A prospective multicenter study demonstrating clinical benefit with a new accelerometer-based DDDR pacemaker. Dromos Dr Investigators Group.

From November 1994 to October 1995, 63 patients (average age 66 years; 41 men) from 15 centers implanted with the Biotronik Dromos DR and Ergos TC 03 pulse generators were prospectively screened with an exercise test in the DDD mode for the presence of chronotropic incompetence (CI). Both pulse generators incorporate an identical accelerometer-based motion sensor. CI was defined as a maximum heart rate < 60% of age predicted maximum heart rate or 100 beats/min. Twenty-five patients (40%) met the criteria for CI. Two weeks later, CI patients were required to complete paired metabolic exercise testing in the DDD and DDDR modes on consecutive days with a 24-hour rest period. The order of testing was randomized and performed double blinded to minimize potential biases. Three patients who did not reach the anaerobic threshold (AT) and one patient who was unable to perform the metabolic testing were excluded from the analysis. Compared to the DDD mode, there were statistically significant improvements in the DDDR mode for all five endpoints: heart rate (84 +/- 3.6 vs 113 +/- 3.5 beats/min; P < 0.0001); total exercise time (8.23 +/- 0.71 vs 9.15 +/- 0.65 min; P = 0.0005); maximum VO2 (17.76 +/- 1.36 vs 20.43 +/- 1.75 mL/kg per min; P = 0.0001); VO2 at AT (13.1 +/- 0.87 vs 14.59 +/- 0.79 mL/kg per min; P < 0.01); and exercise time to AT (5.65 +/- 0.61 vs 6.33 +/- 0.53 min; P = 0.02). In conclusion, the results of paired metabolic exercise tests with the Dromos DR and Ergos TC 03 pulse generators demonstrate a clear clinical benefit using the accelerometer-based sensor in the CI patient.

RCT Entities:   Population Interventions Outcomes