BACKGROUND: Recent advisories and recalls of pacemakers and implantable cardioverter-defibrillators (ICDs) have highlighted the need for evidence-based recommendations regarding management of patients with advisory devices. In order to better facilitate decision-making when weighing the relative risks and benefits of performing generator changes in these patients, we conducted a review to assess operative complication rates. METHODS: We reviewed generator changes performed between 2000 and 2005 at the Mayo Clinic-Rochester, including a total of 732 change-outs consisting of 570 done for elective replacement indicators (ERI) and 162 for manufacturer advisories or recalls. Complications included all those requiring reoperation, occurring within a 60-day period postoperatively and directly attributable to the generator change. These included infection requiring device excision, hematoma requiring evacuation, and incisional dehiscence requiring reclosure. RESULTS: Operation-associated complications requiring intervention were noted in 9 patients, or 1.24% of our population. Of these nine complications, eight occurred among patients receiving pulse generator replacement for ERI (1.40%) and one occurred in a patient receiving replacement for a manufacturer advisory or recall (0.62%). Complications included 5 infections, 3 hematomas, and 1 incisional dehiscence. CONCLUSIONS: Generator replacement is not a benign procedure and associated risks must be weighed in the context of other variables when making management choices in patients with advisory or recall devices.
BACKGROUND: Recent advisories and recalls of pacemakers and implantable cardioverter-defibrillators (ICDs) have highlighted the need for evidence-based recommendations regarding management of patients with advisory devices. In order to better facilitate decision-making when weighing the relative risks and benefits of performing generator changes in these patients, we conducted a review to assess operative complication rates. METHODS: We reviewed generator changes performed between 2000 and 2005 at the Mayo Clinic-Rochester, including a total of 732 change-outs consisting of 570 done for elective replacement indicators (ERI) and 162 for manufacturer advisories or recalls. Complications included all those requiring reoperation, occurring within a 60-day period postoperatively and directly attributable to the generator change. These included infection requiring device excision, hematoma requiring evacuation, and incisional dehiscence requiring reclosure. RESULTS: Operation-associated complications requiring intervention were noted in 9 patients, or 1.24% of our population. Of these nine complications, eight occurred among patients receiving pulse generator replacement for ERI (1.40%) and one occurred in a patient receiving replacement for a manufacturer advisory or recall (0.62%). Complications included 5 infections, 3 hematomas, and 1 incisional dehiscence. CONCLUSIONS: Generator replacement is not a benign procedure and associated risks must be weighed in the context of other variables when making management choices in patients with advisory or recall devices.
Authors: Philip W Chui; Yongfei Wang; Isuru Ranasinghe; Teferi Y Mitiku; Arnold H Seto; Lindsey Rosman; Rachel Lampert; Karl E Minges; Alan D Enriquez; Jeptha P Curtis Journal: Circ Cardiovasc Qual Outcomes Date: 2019-06-12
Authors: François Philippon; Gilles E O'Hara; Jean Champagne; Stefan H Hohnloser; Michael Glikson; Jörg Neuzner; Philippe Mabo; Xavier Vinolas; Josef Kautzner; Fredrik Gadler; Noa Lashevsky; Stuart J Connolly; Yan Y Liu; Jeff S Healey Journal: CJC Open Date: 2020-04-25
Authors: Gregory Webster; Lauren C Balmert; Ami B Patel; Larry K Kociolek; Melanie Gevitz; Rachael Olson; Ahmed S Chaouki; Osama El-Tayeb; Michael C Monge; Carl Backer Journal: World J Pediatr Congenit Heart Surg Date: 2021-05