Boswell Timothy C, Hollatz Pam, Hutcheson Joel C, Vandersteen David R, Reinberg Yuri E
Department of Urology, Mayo Clinic, Rochester, MN, USA.
Children's Hospitals and Clinics of Minnesota, Pediatric Surgical Associates, Minneapolis, MN, USA.
J Pediatr Urol. 2021 Feb;17(1):72.e1-72.e7. doi: 10.1016/j.jpurol.2020.10.010. Epub 2020 Oct 16.
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.
We sought to study the rate and causes of secondary surgeries in pediatric SNM patients.
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.
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.
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).
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.
小儿骶神经调节（SNM）装置在翻修或移除前的使用时长尚不清楚。此外，二次手术可作为包括并发症和症状改善等关键结局的替代指标。
我们试图研究小儿SNM患者二次手术的发生率及原因。
我们评估了小儿SNM患者队列中的二次手术（翻修或移除）情况。采用Fisher精确检验分析与二次手术相关的患者基线特征。使用Kaplan-Meier分析来描述无二次手术的装置生存率。
2002年至2019年间，我院共有187例小儿患者接受了骶神经调节治疗。7例（4%）患者因外置电极试验期反应不佳未植入永久性装置，其余180例患者植入了永久性装置。中位随访3.9年（四分位间距2.0至6.3年）期间，共进行了154次二次手术。其中83次为装置翻修，89%的翻修是因为装置功能失效，8%是因为疼痛，2%是因为感染。在功能失效的装置中，11%是由于电池耗尽，其余是由于电极断裂或移位。71例（39%）患者进行了永久性装置移除，其中38%是出于不利原因（6%为感染，8%为疼痛，24%为不再有效），62%是出于有利原因（症状改善或缓解）。在患者基线特征中，只有装置使用时长与有利的移除相关（p<0.01）。根据Kaplan-Meier分析，5年无二次手术的装置生存率，对于任何二次手术（有利或不利）为32%，对于不利的二次手术为47%。在最后一次随访时，74%的患者情况良好（使用装置、关闭装置进行试验或因症状改善而移除装置），而26%的患者因装置问题或移除而需要其他治疗。
描述后续手术的可能性是小儿SNM患者及其监护人咨询的一个重要方面。我们的队列5年全因再手术率为68%。然而，在理论上的理想情况下，经过充分随访（无论是更换电池，还是为改善症状而取出装置），小儿SNM的再手术率将达到100%。
虽然我们队列中的小儿骶神经调节手术再手术率较高（5年为68%，无论是因并发症还是症状改善），但这些先前有难治性症状的患者中，大多数（74%）要么继续使用装置，要么在中期（中位3.9年）随访时症状有显著改善从而可以取出装置。
