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Выводы  и  заключения   1.

Долгосрочные   наблюдения   за   пациентами   показывают   существенное   подавление   боли,   на   фоне   стимуляции   при   помощи   электрода   S-­‐Series   у   пациентов   с   диагнозами   FBSS   и   люмбоишиалгия  (если  у  пациента  были  операции  -­‐  на  60,9%,  и  если  не  было  –  39,1%).     Лучшее  подавление  боли  в  первое  время  (в  среднем  после   тестового  периода  –  76%),  чем  при   постоперационных  осмотрах  (в  среднем:  51%).  Авторы  считают,  что  такой  эффект  обусловлен   чрезмерными   ожиданиями   пациента   (частично   –   эффект   плацебо),   а   также   изменения   на   кортикальном  уровне   из-­‐за   привыкания.   Другим   объяснением   может   быть   общее   повышение   активности  пациента.  Требуется  дальнейшее  изучение  данного  вопроса.   Меньшее   количество   визитов   по   поддержке   программирования,   эффект   облегчения   боли   и   постоянная  парестезия  –  неизменно  в  месте  локализации  боли.   Все   пациенты   отметили,   что   прошли   бы   заново   терапию   стимуляцией,   вопрос   задавали   на   протяжении  3  годичного  периода  ведения  пациента  .   Продолжаются  исследования  по  оценке  постоянной  парестезии  в  больших  группах.    

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Имплантация  хирургических  электродов   перкутанно:   Долгосрочное  клиническое  ведение  23   пациентов   1

Logé D Vanneste S.

Благодарности   Авторы  выражают  признательность  Frank  D e  Meuter    за  техническую  помощь,  а  так  же  профессора   Dirk  de  Ridder  за  его  научный  вклад.      

Ссылки   1. 2.

D.  Logé,  S.  Vanneste,  T.  Vancamp.  A  long  term  follow-­‐up  of  6  patients  implanted  with  a  perc-­‐ paddle  lead.  Poster  presented  at  the  INS  congress,  London,  05/2011.      D.  Logé,  O.  De  Coster,  S.  Washburn.  A  retrospective  d ata  collection  to  evaluate  the  feasibility  

Признания   Данное  исследование  никак  не  финансировалось  коммерческими  структурами.  Dr  Loge  является   консультантом  компании  St  Jude  Medical,  Tim  Vancamp  –  менеджер  компании  St  Jude  Medical.  

ЗАО  ИМПЛАНТА   119002  Москва,   Карманицкий  пер.  д.9,   Арбат  Бизнес  Центр,  оф.   701   e-­‐mail:  info@implanta.ru     www.neuroimplanta.ru   www.implanta.ru    

Ø

 

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& Vancamp T.

Ø 1Dept  of  Anesthesiology  &  Pain  therapy,  A.Z.  St  Lucas,  Gent,  B elgium     2 Ø TRI  BRAI2N  &  Dept  of  Neurosurgery,  University  Hospital  Antwerp,  Belgium   3  Department  o f  Translational  Neuroscience,  Faculty  of  Medicine,  University  of  Antwerp,  Belgium  


(n=5, 21.7%), T10 (n=1, 4.3%). Information about the performance of the S-Series Lead was collected according to the Belgian reimbursement guidelines at baseline, post-trial (Average: 1 month) and during three follow-up (F-U) visits Introduction 3 Translational Neuroscience, Faculty of Medicine, University of Antwerp, Belgium (averages; F-U 1: 1.2 years [range: 2 months – 2.8 years], F-U 2: 1.1 years [range: 9 months –Department 2.1 years],ofF-U 3: 1.3 years [range: 9 months – 2.3 year]). All visit intervals are counted after the former visit. Average follow-up: 3.2 years [range: TM TM type implantable pulse generator (St. Jude Medical Neuromodulation Division, Plano, TX) after the mandatory 28 days trial period. Pain scores were rated through use of the EONtoCbe 1.6-6.1].All patients were implanted with a GenesisXP Spinal cord stimulation (SCS) has beenor proven a viable therapeutic tool in the arsenal of the painВведение   physician to treat a variety of chronic intractable neuropathic pain conditions. Throughout the years different lead designs have been Introduction visual analogue scale (VAS)developed. and electrophysiological were documented. were documented Frequency: (range: 20-70), Pulse width: 352.9µs [range: Perception amplitude: The S-Series™ Lead (St.parameters Jude Medical Neuromodulation Division,Average Plano, TX)parameter is a steerable values narrow single-column paddle leadasforfollows: SCS systems. The purpose38.1Hz of this study was to assess the long-term results achieved with this104-494], type of Стимуляция   спинного   мозга   п роверенный,   у[range: спешный   мaетод   терапии   боли   и  amplitude: различных   нейропатических   упорных   синдромов.   а  годы   существования   тcathodes ерапии  used: б ыли  1.3 спроектированы   electrode in – a  larger group of 6.5mA patients presenting series of 6 to patients. Favourable outcomes were presented with respect backofand leg pain 5.0mA [range: 0.8-16.0], Comfortable amplitude: 1.4-17.2], Maximum Tolerable [range: 2.8-18.4], Number of anodesneuropathic used:З2.0 Number [range: 1-2], Number of electrodes Spinalafter cord stimulation (SCS)case has been proven be a viable therapeutic tool in the 7.6mA arsenal of the pain physician to treat atovariety chronic intractable pain[range: conditions.1-5], Throughout the yearsof different lead designs have been 1 Earlier data has been showing the safety steerability over several segments withwas ofthe lead. over a mean Э follow-up period of 3 years with and without prior surgery. различные   конструкции   электродов.   лектрод   Selectrode -­‐Series   (arrays St   J(St. ude   edical   Neuromodulation   ivision,   Plano,   TX)   –paddle  the эand то  lead узкий   эpain лектрод,   сof  оthis дной   кthis олонкой   ш2 ироких   контактов,   на  to cover their pain area. The developed. The S-Series™ Lead JudeM Medical Neuromodulation Division, Plano, TX) D is presented acombinations steerable narrow single-column for SCS systems. The purpose study to type assess2 long-term results achieved with this typeк ofак   activated: 3.3 [range: 2-7]. suppression 13 (52.0%) longitudinal guarded were used, and 12 (48.0%) bipolar covered patients’ area with paraesthesia. patients needed 2 stimulation sets electrode in a larger group of patients after presenting a case series of 6 patients. Favourable outcomes were presented with respect to back and leg pain хирургических   электродах,   для  стимуляции   спинного   мof озга.   Цperiod ель  ofд0-15] сследования   –  оdata ценить   долговременный   ффект   терапии   пasked ри   спользовании   подобного   электрода     follow-up visits. number of reprogramming was documented as well with an average 3.0 [range: and awithout median of 2.0 Earlier over thehascourse of the visits. Furthermore patients iftype they would redo the procedure during all в their been presented showing the safety and э steerability over several were segments withи this of lead. suppression over a mean follow-up 3 анного   years with andи prior surgery.

 

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большой  группе  пациентов  (после  опубликования  подробных  клинических  разборов  6  случаев).  Благоприятные  результаты  по  подавлению  боли  в  спине  и  ноге  наблюдались    за   Methods & 1  Materials период  наблюдения  3  года,  при  наличии  или  отсутствии  предыдущих  операционных  вмешательств.   Данные,   опубликованные  ранее,  показывают  эффективность  и  возможности   Methods & Materials 2 имплантации  такого  типа  электрода .  

The S-Series Lead, was introduced into the epidural space to generate paraesthesia in the dermatomes of the patients’ pain area. The lead tips were located at the following vertebral levels: T5 (n=1, 4.3%), T7 (n=8, 34.8%), T8 (n=8, 34.8%), T9 The S-Series Lead, was introduced into the epidural space to generate paraesthesia in the dermatomes of the patients’ pain area. The lead tips were located at the following vertebral levels: T5 (n=1, 4.3%), T7 (n=8, 34.8%), T8 (n=8, 34.8%), T9 (n=5, 21.7%), T10 (n=1, 4.3%). Information about the performance of the S-Series Lead was collected according to the Belgian reimbursement guidelines at baseline, post-trial (Average: 1 month) and during three follow-up (F-U) visits (n=5, 21.7%), T10 (n=1, 4.3%). Information about the performance of the S-Series Lead was collected according to the Belgian reimbursement guidelines at baseline, post-trial (Average: 1 month) and during three follow-up (F-U) visits (averages; F-U 1: 1.2 years [range:(averages; 2 months F-U 2: 1.1 years 9 months – 2.1 years], F-U 3: 1.3years], yearsF-U [range: 9 months year]). All visitAllintervals areare counted theformer former visit. Average follow-up: years [range: F-U–1:2.8 1.2years], years [range: 2 months – 2.8[range: years], F-U 2: 1.1 years [range: 9 months – 2.1 3: 1.3 years [range: –9 2.3 months – 2.3 year]). visit intervals countedafter after the visit. Average follow-up: 3.2 years3.2 [range: TM or EONpulse or EON with CTM type implantable generator (St.pulse Jude Medical Division, Division, Plano, TX) after 2828days period. Pain scores rated through 1.6-6.1].All patients were implanted with a GenesisXP CTM type implantable generator (St.Neuromodulation Jude Medical Neuromodulation Plano, TX) the aftermandatory the mandatory days trial trial period. Pain scores were were rated through use of theuse of the 1.6-6.1].All patients wereTMimplanted a GenesisXP visual analogue scale (VAS) and electrophysiological parameters were documented. values were documented follows: Frequency: (range: 20-70), Pulse width: width: 352.9µs [range: 104-494], Perception amplitude: visual analogue scale (VAS) and electrophysiological parameters were documented. Average parameterAverage valuesparameter were documented as follows:asFrequency: 38.1Hz38.1Hz (range: 20-70), Pulse 352.9µs [range: 104-494], Perception amplitude: 5.0mA [range: 0.8-16.0], Comfortable amplitude: 6.5mA [range:Tolerable 1.4-17.2], Maximum Tolerable amplitude: [range: 2.8-18.4],ofNumber of anodes used: 2.0 [range: 1-5], Numberof of cathodes cathodes used: 1.3 1.3 [range: 1-2], Number of electrodes 5.0mA [range: 0.8-16.0], Comfortable amplitude: 6.5mA [range: 1.4-17.2], Maximum amplitude: 7.6mA [range: 7.6mA 2.8-18.4], Number anodes used: 2.0 [range: 1-5], Number used: [range: 1-2], Number of electrodes activated: 3.3 [range: 2-7]. 13 (52.0%) longitudinal guarded electrode arrays were used, and 12 (48.0%) bipolar combinations covered the patients’ pain area with paraesthesia. 2 patients needed 2 stimulation sets to cover their pain area. The 1. Patient Demographics 3. The average VAS scores were: VAS covered baseline: (range: 4.76-8.99), VAS PT (post -operative): 1.85 (range: 0.60-3.66), VAS FU-1 (follow-up 1): Результаты   activated: 3.3 [range: 2-7]. 13 (52.0%) longitudinal guarded used, and bipolar theof6.91 patients’ pain area with paraesthesia. patients needed 2 stimulation sets tofollow-up cover their number of reprogramming waselectrode documentedarrays as wellwere with an average of 12 3.0 (48.0%) [range: 0-15] and a combinations median of 2.0 over the course the visits. Furthermore patients were asked if 2they would redo the procedure during all their visits.pain area. The number of reprogramming was documented as well with an average of 3.0 [range:(range: 0-15] and1.47-5.17), a median of 2.0 the course of the visits. Furthermore patients were asked if they would redo the procedure during all their follow-up visits. VASover FU-2: 3.88 (range: 2.20-6.28). эпидуральное   1  демография  

Results

Материалы  и  методы  

3.10

ЭлектродыS-­‐Series     имплантировали   в   Gender пространство   для   генерации   парестезий   в   дерматомах   10 Male (%) располагали   8 (34.8%) Пол   3  Средний  результат  по  VAS  на  начальном   болевых   ощущений   пациентов.   Верх   электрода   Resultsуровне  составил:  6,91  (диапазон:  4,76  –  8,99),  VAS  в   9 постоперационном  периоде:1,85  (диапазон:  0,60  –  3,66),  VAS  первый  визит:  3,10  (диапазон:  1,47  –   на   следующих   уровнях:   Т5   (n=1,   4,3%),  Т7  (n=8,   3 4,8%),   Т 8   ( n=8,   Female (%) Муж  (%)   15 (65.2%) 8  (34,8%)   Results 5,17)Б  VAS  второй  3.вThe изит:   3,88   диапазон:   ,20  –  66.91 ,28).   1. Patient Demographics average VAS(scores were: VAS2baseline: (range: 4.76-8.99), VAS PT (post -operative): 1.85 (range: 0.60-3.66), VAS FU-1 (follow-up 1): 3.10 34,8%),  Т9  (n=5,  21,7%),  Т10  (n=1,  4,3%).  Данные  собирались  ,  в   (range: 1.47-5.17), VAS FU-2: 3.88 (range: 2.20-6.28). 8 Age Жен   ( %)   15   ( 65,2%)   соответствии   с   указаниями   страховой   медицины   Бельгии,   на   Gender 1. Patient Demographics 3. The average VAS10scores were: VAS baseline: 6.91 (range: 4.76-8.99), VAS PT (post -operative): 1.85 (range: 0.60-3.66), VAS FU-1 (follow-up 1): 3.10 начальном   этапе,   после   тестового   периода   (в   среднем   –   1   Male (%) 8 (34.8%) Average (±SD) 55.8 (± 11.9)Возраст   (range: 1.47-5.17), VAS FU-2: 3.88 (range: 2.20-6.28). 7 9 месяц)  и  во  время  трёх  постоперационных  визитов  (в  среднем,   Female (%) 15 (65.2%) Gender 10 Diagnosis В   с реднем   ( ±SD)   55,8   ( ±11,9)   Первый  визит   –  1,2  года   [диапазон  от  2   месяцев  до  2.8  года];   Male (%) 8 8 (34.8%) Age 6 Pain now (p < .001) второй   визит   –   1,1   года   [диапазон   от   9  FBSS месяцев   до   2.1   года];   Average (±SD) 55.8 (± 11.9) 9 7 (%) 14 (60.9%)Диагноз   Female (%) 15 (65.2%) Diagnosis третий   визит   –   1,3   года   диапазон   от   9   месяцев   до   2.3   года]).   5 6 Pain highest (p < .001) 8 Боль)сейчас)(р<.001)) Pain now (p < .001) Age FBSS (%) 14  (60,9%)   Lumboischialgia (%) В   FBSS  (%)   9 (39.1%) 14 (60.9%) Все   интервалы   отсчитывались   от   предыдущего   визита.   5 Самая)сильная)боль)(р<.001)) Pain highest (p < .001) Average (±SD) 55.8 (± Lumboischialgia (%)11.9) 9 (39.1%) среднем  период  поддержки  составил  3,2  года  [диапазон  1,6  –   7 4 Pain location Pain lowest (p < .001) Люмбоишиалгия  (%)   9  (39,1%)   4 Самая)слабая)боль(р<.001)) Pain location Pain lowest (p < .001) Diagnosis 6,1].   Всем   пациентам   после   обязательных   28   дней   тестового   6 TM Legs Low Back & Bilateral 11 (47.8%) Low Back & Bilateral 11 (47.8%) Локализация   боли   Legs Pain (p now (p < .001) Pain mean (p < .001) 3 3 Pain mean < .001) Боль)в)среднем(р<.001)) периода   были   имплантированы   генераторы   GenesisXP   или   FBSS (%) 14 (60.9%) TM Low Back & Left Leg 7 (30.4%) 5 EonC   (St   Jude   Medical   Neuromodulation   Plano,   2 Pain highest (p < .001) LowDivision,   Back & Left LegTX).   Lumboischialgia Поясница,   бе  ноги   11   47,8%)   (%) 7о(30.4%) 9 ((39.1%) Low Back & Right Leg 3 (13.0%) 2 Для   оценки   результата   были   использованы   следующие   1 4 location Pain lowest (p < .001) Buttock & Right Leg 1 (4.3%) Low(VAS),   Back & а   Right Legже   3Pain Поясница,   л(13.0%) евая   нога   7  (30,4%)   методы:   Визуально-­‐аналоговая   шкала   так   0 Bilateral Leg 1 (4.3%) 1 Low Back & Bilateral Legs 11 (47.8%) 3 Pain mean (p < .001) фиксация     электрофизиологических   параметров.   В   среднем   Baseline Post Operative Follow-up 1 Follow-up 2 Buttock & Right Leg (4.3%) Поясница,  1правая   нога   3  (13,0%)   Начальный)уровень) Постоперационный) Второй)визит) Первый)визит) 7 (30.4%) параметры   стимуляции   были:   Частота:   38,1   Гц  (диапазон  20   –   Low Back & Left Leg осмотр) 5. Would you redo the procedure? Asked post trial and at the different 0 stimulation2 system 2. Number of back surgeries before receiving a spinal cord 4. Lead tip location. Bilateral Leg 1 (4.3%) 1(4,3%)   Right Legправая  нога   3 (13.0%) 70),   Ширина   импульса:   352,9   μс   (диапазон   104   –   494),   Low Back &Ягодица,   follow-up visits. Baseline Post Operative Follow-up 1 Follow-up 2 1 начальная   амплитуда:     5,0   мАмп   (диапазон   –   0,8   –   16,0),   Buttock & Right Leg 1 (4.3%) Обе  ноги   1  (4,3%)   35% 4.3% 4.3% 7.1% 100% 39.1% комфортная   амплитуда   6,5   мАмп   (диапазон   –   1,4   –   17,2),   Bilateral Leg 0 0 1 (4.3%) 19.0% 5. Would you procedure? Asked post trial and at the different 13.0%redo the 90% 30%   2. Number of back surgeries before receiving a spinal cord stimulation system 4. Lead tip location. Baseline Post Operative Follow-up 1 Follow-up 2 Максимальная   амплитуда:   7,6мАмп   (диапазон   –   2,8   –   18,4),   4  Положение  кончика  электрода   80% 5  Прошли  бы    вы  заново  операцию?   2  количество  спинальных  операций  перед  операцией  по   follow-up visits. 70% 25% 1 количество   анодов:  2.0   (диапазон   –   1-­‐5),   количество   катодов:   имплантации  системы  стимуляции   5.60% Would you redo the procedure? Asked post trial and at the different 2. Number of back surgeries before receiving a spinal cord stimulation system 4. Lead20% tip location. 95.7% 50% 92.9% 39.1% 1,3   (диапазон   1-­‐2),   количество   активных   контактов   3,3   follow-up visits. 82.6% 81.0% 13.0% 40% 35% 15% 2 (диапазон   2-­‐7).   13   (52,0%)   контактов   были   использованы   в   4.3% 4.3% 30% 100% 7.1% 39.1% 0 20% 19.0% продольной   «окружающей»   комбинации,   12   (48,0%)   –   10% 35% 13.0% 8.7% 90% 4.3% 4.3% 30%0 7.1% 100% 10% 39.1% 3 0% 8,70%   биполярных   комбинаций,   перекрывающих   боль   пациента   19.0% 5% 13.0% 80% 90% 30% Post Trial (n=23) F-U 1 (n=23) F-U 2 (n=21) F-U 3 (n=14) 80% парестезиями.   2   пациентам   потребовалось   2   набора   0   70% 25% 0% 1 70% 25% Yes Definitely Yes T5 T7 T8 T9 T10 параметров   для   создания   парестезий.   Задокументировано   в   60%Maybe 1 13,00%   39,10%   60% 1   20% среднем   3   (0-­‐15)   случая   повторного   программирования,   в   95.7% 50% 20% 92.9% 39.1% 95.7% 50% 92.9% 39.1% 82.6% 82.6% 81.0% 81.0% 13.0% 13.0% 40% 40% среднем   2   визита   за   курс.   Кроме   того,   во   время   каждого   39,10%   2   2 Summary Acknowledgment & Conclusions 15% 15% 2 30% 30% визита   пациентам   задавали   вопрос,   прошли   бы   вы   заново   20% 10% 20% 8.7% операцию.     3   10% 10% The authors would like to thank Frank De Meutter for his technical support & Prof dr 8.7% 10% 3 0% 5% Dirk De Ridder for his scientific input.

3

Post Trial 0% (n=23) 1. The long term follow-up of these patients shows that sustained pain suppression is obtained with the S-Series leads for the indications of FBSS and Lumboischialgia with (60.9%) or without (39.1%) prior surgery.

5% 0%

0%

T5

T5

T7

T7

T8

T8

T9

T10

T9

F-U 1 (n=23)

Постоперационно) Post Trial

Maybe

T10

F-U 3 (n=14)

1 (n=23)

Визит)2) F-U

2 (n=21)

Визит)3) F-U

3 (n=14)

Definitely Yes References

1

this might be an effect of the initial expectations of the patients about the pain suppression when receiving therapy (partial placebo effect) as well as a change at the

Maybe возможно)

Yes Да)

Definitely Yes Точно)да)

Acknowledgment

D. Logé, S. Vanneste, T. Vancamp. A long term follow-up of 6 patients implanted with a

perc-paddle lead. Poster presented at the INS congress, London, 05/2011.

cortical level over time due to plasticity, of the initial pain reference point. Another explanation might be increased activity. Further investigation of this topic is warranted.

Summary & Conclusions

F-U 2 (n=21)

Визит)1) F-U

Yes

2. An initial better suppression of the pain (post trial average: 76%) is seen compared to the follow-up visits (average: 51%) as has been reported already. The authors think

Summary & Conclusions

(n=23)

2

D. Logé, O. De Coster, S. Washburn. A retrospective data collection to evaluate the

Acknowledgment

feasibility and safety of percutaneous introduction of a narrow paddle lead into the epidural

3. The low number of reprogramming further supports the sustained pain relief as paresthesia stay located in the patients’ pain area.

The authors would like to thank Frank De Meutter for his technical support & Prof dr

4. All patients indicated they would redo the procedure when asked at the different follow-up visits over the course of three years.

Dirk De Ridder for his scientific input.

space. Poster presented at the WIP congress, New York, 03/2009.

1. The long term follow-up of these patients shows that sustained pain suppression is obtained with the S-Series leads for the indications of FBSS and Lumboischialgia with

Disclosure

5. Further observations in larger groups to evaluate sustained paresthesia coverage and pain suppression as found in this series is ongoing.

The authors would like to thank Frank De Meutter for his technical support & Prof dr

(60.9%) or without (39.1%) prior surgery.

   

References

Dirk De Ridder for his scientific input. No financial or editorial support was received for the preparation of this poster. D. Logé is a paid

initial better suppression the pain (post trial average: 76%) is seen the follow-up visits (average: 51%)the as has been reported already.and The Lumboischialgia authors think 1. The long term follow-up2.ofAnthese patients showsofthat sustained pain suppression iscompared obtainedto with the S-Series leads for indications of FBSS with consultant of St. Jude Medical. T. Vancamp is an employee of St. Jude Medical. 1

this might be an effect of the initial expectations of the patients about the pain suppression when receiving therapy (partial placebo effect) as well as a change at the

D. Logé, S. Vanneste, T. Vancamp. A long term follow-up of 6 patients implanted with a


S series 23pt  
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