Background
Methods
Stage 2: Identifying relevant studies
Stage 3: Study selection
Stage 4: Charting the data
Stage 5: Collating, summarizing, and reporting the results
Results
Search Result and Study Characteristics
Carotid Sinus Hypersensitivity (CSH)
Studies
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Study population Design
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N
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Mean age (SD)
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Gender (% female)
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Setting
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Population
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Intervention
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Exposure Control
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Duration of follow-up (mean)
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Outcome Outcome of falls
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Results
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Conclusion
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Brenner, 2017 (35) | Non-randomized, prospective multicentre study | 78 | 75.4 (8.3) | 50.6 | Cardiology department | Patients with SND (based on 12-lead or Holter ECG) and a class I indication for PPM implantation | Dual-chamber pacemaker | None | 12 months | Primary: fall-incidence Secondary: number of falls (with or without injury/requiring medical treatment/fracture) Fall data before PM implantation retrospectively collected; after PM implantation prospectively. | 53% of patients fell before implantation vs. 15% after implantation (p<0.001, RRR 71%) 127 falls before implantation vs. 13 falls after implantation (p<0.001, RRR 90%). 28% of patients had falls with injury before implantation vs. 10% after implantation (p=0.005, RRR 63%), 31% had falls requiring medical treatment vs. 8% after implantation (p<0.001, RRR 75%), 8% had falls with fracture after implantation vs. 0% after implantation (p=0.013). | Permanent pacemaker implantation is associated with a significantly reduced fall-incidence, fall-related injuries and fractures in patients with SND. |
Crilley, 1997 (30) | Non-randomized, prospective study | 37 | 79.0 (range 58-91) | 57.1 | Geriatric department | Patients with recurrent falls, dizziness, syncope, and a hypersensitive cardio inhibitory reflex (based on CSM and/or HUTT) | Dual-chamber pacemaker | None | 10 months (range 1.5-30) | Fall-incidence. Fall data retrospectively collected. | 81% of patients had falls before implantation vs. 30% after implantation (p<0.0001) | Fall-incidence in patients with CSH was significantly reduced after pacemaker implantation. |
Jansen, 2015 (36) | Non-randomized, prospective singlecentre study | 15 | 74.6 (6.6) | 66.7 | Falls clinic | Patients with one or more falls in the past year who presented in the ER or were referred | Comprehensive cardiovascular assessment, including structured history, echocardiography, ECG and tilt-table testing, followed by a multidisciplinary evaluation and treatment advice | None | 6 months | Primary: identification of a new cardiovascular diagnosis contributing to a fall Secondary: Number of falls Fall data prospectively collected. | 47% of patients were diagnosed with a cardiovascular abnormality contributing to a fall. 33% of patients had a fall incident during follow-up. CVDs contributing to a fall were: initial and delayed OH, drug induced hypotension and carotid sinus syndrome | A comprehensive cardiovascular assessment in fallers led to the identification of cardiovascular abnormalities contributing to falls in almost half of participants. |
Kenny, 2001 (31) | Single-centre RCT | 159 | 73.0 (10) | 59.4 | Emergency department and cardiovascular investigation unit | Non-accidental fallers with cardio inhibitory or mixed CSH (based on CSM) | Dual-chamber pacemaker | Standard treatment (not specified) | 12 months | Number of falls. Number of injurious events. Fall data prospectively collected. | OR 0.42 (0.23-0.75) of falling with pacemaker vs. controls. OR 0.42 (0.31-0.57) of falling with pacemaker vs. controls. 88 controls reported 669 falls (mean 9.3; range 0 to 89), and 87 paced patients reported 216 falls (mean 4.1; range 0 to 29) Injurious events reduced by 70% (202 in controls vs. 61 events in paced patients). | Fall-incidence in patients with CSH was significantly reduced after pacemaker implantation. |
Krasniqi, 2012 (34) | Non-randomized, prospective singlecentre study | 124 | 71.9 (9.7) | 39.3 | Tertiary cardiology clinic | Patients with SND (based on Holter ECG) that underwent PPM implantation | Pacemaker (not specified) | None | >12 months (mean 2.3 years) | Number of (injured) fallers Number of falls (with injury) Fall data retrospectively collected. | 32.3% of patients fell before PM implantation vs. 8.1% after PM implantation (p<0.001, RRR 74.9%). 15.3% of patients had a fall with injury before PM implantation vs. 5.6% after PM implantation (p=0.014, RRR 63.4%) Number of falls reduced from 60 to 22 after PM implantation (p=0.035, RRR 63.3%). Number of falls with injury reduced from 22 to 7 after PM implantation (p=0.013, RRR 66.7%) | Pacemaker implantation significantly reduced number of fallers, number of falls, and fall related injuries in patients with SND. |
Parry, 2009 (32) | Single-centre randomized, double-blind, crossover, placebo controlled trial | 25 | 76.8 (9) | 79.4 | Emergency department or specialist falls and syncope facility | Patients with three or more unexplained falls who had CICSH or mixed CSH based on CSM | Dual-chamber permanent pacemaker (turned on) | Dual-chamber permanent pacemaker (turned off) | 12 months | Primary: number of falls Secondary: time to first fall Fall data prospectively collected. | Pacing intervention had no effect on number of falls (Mean of 4.04 falls (9.54) in paced mode, and 3.48 (7.22) falls) in placebo mode). RR 0.82 (0.62-1.10) of falling with pacemaker turned on vs. pacemaker turned off. | Permanent pacing in older fallers with CSH had no effect on fall incidence. |
Ryan, 2010 (33) | Multicentre, doubleblind, RCT | 128 | 78.0 (7) | 61.7 | Syncope unit | Patients with two or more unexplained falls and/or one syncopal event in the previous year, and CICSH based on CSM | Dual-chamber pacemaker | Implantable loop recorder | 24 months | Primary: number of falls Secondary: time to first fall Fall data prospectively collected. | RR 0.79 (0.41-1.50) of falling with pacemaker vs. loop recorder. RR 0.23 (0.15-0.32) of falling after device implantation vs. before. HR 1.34 (0.84-2.12) of falling with pacemaker vs. loop recorder | There was no difference in fall incidence between patients with CSH who were paced and who were not. |
Kenny, 2001 | Parry, 2009 | Ryan, 2010 | |
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Was the allocation of the intervention to the patients randomized? | ?* | + | + |
The person who includes patients should not be aware of the randomization sequence. Was that the case here? | ? | + | ? |
Were the patients and the practitioners blinded for the treatment? | - | + | + |
Were the effect assessors blinded for treatment? | ? | ? | ? |
Were the groups comparable at the beginning of the trial? If not: has this been corrected in the analyzes? | + | +† | + |
Is a complete follow-up available from a sufficient proportion of all participants? If not: is selective loss-to-follow-up sufficiently excluded? | + | −‡ | + |
Have all the included patients been analyzed in the group in which they were randomized? | + | + | - |
Have the groups been treated equally, apart from the intervention? | ? | + | ? |
Is selective publication of results sufficiently excluded? | ? | ? | ? |
Is unwanted influence of sponsors sufficiently excluded? | ? | + | + |
Brenner, 2017
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Crilley, 1997
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Jansen, 2015
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Krasniqi, 2012
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Bias due to confounding | Low | Serious | Moderate | Serious |
Bias in selection of participants into the study | Low | Low | Moderate | Serious |
Bias in classification of interventions | Low | Low | Low | Moderate |
Bias due to deviations from intended interventions | Low | Low | Low | Low |
Bias due to missing data | Moderate | Serious | Low | Moderate |
Bias in measurement of outcomes | Moderate | Moderate | Moderate | Moderate |
Bias in selection of the reported result | Low | Low | Low | Low |
Overall bias | Low | Moderate | Low | Serious |