Year: 2018
Type: article
Study design: Observational Study
Abstract: Failures of Sacral Neuromodulation for IncontinenceSacral neuromodulation (SNM) is increasingly used to treat lower urinary tract symptoms and bowel symptoms refractory to conventional therapy. 1 The US Food and Drug Administration approved the device in 1997, and the device was modified in 2006, which included a 50% reduction in size and an improvement in leads to decrease lead migration.These changes at least partially explain the more than 3.5-fold increase in the number of SNM procedures in the following 5 years. 2 While guidelines based on small clinical studies with highly selected patients report 50% or greater symptom improvement in most patients, 1,3,4 an early safety report using real world data found that a large number of reinterventions occurred in the Medicare population. 2 The indications for SNM use are growing despite the lack of evidence.Hence, we sought to determine the reintervention rate associated with treatment failures and device malfunctions at 1, 3, and 5 years after surgery.The secondary aim was to evaluate the volume-outcome relationship.Methods | We used data from 2008 to 2015 from the Statewide Planning and Research Cooperative System, with longitudinal records of all procedures conducted in New York.Patients who underwent the SNM second-stage procedure (InterStim; Medtronic) as well as treatment failures and device malfunctions were identified using Current Procedure Terminology, Fourth Edition, International Classification of Diseases, Ninth Revision, and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes.We evaluated the reintervention (ie, revision, replacement, or removal) rate of SNM within 1 year, 3 years, and 5 years following the initial procedure and analyzed principal diagnoses during reinterventions.We defined high hospital and surgeon volumes based on the upper quartile and used multivariable generalized linear mixed models to account for hospital clustering (Figure).This protocol was reviewed and approved by the institutional review board at Weill Cornel Medical College.Because deidentified information from the Statewide Planning and Research Cooperative System database was used, informed consent was waived.
Source: JAMA Surgery
Institutions: Weill Cornell Medicine, Weill Cornell Medical Center
Language: English
Subfield: Urology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Award: G6298563390
OpenAlex ID: W2788806903