Development and validation of a dual sensing scheme to improve accuracy of bradycardia and pause detection in an insertable cardiac monitor

Heart Rhythm

Volumn 14, Issue 7, 2017, Pages 1016-1023

  Passman, Rod S ^a   Rogers, John D ^b   Sarkar, Shantanu ^c   Reiland, Jerry ^c   Reisfeld, Erin ^c   Koehler, Jodi ^c   Mittal, Suneet ^d  

^a NORTHWESTERN MEMORIAL HOSPITAL   (United States)

^b SCRIPPS CLINIC   (United States)

^c Medtronic plc   (United States)

^d The Valley Health System   (United States)

Author keywords

Bradycardia; Diagnosis; Insertable cardiac monitors; Pause

Indexed keywords

ACCURACY; ALGORITHM; ARTICLE; BRADYCARDIA; CARDIAC IMPLANT; COHORT ANALYSIS; FAINTNESS; FALSE POSITIVE RESULT; FEMALE; FOLLOW UP; HUMAN; INSERTABLE CARDIAC MONITOR; MAJOR CLINICAL STUDY; MALE; PREDICTIVE VALUE; PRIORITY JOURNAL; R WAVE; R WAVE AMPLITUDE; SENSITIVITY AND SPECIFICITY; T WAVE; TACHYCARDIA; ADVERSE DEVICE EFFECT; AGED; AMBULATORY ELECTROCARDIOGRAPHY; COMPLICATION; DEVICES; DIAGNOSTIC ERROR; DIMENSIONAL MEASUREMENT ACCURACY; ELECTRODE IMPLANT; EQUIPMENT DESIGN; MIDDLE AGED; PREVENTION AND CONTROL; PROCEDURES; UNITED STATES; VALIDATION STUDY;

AGED; ALGORITHMS; BRADYCARDIA; DIAGNOSTIC ERRORS; DIMENSIONAL MEASUREMENT ACCURACY; ELECTROCARDIOGRAPHY, AMBULATORY; ELECTRODES, IMPLANTED; EQUIPMENT DESIGN; FEMALE; HUMANS; MALE; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; SYNCOPE; UNITED STATES;

EID: 85019870398     PISSN: 15475271     EISSN: 15563871     Source Type: Journal    
DOI: 10.1016/j.hrthm.2017.03.037     Document Type: Article

References (25)

1. Brignole, M., Vardas, P., Hoffman, E., Huikuri, H., Moya, A., Ricci, R., Sulke, N., Wieling, W., Indications for the use of diagnostic implantable and external ECG loop recorders. Europace 11 (2009), 671–687.
2. Benditt, D.G., Brignole, M., Syncope: is a diagnosis a diagnosis?. J Am Coll Cardiol 41 (2003), 791–794.
3. Garcia-Civera, R., Ruiz-Granell, R., Morell-Cabedo, S., Sanjuan-Manez, R., Perez-Alcala, F., Plancha, E., Navarro, A., Botella, S., LLacer, A., Selective use of diagnostic tests in patients with syncope of unknown cause. J Am Coll Cardiol 41 (2003), 787–790.
4. Huikuri, H.V., Mahaux, V., Bloch-Thomsen, P.E., Cardiac arrhythmias and risk stratification after myocardial infarction: results of the CARISMA pilot study. Pacing Clin Electrophysiol 26 (2003), 416–419.
5. Krahn, A.D., Klein, G.J., Skanes, A.C., Yee, R., Insertable loop recorder use for detection of intermittent arrhythmias. Pacing Clin Electrophysiol 27 (2004), 657–664.
6. Rugg-Gunn, F.J., Simister, R.J., Squirrell, M., Holdright, D.R., Duncan, J.S., Cardiac arrhythmias in focal epilepsy: a prospective long-term study. Lancet 364 (2004), 2212–2219.
7. Hindricks, G., Pokushalov, E., Urban, L., Taborsky, M., Kuck, K.H., Lebedev, D., Rieger, G., Pürerfellner, H., Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: results of the XPECT trial. Circ Arrhythm Electrophysiol 3 (2010), 141–147.
8. Sanna, T., Diener, H.C., Passman, R.S., DiLazzaro, V., Bernstein, R.A., Morillo, C.A., Rymer, M.M., Thijs, V., Rogers, T., Beckers, F., Lindborg, K., Brachmann, J., Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med 370 (2014), 2478–2486.
9. Hanke, T., Charitos, E.I., Stierle, U., Karluss, A., Kraatz, E., Graf, B., Hagemann, A., Misfeld, M., Sievers, H.H., Twenty four-hour Holter monitor follow-up does not provide accurate heart rhythm status after surgical atrial fibrillation ablation therapy: up to 12 months experience with a novel permanently implantable heart rhythm monitor device. Circulation 120 (2009), S177–S184.
10. Verma, A., Champagne, J., Sapp, J., Essebag, V., Novak, P., Skanes, A., Morillo, C.A., Khaykin, Y., Birnie, D., Discerning the incidence of symptomatic and asymptomatic episodes of atrial fibrillation before and after catheter ablation (DISCERN AF): a prospective, multicenter study. JAMA Intern Med 173 (2013), 149–156.
11. Ermis, C., Zhu, A.X., Pham, S., Li, J.M., Guerrero, M., Vrudney, A., Hiltner, L., Lu, F., Sakaguchi, S., Lurie, K.G., Benditt, D.G., Comparison of automatic and patient-activated arrhythmia recordings by implantable loop recorders in the evaluation of syncope. Am J Cardiol 92 (2003), 815–819.
12. Krahn, A.D., Klein, G.J., Yee, R., Skanes, A.C., Detection of asymptomatic arrhythmias in unexplained syncope. Am Heart J 148 (2004), 326–332.
13. Ng, E., Stafford, P.J., Ng, G.A., Arrhythmia detection by patient and autoactivation in implantable loop recorders. J Interv Card Electrophysiol 10 (2004), 147–152.
14. Chrysostomakis, S.I., Klapsinos, N.C., Simantirakis, E.N., Marketou, M.E., Kambouraki, D.C., Vardas, P.E., Sensing issues related to the clinical use of implantable loop recorders. Europace 5 (2003), 143–148.
15. Trigano, A., Blandeau, O., Dale, C., Wong, M.F., Wiart, J., Risk of cellular phone interference with an implantable loop recorder. Int J Cardiol 116 (2007), 126–130.
16. Wong, J.A., Yee, R., Gula, L.J., Skanes, A.C., Ross, I.G., White, J.B., Klein, G.J., Krahn, A.D., Feasibility of magnetic resonance imaging in patients with an implantable loop recorder. Pacing Clin Electrophysiol 31 (2008), 333–337.
17. Brignole, M., Bellardine Black, C.L., Thomsen, P.E., Sutton, R., Moya, A., Stadler, R.W., Cao, J., Messier, M., Huikuri, H.V., Improved arrhythmia detection in implantable loop recorders. J Cardiovasc Electrophysiol 19 (2008), 928–934.
18. Cao, J., Lee, B., Abeyratne, A., Gillberg, J.G., Insertable loop recorder R wave sensing performance is improved with dynamic threshold adjustment. Heart Rhythm, 3, 2006, S206.
19. Eitel, C., Husser, D., Hindricks, G., Frühauf, M., Hilbert, S., Arya, A., Gaspar, T., Wetzel, U., Bollmann, A., Piorkowski, C., Performance of an implantable automatic atrial fibrillation detection device: impact of software adjustments and relevance of manual episode analysis. Europace 13 (2011), 480–485.
20. Volosin, K., Stadler, R.W., Wyszynski, R., Kirchhof, P., Tachycardia detection performance of implantable loop recorders: results from a large “real-life” patient cohort and patients with induced ventricular arrhythmias. Europace 15 (2013), 1215–1222.
21. Pürerfellner, H., Pokushalov, E., Sarkar, S., Koehler, J., Zhou, R., Urban, L., Hindricks, G., P-wave evidence as a method for improving algorithm to detect atrial fibrillation in insertable cardiac monitors. Heart Rhythm 11 (2014), 1575–1583.
22. Pürerfellner, H., Sanders, P., Pokushalov, E., Di Bacco, M., Bergemann, T., Dekker, L.R., Miniaturized Reveal LINQ insertable cardiac monitoring system: first-in-human experience. Heart Rhythm 12 (2015), 1113–1119.
23. Sanders, P., Pürerfellner, H., Pokushalov, E., Sarkar, S., DiBacco, M., Maus, B., Dekker, L.R., Performance of a new AF detection algorithm in a miniaturized insertable cardiac monitor: results from the Reveal LINQ Usability Study. Heart Rhythm 13 (2016), 1425–1430.
24. Zeger, S.L., Liang, K.Y., Albert, P.S., Models for longitudinal data: a generalized estimating equation approach. Biometrics 44 (1988), 1049–1060.
25. Kerr, K.F., Wang, Z., Janes, H., McClelland, R.L., Psaty, B.M., Pepe, M.S., Net reclassification indices for evaluating risk-prediction instruments: a critical review. Epidemiology 25 (2014), 114–121.