BACKGROUND: Ninety-nine percent of pacemakers implanted in the United States include an option for rate modulation. OBJECTIVE: The purpose of this study was to determine whether dual-chamber rate-modulated pacing, when compared with dual-chamber pacing alone, improved quality of life. METHODS: This was a single-blind randomized controlled trial comparing dual-chamber with rate-modulated dual-chamber pacing. Patients were enrolled between January 12, 2000, and January 10, 2002, with 1-year follow-up ending December 19, 2002. The study was a U.S. multicenter trial, with 95 sites participating. All patients received a rate modulation-capable dual-chamber pacemaker for standard indications. Patients were screened with an exercise test (Chronotropic Assessment Exercise Protocol) 1 month later. One thousand two hundred seventy-three patients were enrolled; 401 proved ineligible, and 872 (68%) made up the randomized patient cohort. Randomized patients had a mean age of 71 years, 64% were men, and 64% had sinus node dysfunction. Randomization was in a factorial design to (1) dual-chamber rate-modulated pacing versus dual-chamber pacing and (2) automatic mode switching versus no automatic mode switching. The present report is limited to the comparison of rate modulation with no rate modulation (DDDR vs. DDD). The primary endpoint was the score on the Specific Activity Scale, an activity-based cardiovascular disease-specific instrument at 1 year. Secondary endpoints included 6-month treadmill time and additional cardiovascular disease-specific, and generic health-related quality-of-life instruments at 1 year. RESULTS: At 6 months, patients with rate modulation had a higher peak exercise heart rate (rate modulation 113.3 +/- 19.6, no rate modulation 101.1 +/- 21.1; P <.0001). Total exercise time was not different between groups. At 1 year, there were no significant differences between groups with respect to Specific Activity Scale or the secondary quality-of-life endpoints. CONCLUSIONS: We conclude that rate modulation is ineffective in improving the functional status or quality of life of patients with a bradycardia indication for dual-chamber pacing.
RCT Entities:
BACKGROUND: Ninety-nine percent of pacemakers implanted in the United States include an option for rate modulation. OBJECTIVE: The purpose of this study was to determine whether dual-chamber rate-modulated pacing, when compared with dual-chamber pacing alone, improved quality of life. METHODS: This was a single-blind randomized controlled trial comparing dual-chamber with rate-modulated dual-chamber pacing. Patients were enrolled between January 12, 2000, and January 10, 2002, with 1-year follow-up ending December 19, 2002. The study was a U.S. multicenter trial, with 95 sites participating. All patients received a rate modulation-capable dual-chamber pacemaker for standard indications. Patients were screened with an exercise test (Chronotropic Assessment Exercise Protocol) 1 month later. One thousand two hundred seventy-three patients were enrolled; 401 proved ineligible, and 872 (68%) made up the randomized patient cohort. Randomized patients had a mean age of 71 years, 64% were men, and 64% had sinus node dysfunction. Randomization was in a factorial design to (1) dual-chamber rate-modulated pacing versus dual-chamber pacing and (2) automatic mode switching versus no automatic mode switching. The present report is limited to the comparison of rate modulation with no rate modulation (DDDR vs. DDD). The primary endpoint was the score on the Specific Activity Scale, an activity-based cardiovascular disease-specific instrument at 1 year. Secondary endpoints included 6-month treadmill time and additional cardiovascular disease-specific, and generic health-related quality-of-life instruments at 1 year. RESULTS: At 6 months, patients with rate modulation had a higher peak exercise heart rate (rate modulation 113.3 +/- 19.6, no rate modulation 101.1 +/- 21.1; P <.0001). Total exercise time was not different between groups. At 1 year, there were no significant differences between groups with respect to Specific Activity Scale or the secondary quality-of-life endpoints. CONCLUSIONS: We conclude that rate modulation is ineffective in improving the functional status or quality of life of patients with a bradycardia indication for dual-chamber pacing.
Authors: Gilson Soares Feitosa-Filho; José Maria Peixoto; José Elias Soares Pinheiro; Abrahão Afiune Neto; Afonso Luiz Tavares de Albuquerque; Álvaro César Cattani; Amit Nussbacher; Ana Amelia Camarano; Angela Hermínia Sichinels; Antonio Carlos Sobral Sousa; Aristóteles Comte de Alencar Filho; Claudia F Gravina; Dario Celestino Sobral Filho; Eduardo Pitthan; Elisa Franco de Assis Costa; Elizabeth da Rosa Duarte; Elizabete Viana de Freitas; Emilio Hideyuki Moriguchi; Evandro Tinoco Mesquita; Fábio Fernandes; Gilson Soares Feitosa; Humberto Pierre; Ilnei Pereira Filho; Izo Helber; Jairo Lins Borges; Jéssica Myrian de Amorim Garcia; José Antonio Gordillo de Souza; José Carlos da Costa Zanon; Josmar de Castro Alves; Kalil Lays Mohallem; Laura Mariana de Siqueira Mendonça Chaves; Lídia Ana Zytynski Moura; Márcia Cristina Amélia da Silva; Maria Alice de Vilhena Toledo; Maria Elisa Lucena Sales de Melo Assunção; Mauricio Wajngarten; Mauro José Oliveira Gonçalves; Neuza Helena Moreira Lopes; Nezilour Lobato Rodrigues; Paulo Roberto Pereira Toscano; Pedro Rousseff; Ricardo Antonio Rosado Maia; Roberto Alexandre Franken; Roberto Dischinger Miranda; Roberto Gamarski; Ronaldo Fernandes Rosa; Silvio Carlos de Moraes Santos; Siulmara Cristina Galera; Stela Maris da Silva Grespan; Teresa Cristina Rogerio da Silva; William Antonio de Magalhães Esteves Journal: Arq Bras Cardiol Date: 2019-06-06 Impact factor: 2.000
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
Authors: Freddy M Abi-Samra; Narendra Singh; Benjamin L Rosin; Jerome V Dwyer; Crystal D Miller Journal: Europace Date: 2013-02-17 Impact factor: 5.214
Authors: Arjun D Sharma; Mark Richards; Brian Olshansky; Nicholas Wold; Paul Jones; David Perschbacher; Bruce L Wilkoff Journal: Heart Rhythm O2 Date: 2021-02-20