AIMS: The aim of this study was to evaluate whether the use of a double sensor gives additional benefits for patients in improving physical efficiency as well as quality of life (QoL) as compared to the accelerometer sensor alone. METHODS AND RESULTS: The presented research is a prospective, randomized, single-blind clinical trial. Double-sensor (accelerometer and minute-ventilation) pacemakers (Guidant, Pulsar Max DR) were implanted in 20 patients with sinus node dysfunction (SND) and chronotropic incompetence. After randomization, patients were placed in one of two groups: 1, only the accelerometer sensor was activated; 2, both sensors were activated. After a 3-month follow-up, an initial cardio-pulmonary exercise test was performed, after which the patients were placed in the opposite group for a further 3 months. Finally, the second tests were performed. In 75% of the patients an improvement in QoL was observed in the double-sensor group (P = 0.0242) when compared with the single-sensor group. The addition of a ventilating sensor had no influence on the duration of exercise test (A: 11 +/- 3.19 vs. B: 11 +/- 2.92 P = 1.0000). The parameters of cardio-pulmonary exercise tests recorded in situations A and B before exertion, and 6 minutes after exertion were not statistically different. CONCLUSION: The use of double-sensor pacemakers does not improve physical efficiency; however, it does improve QoL.
RCT Entities:
AIMS: The aim of this study was to evaluate whether the use of a double sensor gives additional benefits for patients in improving physical efficiency as well as quality of life (QoL) as compared to the accelerometer sensor alone. METHODS AND RESULTS: The presented research is a prospective, randomized, single-blind clinical trial. Double-sensor (accelerometer and minute-ventilation) pacemakers (Guidant, Pulsar Max DR) were implanted in 20 patients with sinus node dysfunction (SND) and chronotropic incompetence. After randomization, patients were placed in one of two groups: 1, only the accelerometer sensor was activated; 2, both sensors were activated. After a 3-month follow-up, an initial cardio-pulmonary exercise test was performed, after which the patients were placed in the opposite group for a further 3 months. Finally, the second tests were performed. In 75% of the patients an improvement in QoL was observed in the double-sensor group (P = 0.0242) when compared with the single-sensor group. The addition of a ventilating sensor had no influence on the duration of exercise test (A: 11 +/- 3.19 vs. B: 11 +/- 2.92 P = 1.0000). The parameters of cardio-pulmonary exercise tests recorded in situations A and B before exertion, and 6 minutes after exertion were not statistically different. CONCLUSION: The use of double-sensor pacemakers does not improve physical efficiency; however, it does improve QoL.
Authors: F Roosevelt Gilliam; Michael Giudici; Andrew Benn; Bruce Koplan; Kellie Jean Chase Berg; Stacia Merkel Kraus; Kira Q Stolen; Guy E Alvarez; Donald L Hopper; Bruce L Wilkoff Journal: J Cardiovasc Transl Res Date: 2010-11-20 Impact factor: 4.132