Systematic Reviews
Copyright ©The Author(s) 2022.
World J Clin Cases. Jan 21, 2022; 10(3): 939-953
Published online Jan 21, 2022. doi: 10.12998/wjcc.v10.i3.939
Table 1 Characteristics of the included 16 studies, all except 1 were randomized controlled trial studies
Ref.1
Study type
Significant AF burden definition
Adverse outcomes
Sample size
Follow-up period
AF monitoring
Age (male/female)
Nation
Population
Glotzer et al[19], 2003, Ancillary MOSTSecondary analysis of multicenter RCTAF rate > 220 bpm, AF burden ≥ 5 minStroke/systematic embolism312Median: 27 moPM74 yr (141/171)United StatesPatients with sinus node disease who required PM for bradycardia and a history of AF
Capucci et al[7], 2005, Italian AT 500 RegistryProspective, observational studyAF rate > 174 bpm, AF burden ≥ 5 min or ≥ 1 dThromboembolic event725Median: 22 moPM72 yr (360/365)ItalyPatients with symptomatic atrial tachyarrhythmias and a history of AF. Permanent AF were excluded
Botto et al[20], 2009, NAProspective, observational studyAF rate > 174 bpm, AF burden ≥ 5 min or ≥ 1 dStroke/systematic embolism568Mean: 1 yrPM70 yr (NA)ItalyPatients with a class I or II American College of Cardiology/American Heart Association indication for dual-chamber PM, symptomatic atrial tachyarrhythmias and a history of AF. Permanent AF were excluded
Glotzer et al[21], 2009, TRENDSProspective, observational studyAF rate > 175 bpm, AF burden ≥ 20 sIschemic stroke, TIA, and systemic embolism2486Mean: 1.4 yrPM, ICD or CRT70 yr (1650/836)InternationalPatients with an established class I/II indication for an ICD or stroke risk factor and a history of AF. Permanent AF were excluded
Healey et al[8], 2012, ASSERT ClinicalTrialsProspective, observational studyAF rate > 190 bpm, AF burden＞6 minIschemic stroke or systemic embolism2580Mean: 2.5 yrPM or ICD77 yr (1506/1074)InternationalPatients who had a history of hypertension, but no AF
Shanmugam et al[22], 2012, Home Monitor CRTProspective, observational studyAF rate > 180 bpm, AF burden > 14 minThromboembolic event560Median: 370 dPM or ICD66 yr (434/136)EuropePatients with a heart failure, CRT and a history of AF. Permanent AF were excluded
Gonzalez et al[23], 2014, NARetrospective, observational studyAF rate > 178 bpm, AF burden ≥ 5 minStroke and all-cause mortality224Median: 6.6 yrPM74 yr (118/106)United StatesConsecutive patients with no history of AF who underwent dual-chamber PM implantation
Boriani et al[24], 2014, SOS AF project (PANORAMA, TRENDS, ClinicalService)Prospective studiesAF rate > 175 bpm, AF burden > 5 minIschemic stroke or TIA events10016Median: 2 yrPM or ICD70 yr (6859/3157)InternationalPatients who had at least months of follow-up and with a history of AF. Permanent AF were excluded
Turakhia et al[25], 2015, NACase-CrossoverAF burden > 5.5 h in a day during a defined 30-d periodIschemic Stroke9850Case period: 1-30 d Control period: 91-120 dPM or ICDNAUnited StatesPatients with CIEDs remotely monitored in the Veterans Administration Health Care System and a history of AF
Witt et al[26], 2015, NARetrospective, observational studyAF burden > 6 minThromboembolic events394Median: 4.2 yrCRT67 yr (290/104)DenmarkPatients with a CRT device, and no history of AF
Benezet-Mazuecos et al[27], 2015, NAProspective, observational studyAF rate > 225 bpm, AF burden ≥ 5 minSilent ischemic brain lesions109Median: 2 yrPM, ICD or CRT74 yr (61/48)EuropePatients with PMs, ICDs, and CRT capable of atrial activity monitoring, and with no history of AF
Van Gelder et al[28], 2017, ASSERT ClinicalTrialsProspective, observational studyAF rate > 190 bpm, AF burden > 6 minIschemic stroke or systemic embolism2455Mean: 2.5 yrPM or ICDNAInternationalPatients with hypertension but no prior AF requiring medical therapy
Chu et al[29], 2020, NARetrospective, observational studyAF rate > 250 bpm, AF burden > 6 minIschemic stroke, transient ischemic attack, or systemic embolism152Median: 67 moPM73.2 yr (86/66)ChinaPatients who were with a dual-chamber PM and a history of AF
Kaplan et al[30], 2019, NA Retrospective, observational studyAF burden > 6 minIschemic Stroke and systemic embolism21768NAPM, ICD or CRT68.6 yr (13611/8157)United StatesPatients who had a cardiovascular diagnosis code or had a cardiovascular related procedure performed during the data collection period and with a history of AF
Li et al[31], 2019, The West Birmingham Atrial Fibrillation ProjectProspective, observational studyAF rate > 175 bpm, AF burden > 5 minThromboembolic event594Median: 4.2 yrPM, ICD or CRT69 yr (360/234)United KingdomPatients receiving a PM, ICD, or CRT between Januar1999 and January 2017
Nakano et al[32], 2019, NARetrospective, observational studyAF rate > 200 bpmEmbolic stroke348Median: 65 moPM or ICD70 yr (224/124)JapanPatients receiving PMs and ICDs between May 1980 and May 2016
1Healey et al[8], 2012 and Van Gelder et al[28], 2017 were both from ASSERT clinical Trials and were used for analysis the association between atrial fibrillation burden > 5 min and future stroke, the dose-response association, respectively. PM: Pacemaker; ICD: Implantable cardioverter-defibrillator; CRT: Cardiac-resynchronization device; NA: Not applicable; AF: Atrial fibrillation.
Table 2 Quality evaluation and the evidence level for each study
Ref.
Question described
Appropriate study design
Appropriate subject selection
Characteristics described
Random allocation
Investigators blinded
Subjects blinded
Outcome and measures well defined and robust to bias
Sample size appropriate
Analytic methods appropriate
Estimate of variance reported
Controlled for confounding
Results reported in detail
Conclusion supported by results?
Rating
Levels of evidence
Glotzer et al[19], 200322222NA22222222S1b
Capucci et al[7], 200522110NA02222222M2b
Botto et al[20], 200922220NA02222122S2b
Glotzer et al[21], 200922120NA02222122M2b
Healey et al[8], 201222221NA22222222S2b
Shanmugam et al[22], 201222120NA02222222S2b
Gonzalez et al[23], 201422110NA02122222M2b
Boriani et al[24], 201422120NA02222222S2b
Turakhia et al[25], 201522220NA02222222S3a
Witt et al[26], 201522220NA02222222S2b
Benezet-Mazuecos et al[27],22220NA02122222S2b
Van Gelder et al[28], 201722221NA22222222S2b
Chu et al[29], 202022110NA02122222M2b
Kaplan et al[30],22220NA02222222S2b
Li et al[31], 201922220NA02222122S2b
Nakano et al[32], 201922220NA02222122S2b
The quantitative assessment tool ‘QualSyst’ and the Oxford Centre for Evidence-Based Medicine (OCEBM) 2009 Level of Evidence Tool were used to access the methodological quality and the evidence levels. NA: Not applicable; 2 indicates yes, 1 indicates partial, 0 indicates no. Quality scores: ≥ 75% strong (S), 55%-75% moderate (M), ≤ 55% weak (W).