Suneet Mittal1, Prashanthan Sanders2, Evgeny Pokushalov3, Lukas Dekker4, Dean Kereiakes5, Edward J Schloss5, Erika Pouliot6, Noreli Franco6, Yan Zhong6, Marco DI Bacco7, Helmut Pürerfellner8. 1. Electrophysiology Laboratory, The Valley Hospital, Valley Health System, Ridgewood, New Jersey. 2. Centre for Heart Rhythm Disorders, South Australian Health and Medical Research Institute, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia. 3. Arrhythmia Department, State Research Institute of Circulation Pathology, Novosibirsk, Russia. 4. Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands. 5. The Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, Ohio. 6. Departments of Statistics and Clinical Research, Medtronic, Inc, Mounds View, Minnesota. 7. Department of Clinical Research, Medtronic Bakken Research Center BV, Maastricht, the Netherlands. 8. Department of Cardiology, Elisabethinen University Teaching Hospital, Linz, Austria.
Abstract
BACKGROUND: Insertable cardiac monitors (ICMs) are used to continuously monitor the patient's electrocardiogram. In response to patient activation or based on automated device algorithms, arrhythmia episodes are stored and automatically transmitted daily to the clinician. Thus, ICMs can be used to diagnose arrhythmias in at-risk patients and in those with symptoms potentially attributable to arrhythmias. The ICM described in this report has undergone a dramatic change in size and method of insertion. METHODS: To evaluate the safety profile of the ICM procedure, we analyzed procedure-related adverse events (AEs) from two separate trials: A controlled, nonrandomized multicenter study (Reveal LINQ(TM) Usability study) and a multicenter registry (Reveal LINQ(TM) Registry) evaluating real-world experience. For the Registry we reported all procedure-related AEs upon occurrence, whereas for the Usability study, we reported events occurring during the first month of follow-up. RESULTS: The Usability study enrolled 151 patients (age 56.6 ± 12.1 years; male 67%) at 16 centers; during follow-up, an infection was observed in 1.3% patients and a procedure-related serious AE (SAE) in 0.7% patients. The Registry enrolled 122 patients (age 61.0 ± 17.8 years; male 47%) at seven centers; during follow-up, an infection was observed in 1.6% patients and a procedure-related SAE in 1.6% patients. CONCLUSIONS: The cumulative experience from a controlled clinical trial and a "real-world" registry demonstrate that the new ICM can be inserted with very low incidence of AEs.
BACKGROUND: Insertable cardiac monitors (ICMs) are used to continuously monitor the patient's electrocardiogram. In response to patient activation or based on automated device algorithms, arrhythmia episodes are stored and automatically transmitted daily to the clinician. Thus, ICMs can be used to diagnose arrhythmias in at-risk patients and in those with symptoms potentially attributable to arrhythmias. The ICM described in this report has undergone a dramatic change in size and method of insertion. METHODS: To evaluate the safety profile of the ICM procedure, we analyzed procedure-related adverse events (AEs) from two separate trials: A controlled, nonrandomized multicenter study (Reveal LINQ(TM) Usability study) and a multicenter registry (Reveal LINQ(TM) Registry) evaluating real-world experience. For the Registry we reported all procedure-related AEs upon occurrence, whereas for the Usability study, we reported events occurring during the first month of follow-up. RESULTS: The Usability study enrolled 151 patients (age 56.6 ± 12.1 years; male 67%) at 16 centers; during follow-up, an infection was observed in 1.3% patients and a procedure-related serious AE (SAE) in 0.7% patients. The Registry enrolled 122 patients (age 61.0 ± 17.8 years; male 47%) at seven centers; during follow-up, an infection was observed in 1.6% patients and a procedure-related SAE in 1.6% patients. CONCLUSIONS: The cumulative experience from a controlled clinical trial and a "real-world" registry demonstrate that the new ICM can be inserted with very low incidence of AEs.
Authors: Sergio Conti; James A Reiffel; Bernard J Gersh; Peter R Kowey; Rolf Wachter; Jonathan L Halperin; Rachelle E Kaplon; Erika Pouliot; Atul Verma Journal: J Atr Fibrillation Date: 2017-02-28
Authors: Benedict M Wiles; Caroline A Illingworth; Michael Lg Couzins; Paul R Roberts; Stephen P Harden Journal: Br J Radiol Date: 2018-02-01 Impact factor: 3.039
Authors: Barbara Ratajczak-Tretel; Anna Tancin Lambert; Henriette Johansen; Bente Halvorsen; Vigdis Bjerkeli; David Russell; Else Charlotte Sandset; Hege Ihle-Hansen; Erik Eriksen; Halvor Næss; Vojtech Novotny; Andrej Netland Khanevski; Thomas C Truelsen; Titto Idicula; Karen L Ægidius; Håkon Tobro; Siv B Krogseth; Håkon Ihle-Hansen; Guri Hagberg; Christina Kruuse; Kathrine Arntzen; Grete K Bakkejord; Maja Villseth; Ingvild Nakstad; Guttorm Eldøen; Raheel Shafiq; Anne Gulsvik; Martin Kurz; Mehdi Rezai; Jesper Sømark; Stein-Helge Tingvoll; Christine Jonassen; Susanne Ingebrigtsen; Linn Hofsøy Steffensen; Christine Kremer; Dan Atar; Anne Hege Aamodt Journal: Eur Stroke J Date: 2019-03-19
Authors: Jan Steffel; David Jay Wright; Harald Schäfer; Tabinda Rashid-Fadel; Thorsten Lewalter Journal: Europace Date: 2017-10-01 Impact factor: 5.214
Authors: Paul R Roberts; Donah Zachariah; John M Morgan; Arthur M Yue; Elizabeth F Greenwood; Patrick C Phillips; Philip A Kalra; Darren Green; Robert J Lewis; Paul R Kalra Journal: PLoS One Date: 2017-12-14 Impact factor: 3.240