Raymond P Onders1, MaryJo Elmo2, Cindy Kaplan2, Bashar Katirji3, Robert Schilz4. 1. Department of Surgery, University Hospitals Case Medical Center, 11100 Euclid Avenue, Cleveland, OH, USA. Electronic address: Raymond.onders@uhhospitals.org. 2. Department of Surgery, University Hospitals Case Medical Center, 11100 Euclid Avenue, Cleveland, OH, USA. 3. Department of Neurology, University Hospitals Case Medical Center, 11100 Euclid Avenue, Cleveland, OH, USA. 4. Department of Medicine, University Hospitals Case Medical Center, 11100 Euclid Avenue, Cleveland, OH, USA.
Abstract
BACKGROUND: Respiratory insufficiency is the major cause of mortality in patients with amyotrophic lateral sclerosis or Lou Gehrig's disease. This is the final report of the diaphragm pacing (DP) pilot trial. METHODS: Patients underwent laparoscopic diaphragm electrode implantations and subsequent conditioning of diaphragms. Serial respiratory function tests were performed in the initial year and followed until death. RESULTS: Sixteen patients were implanted with no perioperative or unanticipated device-related adverse events. There were 452 implant-months of follow-up. DP allowed greater movement of the diaphragm under fluoroscopy, increased muscle thickness, and decreased the decline in forced vital capacity. Median survival from implant was 19.7 months with the cause of death respiratory in only 31%. CONCLUSIONS: Long-term analysis of DP in amyotrophic lateral sclerosis showed no safety issues and can positively influence diaphragm physiology and survival. This formed the initial basis for subsequent US Food and Drug Administration approval.
BACKGROUND:Respiratory insufficiency is the major cause of mortality in patients with amyotrophic lateral sclerosis or Lou Gehrig's disease. This is the final report of the diaphragm pacing (DP) pilot trial. METHODS:Patients underwent laparoscopic diaphragm electrode implantations and subsequent conditioning of diaphragms. Serial respiratory function tests were performed in the initial year and followed until death. RESULTS: Sixteen patients were implanted with no perioperative or unanticipated device-related adverse events. There were 452 implant-months of follow-up. DP allowed greater movement of the diaphragm under fluoroscopy, increased muscle thickness, and decreased the decline in forced vital capacity. Median survival from implant was 19.7 months with the cause of death respiratory in only 31%. CONCLUSIONS: Long-term analysis of DP in amyotrophic lateral sclerosis showed no safety issues and can positively influence diaphragm physiology and survival. This formed the initial basis for subsequent US Food and Drug Administration approval.
Authors: Darcy Ribeiro Filho Pinto; Miguel Lia Tedde; Alexandre José Gonçalves Avino; Suzan Lúcia Brancher Brandão; Iuri Zanatta; Rafael Hahn Journal: J Bras Pneumol Date: 2015 Jan-Feb Impact factor: 2.624