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骨锚式助听器的长期临床结果:微创骨桥手术与保留组织的线性切口技术的3年比较

Long-Term Clinical Outcomes for Bone-Anchored Hearing Implants: 3-Year Comparison Between Minimally Invasive Ponto Surgery and the Linear Incision Technique With Tissue Preservation.

作者信息

Teunissen Emma, Caspers Coosje, Kruyt Ivo, Mylanus Emmanuel, Hol Myrthe

机构信息

Department of Otorhinolaryngology-Head and Neck Surgery, Donders Center for Neuroscience, Radboud University Medical Center, Radboud University, Nijmegen, the Netherlands.

出版信息

Otol Neurotol. 2025 Feb 1;46(2):161-169. doi: 10.1097/MAO.0000000000004398.

DOI:10.1097/MAO.0000000000004398
PMID:39792980
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11913237/
Abstract

OBJECTIVE

To compare the 3-year outcomes of the modified minimally invasive Ponto surgery (m-MIPS) to both the original MIPS (o-MIPS) and linear incision technique with soft tissue preservation (LIT-TP) for inserting bone-anchored hearing implants (BAHIs).

STUDY DESIGN

Prospective study with three patient groups: m-MIPS, o-MIPS, and LIT-TP.

SETTING

Tertiary referral center.

PATIENTS

In the m-MIPS group, 24 patients with 25 implants were enrolled. The o-MIPS and LIT-TP groups included 25 patients (25 implants) each.

INTERVENTIONS

The patients underwent BAHI surgery using m-MIPS, o-MIPS, or LIT-TP.

MAIN OUTCOME MEASURES

Implant survival and implant stability were compared between all groups. Soft tissue status, skin sensibility, subjective numbness, and hearing-related quality of life (HRQoL) were compared between m-MIPS and LIT-TP and o-MIPS and LIT-TP, respectively.

RESULTS

Implant survival was comparable between m-MIPS and LIT-TP (96 versus 100%), with o-MIPS showing nonsignificant lower survival (88%). Both MIPS groups exhibited fewer (adverse) skin reactions, better skin sensibility, and less subjective numbness than LIT-TP throughout visits. At 3 years, soft tissue status, sensibility, and numbness were comparable between groups. Device use was consistent among groups (83-86% daily users). All groups demonstrated significant improvement in HRQoL post-surgery based on GBI, GHSI, and APHAB total scores.

CONCLUSIONS

Compared with LIT-TP, m-MIPS showed comparable long-term implant survival, fewer (adverse) skin reactions, and earlier sensibility and numbness recovery. M-MIPS resulted in favorable clinical and QoL outcomes with low intra- and postoperative complication rates until 3 years after surgery. It is therefore considered a safe technique for BAHI insertion. Moreover, with a shorter surgery time and the ability to operate under local anesthesia in a controlled outpatient setting, m-MIPS appears to be a more efficient alternative to LIT-TP.

摘要

目的

比较改良微创骨桥手术(m-MIPS)与原始骨桥手术(o-MIPS)以及保留软组织的线性切口技术(LIT-TP)在植入骨锚式听力植入物(BAHI)方面的3年效果。

研究设计

对三个患者组进行前瞻性研究:m-MIPS组、o-MIPS组和LIT-TP组。

研究地点

三级转诊中心。

患者

m-MIPS组纳入了24例患者,共植入25枚植入物。o-MIPS组和LIT-TP组各包括25例患者(25枚植入物)。

干预措施

患者接受使用m-MIPS、o-MIPS或LIT-TP的BAHI手术。

主要观察指标

比较所有组之间的植入物存活率和植入物稳定性。分别比较m-MIPS与LIT-TP组以及o-MIPS与LIT-TP组之间的软组织状况、皮肤感觉、主观麻木感和听力相关生活质量(HRQoL)。

结果

m-MIPS组与LIT-TP组的植入物存活率相当(分别为96%和100%),o-MIPS组的存活率略低但无显著差异(88%)。在整个随访过程中,与LIT-TP组相比,两个MIPS组的皮肤反应(不良)更少、皮肤感觉更好且主观麻木感更少。3年后,各组之间的软组织状况、感觉和麻木感相当。各组之间的设备使用情况一致(每日使用者占83-86%)。根据GBI、GHSI和APHAB总分,所有组在术后的HRQoL均有显著改善。

结论

与LIT-TP相比,m-MIPS显示出相当的长期植入物存活率、更少的(不良)皮肤反应以及更早的感觉和麻木感恢复。m-MIPS在术后3年内产生了良好的临床和生活质量结果,术中及术后并发症发生率低。因此,它被认为是一种安全的BAHI植入技术。此外,m-MIPS手术时间更短,能够在可控的门诊环境中进行局部麻醉下的手术,似乎是LIT-TP更有效的替代方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7539/11913237/cde02591b13c/on-46-161-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7539/11913237/c73b90845f33/on-46-161-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7539/11913237/9b0d037bceb8/on-46-161-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7539/11913237/be89d32415c7/on-46-161-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7539/11913237/cde02591b13c/on-46-161-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7539/11913237/c73b90845f33/on-46-161-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7539/11913237/9b0d037bceb8/on-46-161-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7539/11913237/be89d32415c7/on-46-161-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7539/11913237/cde02591b13c/on-46-161-g004.jpg

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本文引用的文献

1
Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique-A Prospective Multicenter Study.采用微创外科技术评估桥脑植入的临床效果——一项前瞻性多中心研究。
Otol Neurotol. 2024 Oct 1;45(9):1037-1044. doi: 10.1097/MAO.0000000000004315. Epub 2024 Aug 26.
2
Minimally invasive surgery as a new clinical standard for bone anchored hearing implants-real-world data from 10 years of follow-up and 228 surgeries.微创手术作为骨锚式听力植入物的新临床标准——来自10年随访和228例手术的真实世界数据。
Front Surg. 2023 Jul 3;10:1209927. doi: 10.3389/fsurg.2023.1209927. eCollection 2023.
3
Tissue Preservation Techniques for Bone-Anchored Hearing Aid Surgery.
骨锚式助听器手术中的组织保存技术。
Otol Neurotol. 2021 Aug 1;42(7):1044-1050. doi: 10.1097/MAO.0000000000003157.
4
A Clinical Evaluation of Minimally Invasive Ponto Surgery With a Modified Drill System for Inserting Bone-Anchored Hearing Implants.改良钻头系统微创耳内式骨锚定助听植入术的临床评估。
Otol Neurotol. 2021 Sep 1;42(8):1192-1200. doi: 10.1097/MAO.0000000000003195.
5
Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices.微创桥接手术与保留软组织的线性切口技术用于经皮骨传导装置植入的长期疗效比较
Front Neurol. 2021 Feb 24;12:632987. doi: 10.3389/fneur.2021.632987. eCollection 2021.
6
Six-Month Clinical Outcomes for Bone-Anchored Hearing Implants: Comparison Between Minimally Invasive Ponto Surgery and the Linear Incision Technique With Tissue Preservation.骨锚定式听力植入物的六个月临床结果:微创耳内 Pont 手术与保留组织的线性切口技术的比较。
Otol Neurotol. 2020 Apr;41(4):e475-e483. doi: 10.1097/MAO.0000000000002562.
7
Experience with Minimally Invasive Ponto Surgery and Linear Incision Approach for Pediatric and Adult Bone Anchored Hearing Implants.小儿及成人骨锚式助听器的微创桥接手术和线性切口入路经验
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