Journal of pediatric urology · 2020
Device outcomes in pediatric sacral neuromodulation: A single center series of 187 patients.
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Boswell Timothy C, Hollatz Pam, Hutcheson Joel C, Vandersteen David R, Reinberg Yuri E
Аннотация
INTRODUCTION: Pediatric sacral neuromodulation (SNM) device duration before revision or removal is not well known. Furthermore, secondary surgeries serve as surrogates for key outcomes including complications and symptom improvement.
OBJECTIVE: We sought to study the rate and causes of secondary surgeries in pediatric SNM patients.
STUDY DESIGN: We assessed our cohort of pediatric SNM patients for secondary surgeries (revision or removal). Baseline patient characteristics associated with secondary surgery were analyzed with Fisher's exact test. Kaplan-Meier analysis was used to describe secondary-surgery-free device survival.
RESULTS: 187 pediatric patients underwent sacral neuromodulation at our institution between 2002 and 2019. 7 (4%) patients did not have a permanent device placed due to poor response during an externalized lead trial period, leaving 180 patients with permanent implanted devices. Over a median follow-up of 3.9 years (IQR 2.0 to 6.3), there were 154 total secondary surgeries. There were 83 device revisions, with 89% of revisions for a non-functioning device, 8% for pain, and 2% for infection. Of the non-functioning devices, 11% were due to battery depletion and the rest were due to lead fracture or dislodgement. Permanent device removal was performed in 71 (39%) patients, with 38% of these for unfavorable reasons (6% infection, 8% pain, 24% no longer effective) and 62% for favorable reasons (symptom improvement or resolution). Of patient baseline characteristics, only device duration was associated with favorable removal (p < 0.01). On Kaplan-Meier analysis, 5 year device secondary-surgery-free survival was 32% for any secondary surgery (favorable or unfavorable) and was 47% for unfavorable secondary surgery. At last follow-up, 74% of patients were in a favorable position (using the device, trialing with device off, or device had been removed for improvement) while 26% of patients were requiring other treatments due to device problem or removal.
DISCUSSION: Describing the likelihood of subsequent surgery is an important aspect of patient and guardian counseling concerning pediatric SNM. Our cohort had a 68% 5 year all-cause reoperation rate. However, in a theoretical perfect world, pediatric SNM reoperation rate would be 100% after adequate follow-up (either for battery replacement, or device explantation for improvement).
CONCLUSIONS: While sacral neuromodulation in our cohort of children carried a high (68% 5-year) reoperation rate (whether for complication or symptom improvement), the majority (74%) of these patients with previously refractory symptoms either continue to use their device or have had significant symptom improvement to permit device removal at moderate-term (median 3.9 year) follow-up.
OBJECTIVE: We sought to study the rate and causes of secondary surgeries in pediatric SNM patients.
STUDY DESIGN: We assessed our cohort of pediatric SNM patients for secondary surgeries (revision or removal). Baseline patient characteristics associated with secondary surgery were analyzed with Fisher's exact test. Kaplan-Meier analysis was used to describe secondary-surgery-free device survival.
RESULTS: 187 pediatric patients underwent sacral neuromodulation at our institution between 2002 and 2019. 7 (4%) patients did not have a permanent device placed due to poor response during an externalized lead trial period, leaving 180 patients with permanent implanted devices. Over a median follow-up of 3.9 years (IQR 2.0 to 6.3), there were 154 total secondary surgeries. There were 83 device revisions, with 89% of revisions for a non-functioning device, 8% for pain, and 2% for infection. Of the non-functioning devices, 11% were due to battery depletion and the rest were due to lead fracture or dislodgement. Permanent device removal was performed in 71 (39%) patients, with 38% of these for unfavorable reasons (6% infection, 8% pain, 24% no longer effective) and 62% for favorable reasons (symptom improvement or resolution). Of patient baseline characteristics, only device duration was associated with favorable removal (p < 0.01). On Kaplan-Meier analysis, 5 year device secondary-surgery-free survival was 32% for any secondary surgery (favorable or unfavorable) and was 47% for unfavorable secondary surgery. At last follow-up, 74% of patients were in a favorable position (using the device, trialing with device off, or device had been removed for improvement) while 26% of patients were requiring other treatments due to device problem or removal.
DISCUSSION: Describing the likelihood of subsequent surgery is an important aspect of patient and guardian counseling concerning pediatric SNM. Our cohort had a 68% 5 year all-cause reoperation rate. However, in a theoretical perfect world, pediatric SNM reoperation rate would be 100% after adequate follow-up (either for battery replacement, or device explantation for improvement).
CONCLUSIONS: While sacral neuromodulation in our cohort of children carried a high (68% 5-year) reoperation rate (whether for complication or symptom improvement), the majority (74%) of these patients with previously refractory symptoms either continue to use their device or have had significant symptom improvement to permit device removal at moderate-term (median 3.9 year) follow-up.