Pacing for carotid sinus hypersensitivity Title of Trial
Syncope and Falls in the Elderly Pacing and Carotid Sinus Evaluation (SAFE PACE) Trial
Initial Presentation: American College of Cardiology 2002
Date and Citation of Primary Publication(s) or References
Kenny RA, Richardson DA, Steen N, et al. Carotid Sinus Syndrome: A modifiable risk factor for nonaccidental falls in older adults (SAFE PACE). J Am Coll Card 2001; 38: 1491-6.
Purpose of the Trial
Evaluate the effects of cardiac pacing in elderly patients with falls and carotid sinus hypersensitivity.
Study Category
Pacing
Patient Population
Inclusion Criteria
People over 50 years old who experienced a nonaccidental fall, which could not be attributed to another medical cause. Carotid sinus hypersensitivity (> 3 seconds of asystole) supine or during 70º tilt.
Exclusion Criteria
Cognitive impairment, blindness, contraindication to carotid sinus massage, medications known to cause carotid sinus hypersensitivity, or residence greater than 15 miles from the emergency room.
Study Design
Randomized controlled trial. On enrollment patients were randomized to receive a pacemaker or not.
Primary Endpoints
Number of falls during a one-year period
Secondary Endpoints
syncope, injury
Baseline Characteristics
Patient number: 175 patients
Mean Age: 73 ± 10 years
Gender: 60% female
Other characteristics: Diabetes: 12%; previous injury: 70%; previous fracture: 30%. Median number of falls prior to enrollment: 2 (mean 9.3, range 0 to > 100).
Time to Follow-up
16 patients did not complete the study due to death (8) or withdrawal (8). One year follow-up.
Results
Positive response to carotid sinus massage (CSM) was noted in 72-75% of patients while supine and the remainder only had a positive response when upright. The duration of the cardioinhibitory response was 4.4±1.07 seconds. Thirty percent had a witnessed loss of consciousness during CSM and 0.8% had transient neurologic symptoms (despite having no contraindications to CSM). Cardiac pacing was associated with a 66% reduction in the number of falls and a 70% reduction in the number of injurious events. Paced patients were less likely to fall (hazard ratio: 0.42; 95% CI 0.23-0.75) when compared to controls. A trend toward less syncopal events in patients with pacemakers was detected (hazard ratio: 0.53; 95% CI: 0.23-1.20). No significant difference in the number of patients that suffered injurious events was detected between the two groups. However, the pacemakers group had a 70% reduction in the total number of injurious events (fractures and soft tissue injuries).
| Event | No-pacemaker
n=88 | Pacemaker
N=87 | P |
| Total falls, n | 699 | 216 | See CI |
| Number of syncopal episodes, n | 47 | 22 | See CI |
| Proportion of patients who reported syncope (%) | 11% | 22% | 0.063 |
| Number of patients with injury, n | 36 | 29 | NS |
| Injurious events, n | 202 | 61 | Not stated |
Sponsor
National Health Service Cardiovascular Research and Development Programme, Research into Aging, Medtronic
Trial Status: Completed
