Otology Korean J Otorhinolaryngol-Head Neck Surg 2018;61(6):281-6 / pissn / eissn Sho

Size: px

Start display at page:

Download "Otology Korean J Otorhinolaryngol-Head Neck Surg 2018;61(6):281-6 / pissn / eissn Sho"

원빈 빈
5 years ago
Views:

Otology Korean J Otorhinolaryngol-Head Neck Surg 2018;61(6):281-6 / pissn 2092-5859 / eissn 2092-6529 https://doi.org/10.3342/kjorl-hns.2017.

1 Otology Korean J Otorhinolaryngol-Head Neck Surg 2018;61(6):281-6 / pissn / eissn Short-Term Clinical Outcome of Neuro One R System Cochlear Implantation in Korean Adults Yong Woo Lee, Min-Beom Kim, and Sun O Chang Department of Otolaryngology-Head and Neck Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea 한국성인에서의 Neuro One R System 을이용한인공와우이식의단기임상결과 이용우 김민범 장선오성균관대학교의과대학강북삼성병원이비인후과학교실 Received June 22, 2017 Revised July 19, 2017 Accepted July 28, 2017 Address for correspondence Min-Beom Kim, MD, PhD Department of Otolaryngology- Head and Neck Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul 03181, Korea Tel Fax minbeom.kim@gmail.com Background and Objectives This study analyzed short-term clinical outcome and safety of Neuro One (Oticon Medical) cochlear implantation on postlingually deafened Korean adults. Subjects and Method A prospective study was performed on five postlingually deafened Korean adults who underwent Neuro One cochlear implantation between April and June, All cases were successfully implanted via round window approach. Preoperative pure tone audiometry and speech perception score [phonetically balanced (PB) words, bi-syllable words, Korean version-central institute for the deaf (K-CID)], intraoperative evoked compound action potential (ECAP), postoperative audiometry, aided warble-tone thresholds and speech perception scores after 6 months were evaluated. Residual hearing group was defined as patients with below 40 db of average audiometric threshold in low frequency (250 and 500 Hz). Preservation of residual hearing and postoperative complication were also evaluated. Results The mean age of five patients (3 men, 2 women) was 37.6 years. All of the recipients were unsatisfied about the conventional hearing aid. Two patients met the criteria for belonging to a residual hearing group. The audiometric threshold on the implanted side was db, and the opposite side was 89.6 db. The speech perception score with hearing aid resulted in the PB word score of 35.5%, bi-syllable word score of 50%, and the open set sentence test of 62.5% on the average. The mean operation time was 87 minutes. Three patients showed normal ECAP response throughout the entire electrode intraoperatively, but the other two patients could not detect ECAP response intraoperatively. However, we could eventually identify ECAP responses in all cases postoperatively. All patients of residual hearing group could preserve their residual hearing without deteriorating more than 10 db on audiometry. At 6 months after implantation, there was significant improvement of speech perception scores (PB word score was 54.1%; bi-syllable word score was 68.1% and K-CID was 86.2%). Conclusion Neuro One cochlear implant system was able to preserve residual hearing with relative short operation time. Short-term clinical outcome showed no significant difference with other cochlear implant devices. However, intraoperative ECAP measurement was not consistent. Further investigation was necessary. Korean J Otorhinolaryngol-Head Neck Surg 2018;61(6):281-6 Key Words Cochlear implantation ㆍ Hearing aids ㆍ Speech perception. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Copyright 2018 Korean Society of Otorhinolaryngology-Head and Neck Surgery 281

2 Korean J Otorhinolaryngol-Head Neck Surg 2018;61(6):281-6 서론 와우이식술 (cochlear implantation) 은 1984년 3 M/House 단채널인공와우가최초로임상에서사용된이후로현재까지비약적으로발전해왔다. 현재전세계적으로 건이상의와우이식이시술되고있고고도에서심도난청환자들의표준적인치료법으로인정받고있다. 와우이식은언어습득이후의난청환자에서의사소통능력을유지혹은회복시키고, 사회적상호작용과삶의질에도긍정적인영향이있음이알려져있다. 1,2) 인공와우의음향처리기술과수술방법론적인발달로이식술의결과에많은향상을가져오게되었고, 수술적용범위의확장도가능하도록하였다. 음향처리기는청각능력향상을통해의사소통에서의질을높이는것을목표로하여기술상의발전을거듭해오고있으며이식수술자체는 soft surgery 의개념을도입하는방향으로향상되고있다. Soft surgery 는 drilling 등을줄여서와우내의손상을최소화하는개념으로정원창 (round-window) 을통한접근법이기존의와우개창술 (cochleostomy) 을통한전극삽입과비교하여와우의손상을줄일수있는수술법으로근래선호되고있다. 1,2) 또한 dexamethasone과 hyaluronic acid 등의적절한약물학적인보조를통해서전극삽입과정중에발생할수있는손상과이식후염증반응을감소시킬수있다는사실이알려져있다. 3,4) 이러한개선들은환자의수술전잔청 (residual hearing) 을보존할수있게함으로써인공와우가전기적인자극과음향적인자극의조합을제공할수있게함으로써다양한상황에서의언어이해능력이향상되는것이기존에알려져있다. 5,6) Neuro system은 Oticon Medical에서제작된새로운인공와우로, 2015년부터임상에서사용되어현재까지 300건이상이식이시행되었다. 현재전세계적으로 15개국에서사용되어임상적인효과가보고되고있으며, 본원에서도 soft surgery 를통한이식술을시행하여새로운인공와우의의사소통능력의향상을객관적인측정법을통해확인하고자하였다. 유럽과캐나다에서는새로운장치에대한임상결과가보고되어 있으나, 한국을비롯하여아시아에서는아직까지그임상결과가보고되어있지않다. 이에저자들은최근에 Neuro One R (Oticon Medical, Vallauris, France) 장치를이용하여아시아에서최초로인공와우이식을시행하였고새로운장치의단기적인임상결과와그안전성과효율성여부를확인하고문헌고찰과함께보고하는바이다. 대상및방법 환자군 2016년 4월부터 2016년 6월까지강북삼성병원이비인후과에서언어습득후, 양측감각신경성난청으로진단된 5명의성인 ( 남성 3명, 여성 2명 ) 이본연구에포함되었다. 선정된환자들은평균적으로 16.5년 (±15.9) 의기간동안보청기를사용하였고, 보청기를착용하여도술전에시행한언어평가상 speech perception이만족스럽지못했거나주관적으로효과가없어환자스스로보청기를사용하지않는자들이었다. 대상환자들은특이주산기병력은확인되지않았고, 과거만성중이염에이환된경험이없는자들로측두골전산화단층촬영과자기공명영상 (internal auditory canal MRI) 에서해부학적인이상을확인할수없었고수술전에시행된 evaluation 상에서난청의명확한원인을확인할수없어특발성감각신경성난청으로진단된자들이다. 평균연령은 37.8년 (±16.5, 19~50세 ), deaf duration은환자가보청기를사용하여도효과를느끼지못한시점을기준으로하여평균 13.6년 (±14.2, 1~35년 ) 으로관찰되었다. 수술측청력역치는평균 db (±10.1, 90~116 db) 이었다 (Table 1). 대상환자들중수술전순음청력검사상 250 Hz와 500 Hz 주파수의평균역치가 40 db 이내인경우, 잔청 (residual hearing) 군으로분류하였다. 본연구는강북삼성병원임상시험심사위원회의검토와승인을받았고 ( 승인번호 : KBSMC ) 모든환자들에기술과연구의세부적사항을충분히설명한이후자발적동의하에진행되었다. 또한다른인공와우와의임상결과및수술시간을비교, 분석하기위해대조군을의무기록을통해 Table 1. Demographic data of subjects 282 Patient no. Sex Age Op ear PTA (db) Non-OP ear PTA (db) Duration of deafness (yr) Period of hearing aid use (yr) 1 F M F M M Average OP: operation, PTA: pure tone audiometry, yr: year, F: female, M: male Residual hearing

3 Short-Term Clinical Outcome of Neuro One R Cochlear Implantation Lee YW, et al. 후향적으로선정하였다. 연구가진행된같은년도에다른제조 사의인공와우를사용하여일측인공와우수술만을받은환 자들 7 명을대조군으로선정하였고, 평균연령은 63.4 년 (±5.2, 56~72 세 ) 으로해당환자들은중이염의과거력이나해부학적 인이상이없는자들이다. Neuro implant system Neuro Zti Evo R (Oticon Medical) receiver/stimulator 는경 피적으로이식하는인공와우장치로서, 삽입되는전극은 20 개의전극이 25 mm 길이로나열되어있고, 외과적으로와우 내고실계로위치시킨다. Neuro Zti Evo R 는두께 4.5 mm, 가 로와세로가각각 30.5, 40.8 mm 의길이를보여주며, 측두골 의표면에자동 - 태핑나사를이용하여고정할수있다 (Fig. 1). 수술전후의평가 수술전의모든검사는술전 1 달이내에시행하였다. 청각 에대한평가는방음이이루어진부스에서청각보조장치를 사용하지않은상태서순음청력검사가이루어졌고 250, 500, 1000, 2000, 4000 Hz 의주파수를측정하였다. 모든환자서 순음청력검사에대한신뢰도는청성뇌간반응검사 (auditory brainstem response) 와청성지속반응검사 (auditory steadystate response, ASSR) 를시행하여확인하였다. 언어평가는 동일음압단어 [phonetically balanced(pb) word], 이음절어 (bisyllable word), Korean version-central institute for the deaf(k-cid) 3가지항목을측정하였다. 언어평가항목들은 auditory-only(ao) condition 하에서측정된결과를사용하여수술전후로분석하였다. 대상환자들의수술전후의청각검사는모두동일한청각사에의해이루어졌고, 언어평가또한동일한환경에서한명의언어치료사가시행하였다. 수술중에는장치를이식한후전기유발복합활동전위 (evoked compound action potential, ECAP) 를확인하였고수술에소요된시간을마취기록을통해확인하였다. 수술후 SIZE Removable magnet With magnet <1.5T Without magnet <3T 4.5 mm 3.9 mm W/O silicone 40.8 mm 30.5 mm 25 mm 20 electrodes Low-trauma fixation system Fig. 1. Overview of Neuro Zti Evo (Oticon Medical) receiver/stimulator. W/O: without. 임상결과에대한평가는 3개월과 6개월째에이루어졌고음장착용청력검사 (aided sound-field audiometry) 와 PB word, bisyllable word, K-CID sentence 항목을검사하였다. 검사를통하여잔청의보존여부를확인하고수술에대한합병증발생유무는술후 1달간은주 1회씩외래통원하여확인하였고, 그이후로는 3개월과 6개월째경과관찰시확인하였다. 통계학적검정은수술전후의검사결과에대해서는 Wilcoxon signed ranks test를사용하였다. 단, 수술시간에대한대상환자와대조군사이의통계학적인검정은 Mann-Whitney U test를사용하였다. 통계프로그램은 SPSS version 18.0 (SPSS Inc., Chicago, IL, USA) 를이용하였다. p-value 값이 0.05 미만인경우를통계적으로유의한것으로판정하였다. 결 과 수술후인공와우장치를착용한상태에서시행한음장착용청력검사의평균역치는 3개월째 46(±10.8) db HL, 6개월째에 40.7(±6.0) db HL로관찰되었다. 수술전순음청력검사의평균역치 102.6(±10.1) db HL와비교하였을때통계학적으로유의한청력호전이있음을확인하였다 (p<0.001) (Table 2). 수술전에잔청이있는것으로확인된환자두명은술후 6개월째시행한순음청력검사를술전과비교하였을때 250 Hz(p=0.317), 500 Hz(p=0.317) 두주파수에서의미있는역치변화는관찰되지않았다. 따라서환자들의잔청은비교적잘보존되었음을확인할수있었다 (Table 3). AO condition 하에서시행한언어평가에서 PB word 에서술전에 34.4%(±20.5), 3개월째 53.4%(±18.1), 6개월째 57.8% (±26.0) 으로측정되었고 bisyllable word에서술전 49.5% Table 2. Pre- and post-op threshold of audiometry Patient no. Pre-OP (db) 3 mon (db) 6 mon (db) Average * 40.7* *wilcoxon signed ranks test, p< OP: operation Table 3. Pre- and post-op threshold of low-tone audiometry Patient Pre-OP (db) 6 mon (db) no. 250 Hz 500 Hz 250 Hz 500 Hz Average * 62.5* *wilcoxon signed ranks test, p= OP: operation 283

4 Korean J Otorhinolaryngol-Head Neck Surg 2018;61(6):281-6 (±33.6), 3 개월째 58.5%(±18.5), 6 개월째 69.6%(±24.2) 로관 찰되었다. K-CID 에서는술전에 62.8%(±36.8), 3 개월째 71.0%(±34.9), 6 개월째 75.8%(±26.1) 로관찰되었다. 수술전 과비교하여술후 6 개월째에 PB word(p=0.043), bisyllable word(p=0.042), K-CID(p=0.043) 세가지언어평가항목서모 두통계적으로의미있는향상을확인할수있었다 (Fig. 2). 5 명의환자모두에서정원창을통한접근법으로 soft surgery Score (%) Table 4. Result of intra-op variables Patient no. Pre-OP OP time (min) ECAP response Electrode resistance * Average 87 2 cases missing* All fully inserted *after 1 month, normal ECAP response observed in all cases. ECAP: evoked compound action potential, OP: operation mon 6 mon PB word Bisyllable word K-CID Fig. 2. Post-OP change of speech perception score. *wilcoxon signed ranks test, p=0.043, wilcoxon signed ranks test, p=0.042, wilcoxon signed ranks test, p= OP: operation, PB: phonetically balanced, K-CID: Korean version-central institute for the deaf. Surgical time (min) Neuro one R Control group Fig. 3. Difference in surgical time between Neuro one (Oticon Medical) and control groups. *Mann-Whitney U test, p= * Implant device 가성공적으로시행가능하였고전극을삽입하는과정에서저항은확인되지않았다. 술중에 ECAP response는 5명중 3명에서는확인가능하였고 2명은관찰되지않았다. 하지만술중에 ECAP response 가없었던 2명의환자도술후 1달이내에는 ECAP response를정상적으로관찰가능하였다. 모든환자는수술을 2시간이내에마무리할수있었으며평균적으로 87분 (±21.4) 이소요되었다 (Table 4). 수술과관련된합병증은모든환자에서 6개월째까지관찰되지않았다. 고찰 본연구는 Neuro One R system 인공와우의임상결과와안전성여부를 6개월의기간동안확인한국내를비롯한아시아에서최초로시행된임상시험이다. 와우이식후 3개월째와 6 개월째의음장착용청력검사 (aided sound-field audiometry) 와 PB word, bisyllable word, K-CID 를통해서청력과의사소통능력의향상을평가하였고, 합병증발생유무와저주파수음역의청력보존여부를통하여이식후의안전성을확인하였다. 그리고결과적으로선별된조건하의환자들에서임상적인효과가있음을관찰하였고, 특정 protocol 하에서이식술이시행되었을때, 안전하게시술될수있음을확인하였다. 단, 언어습득후청력을상실한성인만을대상으로하였고, 제한된수의환자를통해서도출된결과임을생각해보았을때, 전체난청환자에대해일반화할수는없지만향후더많은수의환자들을대상으로하는임상시험이시행가능하도록하였다. 수술후에시행된음장착용청력검사는술후 3개월째평균역치 46 db로급격한호전을보였고통계적으로도유의미한증가정도 (p<0.001) 로관찰되었으며이후 6개월째는평균역치 42 db로완만하게증가되는것이관찰되었다. 또한단기간의경과관찰동안관찰된청력역치는기존에문헌을통해서보고된기존인공와우와유사한것으로확인하였다. 7) AO condition 하에서시행한세가지항목의언어평가에서는청력역치와는다르게 3개월째 PB word 19%(p=0.043), bisyllable word 9%(p=0.343), K-CID 8.2%(p=0.225) 의증가를보여두가지검사에서는통계적으로의미있는향상이나타나지않았으나 6개월째에이르러세가지검사에서모두통계적으로유의미한향상이관찰되어완만하게증가하는것을확인하였다. 다만 6개월째에관찰된절대적인언어평가상의수치도다른장치를사용한임상결과를보고한기존문헌들과유사하게확인된다. 7-9) 강북삼성병원에서도다른인공와우를사용하여수술을시행한 7명의환자중, 술후 6개월시점의평가가아직되지않은 1명을제외하고 6명에서술후청력역치 (p=0.926) 와 PB word(p=0.200), bisyllable 284

5 Short-Term Clinical Outcome of Neuro One R Cochlear Implantation Lee YW, et al. word(p=0.200), K-CID(p=0.144) 를비교하였을때, Neuro One R 인공와우이식을받은환자들과의미있는차이를보이지않았다. 따라서언어습득이이루어진성인에서기존의장치들만큼의청력이나의사소통능력의향상을기대할수있다고판단된다. 본연구에서비록적은수이지만 residual hearing이있는것으로확인된환자에서는직선형의전극 (25 mm 길이 ) 을완전히삽입하였음에도청력이보존되었음을확인할수있었다. 정원창을통한수술적접근법으로이식술을시행하였을때본인공와우에서청력이보존되는것은기존의문헌에서도보고된바가있다. 7) 그리고전극의삽입과정에서도모든환자에서저항없이완전한삽입이가능하여본장치에서와우내의최소한의손상으로전극삽입이가능함을확인할수있었다. 따라서잔청이있는환자에서청력을보존하면서이식할수있는가능성을확인할수있었고, 이는향후더많은수의환자를포함한임상시험을통해서밝혀져야할부분으로사료된다. 청력보존이외에도, 모든대상환자들에서경과관찰중에안면신경손상, 현훈, 삼출성중이염, 미각변화와같은이식후합병증이확인되지않아청각기관과주변구조물에손상을유발하지않는것으로판단할수있었다. 결론적으로, 제한된환자군에서안전하게이식할수있는장치로평가를내릴수있었다. 수술시간은평균 87분 (±21.4) 으로확인되어인공와우수술이기존에 2시간가량소요되는것으로알려져있는것을생각해봤을때, 비교적단축된것을확인하였다. 수술은대상환자와대조군모두동일한술자들에의해서이루어졌다. 대조군에해당하는환자들은 7명이었고수술에소요된시간은평균 117분 (±13.1) 으로확인되었다. 분석결과를살펴보면, Neuro One R system으로수술한환자군에서는수술시간이평균 87분 (±21.4) 으로통계적으로의미있는시간단축이있음을확인하였다 (Mann-Whitney U test, p=0.045)(fig. 3). Neuro Zti Evo R receiver/stimulator는자동-태핑나사를통해서측두골에고정된다는점에서기존의장치와는차이점을보인다. 수술시에 subperiosteal pocket을만든이후에 receiver에부착되어있는나사를조이는것만으로고정이끝나게된다. 이는 receiver/stimulator를위치시키기위해기존에시행하던 bone-bed drilling이나 suture를필요로하지않아수술시간의의미있는단축을가능하도록하였고, 본연구에서관찰된결과도이러한점에기인하는것으로판단된다. 본저자들은수술중에대상환자 5명중 2명에서는 20개의모든전극에서임피던스가측정되었음에도 ECAP은확인되지않는것을관찰할수있었다. 이 2명은술후 1달째장치를 switch on 하는시점에서는 ECAP이정상적으로관찰되었 지만, receiver/stimulator 의전극에특별한문제가없음에도 술중에 ECAP 이측정되지않는현상에대해서향후보완이 필요하다. 또한환자중한명에서는 speech processor 가 scalp 에잘부착되지않는현상이관찰되었다. 이환자는추가적으 로 scalp 의 volume reduction 을시행하였고이후로는상기의 문제가발생하지않았다. 이처럼 scalp 가두꺼운환자들에서 speech processor 고정에문제를보이는부분또한향후개선 이필요한부분이다. 본연구는언어습득이후청력을소실한 5 명의성인을대상으로진행된것으로임상결과상의향상과 함께수술의안전성을확인하였다. 단, 대상으로선정된환자 가소수이고, 특정조건하의환자들만을포함하고있는점을 고려한다면전체난청환자에대해서일반화할수없다는점 에서한계가있다. 따라서향후더많은수의환자를포함한 randomized study 를통하여본저자들이관찰한부분들에 대한확인이필요할것이다. 결론적으로 Neuro One R system(oticon Medical) 은새로 운고정시스템으로인해외상은줄이면서비교적빠른시간 내에수술이가능한것으로관찰되었다. 또한, 잔청이술후에 도보존되고다른합병증을동반하지않아안전하면서임상 결과상으로도기존의인공와우와큰차이는없는것으로관 찰되었다. 하지만전극상의결함이없음에도수술중 ECAP 이관찰되지않는경우가있고 scalp 의두께에따라 speech processor 의부착에문제를보이는부분에대한보완이필요 할것으로사료된다. Acknowledgments The subjects of this study was supported for fee of the surgery and cochlear implant device by Oticon medical. Surgeons and researchers of the study have no other possible conflicts of interest, including financial, consultant, institutional and other relationships that might lead to bias. REFERENCES 1) Semenov YR, Martinez-Monedero R, Niparko JK. Cochlear implants: clinical and societal outcomes. Otolaryngol Clin North Am 2012; 45(5): ) Gaylor JM, Raman G, Chung M, Lee J, Rao M, Lau J, et al. Cochlear implantation in adults: a systematic review and meta-analysis. JAMA Otolaryngol Head Neck Surg 2013;139(3): ) Géléoc GS, Holt JR. Sound strategies for hearing restoration. Science 2014;344(6184): ) Di Lella F, Bacciu A, Pasanisi E, Vincenti V, Guida M, Bacciu S. Main peak interleaved sampling (MPIS) strategy: effect of stimulation rate variations on speech perception in adult cochlear implant recipients using the Digisonic SP cochlear implant. Acta Otolaryngol 2010;130(1): ) Shannon RV. Advances in auditory prostheses. Curr Opin Neurol 2012;25(1): ) Svirsky MA, Robbins AM, Kirk KI, Pisoni DB, Miyamoto RT. Language development in profoundly deaf children with cochlear implants. Psychol Sci 2000;11(2):

6 Korean J Otorhinolaryngol-Head Neck Surg 2018;61(6): ) Bento RF, Danieli F, Magalhães AT, Gnansia D, Hoen M. Residual Hearing Preservation with the Evo Cochlear Implant Electrode Array: Preliminary Results. Int Arch Otorhinolaryngol 2016;20(4): ) Han JJ, Shin MS, Song JJ, Pai I, Oh S, Kim B, et al. Prognostic value of psychological state in cochlear implantation. Acta Otolaryngol 2016;136(2): ) Moon IJ, Kim EY, Jeong JO, Chung WH, Cho YS, Hong SH. The influence of various factors on the performance of repetition tests in adults with cochlear implants. Eur Arch Otorhinolaryngol 2012; 269(3):

012임수진

012임수진 Received : 2012. 11. 27 Reviewed : 2012. 12. 10 Accepted : 2012. 12. 12 A Clinical Study on Effect of Electro-acupuncture Treatment for Low Back Pain and Radicular Pain in Patients Diagnosed with Lumbar