© 1999 by European Society of Cardiology
SAFE PACE 2: Syncope and Falls in the Elderly — Pacing and Carotid Sinus Evaluation
A randomized controlled trial of cardiac pacing in older patients with falls and carotid sinus hypersensitivity
SAFE PACE is a multicentre randomized controlled trial to assess the efficacy of dual-chamber pacing in older patients with carotid sinus hypersensitivity and recurrent un-explained falls. Patients are eligible if they have had two or more unexplained falls (± up to one syncope) and if they have a cardio-inhibitory response (>3 s asystole) to carotid sinus massage. Patients will be randomized to receive either a Medtronic Kappa 700(Europe)/Kappa 400(North America) pacemaker or an implantable loop recorder (ILR)(control group). Patients will be required to complete weekly fall diaries. The primary outcome measure is the number of patients who fall in the 24-month follow-up period. Recruitment began in October 1998 and continues for 12 months; the follow-up is for 24 months.
Key Words: Falls, syncope, carotid sinus syndrome, dual chamber pacing
Correspondence: R. A. Kenny, Department of Medicine, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne NE1 4LP, U.K.
[1] Cummings SR, Nevitt MC, Kidd S. Forgetting falls: the limited accuracy of recall of falls in the elderly. J Am Geriatr Soc 1988; 36: 613–616.[Web of Science][Medline]
[2] McIntosh SJ, Lawson J, Kenny RA. Clinical characteristics of vasodepressor, cardioinhibitory and mixed carotid sinus syndrome in the elderly. Am J Med 1993; 95: 203–208.[CrossRef][Web of Science][Medline]
[3] Morley CA, Perrins EJ, Grant P, Chan SL, McBrien DJ, Sutton R. Carotid sinus syncope treated by pacing. Analysis of persistent symptoms and role of atrioventricular sequential pacing. Br Heart J 1982; 47: 411–418.
[4] Bexton R, Davies A, Kenny RA. The rate drop response in carotid sinus syndrome: the Newcastle experience. PACE 1997; 20: 840.
[5] O'Loughlin JL, Robitaille Y, Boivin JF, Suissa S. Incidence of and risk factors for falls and injurious falls among the community-dwelling elderly. Am J Epidemiol 1993; 137: 342–345.
[6] Rubenstein LZ and Josephson KR. Falls. In Kenny RA (Ed.). Syncope in the Older Patient 1996; London Chapman and Hall pp. 286.
[7] Richardson DA, Bexton RS, Shaw FE, Bond J, Kenny RA. Prevalence of cardioinhibitory carotid sinus hypersensitivity (CICSH) in accident and emergency attendances with falls or syncope. PACE 1997; 20: 820–823.
[8] Krahn AD, Klein GJ, Norris C, Yee R. The etiology of syncope in patients with negative tilt table and electrophysiological testing. Circulation 1995; 92: 1819–1824.
[9] Krahn AD, Klein GJ, Yee R, Norris C. Maturation of the sensed electrogram amplitude over time in a new subcutaneous implantable loop recorder. PACE 1997; 20: 1686–1690.
[10] Gregorates G, Cheitlin MD, Conill A, et al. ACC/AHA Guidelines for Implementation of Cardiac pacemakers and anti-arrhythmic devices: executive summary. Circulation 1998; 97: 1325–1335.[Medline]
[11] Jacobson GP and Newman CW. The development of the dizziness handicap inventory. Arch Otolaryngol Head Neck Surg 1990; 116: 424–427.
[12] Ware JE and Sherbourne CD. The MoS 36 – item short form health survey (SF-36): conceptual framework and item selection. Med Care 1992; 30: 473–483.[Web of Science][Medline]
[13] Davies AJ and Kenny RA. Falls presenting to the accident and emergency department—types of presentation and risk factor profile. Age and Ageing 1996; 25: 362–366.
[14] Siegel S and Costellan NJ. Non parametric statistics for the behavioural sciences. 1988; London McGraw Hill.
[15] Collet D. Modelling survival data in medical research. 1994; London Chapman and Hall.
[16] Goldstein H. Multi Level Statistical Models. 1995; London Arnold Chapter 6.
CiteULike 
Connotea 
Del.icio.us What's this?
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||