Atul Verma3, Alpesh Amin4, Scott Kasner5, Hans-Cristoph Diener6, Maurizio Del Greco7, Bruce L Wilkoff8, Erika Pouliot9, Noreli Franco10, Suneet Mittal11. 1. Center for Cardiac and Vascular Research, Washington Adventist Hospital, 15225 Shady Grove Rd Ste 201, Rockville, MD. Electronic address: sbeinart@gmail.com. 2. Texas Cardiac Arrhythmia Institute, St. David's Medical Center, 3000 N IH 35, Suite 720, Austin, TX. Electronic address: dr.natale@gmail.com. 3. Southlake Regional Health Centre, 596 Davis Dr, Newmarket, Ontario, Canada. Electronic address: atul.verma@utoronto.ca. 4. Department of Medicine, University of California,1001 Health Sciences Rd, Irvine, CA. Electronic address: anamin@uci.edu. 5. Department of Neurology, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce St, Philadelphia, PA. Electronic address: kasner@mail.med.upenn.edu. 6. Department of Neurology and Stroke Center, University Hospital Essen, Hufelandstraße 55, Essen, Germany. Electronic address: hans.diener@uni-due.de. 7. Santa Maria del Carmine Hospital, Piazza S. Maria, Rovereto, Italy. Electronic address: maurizio.delgreco@apss.tn.it. 8. Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH. Electronic address: wilkofb@ccf.org. 9. CRHF Clinical, Statistics, Medtronic, 8200 Coral Sea St. Mounds View, MN. Electronic address: erika.pouliot@medtronic.com. 10. CRHF Clinical, Medtronic, 8200 Coral Sea St. Mounds View, MN. Electronic address: noreli.c.franco@medtronic.com. 11. Electrophysiology Laboratory, The Valley Hospital Health System, One Linwood Avenue, Paramus, NJ. Electronic address: mittsu@valleyhealth.com.
Abstract
BACKGROUND: Traditionally, insertable cardiac monitor (ICM) procedures have been performed in the cardiac catheterization (CATH) or electrophysiology (EP) laboratory. The introduction of the miniaturized Reveal LINQ ICM has led to simplified and less invasive procedures, affording hospitals flexibility in planning where these procedures occur without compromising patient safety or outcomes. METHODS: The present analysis of the ongoing, prospective, observational, multicenter Reveal LINQ Registry sought to provide real-world feasibility and safety data regarding the ICM procedure performed in the CATH/EP lab or operating room and to compare it with insertions performed outside of these traditional hospital settings. Patients included had at least a 30-day period after the procedure to account for any adverse events. RESULTS: We analyzed 1222 patients (58.1% male, age 61.0 ± 17.1 years) enrolled at 18 centers in the US, 17 centers in Middle East/Asia, and 15 centers in Europe. Patients were categorized into 2 cohorts according to the location of the procedure: in-lab (CATH lab, EP lab, or operating room) (n = 820, 67.1%) and out-of-lab (n = 402, 32.9%). Several differences were observed regarding baseline and procedure characteristics. However, no significant differences in the occurrence of procedure-related adverse events (AEs) were found; of 19 ICM/procedure-related AEs reported in 17 patients (1.4%), 11 occurred in the in-lab group (1.3%) and 6 in the out-of-lab group (1.5%) (P = .80). CONCLUSIONS: This real-world analysis demonstrates the feasibility of performing Reveal LINQ ICM insertion procedures outside of the traditional hospital settings without increasing the risk of infection or other adverse events.
BACKGROUND: Traditionally, insertable cardiac monitor (ICM) procedures have been performed in the cardiac catheterization (CATH) or electrophysiology (EP) laboratory. The introduction of the miniaturized Reveal LINQ ICM has led to simplified and less invasive procedures, affording hospitals flexibility in planning where these procedures occur without compromising patient safety or outcomes. METHODS: The present analysis of the ongoing, prospective, observational, multicenter Reveal LINQ Registry sought to provide real-world feasibility and safety data regarding the ICM procedure performed in the CATH/EP lab or operating room and to compare it with insertions performed outside of these traditional hospital settings. Patients included had at least a 30-day period after the procedure to account for any adverse events. RESULTS: We analyzed 1222 patients (58.1% male, age 61.0 ± 17.1 years) enrolled at 18 centers in the US, 17 centers in Middle East/Asia, and 15 centers in Europe. Patients were categorized into 2 cohorts according to the location of the procedure: in-lab (CATH lab, EP lab, or operating room) (n = 820, 67.1%) and out-of-lab (n = 402, 32.9%). Several differences were observed regarding baseline and procedure characteristics. However, no significant differences in the occurrence of procedure-related adverse events (AEs) were found; of 19 ICM/procedure-related AEs reported in 17 patients (1.4%), 11 occurred in the in-lab group (1.3%) and 6 in the out-of-lab group (1.5%) (P = .80). CONCLUSIONS: This real-world analysis demonstrates the feasibility of performing Reveal LINQ ICM insertion procedures outside of the traditional hospital settings without increasing the risk of infection or other adverse events.
Authors: Prashanthan Sanders; Christopher Piorkowski; Johannes A Kragten; Grahame K Goode; Satish R Raj; Trang Dinh; M Rizwan Sohail; Rishi Anand; Angel Moya-Mitjans; Noreli Franco; Kurt Stromberg; John D Rogers Journal: BMC Cardiovasc Disord Date: 2019-05-31 Impact factor: 2.298
Authors: Thomas Deneke; Pilar Cabanas; Daniel Hofer; Thomas Gaspar; Bertrand Pierre; Giovanni Bisignani; Rajeev Kumar Pathak; Victor Manuel Sanfins; Eimo Martens; Jacques Mansourati; Antonio Berruezo-Sanchez; Marcus Wiemer; Andreas Hain; Thomas Pezawas; Beate Wenzel; Dennis Lau Journal: Heart Rhythm O2 Date: 2022-01-30